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Sample records for randomly selected diabetic

  1. Reduced plasma aldosterone concentrations in randomly selected patients with insulin-dependent diabetes mellitus.

    LENUS (Irish Health Repository)

    Cronin, C C

    2012-02-03

    Abnormalities of the renin-angiotensin system have been reported in patients with diabetes mellitus and with diabetic complications. In this study, plasma concentrations of prorenin, renin, and aldosterone were measured in a stratified random sample of 110 insulin-dependent (Type 1) diabetic patients attending our outpatient clinic. Fifty-four age- and sex-matched control subjects were also examined. Plasma prorenin concentration was higher in patients without complications than in control subjects when upright (geometric mean (95% confidence intervals (CI): 75.9 (55.0-105.6) vs 45.1 (31.6-64.3) mU I-1, p < 0.05). There was no difference in plasma prorenin concentration between patients without and with microalbuminuria and between patients without and with background retinopathy. Plasma renin concentration, both when supine and upright, was similar in control subjects, in patients without complications, and in patients with varying degrees of diabetic microangiopathy. Plasma aldosterone was suppressed in patients without complications in comparison to control subjects (74 (58-95) vs 167 (140-199) ng I-1, p < 0.001) and was also suppressed in patients with microvascular disease. Plasma potassium was significantly higher in patients than in control subjects (mean +\\/- standard deviation: 4.10 +\\/- 0.36 vs 3.89 +\\/- 0.26 mmol I-1; p < 0.001) and plasma sodium was significantly lower (138 +\\/- 4 vs 140 +\\/- 2 mmol I-1; p < 0.001). We conclude that plasma prorenin is not a useful early marker for diabetic microvascular disease. Despite apparently normal plasma renin concentrations, plasma aldosterone is suppressed in insulin-dependent diabetic patients.

  2. PONTIAC (NT-proBNP selected prevention of cardiac events in a population of diabetic patients without a history of cardiac disease): a prospective randomized controlled trial.

    Science.gov (United States)

    Huelsmann, Martin; Neuhold, Stephanie; Resl, Michael; Strunk, Guido; Brath, Helmut; Francesconi, Claudia; Adlbrecht, Christopher; Prager, Rudolf; Luger, Anton; Pacher, Richard; Clodi, Martin

    2013-10-08

    The study sought to assess the primary preventive effect of neurohumoral therapy in high-risk diabetic patients selected by N-terminal pro-B-type natriuretic peptide (NT-proBNP). Few clinical trials have successfully demonstrated the prevention of cardiac events in patients with diabetes. One reason for this might be an inaccurate selection of patients. NT-proBNP has not been assessed in this context. A total of 300 patients with type 2 diabetes, elevated NT-proBNP (>125 pg/ml) but free of cardiac disease were randomized. The "control" group was cared for at 4 diabetes care units; the "intensified" group was additionally treated at a cardiac outpatient clinic for the up-titration of renin-angiotensin system (RAS) antagonists and beta-blockers. The primary endpoint was hospitalization/death due to cardiac disease after 2 years. At baseline, the mean age of the patients was 67.5 ± 9 years, duration of diabetes was 15 ± 12 years, 37% were male, HbA1c was 7 ± 1.1%, blood pressure was 151 ± 22 mm Hg, heart rate was 72 ± 11 beats/min, median NT-proBNP was 265.5 pg/ml (interquartile range: 180.8 to 401.8 pg/ml). After 12 months there was a significant difference between the number of patients treated with a RAS antagonist/beta-blocker and the dosage reached between groups (p titration of RAS antagonists and beta-blockers to maximum tolerated dosages is an effective and safe intervention for the primary prevention of cardiac events for diabetic patients pre-selected using NT-proBNP. (Nt-proBNP Guided Primary Prevention of CV Events in Diabetic Patients [PONTIAC]; NCT00562952). Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  3. Blocked Randomization with Randomly Selected Block Sizes

    Directory of Open Access Journals (Sweden)

    Jimmy Efird

    2010-12-01

    Full Text Available When planning a randomized clinical trial, careful consideration must be given to how participants are selected for various arms of a study. Selection and accidental bias may occur when participants are not assigned to study groups with equal probability. A simple random allocation scheme is a process by which each participant has equal likelihood of being assigned to treatment versus referent groups. However, by chance an unequal number of individuals may be assigned to each arm of the study and thus decrease the power to detect statistically significant differences between groups. Block randomization is a commonly used technique in clinical trial design to reduce bias and achieve balance in the allocation of participants to treatment arms, especially when the sample size is small. This method increases the probability that each arm will contain an equal number of individuals by sequencing participant assignments by block. Yet still, the allocation process may be predictable, for example, when the investigator is not blind and the block size is fixed. This paper provides an overview of blocked randomization and illustrates how to avoid selection bias by using random block sizes.

  4. Minimization over randomly selected lines

    Directory of Open Access Journals (Sweden)

    Ismet Sahin

    2013-07-01

    Full Text Available This paper presents a population-based evolutionary optimization method for minimizing a given cost function. The mutation operator of this method selects randomly oriented lines in the cost function domain, constructs quadratic functions interpolating the cost function at three different points over each line, and uses extrema of the quadratics as mutated points. The crossover operator modifies each mutated point based on components of two points in population, instead of one point as is usually performed in other evolutionary algorithms. The stopping criterion of this method depends on the number of almost degenerate quadratics. We demonstrate that the proposed method with these mutation and crossover operations achieves faster and more robust convergence than the well-known Differential Evolution and Particle Swarm algorithms.

  5. High Entropy Random Selection Protocols

    NARCIS (Netherlands)

    H. Buhrman (Harry); M. Christandl (Matthias); M. Koucky (Michal); Z. Lotker (Zvi); B. Patt-Shamir; M. Charikar; K. Jansen; O. Reingold; J. Rolim

    2007-01-01

    textabstractIn this paper, we construct protocols for two parties that do not trust each other, to generate random variables with high Shannon entropy. We improve known bounds for the trade off between the number of rounds, length of communication and the entropy of the outcome.

  6. Selected antibacterial factors in the saliva of diabetic patients.

    Science.gov (United States)

    Malicka, Barbara; Kaczmarek, Urszula; Skośkiewicz-Malinowska, Katarzyna

    2015-03-01

    Diabetes mellitus leads to many systemic complications, including changes in the morphology, function of the salivary glands, and the composition of saliva. The study comprised a randomly selected 156 adults, of both genders, aged from 21 to 79, out of which patients with diabetes type 1 and 2, and healthy subjects forming two control age- and gender matched to the ill subjects. In unstimulated mixed saliva, total protein, peroxidase, myeloperoxidase and immunoglobulin A were measured as well as salivary flow rate. The periodontal condition was assessed with the use of GI, mSBI and PSR index. The obtained data were analysed with the use of U Mann-Whitney's test, Spearman's rang correlation and Chi-square test at a significant level of p diabetics in comparison to healthy age and gender matched control group had a lower salivary flow rate (p diabetics in comparison to control subjects had a higher level of total protein concentration (p diabetes type 1 and 2 can cause abnormalities in salivary glands function resulting in the diminishing of salivary flow rate and the increase in total protein content. Higher levels of myeloperoxidase and IgA in the saliva can be linked to worse periodontal condition in the diabetic patients. Copyright © 2014. Published by Elsevier Ltd.

  7. Distance education and diabetes empowerment: A single-blind randomized control trial.

    Science.gov (United States)

    Zamanzadeh, Vahid; Zirak, Mohammad; Hemmati Maslakpak, Masomeh; Parizad, Naser

    2017-11-01

    Diabetes is one of the biggest problems in healthcare systems and kills many people every year. Diabetes management is impossible when only utilizing medication. So, patients must be educated to manage their diabetes. This study aims to assess the effect of education by telephone and short message service on empowering patients with type 2 diabetes (primary outcome). A single-blind randomized controlled trial was conducted in the Urmia diabetes association in Iran. Sixty six participants with definitive diagnosis of type 2 diabetes entered into the study. Patients with secondary health problems were excluded. Patients were selected by simple random sampling then allocated into intervention (n=33) and control (n=33) groups. The intervention group received an educational text message daily and instructive phone calls three days a week for three months along with usual care. The Diabetes Empowerment Scale (DES) with confirmed validity and reliability was used for collecting data. Data was analyzed using SPSS V6.1. Independent t-test, paired t-test and chi-square were used to analyze the data. The empowerment of the intervention group compared with the control group significantly improved after three months of distance education (p<0.00, EF=1. 16). The study findings show that the distance education has a significant effect on empowering patients with type 2 diabetes. Therefore, using distance education along with other diabetes management intervention is highly effective and should be part of the care in diabetes treatment. Copyright © 2016 Diabetes India. Published by Elsevier Ltd. All rights reserved.

  8. Effectivity of artrihpi irrigation for diabetic ulcer healing: A randomized controlled trial

    Science.gov (United States)

    Gayatri, Dewi; Asmorohadi, Aries; Dahlia, Debie

    2018-02-01

    The healing process of diabetic ulcer is often impeded by inflammation, infection, and decreased immune state. High pressure irrigation (10-15 psi) may be used to control the infection level. This research was designed to identify the effectiveness of artrihpi irrigation device towards diabetic ulcers in public hospitals in the Central Java. This research is a randomized control trial with cross over design. Sixty four subjects were selected using block randomization technique, and were divided into control and intervention group. The intervention was given in 6 days along with wound healing evaluation in every 3 days. The results demonstrated that there was a significant difference decrease scoring healing after treatment, even though the difference scoring healing between both groups was not statistically significant. However, it means difference was found that in the intervention artrihpi the wound healing was better than the spuit. These results illustrates the artrihpi may be solution of using high pressure irrigation to help healing process diabetic ulcers.

  9. 47 CFR 1.1603 - Conduct of random selection.

    Science.gov (United States)

    2010-10-01

    ... 47 Telecommunication 1 2010-10-01 2010-10-01 false Conduct of random selection. 1.1603 Section 1.1603 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL PRACTICE AND PROCEDURE Random Selection Procedures for Mass Media Services General Procedures § 1.1603 Conduct of random selection. The...

  10. 47 CFR 1.1602 - Designation for random selection.

    Science.gov (United States)

    2010-10-01

    ... 47 Telecommunication 1 2010-10-01 2010-10-01 false Designation for random selection. 1.1602 Section 1.1602 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL PRACTICE AND PROCEDURE Random Selection Procedures for Mass Media Services General Procedures § 1.1602 Designation for random selection...

  11. Selected Physical Therapy Modalities for the treatment of Diabetic Polyneuropathy

    International Nuclear Information System (INIS)

    Sawan, S.; Sayed, N.; Al-Gazzar, S.

    2006-01-01

    The purpose of this study was to examine the effect of using selected physical therapy modalities for the treatment of diabetic polyneuropathy. Thirty patients participated in this study. Patients were randomly divided into study group (ten males and five females) and control group (six males and nine females). The study group received interferential current on the lumbosacral region, followed by repeated contraction as specific technique of proprioceptive neuromuscular facilitation (PNF) to the anterior tibial group muscles. The control group did not receive physical therapy treatment. The treatment for the study group was conducted three times per week, for a period of six weeks. The patients were assessed for intensity of pain, manual muscle testing of the anterior tibial group muscles, and the level of superficial sensation on their feet. Patients were assessed the beginning of the treatment session and after the last session. The result of this study showed a significant decrease in the pain intensity, increase anterior tibial group muscles strength and increase level of superficial sensation in patients of study group in comparison to the control group at the end of the treatment. The control group did not show significant changes. It can be concluded that the combination of interferential current and repeated contraction (specific technique of PNF to the anterior tibial group muscles) is effective in decreasing the pain, increasing anterior tibial group muscles strength and the level of superficial sensation in patients suffering from diabetic polyneuropathy. (author)

  12. Personalized Genetic Risk Counseling to Motivate Diabetes Prevention: A randomized trial

    OpenAIRE

    Grant, Richard W.; O’Brien, Kelsey E.; Waxler, Jessica L.; Vassy, Jason L.; Delahanty, Linda M.; Bissett, Laurie G.; Green, Robert C.; Stember, Katherine G.; Guiducci, Candace; Park, Elyse R.; Florez, Jose C.; Meigs, James B.

    2013-01-01

    OBJECTIVE To examine whether diabetes genetic risk testing and counseling can improve diabetes prevention behaviors. RESEARCH DESIGN AND METHODS We conducted a randomized trial of diabetes genetic risk counseling among overweight patients at increased phenotypic risk for type 2 diabetes. Participants were randomly allocated to genetic testing versus no testing. Genetic risk was calculated by summing 36 single nucleotide polymorphisms associated with type 2 diabetes. Participants in the top an...

  13. Testing, Selection, and Implementation of Random Number Generators

    National Research Council Canada - National Science Library

    Collins, Joseph C

    2008-01-01

    An exhaustive evaluation of state-of-the-art random number generators with several well-known suites of tests provides the basis for selection of suitable random number generators for use in stochastic simulations...

  14. Random effect selection in generalised linear models

    DEFF Research Database (Denmark)

    Denwood, Matt; Houe, Hans; Forkman, Björn

    We analysed abattoir recordings of meat inspection codes with possible relevance to onfarm animal welfare in cattle. Random effects logistic regression models were used to describe individual-level data obtained from 461,406 cattle slaughtered in Denmark. Our results demonstrate that the largest...

  15. Interference-aware random beam selection for spectrum sharing systems

    KAUST Repository

    Abdallah, Mohamed M.; Sayed, Mostafa M.; Alouini, Mohamed-Slim; Qaraqe, Khalid A.

    2012-01-01

    . In this paper, we develop interference-aware random beam selection schemes that provide enhanced throughput for the secondary link under the condition that the interference observed at the primary link is within a predetermined acceptable value. For a secondary

  16. A review of randomized controlled trials of medical record powered clinical decision support system to improve quality of diabetes care.

    Science.gov (United States)

    Ali, Syed Mustafa; Giordano, Richard; Lakhani, Saima; Walker, Dawn Marie

    2016-03-01

    A gap between current diabetes care practice and recommended diabetes care standards has consistently been reported in the literature. Many IT-based interventions have been developed to improve adherence to the quality of care standards for chronic illness like diabetes. The widespread implementation of electronic medical/health records has catalyzed clinical decision support systems (CDSS) which may improve the quality of diabetes care. Therefore, the objective of the review is to evaluate the effectiveness of CDSS in improving quality of type II diabetes care. Moreover, the review aims to highlight the key indicators of quality improvement to assist policy makers in development of future diabetes care policies through the integration of information technology and system. Setting inclusion criteria, a systematic literature search was conducted using Medline, Web of Science and Science Direct. Critical Appraisal Skills Programme (CASP) tools were used to evaluate the quality of studies. Eight randomized controlled trials (RCTs) were selected for the review. In the selected studies, seventeen clinical markers of diabetes care were discussed. Three quality of care indicators were given more importance in monitoring the progress of diabetes care, which is consistent with National Institute for Health and Care Excellence (NICE) guidelines. The presence of these indicators in the studies helped to determine which studies were selected for review. Clinical- and process-related improvements are compared between intervention group using CDSS and control group with usual care. Glycated hemoglobin (HbA1c), low density lipid cholesterol (LDL-C) and blood pressure (BP) were the quality of care indicators studied at the levels of process of care and clinical outcome. The review has found both inconsistent and variable results for quality of diabetes care measures. A significant improvement has been found in the process of care for all three measures of quality of diabetes care

  17. Selective plantar fascia release for nonhealing diabetic plantar ulcerations.

    Science.gov (United States)

    Kim, J Young; Hwang, Seungkeun; Lee, Yoonjung

    2012-07-18

    Achilles tendon lengthening can decrease plantar pressures, leading to resolution of forefoot ulceration in patients with diabetes mellitus. However, this procedure has been reported to have a complication rate of 10% to 30% and can require a long period of postoperative immobilization. We have developed a new technique, selective plantar fascia release, as an alternative to Achilles tendon lengthening for managing these forefoot ulcers. We evaluated sixty patients with diabetes for a mean of 23.5 months after selective plantar fascia release for the treatment of nonhealing diabetic neuropathic ulcers in the forefoot. Preoperative and postoperative dorsiflexion range of motion of the affected metatarsophalangeal joint and wound-healing data were used to evaluate the effectiveness of the procedure and to determine the relationship between plantar fascia release and ulcer healing. Complications were recorded. Thirty-six (56%) of the ulcers healed within six weeks, including twenty-nine (60%) of the plantar toe ulcers and seven (44%) of the metatarsophalangeal joint ulcers. The mean range of motion of the affected metatarsophalangeal joint increased from 15.3° ± 7.8° to 30.6° ± 14.1° postoperatively (p plantar fascia release. Our results suggest that selective plantar fascia release can lead to healing of neuropathic plantar forefoot ulcers in diabetic patients. Ulcers in patients in whom the preoperative dorsiflexion angle of the affected metatarsophalangeal joint is between 5° and 30° and in whom the increase in range of motion is ≥13° postoperatively have the greatest chance of being cured. Therapeutic level IV. See Instructions for Authors for a complete description of the levels of evidence.

  18. Selectivity and sparseness in randomly connected balanced networks.

    Directory of Open Access Journals (Sweden)

    Cengiz Pehlevan

    Full Text Available Neurons in sensory cortex show stimulus selectivity and sparse population response, even in cases where no strong functionally specific structure in connectivity can be detected. This raises the question whether selectivity and sparseness can be generated and maintained in randomly connected networks. We consider a recurrent network of excitatory and inhibitory spiking neurons with random connectivity, driven by random projections from an input layer of stimulus selective neurons. In this architecture, the stimulus-to-stimulus and neuron-to-neuron modulation of total synaptic input is weak compared to the mean input. Surprisingly, we show that in the balanced state the network can still support high stimulus selectivity and sparse population response. In the balanced state, strong synapses amplify the variation in synaptic input and recurrent inhibition cancels the mean. Functional specificity in connectivity emerges due to the inhomogeneity caused by the generative statistical rule used to build the network. We further elucidate the mechanism behind and evaluate the effects of model parameters on population sparseness and stimulus selectivity. Network response to mixtures of stimuli is investigated. It is shown that a balanced state with unselective inhibition can be achieved with densely connected input to inhibitory population. Balanced networks exhibit the "paradoxical" effect: an increase in excitatory drive to inhibition leads to decreased inhibitory population firing rate. We compare and contrast selectivity and sparseness generated by the balanced network to randomly connected unbalanced networks. Finally, we discuss our results in light of experiments.

  19. COMPARISON OF ASTYM THERAPY AND KINESIOTAPING FOR ROTATOR CUFF TENDINOPATHY IN DIABETIC PATIENTS: RANDOMIZED CONTROLLED TRIAL

    OpenAIRE

    Azza Atya; Mahmoud Nasser; Aisha Hagag

    2017-01-01

    Background: Rotator cuff tendinopathy is a significant problem among diabetics that frequently restricts patient’s activity in terms of pain and disability. The purpose of this study was to compare between the effect of Astym therapy and kinesiotaping in treating diabetic patients with chronic rotator cuff tendinopathy. Methods: 56 diabetic patients diagnosed with chronic rotator cuff tendinopathy were randomly assigned into Astym therapy group (n=28) or kinesiotaping group (n= 28). All pa...

  20. A Pilot Randomized Trial of Text-Messaging for Symptom Awareness and Diabetes Knowledge in Adolescents With Type 1 Diabetes

    Science.gov (United States)

    Han, Yi; Faulkner, Melissa Spezia; Fritz, Heather; Fadoju, Doris; Muir, Andrew; Abowd, Gregory D.; Head, Lauren; Arriaga, Rosa I.

    2015-01-01

    Adolescents with type 1 diabetes typically receive clinical care every 3 months. Between visits, diabetes-related issues may not be frequently reflected, learned, and documented by the patients, limiting their self-awareness and knowledge about their condition. We designed a text-messaging system to help resolve this problem. In a pilot, randomized controlled trial with 30 adolescents, we examined the effect of text messages about symptom awareness and diabetes knowledge on glucose control and quality of life. The intervention group that received more text messages between visits had significant improvements in quality of life. PMID:25720675

  1. Self-tracking of physical activity in people with type 2 diabetes : a randomized controlled trial

    NARCIS (Netherlands)

    Kooiman, Thea; de Groot, Martijn; Hoogenberg, Klaas; Krijnen, Wim P; van der Schans, Cees P; Kooy, Adriaan

    2018-01-01

    The purpose of this study was to determine the efficacy of an online self-tracking program on physical activity, glycated hemoglobin, and other health measures in patients with type 2 diabetes. Seventy-two patients with type 2 diabetes were randomly assigned to an intervention or control group. All

  2. Integrating CHWs as part of the team leading diabetes group visits: A randomized controlled feasibility study

    Science.gov (United States)

    The purpose of the study was to evaluate the feasibility of integrating Community Health Workers (CHWs) as part of the team leading diabetes group visits. This was a randomized controlled study that integrated CHWs as part of the team leading diabetes group visits for low-income Hispanic adults (n=5...

  3. The signature of positive selection at randomly chosen loci.

    OpenAIRE

    Przeworski, Molly

    2002-01-01

    In Drosophila and humans, there are accumulating examples of loci with a significant excess of high-frequency-derived alleles or high levels of linkage disequilibrium, relative to a neutral model of a random-mating population of constant size. These are features expected after a recent selective sweep. Their prevalence suggests that positive directional selection may be widespread in both species. However, as I show here, these features do not persist long after the sweep ends: The high-frequ...

  4. Comparative Evaluations of Randomly Selected Four Point-of-Care Glucometer Devices in Addis Ababa, Ethiopia.

    Science.gov (United States)

    Wolde, Mistire; Tarekegn, Getahun; Kebede, Tedla

    2018-05-01

    Point-of-care glucometer (PoCG) devices play a significant role in self-monitoring of the blood sugar level, particularly in the follow-up of high blood sugar therapeutic response. The aim of this study was to evaluate blood glucose test results performed with four randomly selected glucometers on diabetes and control subjects versus standard wet chemistry (hexokinase) methods in Addis Ababa, Ethiopia. A prospective cross-sectional study was conducted on randomly selected 200 study participants (100 participants with diabetes and 100 healthy controls). Four randomly selected PoCG devices (CareSens N, DIAVUE Prudential, On Call Extra, i-QARE DS-W) were evaluated against hexokinase method and ISO 15197:2003 and ISO 15197:2013 standards. The minimum and maximum blood sugar values were recorded by CareSens N (21 mg/dl) and hexokinase method (498.8 mg/dl), respectively. The mean sugar values of all PoCG devices except On Call Extra showed significant differences compared with the reference hexokinase method. Meanwhile, all four PoCG devices had strong positive relationship (>80%) with the reference method (hexokinase). On the other hand, none of the four PoCG devices fulfilled the minimum accuracy measurement set by ISO 15197:2003 and ISO 15197:2013 standards. In addition, the linear regression analysis revealed that all four selected PoCG overestimated the glucose concentrations. The overall evaluation of the selected four PoCG measurements were poorly correlated with standard reference method. Therefore, before introducing PoCG devices to the market, there should be a standardized evaluation platform for validation. Further similar large-scale studies on other PoCG devices also need to be undertaken.

  5. The reliability of randomly selected final year pharmacy students in ...

    African Journals Online (AJOL)

    Employing ANOVA, factorial experimental analysis, and the theory of error, reliability studies were conducted on the assessment of the drug product chloroquine phosphate tablets. The G–Study employed equal numbers of the factors for uniform control, and involved three analysts (randomly selected final year Pharmacy ...

  6. Local randomization in neighbor selection improves PRM roadmap quality

    KAUST Repository

    McMahon, Troy

    2012-10-01

    Probabilistic Roadmap Methods (PRMs) are one of the most used classes of motion planning methods. These sampling-based methods generate robot configurations (nodes) and then connect them to form a graph (roadmap) containing representative feasible pathways. A key step in PRM roadmap construction involves identifying a set of candidate neighbors for each node. Traditionally, these candidates are chosen to be the k-closest nodes based on a given distance metric. In this paper, we propose a new neighbor selection policy called LocalRand(k,K\\'), that first computes the K\\' closest nodes to a specified node and then selects k of those nodes at random. Intuitively, LocalRand attempts to benefit from random sampling while maintaining the higher levels of local planner success inherent to selecting more local neighbors. We provide a methodology for selecting the parameters k and K\\'. We perform an experimental comparison which shows that for both rigid and articulated robots, LocalRand results in roadmaps that are better connected than the traditional k-closest policy or a purely random neighbor selection policy. The cost required to achieve these results is shown to be comparable to k-closest. © 2012 IEEE.

  7. Local randomization in neighbor selection improves PRM roadmap quality

    KAUST Repository

    McMahon, Troy; Jacobs, Sam; Boyd, Bryan; Tapia, Lydia; Amato, Nancy M.

    2012-01-01

    Probabilistic Roadmap Methods (PRMs) are one of the most used classes of motion planning methods. These sampling-based methods generate robot configurations (nodes) and then connect them to form a graph (roadmap) containing representative feasible pathways. A key step in PRM roadmap construction involves identifying a set of candidate neighbors for each node. Traditionally, these candidates are chosen to be the k-closest nodes based on a given distance metric. In this paper, we propose a new neighbor selection policy called LocalRand(k,K'), that first computes the K' closest nodes to a specified node and then selects k of those nodes at random. Intuitively, LocalRand attempts to benefit from random sampling while maintaining the higher levels of local planner success inherent to selecting more local neighbors. We provide a methodology for selecting the parameters k and K'. We perform an experimental comparison which shows that for both rigid and articulated robots, LocalRand results in roadmaps that are better connected than the traditional k-closest policy or a purely random neighbor selection policy. The cost required to achieve these results is shown to be comparable to k-closest. © 2012 IEEE.

  8. Completion report : Effect of Comprehensive Yogic Breathing program on type 2 diabetes: A randomized control trial

    Directory of Open Access Journals (Sweden)

    V P Jyotsna

    2014-01-01

    Full Text Available Background: Yoga has been shown to be benefi cial in diabetes in many studies, though randomized control trials are few. The aim of this randomized control trial was to see the effect of Sudarshan Kriya and related practices (comprehensive yogic breathing program on quality of life, glycemic control, and cardiac autonomic functions in diabetes. Diabetes mellitus is a risk factor for sudden cardiac death. Cardiac autonomic neuropathy has been implicated in the causation of sudden cardiac death. Therefore, a maneuver to prevent progression of cardiac autonomic neuropathy holds signifi cance. Materials and Methods: A total of 120 patients of diabetes on oral medication and diet and exercise advice were randomized into two groups: (1 Continued to receive standard treatment for diabetes. (2 Patients administered comprehensive yogic breathing program and monitored to regularly practice yoga in addition to standard treatment of diabetes. At 6 months, quality of life and postprandial plasma glucose signifi cantly improved in the group practicing yoga compared to baseline, but there was no significant improvement in the fasting plasma glucose and glycated hemoglobin. Results: On per protocol analysis, sympathetic cardiac autonomic functions signifi cantly improved from baseline in the group practicing comprehensive yogic breathing. Conclusion: This randomized control trial points towards the beneficial effect of yogic breathing program in preventing progression of cardiac neuropathy. This has important implications as cardiac autonomic neuropathy has been considered as one of the factors for sudden cardiac deaths.Keywords: comprehensive yogic breathing program, diabetes mellitus, cardiac autonomic function

  9. Selection for altruism through random drift in variable size populations

    Directory of Open Access Journals (Sweden)

    Houchmandzadeh Bahram

    2012-05-01

    Full Text Available Abstract Background Altruistic behavior is defined as helping others at a cost to oneself and a lowered fitness. The lower fitness implies that altruists should be selected against, which is in contradiction with their widespread presence is nature. Present models of selection for altruism (kin or multilevel show that altruistic behaviors can have ‘hidden’ advantages if the ‘common good’ produced by altruists is restricted to some related or unrelated groups. These models are mostly deterministic, or assume a frequency dependent fitness. Results Evolutionary dynamics is a competition between deterministic selection pressure and stochastic events due to random sampling from one generation to the next. We show here that an altruistic allele extending the carrying capacity of the habitat can win by increasing the random drift of “selfish” alleles. In other terms, the fixation probability of altruistic genes can be higher than those of a selfish ones, even though altruists have a smaller fitness. Moreover when populations are geographically structured, the altruists advantage can be highly amplified and the fixation probability of selfish genes can tend toward zero. The above results are obtained both by numerical and analytical calculations. Analytical results are obtained in the limit of large populations. Conclusions The theory we present does not involve kin or multilevel selection, but is based on the existence of random drift in variable size populations. The model is a generalization of the original Fisher-Wright and Moran models where the carrying capacity depends on the number of altruists.

  10. Prevention of diabetic nephropathy by compound 21, selective agonist of angiotensin type 2 receptors, in Zucker diabetic fatty rats

    DEFF Research Database (Denmark)

    Castoldi, Giovanna; di Gioia, Cira Rt; Bombardi, Camila

    2014-01-01

    Aim of the study was to evaluate the effect of compound 21 (C21), selective AT2 receptor agonist, in diabetic nephropathy and the potential additive effect of C21, when associated to losartan treatment, on the development of albuminuria and renal fibrosis in Zucker diabetic fatty (ZDF) rats. The ...

  11. Diminished performance on response-selection tasks in type-2 diabetes

    NARCIS (Netherlands)

    H.A. Keizer; P.C. Groot; J.J. Adam; dr. Lars B. Borghouts

    2003-01-01

    Comparisons of visual perception, response-selection, and response-execution performance were made between Type 2 diabetes mellitus patients and a matched nondiabetic control group. 10 well-controlled male patients with Type 2 diabetes without diabetic complications (M age 58 yr.) and an age and

  12. Cinnamon Bark, Water Soluble Cinnamon Extract, and Metformin as Initial Treatment for Type 2 Diabetes Mellitus: A Randomized, Controlled Trial

    Science.gov (United States)

    2016-12-14

    Cinnamon Extract, and Metformin as Initial Treatment for Type 2 Diabetes Mellitus : A Randomized, Controlled Trial. Paul Crawford, MD Clinical Investigation...Title: “Cinnamon Bark, Water-Soluble Cinnamon Extract, and Metformin as Initial Treatment for Type 2 Diabetes Mellitus : A Randomized, Controlled...as initial treatment for Type 2 diabetes mellitus : A randomized, controlled trial. IRB #: FWH20110004H Principal Investigator (PI) Rank / Civ

  13. A Randomized Controlled Trial Comparing Telemedical and Standard Outpatient Monitoring of Diabetic Foot Ulcers

    DEFF Research Database (Denmark)

    Rasmussen, Benjamin S B; Froekjaer, Johnny; Bjerregaard, Mads R

    2015-01-01

    OBJECTIVE: The role of telemedical monitoring in diabetic foot ulcer care is still uncertain. Our aim was to compare telemedical and standard outpatient monitoring in the care of patients with diabetic foot ulcers in a randomized controlled trial. RESEARCH DESIGN AND METHODS: Of the 736 screened...... individuals with diabetic foot ulcers, 401 met the eligibility criteria and were randomized between October 2010 and November 2014. The per-protocol telemedical monitoring consisted of two consultations in the patient's own home and one consultation at the outpatient clinic. Standard practice consisted...... monitoring, a higher mortality throws into question the role of telemedicine in monitoring diabetic foot ulcers. Further studies are needed to investigate effects of telemedicine on mortality and other clinical outcomes and to identify patient subgroups that may have a poorer outcome through telemedical...

  14. A modified scintigrafic technique for amputation level selection in diabetics

    International Nuclear Information System (INIS)

    Dwars, B.J.; Rauwerda, J.A.; Broek, T.A.A. van den; Rij, G.L. van; Hollander, W. den; Heidendal, G.A.K.

    1989-01-01

    A modified 123 I-antipyrine cutaneous washout technique for the selection of amputation levels is described. The modifications imply a reduction of time needed for the examination by simultaneous recordings on different levels, and a better patient acceptance by reducing inconvenience. Furthermore, both skin perfusion pressure (SPP) and skin blood flow (SBF) are determined from each clearance curve. In a prospective study among 26 diabetic patients presenting with ulcers or gangrene of the foot, both SPP and SBF were determined preoperatively on the selected level of surgery and on adjacent amputation sites. These 26 patients underwent 12 minor foot amputations and 17 major lower limb amputations. Two of these amputations failed to heal. SBF values appeared indicative for the degree of peripheral vascular disease, as low SBF values were found with low SPP values. SPP determinations revealed good predictive values: All surgical procedures healed when SPP>20 mmHg, but 2 out of 3 failed when SPP<2 mmHg. If SPP values would have been decisive, the amputation would have been converted to a lower level in 6 out of 17 cases. This modified scintigrafic technique provides accurate objective information for amputation level selection. (orig.)

  15. Modified scintigrafic technique for amputation level selection in diabetics

    Energy Technology Data Exchange (ETDEWEB)

    Dwars, B.J.; Rauwerda, J.A.; Broek, T.A.A. van den; Rij, G.L. van; Hollander, W. den; Heidendal, G.A.K.

    1989-01-01

    A modified /sup 123/I-antipyrine cutaneous washout technique for the selection of amputation levels is described. The modifications imply a reduction of time needed for the examination by simultaneous recordings on different levels, and a better patient acceptance by reducing inconvenience. Furthermore, both skin perfusion pressure (SPP) and skin blood flow (SBF) are determined from each clearance curve. In a prospective study among 26 diabetic patients presenting with ulcers or gangrene of the foot, both SPP and SBF were determined preoperatively on the selected level of surgery and on adjacent amputation sites. These 26 patients underwent 12 minor foot amputations and 17 major lower limb amputations. Two of these amputations failed to heal. SBF values appeared indicative for the degree of peripheral vascular disease, as low SBF values were found with low SPP values. SPP determinations revealed good predictive values: All surgical procedures healed when SPP>20 mmHg, but 2 out of 3 failed when SPP<2 mmHg. If SPP values would have been decisive, the amputation would have been converted to a lower level in 6 out of 17 cases. This modified scintigrafic technique provides accurate objective information for amputation level selection.

  16. Interference-aware random beam selection for spectrum sharing systems

    KAUST Repository

    Abdallah, Mohamed M.

    2012-09-01

    Spectrum sharing systems have been introduced to alleviate the problem of spectrum scarcity by allowing secondary unlicensed networks to share the spectrum with primary licensed networks under acceptable interference levels to the primary users. In this paper, we develop interference-aware random beam selection schemes that provide enhanced throughput for the secondary link under the condition that the interference observed at the primary link is within a predetermined acceptable value. For a secondary transmitter equipped with multiple antennas, our schemes select a random beam, among a set of power- optimized orthogonal random beams, that maximizes the capacity of the secondary link while satisfying the interference constraint at the primary receiver for different levels of feedback information describing the interference level at the primary receiver. For the proposed schemes, we develop a statistical analysis for the signal-to-noise and interference ratio (SINR) statistics as well as the capacity of the secondary link. Finally, we present numerical results that study the effect of system parameters including number of beams and the maximum transmission power on the capacity of the secondary link attained using the proposed schemes. © 2012 IEEE.

  17. Phyto-metals screening of selected anti-diabetic herbs and infused concoctions

    OpenAIRE

    Olanrewaju O. Olujimi; Olusegun N. Onifade; Adeleke T. Towolawi; Temilade F. Akinhanmi; Adeniyi A. Afolabi; Kabir A. Olanite

    2017-01-01

    Objective: To determine the levels of some selected heavy metals in both the selected anti-diabetic herbal plants and infused concoctions for diabetes treatment. Methods: Ten anti-diabetic plant samples: pawpaw leaves (Carica papaya), bitter melon leaves (Momordica charantia), holy basil leaves (Ocimum sanctum), bitter leaf (Vernonia amygdalina), ginger rhizome (Zingiber officinale), garlic (Allium sativum), African red pepper fruits (Capsicum frutescens), negro pepper grain (Xylopia aethi...

  18. Design of a randomized trial of diabetes genetic risk testing to motivate behavior change: the Genetic Counseling/lifestyle Change (GC/LC) Study for Diabetes Prevention.

    Science.gov (United States)

    Grant, Richard W; Meigs, James B; Florez, Jose C; Park, Elyse R; Green, Robert C; Waxler, Jessica L; Delahanty, Linda M; O'Brien, Kelsey E

    2011-10-01

    The efficacy of diabetes genetic risk testing to motivate behavior change for diabetes prevention is currently unknown. This paper presents key issues in the design and implementation of one of the first randomized trials (The Genetic Counseling/Lifestyle Change (GC/LC) Study for Diabetes Prevention) to test whether knowledge of diabetes genetic risk can motivate patients to adopt healthier behaviors. Because individuals may react differently to receiving 'higher' vs 'lower' genetic risk results, we designed a 3-arm parallel group study to separately test the hypotheses that: (1) patients receiving 'higher' diabetes genetic risk results will increase healthy behaviors compared to untested controls, and (2) patients receiving 'lower' diabetes genetic risk results will decrease healthy behaviors compared to untested controls. In this paper we describe several challenges to implementing this study, including: (1) the application of a novel diabetes risk score derived from genetic epidemiology studies to a clinical population, (2) the use of the principle of Mendelian randomization to efficiently exclude 'average' diabetes genetic risk patients from the intervention, and (3) the development of a diabetes genetic risk counseling intervention that maintained the ethical need to motivate behavior change in both 'higher' and 'lower' diabetes genetic risk result recipients. Diabetes genetic risk scores were developed by aggregating the results of 36 diabetes-associated single nucleotide polymorphisms. Relative risk for type 2 diabetes was calculated using Framingham Offspring Study outcomes, grouped by quartiles into 'higher', 'average' (middle two quartiles) and 'lower' genetic risk. From these relative risks, revised absolute risks were estimated using the overall absolute risk for the study group. For study efficiency, we excluded all patients receiving 'average' diabetes risk results from the subsequent intervention. This post-randomization allocation strategy was

  19. Randomized trial of a diabetes self-management education and family teamwork intervention in adolescents with Type1 diabetes

    DEFF Research Database (Denmark)

    Murphy, H. R.; Wadham, C.; Hassler-Hurst, J.

    2012-01-01

    Aims To evaluate the effectiveness of a family-centred group education programme, in adolescents with Type1 diabetes. Methods Three hundred and five adolescents with Type1 diabetes; age 13.1±1.9years, diabetes duration 5.6±3.3years, BMI 20.9±3.7kg/m 2, HbA 1c 78±6mmol/mol (9.3±1.9%) were randomly...... attendance of group education sessions delivered in routine clinics was a major challenge. More personalized educational approaches may be required to support and motivate families who are struggling to integrate the demands of intensive insulin regimens into their daily lives....

  20. The Diabetes Telephone Study: Design and challenges of a pragmatic cluster randomized trial to improve diabetic peripheral neuropathy treatment.

    Science.gov (United States)

    Adams, Alyce S; Bayliss, Elizabeth A; Schmittdiel, Julie A; Altschuler, Andrea; Dyer, Wendy; Neugebauer, Romain; Jaffe, Marc; Young, Joseph D; Kim, Eileen; Grant, Richard W

    2016-06-01

    Challenges to effective pharmacologic management of symptomatic diabetic peripheral neuropathy include the limited effectiveness of available medicines, frequent side effects, and the need for ongoing symptom assessment and treatment titration for maximal effectiveness. We present here the rationale and implementation challenges of the Diabetes Telephone Study, a randomized trial designed to improve medication treatment, titration, and quality of life among patients with symptomatic diabetic peripheral neuropathy. We implemented a pragmatic cluster randomized controlled trial to test the effectiveness of an automated interactive voice response tool designed to provide physicians with real-time patient-reported data about responses to newly prescribed diabetic peripheral neuropathy medicines. A total of 1834 primary care physicians treating patients in the diabetes registry at Kaiser Permanente Northern California were randomized into the intervention or control arm. In September 2014, we began identification and recruitment of patients assigned to physicians in the intervention group who receive three brief interactive calls every 2 months after a medication is prescribed to alleviate diabetic peripheral neuropathy symptoms. These calls provide patients with the opportunity to report on symptoms, side effects, self-titration of medication dose and overall satisfaction with treatment. We plan to compare changes in self-reported quality of life between the intervention group and patients in the control group who receive three non-interactive automated educational phone calls. Successful implementation of this clinical trial required robust stakeholder engagement to help tailor the intervention and to address pragmatic concerns such as provider time constraints. As of 27 October 2015, we had screened 2078 patients, 1447 of whom were eligible for participation. We consented and enrolled 1206 or 83% of those eligible. Among those enrolled, 53% are women and the mean age

  1. A preliminary study of levels of selected nutrients for neonates born to diabetic and non-diabetic mothers in Bangladesh

    International Nuclear Information System (INIS)

    Alam, A.M.S.; Chhowdhury, S.A.; Rahman, M.A.; Ali, S.M.K.; Huda, A.S.N.

    2006-01-01

    To investigate some selected nutrients status in the neonates born to diabetic and non-diabetic mothers a prospective study was carried out. From the Obstetric Unit of Bangladesh Institute of Rehabilitation in Diabetes, Endocrine and Metabolic disorder (BIRDEM) Hospital, Dhaka, Bangladesh, 236 newborns were recruited; 74 from diabetic, 59 from gestational diabetic and 103 from non-diabetic mothers group for this study. Cord-serum levels of Cu, Zn, Fe, Mg, Ca and ascorbic acid were investigated, and some anthropometric measurements were recorded to correlate with the nutrient levels. Fe was found significantly higher (p<0.05) whereas, ascorbic acid was found significantly lower (p<0.05) in diabetic group compared with other two groups. However, Mg and Ca levels were found significantly higher (p<0.05) in non-diabetic group. There was no significant difference observed in Cu, Zn levels for the 3 groups. Ca level was significantly correlated with birth weight and length of the neonates. These data suggests that diabetes has some effects on fetal growth and its nutritional status that also reflect the socio-economical status of the families of the neonates. (author)

  2. Random selection of items. Selection of n1 samples among N items composing a stratum

    International Nuclear Information System (INIS)

    Jaech, J.L.; Lemaire, R.J.

    1987-02-01

    STR-224 provides generalized procedures to determine required sample sizes, for instance in the course of a Physical Inventory Verification at Bulk Handling Facilities. The present report describes procedures to generate random numbers and select groups of items to be verified in a given stratum through each of the measurement methods involved in the verification. (author). 3 refs

  3. The signature of positive selection at randomly chosen loci.

    Science.gov (United States)

    Przeworski, Molly

    2002-03-01

    In Drosophila and humans, there are accumulating examples of loci with a significant excess of high-frequency-derived alleles or high levels of linkage disequilibrium, relative to a neutral model of a random-mating population of constant size. These are features expected after a recent selective sweep. Their prevalence suggests that positive directional selection may be widespread in both species. However, as I show here, these features do not persist long after the sweep ends: The high-frequency alleles drift to fixation and no longer contribute to polymorphism, while linkage disequilibrium is broken down by recombination. As a result, loci chosen without independent evidence of recent selection are not expected to exhibit either of these features, even if they have been affected by numerous sweeps in their genealogical history. How then can we explain the patterns in the data? One possibility is population structure, with unequal sampling from different subpopulations. Alternatively, positive selection may not operate as is commonly modeled. In particular, the rate of fixation of advantageous mutations may have increased in the recent past.

  4. A Bayesian random effects discrete-choice model for resource selection: Population-level selection inference

    Science.gov (United States)

    Thomas, D.L.; Johnson, D.; Griffith, B.

    2006-01-01

    Modeling the probability of use of land units characterized by discrete and continuous measures, we present a Bayesian random-effects model to assess resource selection. This model provides simultaneous estimation of both individual- and population-level selection. Deviance information criterion (DIC), a Bayesian alternative to AIC that is sample-size specific, is used for model selection. Aerial radiolocation data from 76 adult female caribou (Rangifer tarandus) and calf pairs during 1 year on an Arctic coastal plain calving ground were used to illustrate models and assess population-level selection of landscape attributes, as well as individual heterogeneity of selection. Landscape attributes included elevation, NDVI (a measure of forage greenness), and land cover-type classification. Results from the first of a 2-stage model-selection procedure indicated that there is substantial heterogeneity among cow-calf pairs with respect to selection of the landscape attributes. In the second stage, selection of models with heterogeneity included indicated that at the population-level, NDVI and land cover class were significant attributes for selection of different landscapes by pairs on the calving ground. Population-level selection coefficients indicate that the pairs generally select landscapes with higher levels of NDVI, but the relationship is quadratic. The highest rate of selection occurs at values of NDVI less than the maximum observed. Results for land cover-class selections coefficients indicate that wet sedge, moist sedge, herbaceous tussock tundra, and shrub tussock tundra are selected at approximately the same rate, while alpine and sparsely vegetated landscapes are selected at a lower rate. Furthermore, the variability in selection by individual caribou for moist sedge and sparsely vegetated landscapes is large relative to the variability in selection of other land cover types. The example analysis illustrates that, while sometimes computationally intense, a

  5. Selection bias and subject refusal in a cluster-randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Rochelle Yang

    2017-07-01

    Full Text Available Abstract Background Selection bias and non-participation bias are major methodological concerns which impact external validity. Cluster-randomized controlled trials are especially prone to selection bias as it is impractical to blind clusters to their allocation into intervention or control. This study assessed the impact of selection bias in a large cluster-randomized controlled trial. Methods The Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care (ICARE study examined the impact of a remote pharmacist-led intervention in twelve medical offices. To assess eligibility, a standardized form containing patient demographics and medical information was completed for each screened patient. Eligible patients were approached by the study coordinator for recruitment. Both the study coordinator and the patient were aware of the site’s allocation prior to consent. Patients who consented or declined to participate were compared across control and intervention arms for differing characteristics. Statistical significance was determined using a two-tailed, equal variance t-test and a chi-square test with adjusted Bonferroni p-values. Results were adjusted for random cluster variation. Results There were 2749 completed screening forms returned to research staff with 461 subjects who had either consented or declined participation. Patients with poorly controlled diabetes were found to be significantly more likely to decline participation in intervention sites compared to those in control sites. A higher mean diastolic blood pressure was seen in patients with uncontrolled hypertension who declined in the control sites compared to those who declined in the intervention sites. However, these findings were no longer significant after adjustment for random variation among the sites. After this adjustment, females were now found to be significantly more likely to consent than males (odds ratio = 1.41; 95% confidence interval = 1.03, 1

  6. Antioxidant effects of curcuminoids in patients with type 2 diabetes mellitus: a randomized controlled trial.

    Science.gov (United States)

    Panahi, Yunes; Khalili, Nahid; Sahebi, Ebrahim; Namazi, Soha; Karimian, Maryam Saberi; Majeed, Muhammed; Sahebkar, Amirhossein

    2017-02-01

    Oxidative stress has a key role in the pathogenesis of type II diabetes mellitus (T2DM) and its vascular complications. Antioxidant therapy has been suggested as a potential approach to blunt T2DM development and progression. The aim of this study was to assess the effects of supplementation with curcuminoids, which are natural polyphenolics from turmeric, on oxidative indices in diabetic individuals. In this randomized double-blind placebo-controlled trial, 118 subjects with T2DM were randomized to curcuminoids (1000 mg/day co-administered with piperine 10 mg/day) or matching placebo for a period of 8 weeks. Serum total antioxidant capacity, superoxide dismutase (SOD) activities and malondialdehyde (MDA) concentrations were measured at baseline and after the supplementation period. Curcuminoids supplementation caused a significant elevation in serum total antioxidant capacity (TAC) (p diabetic complications and cardiovascular endpoints.

  7. Topical propolis improves wound healing in patients with diabetic foot ulcer: a randomized controlled trial.

    Science.gov (United States)

    Afkhamizadeh, Mozhgan; Aboutorabi, Robab; Ravari, Hassan; Fathi Najafi, Mohsen; Ataei Azimi, Sajad; Javadian Langaroodi, Adineh; Yaghoubi, Mohammad Ali; Sahebkar, Amirhossein

    2017-08-22

    In this randomized controlled trial, diabetic patients with foot ulcers (Wagner grades 1 and 2) were randomly assigned to conventional therapies for diabetic foot ulcer plus topical propolis ointment (5%; twice daily) or conventional therapies alone. The process of ulcer healing was observed during 4 weeks and compared between the two groups regarding the size, erythema, exudates, white blood cell (WBC) count and erythrocyte sedimentation rate (ESR). The process of ulcer size reduction during the four-week period of study was significantly different between the groups. However, this difference was not significant between the third and fourth weeks. There was no significant difference between two groups regarding erythema and exudate reduction as well as WBC count and ESR. Administration of topical propolis ointment in addition to the conventional treatments of diabetic foot ulcer could reduce the size of ulcers with Wagner grades 1 and 2.

  8. Metformin Treatment in Type 2 Diabetes in Pregnancy: An Active Controlled, Parallel-Group, Randomized, Open Label Study in Patients with Type 2 Diabetes in Pregnancy

    Directory of Open Access Journals (Sweden)

    Jahan Ara Ainuddin

    2015-01-01

    Full Text Available Aims. To assess the effect of metformin and to compare it with insulin treatment in patients with type 2 diabetes in pregnancy in terms of perinatal outcome, maternal complications, additional insulin requirement, and treatment acceptability. Methods. In this randomized, open label study, 206 patients with type 2 diabetes in pregnancy who met the eligibility criteria were selected from the antenatal clinics. Insulin was added to metformin treatment when required, to maintain the target glycemic control. The patients were followed up till delivery. Maternal, and perinatal outcomes and pharmacotherapeutic characteristics were recorded on a proforma. Results. Maternal characteristics were comparable in metformin and insulin treated group. 84.9% patients in metformin group required add-on insulin therapy at mean gestational age of 26.58 ± 3.85 weeks. Less maternal weight gain (P24 hours in metformin group (P<0.01. Significant reduction in cost of treatment was found in metformin group. Conclusion. Metformin alone or with add-on insulin is an effective and cheap treatment option for patients with type 2 diabetes in pregnancy. This trial is registered with clinical trial registration number: Clinical trials.gov NCT01855763.

  9. Metformin treatment in type 2 diabetes in pregnancy: an active controlled, parallel-group, randomized, open label study in patients with type 2 diabetes in pregnancy.

    Science.gov (United States)

    Ainuddin, Jahan Ara; Karim, Nasim; Zaheer, Sidra; Ali, Syed Sanwer; Hasan, Anjum Ara

    2015-01-01

    To assess the effect of metformin and to compare it with insulin treatment in patients with type 2 diabetes in pregnancy in terms of perinatal outcome, maternal complications, additional insulin requirement, and treatment acceptability. In this randomized, open label study, 206 patients with type 2 diabetes in pregnancy who met the eligibility criteria were selected from the antenatal clinics. Insulin was added to metformin treatment when required, to maintain the target glycemic control. The patients were followed up till delivery. Maternal, and perinatal outcomes and pharmacotherapeutic characteristics were recorded on a proforma. Maternal characteristics were comparable in metformin and insulin treated group. 84.9% patients in metformin group required add-on insulin therapy at mean gestational age of 26.58 ± 3.85 weeks. Less maternal weight gain (P pregnancy induced hypertension (P = 0.029) were observed in metformin treated group. Small for date babies were more in metformin group (P 24 hours in metformin group (P metformin group. Metformin alone or with add-on insulin is an effective and cheap treatment option for patients with type 2 diabetes in pregnancy. This trial is registered with clinical trial registration number: Clinical trials.gov NCT01855763.

  10. Home-based diabetes self-management coaching delivered by paraprofessionals: A randomized controlled trial.

    Science.gov (United States)

    Pauley, Tim; Gargaro, Judith; Chenard, Glen; Cavanagh, Helen; McKay, Sandra M

    2016-01-01

    This study evaluated paraprofessional-led diabetes self-management coaching (DSMC) among 94 clients with type 2 diabetes recruited from a Community Care Access Centre in Ontario, Canada. Subjects were randomized to standard care or standard care plus coaching. Measures included the Diabetes Self-Efficacy Scale (DSES), Insulin Management Diabetes Self-Efficacy Scale (IMDSES), and Hospital Anxiety and Depression Scale (HADS). Both groups showed improvement in DSES (6.6 + 1.5 vs. 7.2 + 1.5, p  .05 for all) or depression scores (p > .05 for all), or anxiety (p > .05 for all) or depression (p > .05 for all) categories at baseline, postintervention, or follow-up. While all subjects demonstrated significant improvements in self-efficacy measures, there is no evidence to support paraprofessional-led DSMC as an intervention which conveys additional benefits over standard care.

  11. Cluster randomized controlled trial of a peer support program for people with diabetes

    DEFF Research Database (Denmark)

    Riddell, Michaela A; Renwick, Carla; Wolfe, Rory

    2012-01-01

    ABSTRACT: BACKGROUND: Well managed diabetes requires active self-management in order to ensure optimal glycaemic control and appropriate use of available clinical services and other supports. Peer supporters can assist people with their daily diabetes self-management activities, provide emotional...... and social support, assist and encourage clinical care and be available when needed. METHODS: A national database of Australians diagnosed with type 2 diabetes is being used to invite people in pre-determined locations to participate in community-based peer support groups. Peer supporters are self......-identified from these communities. All consenting participants receive diabetes self-management education and education manual prior to randomization by community to a peer support intervention or usual care. This multi-faceted intervention comprises four interconnected components for delivering support...

  12. A Mendelian Randomization Study of Circulating Uric Acid and Type 2 Diabetes

    NARCIS (Netherlands)

    Sluijs, Ivonne; Holmes, Michael V.; van der Schouw, Yvonne T.; Beulens, Joline W J; Asselbergs, Folkert W.; Huerta, José María; Palmer, Tom M.; Arriola, Larraitz; Balkau, Beverley; Barricarte, Aurelio; Boeing, Heiner; Clavel-Chapelon, Françoise; Fagherazzi, Guy; Franks, Paul W.; Gavrila, Diana; Kaaks, Rudolf; Khaw, Kay T ee; Kühn, Tilman; Molina-Montes, Esther; Mortensen, Lotte M axild; Nilsson, Peter M.; Overvad, Kim; Palli, Domenico; Panico, Salvatore; Quirós, J. Ramón; Rolandsson, Olov; Sacerdote, Carlotta; Sala, Núria; Schmidt, Julie A.; Scott, Robert A.; Sieri, Sabina; Slimani, Nadia; Spijkerman, Annemieke M W; Tjonneland, Anne; Travis, Ruth C.; Tumino, Rosario; van der A, Daphne L.; Sharp, Stephen J.; Forouhi, Nita G.; Langenberg, Claudia; Riboli, Elio; Wareham, Nicholas J.

    2015-01-01

    We aimed to investigate the causal effect of circulating uric acid concentrations on type 2 diabetes risk. A Mendelian randomization study was performed using a genetic score with 24 uric acid-associated loci. We used data of the European Prospective Investigation into Cancer and Nutrition

  13. Aerobic exercise in obese diabetic patients with chronic kidney disease: a randomized and controlled pilot study

    Directory of Open Access Journals (Sweden)

    Cooper Cheryl

    2009-12-01

    Full Text Available Abstract Background Patients with obesity, diabetes, and chronic kidney disease (CKD are generally physically inactive, have a high mortality rate, and may benefit from an exercise program. Methods We performed a 24-week randomized controlled feasibility study comparing aerobic exercise plus optimal medical management to medical management alone in patients with type 2 diabetes, obesity (body mass index [BMI] > 30 kg/m2, and stage 2-4 CKD (estimated glomerular filtration rate [eGFR] 15-90 mL/min/1.73 m2 with persistent proteinuria. Subjects randomized to exercise underwent thrice weekly aerobic training for 6 followed by 18 weeks of supervised home exercise. The primary outcome variable was change in proteinuria. Results Seven subjects randomized to exercise and 4 control subjects completed the study. Exercise training resulted in an increase in exercise duration during treadmill testing, which was accompanied by slight but insignificant decreases in resting systolic blood pressure and 24-hour proteinuria. Exercise did not alter GFR, hemoglobin, glycated hemoglobin, serum lipids, or C-reactive protein (CRP. Caloric intake and body weight and composition also did not change with exercise training. Conclusion Exercise training in obese diabetic patients with CKD is feasible and may have clinical benefits. A large-scale randomized controlled trial to determine the effects of exercise on renal functions, cardiovascular fitness, inflammation, and oxidative stress in diabetic patients with CKD is planned.

  14. Community-based peer-led diabetes self-management: a randomized trial.

    Science.gov (United States)

    Lorig, Kate; Ritter, Philip L; Villa, Frank J; Armas, Jean

    2009-01-01

    The purpose of this study is to determine the effectiveness of a community-based diabetes self-management program comparing treatment participants to a randomized usual-care control group at 6 months. A total of 345 adults with type 2 diabetes but no criteria for high A1C were randomized to a usual-care control group or 6-week community-based, peer-led diabetes self-management program (DSMP). Randomized participants were compared at 6 months. The DSMP intervention participants were followed for an additional 6 months (12 months total). A1C and body mass index were measured at baseline, 6 months, and 12 months. All other data were collected by self-administered questionnaires. At 6 months, DSMP participants did not demonstrate improvements in A1C as compared with controls. Baseline A1C was much lower than in similar trials. Participants did have significant improvements in depression, symptoms of hypoglycemia, communication with physicians, healthy eating, and reading food labels (P < .01). They also had significant improvements in patient activation and self-efficacy. At 12 months, DSMP intervention participants continued to demonstrate improvements in depression, communication with physicians, healthy eating, patient activation, and self-efficacy (P < .01). There were no significant changes in utilization measures. These findings suggest that people with diabetes without elevated A1C can benefit from a community-based, peer-led diabetes program. Given the large number of people with diabetes and lack of low-cost diabetes education, the DSMP deserves consideration for implementation.

  15. Blind Measurement Selection: A Random Matrix Theory Approach

    KAUST Repository

    Elkhalil, Khalil

    2016-12-14

    This paper considers the problem of selecting a set of $k$ measurements from $n$ available sensor observations. The selected measurements should minimize a certain error function assessing the error in estimating a certain $m$ dimensional parameter vector. The exhaustive search inspecting each of the $n\\\\choose k$ possible choices would require a very high computational complexity and as such is not practical for large $n$ and $k$. Alternative methods with low complexity have recently been investigated but their main drawbacks are that 1) they require perfect knowledge of the measurement matrix and 2) they need to be applied at the pace of change of the measurement matrix. To overcome these issues, we consider the asymptotic regime in which $k$, $n$ and $m$ grow large at the same pace. Tools from random matrix theory are then used to approximate in closed-form the most important error measures that are commonly used. The asymptotic approximations are then leveraged to select properly $k$ measurements exhibiting low values for the asymptotic error measures. Two heuristic algorithms are proposed: the first one merely consists in applying the convex optimization artifice to the asymptotic error measure. The second algorithm is a low-complexity greedy algorithm that attempts to look for a sufficiently good solution for the original minimization problem. The greedy algorithm can be applied to both the exact and the asymptotic error measures and can be thus implemented in blind and channel-aware fashions. We present two potential applications where the proposed algorithms can be used, namely antenna selection for uplink transmissions in large scale multi-user systems and sensor selection for wireless sensor networks. Numerical results are also presented and sustain the efficiency of the proposed blind methods in reaching the performances of channel-aware algorithms.

  16. Hypoglycemia in type 1 diabetic pregnancy: role of preconception insulin aspart treatment in a randomized study

    DEFF Research Database (Denmark)

    Heller, Simon; Damm, Peter; Mersebach, Henriette

    2010-01-01

    OBJECTIVE A recent randomized trial compared prandial insulin aspart (IAsp) with human insulin in type 1 diabetic pregnancy. The aim of this exploratory analysis was to investigate the incidence of severe hypoglycemia during pregnancy and compare women enrolled preconception with women enrolled...... during early pregnancy. RESEARCH DESIGN AND METHODS IAsp administered immediately before each meal was compared with human insulin administered 30 min before each meal in 99 subjects (44 to IAsp and 55 to human insulin) randomly assigned preconception and in 223 subjects (113 for IAsp and 110 for human...... insulin) randomly assigned in early pregnancy (...

  17. Materials selection for oxide-based resistive random access memories

    International Nuclear Information System (INIS)

    Guo, Yuzheng; Robertson, John

    2014-01-01

    The energies of atomic processes in resistive random access memories (RRAMs) are calculated for four typical oxides, HfO 2 , TiO 2 , Ta 2 O 5 , and Al 2 O 3 , to define a materials selection process. O vacancies have the lowest defect formation energy in the O-poor limit and dominate the processes. A band diagram defines the operating Fermi energy and O chemical potential range. It is shown how the scavenger metal can be used to vary the O vacancy formation energy, via controlling the O chemical potential, and the mean Fermi energy. The high endurance of Ta 2 O 5 RRAM is related to its more stable amorphous phase and the adaptive lattice rearrangements of its O vacancy

  18. Primitive polynomials selection method for pseudo-random number generator

    Science.gov (United States)

    Anikin, I. V.; Alnajjar, Kh

    2018-01-01

    In this paper we suggested the method for primitive polynomials selection of special type. This kind of polynomials can be efficiently used as a characteristic polynomials for linear feedback shift registers in pseudo-random number generators. The proposed method consists of two basic steps: finding minimum-cost irreducible polynomials of the desired degree and applying primitivity tests to get the primitive ones. Finally two primitive polynomials, which was found by the proposed method, used in pseudorandom number generator based on fuzzy logic (FRNG) which had been suggested before by the authors. The sequences generated by new version of FRNG have low correlation magnitude, high linear complexity, less power consumption, is more balanced and have better statistical properties.

  19. Materials selection for oxide-based resistive random access memories

    Energy Technology Data Exchange (ETDEWEB)

    Guo, Yuzheng; Robertson, John [Engineering Department, Cambridge University, Cambridge CB2 1PZ (United Kingdom)

    2014-12-01

    The energies of atomic processes in resistive random access memories (RRAMs) are calculated for four typical oxides, HfO{sub 2}, TiO{sub 2}, Ta{sub 2}O{sub 5}, and Al{sub 2}O{sub 3}, to define a materials selection process. O vacancies have the lowest defect formation energy in the O-poor limit and dominate the processes. A band diagram defines the operating Fermi energy and O chemical potential range. It is shown how the scavenger metal can be used to vary the O vacancy formation energy, via controlling the O chemical potential, and the mean Fermi energy. The high endurance of Ta{sub 2}O{sub 5} RRAM is related to its more stable amorphous phase and the adaptive lattice rearrangements of its O vacancy.

  20. Optimizing Event Selection with the Random Grid Search

    Energy Technology Data Exchange (ETDEWEB)

    Bhat, Pushpalatha C. [Fermilab; Prosper, Harrison B. [Florida State U.; Sekmen, Sezen [Kyungpook Natl. U.; Stewart, Chip [Broad Inst., Cambridge

    2017-06-29

    The random grid search (RGS) is a simple, but efficient, stochastic algorithm to find optimal cuts that was developed in the context of the search for the top quark at Fermilab in the mid-1990s. The algorithm, and associated code, have been enhanced recently with the introduction of two new cut types, one of which has been successfully used in searches for supersymmetry at the Large Hadron Collider. The RGS optimization algorithm is described along with the recent developments, which are illustrated with two examples from particle physics. One explores the optimization of the selection of vector boson fusion events in the four-lepton decay mode of the Higgs boson and the other optimizes SUSY searches using boosted objects and the razor variables.

  1. Selective decontamination in pediatric liver transplants. A randomized prospective study.

    Science.gov (United States)

    Smith, S D; Jackson, R J; Hannakan, C J; Wadowsky, R M; Tzakis, A G; Rowe, M I

    1993-06-01

    Although it has been suggested that selective decontamination of the digestive tract (SDD) decreases postoperative aerobic Gram-negative and fungal infections in orthotopic liver transplantation (OLT), no controlled trials exist in pediatric patients. This prospective, randomized controlled study of 36 pediatric OLT patients examines the effect of short-term SDD on postoperative infection and digestive tract flora. Patients were randomized into two groups. The control group received perioperative parenteral antibiotics only. The SDD group received in addition polymyxin E, tobramycin, and amphotericin B enterally and by oropharyngeal swab postoperatively until oral intake was tolerated (6 +/- 4 days). Indications for operation, preoperative status, age, and intensive care unit and hospital length of stay were no different in SDD (n = 18) and control (n = 18) groups. A total of 14 Gram-negative infections (intraabdominal abscess 7, septicemia 5, pneumonia 1, urinary tract 1) developed in the 36 patients studied. Mortality was not significantly different in the two groups. However, there were significantly fewer patients with Gram-negative infections in the SDD group: 3/18 patients (11%) vs. 11/18 patients (50%) in the control group, P < 0.001. There was also significant reduction in aerobic Gram-negative flora in the stool and pharynx in patients receiving SDD. Gram-positive and anaerobic organisms were unaffected. We conclude that short-term postoperative SDD significantly reduces Gram-negative infections in pediatric OLT patients.

  2. Telemonitoring and Mobile Phone-Based Health Coaching Among Finnish Diabetic and Heart Disease Patients: Randomized Controlled Trial.

    Science.gov (United States)

    Karhula, Tuula; Vuorinen, Anna-Leena; Rääpysjärvi, Katja; Pakanen, Mira; Itkonen, Pentti; Tepponen, Merja; Junno, Ulla-Maija; Jokinen, Tapio; van Gils, Mark; Lähteenmäki, Jaakko; Kohtamäki, Kari; Saranummi, Niilo

    2015-06-17

    There is a strong will and need to find alternative models of health care delivery driven by the ever-increasing burden of chronic diseases. The purpose of this 1-year trial was to study whether a structured mobile phone-based health coaching program, which was supported by a remote monitoring system, could be used to improve the health-related quality of life (HRQL) and/or the clinical measures of type 2 diabetes and heart disease patients. A randomized controlled trial was conducted among type 2 diabetes patients and heart disease patients of the South Karelia Social and Health Care District. Patients were recruited by sending invitations to randomly selected patients using the electronic health records system. Health coaches called patients every 4 to 6 weeks and patients were encouraged to self-monitor their weight, blood pressure, blood glucose (diabetics), and steps (heart disease patients) once per week. The primary outcome was HRQL measured by the Short Form (36) Health Survey (SF-36) and glycosylated hemoglobin (HbA1c) among diabetic patients. The clinical measures assessed were blood pressure, weight, waist circumference, and lipid levels. A total of 267 heart patients and 250 diabetes patients started in the trial, of which 246 and 225 patients concluded the end-point assessments, respectively. Withdrawal from the study was associated with the patients' unfamiliarity with mobile phones—of the 41 dropouts, 85% (11/13) of the heart disease patients and 88% (14/16) of the diabetes patients were familiar with mobile phones, whereas the corresponding percentages were 97.1% (231/238) and 98.6% (208/211), respectively, among the rest of the patients (P=.02 and P=.004). Withdrawal was also associated with heart disease patients' comorbidities—40% (8/20) of the dropouts had at least one comorbidity, whereas the corresponding percentage was 18.9% (47/249) among the rest of the patients (P=.02). The intervention showed no statistically significant benefits over

  3. Quality of reporting randomized controlled trials (RCTs) in diabetes in Iran; a systematic review.

    Science.gov (United States)

    Gohari, Faeze; Baradaran, Hamid Reza; Tabatabaee, Morteza; Anijidani, Shabnam; Mohammadpour Touserkani, Fatemeh; Atlasi, Rasha; Razmgir, Maryam

    2015-01-01

    To determine the quality of randomized controlled clinical trial (RCT) reports in diabetes research in Iran. Systematized review. We included RCTs conducted on diabetes mellitus in Iran. Animal studies, educational interventions, and non-randomized trials were excluded. We excluded duplicated publications reporting the same groups of participants and intervention. Two independent reviewers identify all eligible articles specifically designed data extraction form. We searched through international databases; Scopus, ProQuest, EBSCO, Science Direct, Web of Science, Cochrane Library, PubMed; and national databases (In Persian language) such as Magiran, Scientific Information Database (SID) and IranMedex from January 1995 to January of 2013 Two investigators assessed the quality of reporting by CONSORT 2010 (Consolidated Standards of Reporting Trials) checklist statemen.t,. Discrepancies were resolved by third reviewer consulting. One hundred and eight five (185) studies were included and appraised. Half of them (55.7 %) were published in Iranian journals. Most (89.7 %) were parallel RCTs, and being performed on type2 diabetic patients (77.8 %). Less than half of the CONSORT items (43.2 %) were reported in studies, totally. The reporting of randomization and blinding were poor. A few studies 15.1 % mentioned the method of random sequence generation and strategy of allocation concealment. And only 34.8 % of trials report how blinding was applied. The findings of this study show that the quality of RCTs conducted in Iran in diabetes research seems suboptimal and the reporting is also incomplete however an increasing trend of improvement can be seen over time. Therefore, it is suggested Iranian researchers pay much more attention to design and methodological quality in conducting and reporting of diabetes RCTs.

  4. Randomized Efficacy Trial of Early Preconception Counseling for Diabetic Teens (READY-Girls)

    OpenAIRE

    Charron-Prochownik, Denise; Ferons-Hannan, Margaret; Sereika, Susan; Becker, Dorothy

    2008-01-01

    OBJECTIVE?To develop and assess the feasibility of an early preconception counseling program for adolescents called READY-Girls (Reproductive-health Education and Awareness of Diabetes in Youth for Girls). RESEARCH DESIGN AND METHODS?A total of 53 adolescent females with type 1 diabetes between 16 and 19.9 years of age were randomized into groups receiving a CD-ROM, a book, or standard care (control) and given one comprehensive session. Outcomes were assessed at baseline, immediately after, a...

  5. Pediatric selective mutism therapy: a randomized controlled trial.

    Science.gov (United States)

    Esposito, Maria; Gimigliano, Francesca; Barillari, Maria R; Precenzano, Francesco; Ruberto, Maria; Sepe, Joseph; Barillari, Umberto; Gimigliano, Raffaele; Militerni, Roberto; Messina, Giovanni; Carotenuto, Marco

    2017-10-01

    Selective mutism (SM) is a rare disease in children coded by DSM-5 as an anxiety disorder. Despite the disabling nature of the disease, there is still no specific treatment. The aims of this study were to verify the efficacy of six-month standard psychomotor treatment and the positive changes in lifestyle, in a population of children affected by SM. Randomized controlled trial registered in the European Clinical Trials Registry (EuDract 2015-001161-36). University third level Centre (Child and Adolescent Neuropsychiatry Clinic). Study population was composed by 67 children in group A (psychomotricity treatment) (35 M, mean age 7.84±1.15) and 71 children in group B (behavioral and educational counseling) (37 M, mean age 7.75±1.36). Psychomotor treatment was administered by trained child therapists in residential settings three times per week. Each child was treated for the whole period by the same therapist and all the therapists shared the same protocol. The standard psychomotor session length is of 45 minutes. At T0 and after 6 months (T1) of treatments, patients underwent a behavioral and SM severity assessment. To verify the effects of the psychomotor management, the Child Behavior Checklist questionnaire (CBCL) and Selective Mutism Questionnaire (SMQ) were administered to the parents. After 6 months of psychomotor treatment SM children showed a significant reduction among CBCL scores such as in social relations, anxious/depressed, social problems and total problems (Pselective mutism, even if further studies are needed. The present study identifies in psychomotricity a safe and efficacy therapy for pediatric selective mutism.

  6. Peer Coaches to Improve Diabetes Outcomes in Rural Alabama: A Cluster Randomized Trial.

    Science.gov (United States)

    Safford, Monika M; Andreae, Susan; Cherrington, Andrea L; Martin, Michelle Y; Halanych, Jewell; Lewis, Marquita; Patel, Ashruta; Johnson, Ethel; Clark, Debra; Gamboa, Christopher; Richman, Joshua S

    2015-08-01

    It is unclear whether peer coaching is effective in minority populations living with diabetes in hard-to-reach, under-resourced areas such as the rural South. We examined the effect of an innovative peer-coaching intervention plus brief education vs brief education alone on diabetes outcomes. This was a community-engaged, cluster-randomized, controlled trial with primary care practices and their surrounding communities serving as clusters. The trial enrolled 424 participants, with 360 completing baseline and follow-up data collection (84.9% retention). The primary outcomes were change in glycated hemoglobin (HbA1c), systolic blood pressure (BP), low density lipoprotein cholesterol (LDL-C), body mass index (BMI), and quality of life, with diabetes distress and patient activation as secondary outcomes. Peer coaches were trained for 2 days in community settings; the training emphasized motivational interviewing skills, diabetes basics, and goal setting. All participants received a 1-hour diabetes education class and a personalized diabetes report card at baseline. Intervention arm participants were also paired with peer coaches; the protocol called for telephone interactions weekly for the first 8 weeks, then monthly for a total of 10 months. Due to real-world constraints, follow-up was protracted, and intervention effects varied over time. The analysis that included the 68% of participants followed up by 15 months showed only a significant increase in patient activation in the intervention group. The analysis that included all participants who eventually completed follow-up revealed that intervention arm participants had significant differences in changes in systolic BP (P = .047), BMI (P = .02), quality of life (P = .003), diabetes distress (P = .004), and patient activation (P = .03), but not in HbA1c (P = .14) or LDL-C (P = .97). Telephone-delivered peer coaching holds promise to improve health for individuals with diabetes living in under-resourced areas. © 2015

  7. Adjustable Gastric Band Surgery or Medical Management in Patients With Type 2 Diabetes: A Randomized Clinical Trial.

    Science.gov (United States)

    Ding, Su-Ann; Simonson, Donald C; Wewalka, Marlene; Halperin, Florencia; Foster, Kathleen; Goebel-Fabbri, Ann; Hamdy, Osama; Clancy, Kerri; Lautz, David; Vernon, Ashley; Goldfine, Allison B

    2015-07-01

    Recommendations for surgical, compared with lifestyle and pharmacologically based, approaches for type 2 diabetes (T2D) management remain controversial. The objective was to compare laparoscopic adjustable gastric band (LAGB) to an intensive medical diabetes and weight management (IMWM) program for T2D. This was designed as a prospective, randomized clinical trial. The setting was two Harvard Medical School-affiliated academic institutions. INTERVENTIONS AND PARTICIPANTS: A 12-month randomized trial comparing LAGB (n = 23) vs IMWM (n = 22) in persons aged 21-65 years with body mass index of 30-45 kg/m(2), T2D diagnosed more than 1 year earlier, and glycated hemoglobin (HbA(1c)) ≥ 6.5% on antihyperglycemic medication(s). The proportion meeting the prespecified primary glycemic endpoint, defined as HbA(1c) medication. After randomization, five participants did not undergo the surgical intervention. Of the 40 initiating intervention (22 males/18 females; age, 51 ± 10 y; body mass index, 36.5 ± 3.7 kg/m(2); diabetes duration, 9 ± 5 y; HbA(1c), 8.2 ± 1.2%; 40% on insulin), the proportion meeting the primary glycemic endpoint was achieved in 33% of the LAGB patients and 23% of the IMWM patients (P = .457). HbA(1c) reduction was similar between groups at both 3 and 12 months (-1.2 ± 0.3 vs -1.0 ± 0.3%; P = .496). Weight loss was similar at 3 months but greater 12 months after LAGB (-13.5 ± 1.7 vs -8.5 ± 1.6 kg; P = .027). Systolic blood pressure reduction was greater after IMWM than LAGB, whereas changes in diastolic blood pressure, lipids, fitness, and cardiovascular risk scores were similar between groups. Patient-reported health status, assessed using the Short Form-36, Impact of Weight on Quality of Life, and Problem Areas in Diabetes, all improved similarly between groups. LAGB and a multidisciplinary IMWM program have similar 1-year benefits on diabetes control, cardiometabolic risk, and patient satisfaction, which should be considered in the context of

  8. A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol.

    Science.gov (United States)

    Block, Gladys; Azar, Kristen Mj; Block, Torin J; Romanelli, Robert J; Carpenter, Heather; Hopkins, Donald; Palaniappan, Latha; Block, Clifford H

    2015-01-21

    In the United States, 86 million adults have pre-diabetes. Evidence-based interventions that are both cost effective and widely scalable are needed to prevent diabetes. Our goal was to develop a fully automated diabetes prevention program and determine its effectiveness in a randomized controlled trial. Subjects with verified pre-diabetes were recruited to participate in a trial of the effectiveness of Alive-PD, a newly developed, 1-year, fully automated behavior change program delivered by email and Web. The program involves weekly tailored goal-setting, team-based and individual challenges, gamification, and other opportunities for interaction. An accompanying mobile phone app supports goal-setting and activity planning. For the trial, participants were randomized by computer algorithm to start the program immediately or after a 6-month delay. The primary outcome measures are change in HbA1c and fasting glucose from baseline to 6 months. The secondary outcome measures are change in HbA1c, glucose, lipids, body mass index (BMI), weight, waist circumference, and blood pressure at 3, 6, 9, and 12 months. Randomization and delivery of the intervention are independent of clinic staff, who are blinded to treatment assignment. Outcomes will be evaluated for the intention-to-treat and per-protocol populations. A total of 340 subjects with pre-diabetes were randomized to the intervention (n=164) or delayed-entry control group (n=176). Baseline characteristics were as follows: mean age 55 (SD 8.9); mean BMI 31.1 (SD 4.3); male 68.5%; mean fasting glucose 109.9 (SD 8.4) mg/dL; and mean HbA1c 5.6 (SD 0.3)%. Data collection and analysis are in progress. We hypothesize that participants in the intervention group will achieve statistically significant reductions in fasting glucose and HbA1c as compared to the control group at 6 months post baseline. The randomized trial will provide rigorous evidence regarding the efficacy of this Web- and Internet-based program in reducing or

  9. Foot reflexology in feet impairment of people with type 2 diabetes mellitus: randomized trial

    Directory of Open Access Journals (Sweden)

    Natália Chantal Magalhães da Silva

    2015-08-01

    Full Text Available AbstractObjective: to evaluate the effect of foot reflexology on feet impairment of people with type 2 diabetes mellitus.Method: this is a randomized, controlled and blind clinical trial. The sample was comprised by people with type 2 diabetes mellitus who, after being randomized into Treated group (n = 21 and Control group (n = 24, received guidelines on foot self-care. To the Treated Group it was also provided 12 sessions of foot reflexology. The scores of impairment indicators related to skin and hair, blood circulation, tissue sensitivity and temperature were measured by means of the instrument for assessing tissue integrity of the feet of people with diabetes mellitus. Chi-square test, Fisher exact test, Mann-Whitney test and regression analyzes were applied to the data, considering a significance level of 5% (P value <0.05.Results: participants who received the therapy showed better scores in some impairment indicators related to skin and hair (hair growth, elasticity/turgor, hydration, perspiration, texture and integrity of the skin/ skin peeling.Conclusion: the foot reflexology had a beneficial effect on feet impairment of people with type 2 diabetes mellitus, which makes it a viable therapy, deserving investment. This study was registered in the Brazilian Registry of Clinical Trials - RBR-8zk8sz.

  10. Foot reflexology in feet impairment of people with type 2 diabetes mellitus: randomized trial.

    Science.gov (United States)

    da Silva, Natália Chantal Magalhães; Chaves, Érika de Cássia Lopes; de Carvalho, Emilia Campos; Carvalho, Leonardo César; Iunes, Denise Hollanda

    2015-01-01

    to evaluate the effect of foot reflexology on feet impairment of people with type 2 diabetes mellitus. this is a randomized, controlled and blind clinical trial. The sample was comprised by people with type 2 diabetes mellitus who, after being randomized into Treated group (n = 21) and Control group (n = 24), received guidelines on foot self-care. To the Treated Group it was also provided 12 sessions of foot reflexology. The scores of impairment indicators related to skin and hair, blood circulation, tissue sensitivity and temperature were measured by means of the instrument for assessing tissue integrity of the feet of people with diabetes mellitus. Chi-square test, Fisher exact test, Mann-Whitney test and regression analyzes were applied to the data, considering a significance level of 5% (P value foot reflexology had a beneficial effect on feet impairment of people with type 2 diabetes mellitus, which makes it a viable therapy, deserving investment. This study was registered in the Brazilian Registry of Clinical Trials - RBR-8zk8sz.

  11. Foot reflexology in feet impairment of people with type 2 diabetes mellitus: randomized trial 1

    Science.gov (United States)

    da Silva, Natália Chantal Magalhães; Chaves, Érika de Cássia Lopes; de Carvalho, Emilia Campos; Carvalho, Leonardo César; Iunes, Denise Hollanda

    2015-01-01

    Abstract Objective: to evaluate the effect of foot reflexology on feet impairment of people with type 2 diabetes mellitus. Method: this is a randomized, controlled and blind clinical trial. The sample was comprised by people with type 2 diabetes mellitus who, after being randomized into Treated group (n = 21) and Control group (n = 24), received guidelines on foot self-care. To the Treated Group it was also provided 12 sessions of foot reflexology. The scores of impairment indicators related to skin and hair, blood circulation, tissue sensitivity and temperature were measured by means of the instrument for assessing tissue integrity of the feet of people with diabetes mellitus. Chi-square test, Fisher exact test, Mann-Whitney test and regression analyzes were applied to the data, considering a significance level of 5% (P value foot reflexology had a beneficial effect on feet impairment of people with type 2 diabetes mellitus, which makes it a viable therapy, deserving investment. This study was registered in the Brazilian Registry of Clinical Trials - RBR-8zk8sz. PMID:26444161

  12. Effect of Pentoxifylline on Microalbuminuria in Diabetic Patients: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Shahrzad Shahidi

    2015-01-01

    Full Text Available Background. Pentoxifylline is a nonspecific phosphodiesterase inhibitor with anti-inflammatory properties. Human studies have proved its antiproteinuric effect in patients with glomerular diseases, but this study was designed to assess the effects of add-on pentoxifylline to available treatment on reduction of microalbuminuria in diabetic patients without glomerular diseases. Methods. In a double-blind placebo-controlled, randomized study we evaluated the influence of pentoxifylline on microalbuminuria in type 2 diabetic patients. 40 diabetic patients with estimated glomerular filtration rate (eGFR of more than 60 mL/min/1.73 m2 in eight weeks and microalbuminuria were randomized to two groups which will receive pentoxifylline 1200 mg/day or placebo added to regular medications for 6 months. albuminuria; eGFR was evaluated at three- and six-month follow-up period. Results. Baseline characteristics were similar between the two groups. At six months, the mean estimated GFR and albuminuria were not different between two groups at 3- and 6-month follow-up. Trend of albumin to creatinine ratio, systolic and diastolic blood pressure, and eGFR in both groups were decreased, but no significant differences were noted between two groups (P value > 0.05. Conclusion. Pentoxifylline has not a significant additive antimicroalbuminuric effect compared with placebo in patients with type 2 diabetes with early stage of kidney disease; however, further clinical investigations are necessary to be done.

  13. Random glucose is useful for individual prediction of type 2 diabetes: results of the Study of Health in Pomerania (SHIP).

    Science.gov (United States)

    Kowall, Bernd; Rathmann, Wolfgang; Giani, Guido; Schipf, Sabine; Baumeister, Sebastian; Wallaschofski, Henri; Nauck, Matthias; Völzke, Henry

    2013-04-01

    Random glucose is widely used in routine clinical practice. We investigated whether this non-standardized glycemic measure is useful for individual diabetes prediction. The Study of Health in Pomerania (SHIP), a population-based cohort study in north-east Germany, included 3107 diabetes-free persons aged 31-81 years at baseline in 1997-2001. 2475 persons participated at 5-year follow-up and gave self-reports of incident diabetes. For the total sample and for subjects aged ≥50 years, statistical properties of prediction models with and without random glucose were compared. A basic model (including age, sex, diabetes of parents, hypertension and waist circumference) and a comprehensive model (additionally including various lifestyle variables and blood parameters, but not HbA1c) performed statistically significantly better after adding random glucose (e.g., the area under the receiver-operating curve (AROC) increased from 0.824 to 0.856 after adding random glucose to the comprehensive model in the total sample). Likewise, adding random glucose to prediction models which included HbA1c led to significant improvements of predictive ability (e.g., for subjects ≥50 years, AROC increased from 0.824 to 0.849 after adding random glucose to the comprehensive model+HbA1c). Random glucose is useful for individual diabetes prediction, and improves prediction models including HbA1c. Copyright © 2012 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

  14. Hypoglycemia in type 1 diabetic pregnancy: role of preconception insulin aspart treatment in a randomized study

    DEFF Research Database (Denmark)

    Heller, Simon; Damm, Peter; Mersebach, Henriette

    2010-01-01

    OBJECTIVE A recent randomized trial compared prandial insulin aspart (IAsp) with human insulin in type 1 diabetic pregnancy. The aim of this exploratory analysis was to investigate the incidence of severe hypoglycemia during pregnancy and compare women enrolled preconception with women enrolled...... during early pregnancy. RESEARCH DESIGN AND METHODS IAsp administered immediately before each meal was compared with human insulin administered 30 min before each meal in 99 subjects (44 to IAsp and 55 to human insulin) randomly assigned preconception and in 223 subjects (113 for IAsp and 110 for human...

  15. Integrating CHWs as Part of the Team Leading Diabetes Group Visits: A Randomized Controlled Feasibility Study.

    Science.gov (United States)

    Vaughan, Elizabeth M; Johnston, Craig A; Cardenas, Victor J; Moreno, Jennette P; Foreyt, John P

    2017-12-01

    Purpose The purpose of the study was to evaluate the feasibility of integrating Community Health Workers (CHWs) as part of the team leading diabetes group visits. Methods This was a randomized controlled study that integrated CHWs as part of the team leading diabetes group visits for low-income Hispanic adults (n = 50). Group visits met for 3 hours each month for a 6-month duration. Main measures included baseline and 6-month clinical outcomes (ie, A1C, lipids), concordance with 8 standard of care guidelines (ie, screens for cervical, breast, and colon cancer) from the US Preventive Task Force and American Diabetes Association, and participant acceptability. Results Compared to control participants, the intervention group resulted in significantly better clinical outcomes or guideline concordance for the following areas: target A1C levels, retinal eye exams, diabetes foot exams, mammograms, and urine microalbumin. Significantly more individuals in the control group gained weight, whereas a greater number of participants in the intervention group lost weight. Intervention participants found the group visits highly acceptable. Conclusions Integrating CHWs as part a comprehensive diabetes group visit program is a feasible and effective system-level intervention to improve glycemic control and achieve guideline concordance.

  16. Inflammation, insulin resistance, and diabetes--Mendelian randomization using CRP haplotypes points upstream.

    Directory of Open Access Journals (Sweden)

    Eric J Brunner

    2008-08-01

    Full Text Available Raised C-reactive protein (CRP is a risk factor for type 2 diabetes. According to the Mendelian randomization method, the association is likely to be causal if genetic variants that affect CRP level are associated with markers of diabetes development and diabetes. Our objective was to examine the nature of the association between CRP phenotype and diabetes development using CRP haplotypes as instrumental variables.We genotyped three tagging SNPs (CRP + 2302G > A; CRP + 1444T > C; CRP + 4899T > G in the CRP gene and measured serum CRP in 5,274 men and women at mean ages 49 and 61 y (Whitehall II Study. Homeostasis model assessment-insulin resistance (HOMA-IR and hemoglobin A1c (HbA1c were measured at age 61 y. Diabetes was ascertained by glucose tolerance test and self-report. Common major haplotypes were strongly associated with serum CRP levels, but unrelated to obesity, blood pressure, and socioeconomic position, which may confound the association between CRP and diabetes risk. Serum CRP was associated with these potential confounding factors. After adjustment for age and sex, baseline serum CRP was associated with incident diabetes (hazard ratio = 1.39 [95% confidence interval 1.29-1.51], HOMA-IR, and HbA1c, but the associations were considerably attenuated on adjustment for potential confounding factors. In contrast, CRP haplotypes were not associated with HOMA-IR or HbA1c (p = 0.52-0.92. The associations of CRP with HOMA-IR and HbA1c were all null when examined using instrumental variables analysis, with genetic variants as the instrument for serum CRP. Instrumental variables estimates differed from the directly observed associations (p = 0.007-0.11. Pooled analysis of CRP haplotypes and diabetes in Whitehall II and Northwick Park Heart Study II produced null findings (p = 0.25-0.88. Analyses based on the Wellcome Trust Case Control Consortium (1,923 diabetes cases, 2,932 controls using three SNPs in tight linkage disequilibrium with our

  17. Prospective randomized study for optimal insulin therapy in type 2 diabetic patients with secondary failure

    Directory of Open Access Journals (Sweden)

    Tojo Katsuyoshi

    2008-05-01

    Full Text Available Abstract Background The large clinical trials proved that Basal-Bolus (BB insulin therapy was effective in the prevention of diabetic complications and their progression. However, BB therapy needs multiple insulin injections per a day. In this regard, a biphasic insulin analogue needs only twice-daily injections, and is able to correct postprandial hyperglycemia. Therefore it may achieve the blood glucose control as same as that of BB therapy and prevent the diabetic complications including macroangiopathy. Methods In PROBE (Prospective, Randomized, Open, Blinded-Endpoint design, forty-two type 2 diabetic patients (male: 73.8%, median(inter quartile range age: 64.5(56.8~71.0years with secondary failure of sulfonylurea (SU were randomly assigned to BB therapy with a thrice-daily insulin aspart and once-daily basal insulin (BB group or to conventional therapy with a twice-daily biphasic insulin analogue (30 Mix group, and were followed up for 6 months to compare changes in HbA1c, daily glycemic profile, intima-media thickness (IMT of carotid artery, adiponectin levels, amounts of insulin used, and QOL between the two groups. Results After 6 months, HbA1c was significantly reduced in both groups compared to baseline (30 Mix; 9.3(8.1~11.3 → 7.4(6.9~8.7%, p Conclusion Both BB and 30 mix group produced comparable reductions in HbA1c in type 2 diabetic patients with secondary failure. There was no significant change in IMT as an indicator of early atherosclerotic changes between the two groups. The basal-bolus insulin therapy may not be necessarily needed if the type 2 diabetic patients have become secondary failure. Trial registration Current Controlled Trials number, NCT00348231

  18. Walking Away from Type 2 diabetes: a cluster randomized controlled trial.

    Science.gov (United States)

    Yates, T; Edwardson, C L; Henson, J; Gray, L J; Ashra, N B; Troughton, J; Khunti, K; Davies, M J

    2017-05-01

    This study aimed to investigate whether an established behavioural intervention, Walking Away from Type 2 Diabetes, is effective at promoting and sustaining increased walking activity when delivered within primary care. Cluster randomized controlled trial involving 10 general practices recruited from Leicestershire, UK, in 2009-2010. Eight hundred and eight (36% female) individuals with a high risk of Type 2 diabetes mellitus, identified through a validated risk score, were included. Participants in five practices were randomized to Walking Away from Type 2 Diabetes, a pragmatic 3-h group-based structured education programme incorporating pedometer use with annual follow-on refresher sessions. The primary outcome was accelerometer assessed ambulatory activity (steps/day) at 12 months. Longer term maintenance was assessed at 24 and 36 months. Results were analysed using generalized estimating equation models, accounting for clustering. Complete accelerometer data for the primary outcome were available for 571 (71%) participants. Increases in ambulatory activity of 411 steps/day [95% confidence interval (CI): 117, 704] and self-reported vigorous-intensity physical activity of 218 metabolic equivalent min/week (95% CI: 6, 425) at 12 months were observed in the intervention group compared with control; differences between groups were not sustained at 36 months. No differences between groups were observed for markers of cardiometabolic health. Replacing missing data with multiple imputation did not affect the results. A pragmatic low-resource group-based structured education programme with pedometer use resulted in modest increases in ambulatory activity compared with control conditions after 12 months when implemented within a primary care setting to those at high risk of Type 2 diabetes mellitus; however, the results were not maintained over 36 months. © 2016 Diabetes UK.

  19. A novel telemonitoring device for improving diabetes control: protocol and results from a randomized clinical trial.

    Science.gov (United States)

    Pressman, Alice R; Kinoshita, Linda; Kirk, Susan; Barbosa, Gina Monraz; Chou, Cathy; Minkoff, Jerome

    2014-02-01

    Telemedicine is one approach to managing patients with chronic illness. Several telephone-based monitoring studies of diabetes patients have shown improved glycosylated hemoglobin (HbA1c), blood pressure (BP), and low-density lipoprotein (LDL) levels. The purpose of this study was to evaluate an investigational in-home telemetry device for improving glucose and BP control over 6 months for patients with type 2 diabetes. The device was used to transmit weekly blood glucose, weight, and BP readings to a diabetes care manager. We conducted a two-arm, parallel-comparison, single-blind, randomized controlled trial among Kaiser Permanente Northern California members 18-75 years old with type 2 diabetes mellitus and entry HbA1c levels between 7.5% and 10.0%. Participants were randomly assigned to either the telemonitoring arm or the usual care arm. We observed very small, nonsignificant changes in fructosamine (telemonitoring, -54.9 μmol; usual care, -59.4 μmol) and systolic BP (telemonitoring, -6.3 mm Hg; usual care, -3.2 mm Hg) from baseline to 6 weeks in both groups. At 6 months, we observed no significant intergroup differences in change from baseline for HbA1c, fructosamine, or self-efficacy. However, LDL cholesterol in the telemonitoring arm decreased more than in the usual care arm (-17.1 mg/dL versus -5.4 mg/dL; P=0.045). Although HbA1c improved significantly over 6 months in both groups, the difference in improvement between the groups was not significant. This lack of significance may be due to the relatively healthy status of the volunteers in our study and to the high level of care provided by the care managers in the Santa Rosa, CA clinic. Further study in subgroups of less healthy diabetes patients is recommended.

  20. HbA1c as a Predictor of Diabetes and as an Outcome in the Diabetes Prevention Program: A Randomized Clinical Trial

    Science.gov (United States)

    2015-01-01

    OBJECTIVE Glycated hemoglobin (HbA1c), a standard measure of chronic glycemia for managing diabetes, has been proposed to diagnose diabetes and identify people at risk. The Diabetes Prevention Program (DPP) was a 3.2-year randomized clinical trial of preventing type 2 diabetes with a 10-year follow-up study, the DPP Outcomes Study (DPPOS). We evaluated baseline HbA1c as a predictor of diabetes and determined the effects of treatments on diabetes defined by an HbA1c ≥6.5% (48 mmol/mol). RESEARCH DESIGN AND METHODS We randomized 3,234 nondiabetic adults at high risk of diabetes to placebo, metformin, or intensive lifestyle intervention and followed them for the development of diabetes as diagnosed by fasting plasma glucose (FPG) and 2-h postload glucose (2hPG) concentrations (1997 American Diabetes Association [ADA] criteria). HbA1c was measured but not used for study eligibility or outcomes. We now evaluate treatment effects in the 2,765 participants who did not have diabetes at baseline according to FPG, 2hPG, or HbA1c (2010 ADA criteria). RESULTS Baseline HbA1c predicted incident diabetes in all treatment groups. Diabetes incidence defined by HbA1c ≥6.5% was reduced by 44% by metformin and 49% by lifestyle during the DPP and by 38% by metformin and 29% by lifestyle throughout follow-up. Unlike the primary DPP and DPPOS findings based on glucose criteria, metformin and lifestyle were similarly effective in preventing diabetes defined by HbA1c. CONCLUSIONS HbA1c predicted incident diabetes. In contrast to the superiority of the lifestyle intervention on glucose-defined diabetes, metformin and lifestyle interventions had similar effects in preventing HbA1c-defined diabetes. The long-term implications for other health outcomes remain to be determined. PMID:25336746

  1. Autoregulation of glomerular filtration rate during spironolactone treatment in hypertensive patients with type 1 diabetes: a randomized crossover trial

    DEFF Research Database (Denmark)

    Schjoedt, K.J.; Christensen, P.K.; Jorsal, A.

    2009-01-01

    if spironolactone affects the ability to autoregulate GFR. METHODS: Sixteen hypertensive type 1 diabetic patients with persistent normoalbuminuria (presumed normal autoregulation) completed this randomized, double-masked, crossover trial. After a 4-week wash-out period, patients received spironolactone 25 mg o...... correlated with diabetes duration (R = 0.67, P type 1 diabetic patients with normoalbuminuria. Our data......BACKGROUND: Autoregulation of GFR, i.e. maintenance of relative constancy of GFR despite variations in mean arterial pressure (MAP) >80 mmHg, is impaired in diabetic kidney disease; furthermore, some antihypertensive drugs may jeopardize autoregulation. The aim of our study was to establish...

  2. The role of adding metformin in insulin-resistant diabetic pregnant women: a randomized controlled trial.

    Science.gov (United States)

    Ibrahim, Moustafa Ibrahim; Hamdy, Ahmed; Shafik, Adel; Taha, Salah; Anwar, Mohammed; Faris, Mohammed

    2014-05-01

    The aim of the present study is to assess the impact of adding oral metformin to insulin therapy in pregnant women with insulin-resistant diabetes mellitus. The current non-inferiority randomized controlled trial was conducted at Ain Shams University Maternity Hospital. The study included pregnant women with gestational or pre-existing diabetes mellitus at gestations between 20 and 34 weeks, who showed insulin resistance (defined as poor glycemic control at a daily dose of ≥1.12 units/kg). Recruited women were randomized into one of two groups: group I, including women who received oral metformin without increasing the insulin dose; and group II, including women who had their insulin dose increased. The primary outcome was maternal glycemic control. Secondary outcomes included maternal bouts of hypoglycemia, need for another hospital admission for uncontrolled diabetes during pregnancy, gestational age at delivery, mode of delivery, birth weight, birth trauma, congenital anomalies, 1- and 5-min Apgar score, neonatal hypoglycemia, need for neonatal intensive care unit (NICU) admission and adverse neonatal outcomes. A total number of 154 women with diabetes mellitus with pregnancy were approached; of them 90 women were eligible and were randomly allocated and included in the final analysis. The recruited 90 women were randomized into one of two groups: group I (metformin group) (n = 46), including women who received oral metformin in addition to the same initial insulin dose; and group II (control group) (n = 44), including women who had their insulin dose increased according to the standard protocol. The mean age of included women was 29.84 ± 5.37 years (range 20-42 years). The mean gestational age at recruitment was 28.7 ± 3.71 weeks (range 21-34 weeks). Among the 46 women of group I, 17 (36.9 %) women reached proper glycemic control at a daily metformin dose of 1,500 mg, 18 (39.2 %) at a daily dose of 2,000 mg, while 11 (23.9 %) received metformin at a daily

  3. A yoga intervention for type 2 diabetes risk reduction: a pilot randomized controlled trial

    Science.gov (United States)

    2014-01-01

    Background Type 2 diabetes is a major health problem in many countries including India. Yoga may be an effective type 2 diabetes prevention strategy in India, particularly given its cultural familiarity. Methods This was a parallel, randomized controlled pilot study to collect feasibility and preliminary efficacy data on yoga for diabetes risk factors among people at high risk of diabetes. Primary outcomes included: changes in BMI, waist circumference, fasting blood glucose, postprandial blood glucose, insulin, insulin resistance, blood pressure, and cholesterol. We also looked at measures of psychological well-being including changes in depression, anxiety, positive and negative affect and perceived stress. Forty-one participants with elevated fasting blood glucose in Bangalore, India were randomized to either yoga (n = 21) or a walking control (n = 20). Participants were asked to either attend yoga classes or complete monitored walking 3–6 days per week for eight weeks. Randomization and allocation was performed using computer-generated random numbers and group assignments delivered in sealed, opaque envelopes generated by off-site study staff. Data were analyzed based on intention to treat. Results This study was feasible in terms of recruitment, retention and adherence. In addition, yoga participants had significantly greater reductions in weight, waist circumference and BMI versus control (weight −0.8 ± 2.1 vs. 1.4 ± 3.6, p = 0.02; waist circumference −4.2 ± 4.8 vs. 0.7 ± 4.2, p yoga intervention and walking control over the course of the study. Conclusion Among Indians with elevated fasting blood glucose, we found that participation in an 8-week yoga intervention was feasible and resulted in greater weight loss and reduction in waist circumference when compared to a walking control. Yoga offers a promising lifestyle intervention for decreasing weight-related type 2 diabetes risk factors and potentially increasing

  4. Increasing patient involvement in the diabetic foot pathway: a pilot randomized controlled trial.

    Science.gov (United States)

    McBride, E; Hacking, B; O'Carroll, R; Young, M; Jahr, J; Borthwick, C; Callander, A; Berrada, Z

    2016-11-01

    This pilot study aimed to explore whether the use of an intervention to increase shared decision-making (Decision Navigation) increased decision self-efficacy and foot-treatment adherence in patients with a diabetic foot ulcer. Fifty-six patients with a diabetic foot ulcer were randomized to receive Decision Navigation (N = 30) or usual care (N = 26). Primary outcomes included decision self-efficacy, adherence to foot treatment as reported by the participant and adherence to foot treatment as reported by the clinician. Secondary outcomes included foot ulcer healing rate, health-related quality of life, decision conflict and decision regret. Despite participants rating Decision Navigation as very helpful, mixed analyses of variance revealed no differences in decision self-efficacy or adherence between those receiving Decision Navigation and those receiving usual care. There were no differences between groups with regards to the secondary outcomes, with the exception of decision conflict which increased over time (12 weeks) for those receiving Decision Navigation. An intervention that facilitated patient involvement in treatment decisions did not have any impact on decisional confidence or adherence to foot treatment. This does not provide support for the suggestion that personalized care can improve health-related outcomes at this progressed stage of the patient's disease trajectory. We suggest that the diabetic foot population may benefit from interventions aimed at increasing motivation to engage with care pathways, centred on challenging personal controllability beliefs. © 2016 Diabetes UK.

  5. Group Singing as a Therapy during Diabetes Training--A Randomized Controlled Pilot Study.

    Science.gov (United States)

    Groener, J B; Neus, I; Kopf, S; Hartmann, M; Schanz, J; Kliemank, E; Wetekam, B; Kihm, L; Fleming, T; Herzog, W; Nawroth, P P

    2015-11-01

    Comprehensive diabetes treatment has been shown to reduce quality of life in diabetic patients. However, there is evidence to suggest that group singing can have positive effects on quality of life in various clinical settings. In this randomized controlled pilot study, the effect of singing as a therapy to reduce stress and improve quality of life was investigated in insulin-dependent diabetic patients, undergoing a lifestyle intervention program. Patients from the singing group felt less discontented following treatment. This effect, however, was lost after 3 months. No effect on serum cortisol and plasma adrenocorticotropic hormone (ACTH) levels could be seen when comparing the singing group with the control group, although reduced levels of ACTH and cortisol 3 days after treatment could be found and were still present after 3 months within the group of patients who undertook singing as a therapy. Singing led to an increase in bodyweight, which interestingly had no effect on glucose control or methylglyoxal levels. Therefore, singing during a lifestyle intervention program for insulin-dependent diabetic patients had a short lasting and weak effect on patients' mood without affecting glucose control, but no significant effect on stress related hormones. © Georg Thieme Verlag KG Stuttgart · New York.

  6. COMPARISON OF ASTYM THERAPY AND KINESIOTAPING FOR ROTATOR CUFF TENDINOPATHY IN DIABETIC PATIENTS: RANDOMIZED CONTROLLED TRIAL

    Directory of Open Access Journals (Sweden)

    Azza Atya

    2017-09-01

    Full Text Available Background: Rotator cuff tendinopathy is a significant problem among diabetics that frequently restricts patient’s activity in terms of pain and disability. The purpose of this study was to compare between the effect of Astym therapy and kinesiotaping in treating diabetic patients with chronic rotator cuff tendinopathy. Methods: 56 diabetic patients diagnosed with chronic rotator cuff tendinopathy were randomly assigned into Astym therapy group (n=28 or kinesiotaping group (n= 28. All patients received conventional program in addition to Astym treatment or Kinesiotaping for 24 sessions (2times/week. Patients were assessed at baseline and at the end of corresponding intervention with visual analogy scale (VAS for pain intensity, shoulder disability questioner (SDQ for shoulder disability, and electrogoniometer for shoulder range of motion. Results: For the 56 study participants (21 males and 35 females; mean age=41.9±6.9 years there were significant differences in all measuring outcomes in both group when compared to baseline measurements (p 0.05. Conclusion: kinesiotaping appears to be more effective than Astym therapy in reducing pain for diabetic patients with chronic rotator cuff tendinopathy.

  7. Selection effects may account for better outcomes of the German Disease Management Program for type 2 diabetes.

    Science.gov (United States)

    Schäfer, Ingmar; Küver, Claudia; Gedrose, Benjamin; von Leitner, Eike-Christin; Treszl, András; Wegscheider, Karl; van den Bussche, Hendrik; Kaduszkiewicz, Hanna

    2010-12-31

    The nationwide German disease management program (DMP) for type 2 diabetes was introduced in 2003. Meanwhile, results from evaluation studies were published, but possible baseline differences between DMP and usual-care patients have not been examined. The objective of our study was therefore to find out if patient characteristics as socio-demographic variables, cardiovascular risk profile or motivation for life style changes influence the chance of being enrolled in the German DMP for type 2 diabetes and may therefore account for outcome differences between DMP and usual-care patients. Case control study comparing DMP patients with usual-care patients at baseline and follow up; mean follow-up period of 36 ± 14 months. We used chart review data from 51 GP surgeries. Participants were 586 DMP and 250 usual-care patients with type 2 diabetes randomly selected by chart registry. Data were analysed by multivariate logistic and linear regression analyses. Significance levels were p ≤ 0.05. There was a better chance for enrolment if patients a) had a lower risk status for diabetes complications, i.e. non-smoking (odds ratio of 1.97, 95% confidence interval of 1.11 to 3.48) and lower systolic blood pressure (1.79 for 120 mmHg vs. 160 mmHg, 1.15 to 2.81); b) had higher activity rates, i.e. were practicing blood glucose self-monitoring (1.67, 1.03 to 2.76) and had been prescribed a diabetes patient education before enrolment (2.32, 1.29 to 4.19) c) were treated with oral medication (2.17, 1.35 to 3.49) and d) had a higher GP-rated motivation for diabetes education (4.55 for high motivation vs. low motivation, 2.21 to 9.36). At baseline, future DMP patients had a lower risk for diabetes complications, were treated more intensively and were more active and motivated in managing their disease than usual-care patients. This finding a) points to the problem that the German DMP may not reach the higher risk patients and b) selection bias may impair the assessment of differences

  8. Control of Lower Extremity Edema in Patients with Diabetes: Double Blind Randomized Controlled Trial Assessing the Efficacy of Mild Compression Diabetic Socks

    Science.gov (United States)

    Wu, Stephanie C.; Crews, Ryan T.; Skratsky, Melissa; Overstreet, Julia; Yalla, Sai V.; Winder, Michelle; Ortiz, Jacquelyn; Andersen, Charles A.

    2017-01-01

    Aims Persons with diabetes frequently present with lower extremity (LE) edema; however, compression therapy is generally avoided for fear of compromising arterial circulation in a population with a high prevalence of peripheral arterial disease. This double blind randomized controlled trial (RCT) assessed whether diabetic socks with mild compression could reduce LE edema in patients with diabetes without negatively impacting vascularity. Methods Eighty subjects with LE edema and diabetes were randomized to receive either mild-compression knee high diabetic socks (18–25mmHg) or non-compression knee high diabetic socks. Subjects were instructed to wear the socks during all waking hours. Follow-up visits occurred weekly for four consecutive weeks. Edema was quantified through midfoot, ankle, and calf circumferences and cutaneous fluid measurements. Vascular status was tracked via ankle brachial index (ABI), toe brachial index (TBI), and skin perfusion pressure (SPP). Results Seventy-seven subjects (39 controls and 38 mild-compression subjects) successfully completed the study. No statistical differences between the two groups in terms of age, body mass index, gender, and ethnicity. Repeated measures analysis of variance and Sidak corrections for multiple comparisons were used for data analyses. Subjects randomized to mild-compression diabetic socks demonstrated significant decreases in calf and ankle circumferences at the end of treatment as compared to baseline. LE circulation did not diminish throughout the study with no significant decreases in ABI, TBI or SPP for either group. Conclusions Results of this RCT suggest that mild compression diabetic sock may be effectively and safely used in patients with diabetes and LE edema. PMID:28315576

  9. Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: an update to the study protocol for a randomized controlled trial.

    Science.gov (United States)

    Shih, Sophy T F; Davis-Lameloise, Nathalie; Janus, Edward D; Wildey, Carol; Versace, Vincent L; Hagger, Virginia; Asproloupos, Dino; O'Reilly, Sharleen L; Phillips, Paddy A; Ackland, Michael; Skinner, Timothy; Oats, Jeremy; Carter, Rob; Best, James D; Dunbar, James A

    2014-06-30

    The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial (RCT) that aims to assess the effectiveness of a structured diabetes prevention intervention for women who had gestational diabetes. The original protocol was published in Trials (http://www.trialsjournal.com/content/14/1/339). This update reports on an additional exclusion criterion and change in first eligibility screening to provide greater clarity. The new exclusion criterion "surgical or medical intervention to treat obesity" has been added to the original protocol. The risks of developing diabetes will be affected by any medical or surgical intervention as its impact on obesity will alter the outcomes being assessed by MAGDA-DPP. The screening procedures have also been updated to reflect the current recruitment operation. The first eligibility screening is now taking place either during or after pregnancy, depending on recruitment strategy. Australian New Zealand Clinical Trials Registry ANZCTRN 12610000338066.

  10. Blind Measurement Selection: A Random Matrix Theory Approach

    KAUST Repository

    Elkhalil, Khalil; Kammoun, Abla; Al-Naffouri, Tareq Y.; Alouini, Mohamed-Slim

    2016-01-01

    -aware fashions. We present two potential applications where the proposed algorithms can be used, namely antenna selection for uplink transmissions in large scale multi-user systems and sensor selection for wireless sensor networks. Numerical results are also

  11. Enhancing evidence-based diabetes and chronic disease control among local health departments: a multi-phase dissemination study with a stepped-wedge cluster randomized trial component.

    Science.gov (United States)

    Parks, Renee G; Tabak, Rachel G; Allen, Peg; Baker, Elizabeth A; Stamatakis, Katherine A; Poehler, Allison R; Yan, Yan; Chin, Marshall H; Harris, Jenine K; Dobbins, Maureen; Brownson, Ross C

    2017-10-18

    The rates of diabetes and prediabetes in the USA are growing, significantly impacting the quality and length of life of those diagnosed and financially burdening society. Premature death and disability can be prevented through implementation of evidence-based programs and policies (EBPPs). Local health departments (LHDs) are uniquely positioned to implement diabetes control EBPPs because of their knowledge of, and focus on, community-level needs, contexts, and resources. There is a significant gap, however, between known diabetes control EBPPs and actual diabetes control activities conducted by LHDs. The purpose of this study is to determine how best to support the use of evidence-based public health for diabetes (and related chronic diseases) control among local-level public health practitioners. This paper describes the methods for a two-phase study with a stepped-wedge cluster randomized trial that will evaluate dissemination strategies to increase the uptake of public health knowledge and EBPPs for diabetes control among LHDs. Phase 1 includes development of measures to assess practitioner views on and organizational supports for evidence-based public health, data collection using a national online survey of LHD chronic disease practitioners, and a needs assessment of factors influencing the uptake of diabetes control EBPPs among LHDs within one state in the USA. Phase 2 involves conducting a stepped-wedge cluster randomized trial to assess effectiveness of dissemination strategies with local-level practitioners at LHDs to enhance capacity and organizational support for evidence-based diabetes prevention and control. Twelve LHDs will be selected and randomly assigned to one of the three groups that cross over from usual practice to receive the intervention (dissemination) strategies at 8-month intervals; the intervention duration for groups ranges from 8 to 24 months. Intervention (dissemination) strategies may include multi-day in-person workshops, electronic

  12. Randomized efficacy trial of early preconception counseling for diabetic teens (READY-girls).

    Science.gov (United States)

    Charron-Prochownik, Denise; Ferons-Hannan, Margaret; Sereika, Susan; Becker, Dorothy

    2008-07-01

    To develop and assess the feasibility of an early preconception counseling program for adolescents called READY-Girls (Reproductive-health Education and Awareness of Diabetes in Youth for Girls). A total of 53 adolescent females with type 1 diabetes between 16 and 19.9 years of age were randomized into groups receiving a CD-ROM, a book, or standard care (control) and given one comprehensive session. Outcomes were assessed at baseline, immediately after, and at 3 months. Teens who received the CD and those who received the book demonstrated significant (P Future studies should examine repeated boosters of a CD and a book, which are not meant to replace but rather to reinforce and supplement health professional education.

  13. Effect of candesartan on microalbuminuria and albumin excretion rate in diabetes: three randomized trials

    DEFF Research Database (Denmark)

    Bilous, Rudy; Chaturvedi, Nish; Sjølie, Anne Katrin

    2009-01-01

    candesartan compared with placebo affects microalbuminuria incidence or rate of change in albuminuria in type 1 and type 2 diabetes. DESIGN: 3 randomized trials of the DIRECT (Diabetic Retinopathy Candesartan Trials) Program. SETTING: 309 secondary care centers. PATIENTS: 3326 and 1905 patients with type 1...... further collections were done. The primary end point was new microalbuminuria (3 or 4 collections of urinary albumin excretion rate >or=20 microg/min). The secondary end point was rate of change in albuminuria. RESULTS: Individual and pooled results of the 3 trials showed that candesartan had little...... normotensive patients or patients with well-controlled hypertension who were at low overall vascular risk, which resulted in a low rate of microalbuminuria. Studies were powered for retinal and not renal end points. CONCLUSION: Candesartan, 32 mg/d, for 4.7 years did not prevent microalbuminuria in mainly...

  14. Intermittent fasting in Type 2 diabetes mellitus and the risk of hypoglycaemia: a randomized controlled trial.

    Science.gov (United States)

    Corley, B T; Carroll, R W; Hall, R M; Weatherall, M; Parry-Strong, A; Krebs, J D

    2018-05-01

    To establish whether the risk of hypoglycaemia is greater with 2 consecutive days of very-low-calorie diet compared with 2 non-consecutive days of very-low-calorie diet in people with Type 2 diabetes. This was a non-blinded randomized parallel group interventional trial of intermittent fasting in adults. The participants had a BMI of 30-45 kg/m 2 , Type 2 diabetes treated with metformin and/or hypoglycaemic medications and an HbA 1c concentration of 50-86 mmol/mol (6.7-10%). The participants followed a 2092-2510-kJ diet on 2 days per week for 12 weeks. A total of 41 participants were randomized 1:1 to consecutive (n=19) or non-consecutive (n=22) day fasts, of whom 37 (n=18 and n=19, respectively) were included in the final analysis. The primary outcome was difference in the rate of hypoglycaemia between the two study arms. Secondary outcomes included change in diet, quality of life, weight, lipid, glucose and HbA 1c levels, and liver function. The mean hypoglycaemia rate was 1.4 events over 12 weeks. Fasting increased the rate of hypoglycaemia despite medication reduction (RR 2.05, 95% CI 1.17 to 3.52). There was no difference between fasting on consecutive days and fasting on non-consecutive days (RR 1.54, 95% CI 0.35 to 6.11). Improvements in weight, HbA 1c , fasting glucose and quality of life were experienced by participants in both arms. In individuals with Type 2 diabetes on hypoglycaemic medications, fasting of any type increased the rate of hypoglycaemia. With education and medication reduction, fewer than expected hypoglycaemic events occurred. Although it was not possible to determine whether fasting on consecutive days increased the risk of hypoglycaemia, an acceptable rate was observed in both arms. © 2018 Diabetes UK.

  15. Selected risk factors of diabetes mellitus among road transport drivers.

    Science.gov (United States)

    Marcinkiewicz, Andrzej; Szosland, Dorota

    2010-01-01

    Road transport drivers are one of the professional groups whose activities have a strong impact on public safety. In view of the nature of their professional activity, the drivers are at a higher risk of obesity and hypertension, and thus, indirectly, of carbohydrate metabolism disorders such as diabetes mellitus. Medical documentation was a source of data for the reported study. It derived from medical examinations of truck and bus drivers applying for the new category II driving licence or for prolongation of the one they already had. Excessive body weight was recorded in 62.6% of the study population; 45.3% had overweight and 17.4% were diagnosed with obesity. Hypertension was noted in the medical records of 36.7% drivers. The prevalence of abnormal BP values was increasing with age. Overweight was found to be a risk factor for hypertension. Hyperglycaemia was found in 47.5% of the drivers and was also increasing with age. In road transport drivers, the high prevalence of excessive body weight and elevated arterial blood pressure as the risk factors for diabetes indicates a need to undertake multidimensional actions targeted on this particular profession and involving various health care sectors. Prophylactic and detailed pre-placement examinations should be considered, depending on the rate and intensity of the disorders diagnosed. This should be coupled with an introduction of primary and secondary prophylactic activities and monitoring of relevant treatment. A close collaboration with the patient's GP is necessary.

  16. Optimizing weight control in diabetes: antidiabetic drug selection

    Directory of Open Access Journals (Sweden)

    S Kalra

    2010-08-01

    Full Text Available S Kalra1, B Kalra1, AG Unnikrishnan2, N Agrawal3, S Kumar41Bharti Hospital, Karnal; 2Amrita Institute of Medical Science, Kochi; 3Medical College, Gwalior; 4Excel Life Sciences, Noida, IndiaDate of preparation: 18th August 2010Conflict of interest: SK has received speaker fees from Novo Nordisk, sanofi-aventis, MSD, Eli Lilly, BMS, and AstraZeneca.Clinical question: Which antidiabetic drugs provide optimal weight control in patients with type 2 diabetes?Results: Metformin reduces weight gain, and may cause weight loss, when given alone or in combination with other drugs. Pioglitazone and rosiglitazone use is associated with weight gain. Use of the glucagon-like peptide-1 (GLP-1 analogs, liraglutide and exenatide, is associated with weight loss. Dipeptidyl peptidase-4 (DPP-4 inhibitors are considered weight-neutral. Results with insulin therapy are conflicting. Insulin detemir provides weight control along with glycemic control.Implementation: • Weight gain is considered an inevitable part of good glycemic control using conventional modalities of treatment such as sulfonylureas.• Use of metformin, weight-sparing insulin analogs such as insulin detemir, and liraglutide, should be encouraged as monotherapy, or in combination with other drugs.Keywords: weight control, diabetes

  17. Preventing diabetes in obese Latino youth with prediabetes: a study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Erica G. Soltero

    2017-03-01

    Full Text Available Abstract Background Obese Latino adolescents are disproportionately impacted by insulin resistance and type 2 diabetes. Prediabetes is an intermediate stage in the pathogenesis of type 2 diabetes and represents a critical opportunity for intervention. However, to date, no diabetes prevention studies have been conducted in obese Latino youth with prediabetes, a highly vulnerable and underserved group. Therefore, we propose a randomized-controlled trial to test the short-term (6-month and long-term (12-month efficacy of a culturally-grounded, lifestyle intervention, as compared to usual care, for improving glucose tolerance and reducing diabetes risk in 120 obese Latino adolescents with prediabetes. Methods Participants will be randomized to a lifestyle intervention or usual care group. Participants in the intervention group will attend weekly nutrition and wellness sessions and physical activity sessions twice a week for six months, followed by three months of booster sessions. The overall approach of the intervention is framed within a multilevel Ecodevelopmental model that leverages community, family, peer, and individual factors during the critical transition period of adolescence. The intervention is also guided by Social Cognitive Theory and employs key behavioral modification strategies to enhance self-efficacy and foster social support for making and sustaining healthy behavior changes. We will test intervention effects on quality of life, explore the potential mediating effects of changes in body composition, total, regional, and organ fat on improving glucose tolerance and increasing insulin sensitivity, and estimate the initial incremental cost effectiveness of the intervention as compared with usual care for improving glucose tolerance. Discussion The proposed trial builds upon extant collaborations of a transdisciplinary team of investigators working in concert with local community agencies to address critical gaps in how diabetes

  18. Selective nitrergic neurodegeneration in diabetes mellitus–a nitric oxide-dependent phenomenon

    Science.gov (United States)

    Cellek, Selim; Rodrigo, José; Lobos, Edgar; Fernández, Patricia; Serrano, Julia; Moncada, Salvador

    1999-01-01

    In vitro and in vivo studies have demonstrated a dysfunctional nitrergic system in diabetes mellitus, thus explaining the origin of diabetic impotence. However, the mechanism of this nitrergic defect is not understood.In the penises of streptozotocin (STZ)-induced diabetic rats, here, we show by immunohistochemistry that nitrergic nerves undergo selective degeneration since the noradrenergic nerves which have an anti-erectile function in the penis remained intact.Nitrergic relaxation responses in vitro and erectile responses to cavernous nerve stimulation in vivo were attenuated in these animals, whereas noradrenergic responses were enhanced.Activity and protein amount of neuronal nitric oxide synthase (nNOS) were also reduced in the penile tissue of diabetic rats.We, thus, hypothesized that NO in the nitrergic nerves may be involved in the nitrergic nerve damage, since only the nerves which contain neuronal NO synthase underwent degeneration.We administered an inhibitor of NO synthase, NG-nitro-L-arginine methyl ester (L-NAME), in the drinking water of rats for up to 12 weeks following the establishment of diabetes with STZ.Here we demonstrate that this compound protected the nitrergic nerves from morphological and functional impairment. Our results show that selective nitrergic degeneration in diabetes is NO-dependent and suggest that inhibition of NO synthase is neuroprotective in this condition. PMID:10588937

  19. Strategyproof Peer Selection using Randomization, Partitioning, and Apportionment

    OpenAIRE

    Aziz, Haris; Lev, Omer; Mattei, Nicholas; Rosenschein, Jeffrey S.; Walsh, Toby

    2016-01-01

    Peer review, evaluation, and selection is a fundamental aspect of modern science. Funding bodies the world over employ experts to review and select the best proposals of those submitted for funding. The problem of peer selection, however, is much more general: a professional society may want to give a subset of its members awards based on the opinions of all members; an instructor for a MOOC or online course may want to crowdsource grading; or a marketing company may select ideas from group b...

  20. Rosiglitazone Decreases Plasma Levels of Osteoprotegerin in a Randomized Clinical Trial with Type 2 Diabetes Patients

    DEFF Research Database (Denmark)

    Nybo, Mads; Preil, Simone Rørdam; Juhl, Henning Friis

    2011-01-01

    regarding cardiovascular disease. The South Danish Diabetes Study, an investigator-driven, randomized, controlled clinical trial lasting 2 years, was used to test this hypothesis in patient groups with different medication strategies (insulin aspart or NPH insulin, added either metformin...... (R = 0.29, p = 0.0002), while this correlation was poor in those not receiving rosiglitazone (R = 0.06, p = 0.48). Treatment with rosiglitazone among patients with T2DM reduces the concentration of plasma OPG. This is not seen with metformin despite similar reductions in HbA(1c) . Alteration...

  1. Acupuncture Combined with Hydrotherapy in Diabetes Patients with Mild Lower-Extremity Arterial Disease: A Prospective, Randomized, Nonblinded Clinical Study.

    Science.gov (United States)

    Qi, Zhengqin; Pang, Yan; Lin, Lin; Zhang, Bing; Shao, Juntao; Liu, Xiaodong; Zhang, Xin

    2018-05-08

    BACKGROUND The aim of this pragmatic study was to explore the intervention of acupuncture combined with hydrotherapy and perceived effects in type 2 diabetic patients with recently diagnosed, mild, lower-extremity arterial disease (LEAD) in comparison with a control group. MATERIAL AND METHODS One hundred twenty-six diabetes patients who were diagnosed mild LEAD according to ankle-brachial blood pressure index (ABPI) and peripheral neuropathy symptom were randomly assigned to either an experimental (n=64) or control group (n=62). The experimental group attended and completed (1) a 30-min session of acupuncture in certain selected points, and (2) a 30-min hydrotherapy exercise every 2 days for 15 weeks. The outcome parameters were assessed at baseline, after intervention, and at 6-week follow-up. RESULTS The intervention was associated with an improvement in leg flow conductance and partial physical capacities, including chair-sit-and-reach, the walking impairment questionnaire (WIQ), and physical component summary score (PCS), compared to the control group. The treatment benefits were sustained throughout the 6-week follow-up endpoint. There was no difference in fasting glucose levels, Hb1Ac, blood pressure, or BMI after the intervention. At the endpoint of 6-week follow-up, acupuncture plus hydrotherapy appeared to reduce inflammatory response by decreasing IL-6, TNF-α, malondialdehyde, and SOD, and increasing glutathione. CONCLUSIONS Acupuncture plus hydrotherapy, without significant glycemic-controlling effects in the type 2 diabetic patients with mild LEAD, exerts a measurable benefit in disease-specific physical functions and health-related quality of life. Our results suggest that the combined therapy regulates the inflammatory process and oxidative stress and contributes to immune protection.

  2. Effectiveness of self-management training in type 2 diabetes: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Norris, S L; Engelgau, M M; Narayan, K M

    2001-03-01

    To systematically review the effectiveness of self-management training in type 2 diabetes. MEDLINE, Educational Resources Information Center (ERIC), and Nursing and Allied Health databases were searched for English-language articles published between 1980 and 1999. Studies were original articles reporting the results of randomized controlled trials of the effectiveness of self-management training in people with type 2 diabetes. Relevant data on study design, population demographics, interventions, outcomes, methodological quality, and external validity were tabulated. Interventions were categorized based on educational focus (information, lifestyle behaviors, mechanical skills, and coping skills), and outcomes were classified as knowledge, attitudes, and self-care skills; lifestyle behaviors, psychological outcomes, and quality of life; glycemic control; cardiovascular disease risk factors; and economic measures and health service utilization. A total of 72 studies described in 84 articles were identified for this review. Positive effects of self-management training on knowledge, frequency and accuracy of self-monitoring of blood glucose, self-reported dietary habits, and glycemic control were demonstrated in studies with short follow-up (studies demonstrated the effectiveness of self-management training on cardiovascular disease-related events or mortality; no economic analyses included indirect costs; few studies examined health-care utilization. Performance, selection, attrition, and detection bias were common in studies reviewed, and external generalizability was often limited. Evidence supports the effectiveness of self-management training in type 2 diabetes, particularly in the short term. Further research is needed to assess the effectiveness of self-management interventions on sustained glycemic control, cardiovascular disease risk factors, and ultimately, microvascular and cardiovascular disease and quality of life.

  3. Medication adherence in type 2 diabetes patients: study of patients ...

    African Journals Online (AJOL)

    Medication adherence in type 2 diabetes patients: study of patients in ... impact of medication adherence on the clinical outcomes of type 2 diabetes patients at ... the review of case notes of one-hundred and fifty two randomly selected patients.

  4. Mobile phone intervention to improve diabetes care in rural areas of Pakistan: a randomized controlled trial.

    Science.gov (United States)

    Shahid, Muhammad; Mahar, Saeed Ahmed; Shaikh, Shiraz; Shaikh, Zuhaib-u-ddin

    2015-03-01

    To determine the effect of mobile phone intervention on HbA1c in type-2 Diabetes Mellitus (DM) patients living in rural areas of Pakistan. Randomized controlled trial. Department of Endocrinology, Liaquat National Hospital, Karachi, from December 2013 to June 2014. A total of 440 patients in intervention and control groups were enrolled. All patients between 18 - 70 years of age, residing in rural areas of Pakistan, HbA1c ³ 8.0% and having personal functional mobile phone were included. The intervention group patients were called directly on mobile phone after every 15 days for a period of 4 months. They were asked about the self-monitoring blood glucose, intake of medications, physical activity, healthy eating and were physically examined after 4 months. However, the control group was examined initially and after 4 months physically in the clinic and there were no mobile phone contacts with these patients. Patients in intervention group showed improvement (p Mobile phone technology in rural areas of Pakistan was helpful in lowering HbA1c levels in intervention group through direct communication with the diabetic patients. Lowering LDL and following diabetic diet plan can reduce HbA1c in these patients and help in preventing future complications.

  5. Determination of Efficacy of Reflexology in Managing Patients with Diabetic Neuropathy: A Randomized Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Krishna Dalal

    2014-01-01

    Full Text Available Background. The restricted usage of existing pharmacological methods which do not seem to provide the treatment of diabetic neuropathy may lead to exploring the efficacy of a complementary therapy. In this context, this paper was devoted to evaluate the efficacy of foot reflexology. This health science works on the hypothesis that the dysfunctional states of body parts could be identified by observing certain skin features and be rectified by stimulating certain specific areas mapped on feet. Method. Subjects (N=58 with diagnosed diabetic neuropathy were randomly distributed into reflexology and control groups in which both group patients were treated with ongoing pharmacological drugs. Reflexology group patients were additionally treated holistically with the hypothesis that this therapy would bring homeostasis among body organ functions. This was a caregiver-based study with a follow-up period of 6 months. The outcome measures were pain reduction, glycemic control, nerve conductivity, and thermal and vibration sensitivities. The skin features leading to the detection of the abnormal functional states of body parts were also recorded and analyzed. Results. Reflexology group showed more improvements in all outcome measures than those of control subjects with statistical significance. Conclusion. This study exhibited the efficient utility of reflexology therapy integrated with conventional medicines in managing diabetic neuropathy.

  6. Determination of Efficacy of Reflexology in Managing Patients with Diabetic Neuropathy: A Randomized Controlled Clinical Trial

    Science.gov (United States)

    Dalal, Krishna; Maran, V. Bharathi; Pandey, Ravindra M.; Tripathi, Manjari

    2014-01-01

    Background. The restricted usage of existing pharmacological methods which do not seem to provide the treatment of diabetic neuropathy may lead to exploring the efficacy of a complementary therapy. In this context, this paper was devoted to evaluate the efficacy of foot reflexology. This health science works on the hypothesis that the dysfunctional states of body parts could be identified by observing certain skin features and be rectified by stimulating certain specific areas mapped on feet. Method. Subjects (N = 58) with diagnosed diabetic neuropathy were randomly distributed into reflexology and control groups in which both group patients were treated with ongoing pharmacological drugs. Reflexology group patients were additionally treated holistically with the hypothesis that this therapy would bring homeostasis among body organ functions. This was a caregiver-based study with a follow-up period of 6 months. The outcome measures were pain reduction, glycemic control, nerve conductivity, and thermal and vibration sensitivities. The skin features leading to the detection of the abnormal functional states of body parts were also recorded and analyzed. Results. Reflexology group showed more improvements in all outcome measures than those of control subjects with statistical significance. Conclusion. This study exhibited the efficient utility of reflexology therapy integrated with conventional medicines in managing diabetic neuropathy. PMID:24527055

  7. Topical Administration of Pirfenidone Increases Healing of Chronic Diabetic Foot Ulcers: A Randomized Crossover Study

    Directory of Open Access Journals (Sweden)

    Marcela Janka-Zires

    2016-01-01

    Full Text Available Only 30 percent of chronic diabetic foot ulcers heal after 20 weeks of standard treatment. Pirfenidone is a drug with biological, anti-inflammatory, and antifibrotic effects. The aim of this study was to evaluate the effect of topical pirfenidone added to conventional treatment in noninfected chronic diabetic foot ulcers. This was a randomized crossover study. Group 1 received topical pirfenidone plus conventional treatment for 8 weeks; after this period, they were switched to receive conventional treatment only for 8 more weeks. In group 2, the order of the treatments was the opposite. The end points were complete ulcer healing and size reduction. Final data were obtained from 35 ulcers in 24 patients. Fifty-two percent of ulcers treated with pirfenidone healed before 8 weeks versus 14.3% treated with conventional treatment only (P=0.025. Between 8 and 16 weeks, 30.8% ulcers that received pirfenidone healed versus 0% with conventional treatment (P=0.081. By week 8, the reduction in ulcer size was 100% [73–100] with pirfenidone versus 57.5% with conventional treatment [28.9–74] (P=0.011. By week 16, the reduction was 93% [42.7–100] with pirfenidone and 21.8% [8–77.5] with conventional treatment (P=0.050. The addition of topical pirfenidone to conventional treatment significantly improves the healing of chronic diabetic noninfected foot ulcers.

  8. Variable Selection in Time Series Forecasting Using Random Forests

    Directory of Open Access Journals (Sweden)

    Hristos Tyralis

    2017-10-01

    Full Text Available Time series forecasting using machine learning algorithms has gained popularity recently. Random forest is a machine learning algorithm implemented in time series forecasting; however, most of its forecasting properties have remained unexplored. Here we focus on assessing the performance of random forests in one-step forecasting using two large datasets of short time series with the aim to suggest an optimal set of predictor variables. Furthermore, we compare its performance to benchmarking methods. The first dataset is composed by 16,000 simulated time series from a variety of Autoregressive Fractionally Integrated Moving Average (ARFIMA models. The second dataset consists of 135 mean annual temperature time series. The highest predictive performance of RF is observed when using a low number of recent lagged predictor variables. This outcome could be useful in relevant future applications, with the prospect to achieve higher predictive accuracy.

  9. The effectiveness of an emotion-focused educational programme in reducing diabetes distress in adults with Type 2 diabetes mellitus (VEMOFIT): a cluster randomized controlled trial.

    Science.gov (United States)

    Chew, B H; Vos, R C; Stellato, R K; Ismail, M; Rutten, G E H M

    2018-06-01

    To evaluate the effectiveness of a brief, value-based emotion-focused educational programme (VEMOFIT) in Malay adults with Type 2 diabetes mellitus compared with a programme of active listening to participants' emotional experiences, social support and their opinion on the health clinic diabetes care services (attention control). Malay adults with severe diabetes distress [Diabetes Distress Scale (DDS-17) mean score ≥ 3] were included. VEMOFIT consisted of four biweekly group sessions, a booster session after 3 months and a follow-up 6 months post intervention. The attention control programme consisted of three sessions over the same period. Outcomes included diabetes distress, depressive symptoms, self-efficacy and disease control. Required total sample size was 165. Participants (n = 124) were randomized to either VEMOFIT (n = 53) or the attention control programme (n = 71). Participants had a mean (sd) age of 55.7 (9.7) years, median diabetes duration of 7.0 (8.0) years and mean HbA 1c level of 82 mmol/mol (9.7%). The mean DDS-17 level decreased significantly in both the VEMOFIT and the attention control programmes (3.4 to 2.9 vs. 3.1 to 2.7, respectively). The adjusted between-group DDS-17 difference was not significant [-0.01, 95% confidence interval (CI) -0.38, 0.35]. The proportion of individuals with severe diabetes distress decreased in both groups, from 89% to 47% vs. 69% to 39% (odds ratio 0.88; 95% CI 0.26, 2.90). Other outcomes did not differ between groups. Both interventions decreased diabetes distress significantly. The theory-based VEMOFIT programme was not superior to the attention control programme. The latter approach is a simpler way to decrease severe diabetes distress (Trial registration: NCT02730078; NMRR-15-1144-24803). © 2018 Diabetes UK.

  10. Bilirubin as a potential causal factor in type 2 diabetes risk: a Mendelian randomization study

    Science.gov (United States)

    Abbasi, Ali; Deetman, Petronella E.; Corpeleijn, Eva; Gansevoort, Ron T.; Gans, Rijk O.B.; Hillege, Hans L.; van der Harst, Pim; Stolk, Ronald P.; Navis, Gerjan; Alizadeh, Behrooz Z.; Bakker, Stephan J.L.

    2014-01-01

    Circulating bilirubin, a natural antioxidant, is associated with decreased risk of type 2 diabetes (T2D), but the nature of the relationship remains unknown. We performed Mendelian randomization in a prospective cohort of 3,381 participants free of diabetes at baseline (aged 28-75 years; women, 52.6%). We used rs6742078 located in UDP-glucuronosyltransferase (UGT1A1) locus as instrumental variable (IV) to study a potential causal effect of serum total bilirubin on T2D risk. T2D developed in a total of 210 (6.2%) participants during a median follow-up of 7.8 years. In adjusted analyses, rs6742078, which explained 19.5% of bilirubin variation, was strongly associated with total bilirubin (a 0.68-SD increase in bilirubin levels per T allele; Pbilirubin levels, we observed a 25% (OR 0.75 [95%CI, 0.62-0.92]; P=0.004) lower risk of T2D. In Mendelian randomization analysis, the causal risk reduction for T2D was estimated to be 42% (causal ORIVestimation per 1-SD increase in log-transformed bilirubin 0.58 [95%CI, 0.39-0.84]; P=0.005), which was comparable to the observational estimate (Durbin-Wu-Hausman chi-square test Pfor difference =0.19). These novel results provide evidence that elevated bilirubin is causally associated with risk of T2D and support its role as a protective determinant. PMID:25368098

  11. Effect of Jeju Water on Blood Glucose Levels in Diabetic Patients: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Gwanpyo Koh

    2013-01-01

    Full Text Available Jeju water is the groundwater of Jeju Island, a volcanic island located in Republic of Korea. We investigated whether Jeju water improved glycemic control in patients with diabetes. This was a 12-week single-center, double-blind, randomized, and controlled trial. The subjects daily drank a liter of one of three kinds of water: two Jeju waters (S1 and S2 and Seoul tap water (SS. The primary outcome was the proportion of patients in the per-protocol (PP population achieving glycated hemoglobin (HbA1c < 7.0% at week 12. In total, 196 patients were randomized and analyzed in the intention-to-treat (ITT population (66 consuming S1, 63 consuming S2, and 67 consuming SS; 146 patients were considered in the PP population. There were no significant differences in the primary outcomes of the groups consuming S1, S2, or SS. However, the percentage of patients achieving HbA1c < 8% was significantly higher in the S2 group than in the SS group. In the ITT population, the 12-week HbA1c and fructosamine levels were lower in the S1 group than in the SS group and the 4-, 8-, and 12-week fructosamine levels were lower in the S2 group than in the SS group. Although we failed to achieve the primary outcome, it is possible that the Jeju waters improve glycemic control compared with the Seoul tap water in diabetic patients.

  12. Liver Enzymes and Risk of Ischemic Heart Disease and Type 2 Diabetes Mellitus: A Mendelian Randomization Study

    OpenAIRE

    Liu, Junxi; Au Yeung, Shiu Lun; Lin, Shi Lin; Leung, Gabriel M.; Schooling, C. Mary

    2016-01-01

    We used Mendelian randomization to estimate the causal effects of the liver enzymes, alanine aminotransferase (ALT), alkaline phosphatase (ALP) and gamma glutamyltransferase (GGT), on diabetes and cardiovascular disease, using genetic variants predicting these liver enzymes at genome wide significance applied to extensively genotyped case-control studies of diabetes (DIAGRAM) and coronary artery disease (CAD)/myocardial infarction (MI) (CARDIoGRAMplusC4D 1000 Genomes). Genetically higher ALT ...

  13. Moderate alcohol consumption, adiponectin, inflammation and type 2 diabetes risk : prospective cohort studies and randomized crossover trials

    OpenAIRE

    Joosten, M.M.

    2011-01-01

    Background: Moderate alcohol consumption has been associated with a lower risk of type 2 diabetes in various populations. However, the underlying mechanisms are not entirely clear. The aims of this thesis were 1) to substantiate the evidence of the association between alcohol consumption and type 2 diabetes in observational research and 2) to examine physiological mechanisms in randomized trials with specific attention to adiponectin, inflammation and insulin sensitivity which may mediate the...

  14. A randomized trial of a home system to reduce nocturnal hypoglycemia in type 1 diabetes.

    Science.gov (United States)

    Maahs, David M; Calhoun, Peter; Buckingham, Bruce A; Chase, H Peter; Hramiak, Irene; Lum, John; Cameron, Fraser; Bequette, B Wayne; Aye, Tandy; Paul, Terri; Slover, Robert; Wadwa, R Paul; Wilson, Darrell M; Kollman, Craig; Beck, Roy W

    2014-07-01

    Overnight hypoglycemia occurs frequently in individuals with type 1 diabetes and can result in loss of consciousness, seizure, or even death. We conducted an in-home randomized trial to determine whether nocturnal hypoglycemia could be safely reduced by temporarily suspending pump insulin delivery when hypoglycemia was predicted by an algorithm based on continuous glucose monitoring (CGM) glucose levels. Following an initial run-in phase, a 42-night trial was conducted in 45 individuals aged 15-45 years with type 1 diabetes in which each night was assigned randomly to either having the predictive low-glucose suspend system active (intervention night) or inactive (control night). The primary outcome was the proportion of nights in which ≥1 CGM glucose values ≤60 mg/dL occurred. Overnight hypoglycemia with at least one CGM value ≤60 mg/dL occurred on 196 of 942 (21%) intervention nights versus 322 of 970 (33%) control nights (odds ratio 0.52 [95% CI 0.43-0.64]; P 2 h was reduced by 74%. Overnight sensor glucose was >180 mg/dL during 57% of control nights and 59% of intervention nights (P = 0.17), while morning blood glucose was >180 mg/dL following 21% and 27% of nights, respectively (P 250 mg/dL following 6% and 6%, respectively. Morning ketosis was present <1% of the time in each arm. Use of a nocturnal low-glucose suspend system can substantially reduce overnight hypoglycemia without an increase in morning ketosis. © 2014 by the American Diabetes Association.

  15. Connective Tissue Reflex Massage for Type 2 Diabetic Patients with Peripheral Arterial Disease: Randomized Controlled Trial

    Science.gov (United States)

    Castro-Sánchez, Adelaida María; Moreno-Lorenzo, Carmen; Matarán-Peñarrocha, Guillermo A.; Feriche-Fernández-Castanys, Belen; Granados-Gámez, Genoveva; Quesada-Rubio, José Manuel

    2011-01-01

    The objective of this study was to evaluate the efficacy of connective tissue massage to improve blood circulation and intermittent claudication symptoms in type 2 diabetic patients. A randomized, placebo-controlled trial was undertaken. Ninety-eight type 2 diabetes patients with stage I or II-a peripheral arterial disease (PAD) (Leriche-Fontaine classification) were randomly assigned to a massage group or to a placebo group treated using disconnected magnetotherapy equipment. Peripheral arterial circulation was determined by measuring differential segmental arterial pressure, heart rate, skin temperature, oxygen saturation and skin blood flow. Measurements were taken before and at 30 min, 6 months and 1 year after the 15-week treatment. After the 15-week program, the groups differed (P < .05) in differential segmental arterial pressure in right lower limb (lower one-third of thigh, upper and lower one-third of leg) and left lower limb (lower one-third of thigh and upper and lower one-third of leg). A significant difference (P < .05) was also observed in skin blood flow in digits 1 and 4 of right foot and digits 2, 4 and 5 of left foot. ANOVA results were significant (P < .05) for right and left foot oxygen saturation but not for heart rate and temperature. At 6 months and 1 year, the groups differed in differential segmental arterial pressure in upper third of left and right legs. Connective tissue massage improves blood circulation in the lower limbs of type 2 diabetic patients at stage I or II-a and may be useful to slow the progression of PAD. PMID:19933770

  16. Connective Tissue Reflex Massage for Type 2 Diabetic Patients with Peripheral Arterial Disease: Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Adelaida María Castro-Sánchez

    2011-01-01

    Full Text Available The objective of this study was to evaluate the efficacy of connective tissue massage to improve blood circulation and intermittent claudication symptoms in type 2 diabetic patients. A randomized, placebo-controlled trial was undertaken. Ninety-eight type 2 diabetes patients with stage I or II-a peripheral arterial disease (PAD (Leriche-Fontaine classification were randomly assigned to a massage group or to a placebo group treated using disconnected magnetotherapy equipment. Peripheral arterial circulation was determined by measuring differential segmental arterial pressure, heart rate, skin temperature, oxygen saturation and skin blood flow. Measurements were taken before and at 30 min, 6 months and 1 year after the 15-week treatment. After the 15-week program, the groups differed (P<.05 in differential segmental arterial pressure in right lower limb (lower one-third of thigh, upper and lower one-third of leg and left lower limb (lower one-third of thigh and upper and lower one-third of leg. A significant difference (P<.05 was also observed in skin blood flow in digits 1 and 4 of right foot and digits 2, 4 and 5 of left foot. ANOVA results were significant (P<.05 for right and left foot oxygen saturation but not for heart rate and temperature. At 6 months and 1 year, the groups differed in differential segmental arterial pressure in upper third of left and right legs. Connective tissue massage improves blood circulation in the lower limbs of type 2 diabetic patients at stage I or II-a and may be useful to slow the progression of PAD.

  17. A prospective randomized evaluation of negative-pressure wound dressings for diabetic foot wounds.

    Science.gov (United States)

    Eginton, Mark T; Brown, Kellie R; Seabrook, Gary R; Towne, Jonathan B; Cambria, Robert A

    2003-11-01

    Optimal treatment for large diabetic foot wounds is ill defined. The purpose of this study was to compare the rate of wound healing with the Vacuum Assisted Closure device trade mark (VAC) to conventional moist dressings in the treatment of large diabetic foot wounds. Diabetics with significant soft tissue defects of the foot were considered for enrollment. Patients were randomized to receive either moist gauze dressings or VAC treatments for 2 weeks, after which they were treated with the alternative dressing for an additional 2 weeks. Wounds were photographed weekly and wound dimensions calculated in a blinded fashion with spatial analysis software. Percent change in wound dimensions were calculated and compared for each weekly assessment and over 2 weeks of therapy with each dressing type. Ten patients were enrolled in the trial, but two were lost to follow-up and two were withdrawn. Complete data were available for analysis on seven wounds in six patients. Average length, width, and depth of the wounds at initiation of the trial was 7.7, 3.5, and 3.1 cm, respectively. Only the wound depth was significantly decreased over the weeks of the trial to 1.2 cm ( p VAC dressings decreased the wound volume and depth significantly more than moist gauze dressings (59% vs. 0% and 49% vs. 8%, respectively). VAC dressings were associated with a decrease in all wound dimensions while wound length and width increased with moist dressings. In summary, over the first several weeks of therapy, VAC dressings decreased wound depth and volume more effectively than moist gauze dressings. Negative-pressure wound treatment may accelerate closure of large foot wounds in the diabetic patient.

  18. Community health workers in diabetes care: A systematic review of randomized controlled trials.

    Science.gov (United States)

    Trump, Lisa J; Mendenhall, Tai J

    2017-09-01

    Maintaining optimal self-care in managing Type 2 diabetes is a common struggle for patients due to several barriers, including access to quality services, financial insecurity and/or lack of insurance, and emotional distress. Consequently, morbidity and mortality rates are high, alongside rising health care costs. Alternative approaches that address common barriers require further investigation. This systematic review of randomized controlled trials examines the effectiveness of using community health workers (CHWs) in Type 2 diabetes care. This effort is warranted to orient practitioners and researchers to the state of existing knowledge, and to direct clinical practice and future research. Data were extracted from 17 peer-reviewed articles; they were examined with respect to theory integration, CHW intervention design, outcome variables, and findings. Approximately one-third of articles explicitly integrated theory into their research conceptualization and design. There was great variation across intervention dosages, attrition rates, and methods of CHW training. Main foci across studies' findings suggest that a CHW intervention has significant impacts on physical health outcomes, diabetes knowledge, self-care behaviors, and emotional distress and well-being. Principal implications relate to the need for more research regarding CHW intervention types and methods, and further investigation about the mechanisms of change within a CHW-delivered intervention. Findings support the case for more CHWs in treatment teams to bridge patients with the medical system. This research will serve to better equip providers in the support of patients managing Type 2 diabetes and advance the Triple Aim of health care. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  19. Jump starting shared medical appointments for diabetes with weight management: Rationale and design of a randomized controlled trial.

    Science.gov (United States)

    Crowley, Matthew J; Edelman, David; Voils, Corrine I; Maciejewski, Matthew L; Coffman, Cynthia J; Jeffreys, Amy S; Turner, Marsha J; Gaillard, Leslie A; Hinton, Teresa A; Strawbridge, Elizabeth; Zervakis, Jennifer; Barton, Anna Beth; Yancy, William S

    2017-07-01

    Rates of glycemic control remain suboptimal nationwide. Medication intensification for diabetes can have undesirable side effects (weight gain, hypoglycemia), which offset the benefits of glycemic control. A Shared Medical Appointment (SMA) intervention for diabetes that emphasizes weight management could improve glycemic outcomes and reduce weight while simultaneously lowering diabetes medication needs, resulting in less hypoglycemia and better quality of life. We describe the rationale and design for a study evaluating a novel SMA intervention for diabetes that primarily emphasizes low-carbohydrate diet-focused weight management. Jump Starting Shared Medical Appointments for Diabetes with Weight Management (Jump Start) is a randomized, controlled trial that is allocating overweight Veterans (body mass index≥27kg/m 2 ) with type 2 diabetes into two arms: 1) a traditional SMA group focusing on medication management and self-management counseling; or 2) an SMA group that combines low-carbohydrate diet-focused weight management (WM/SMA) with medication management. Hemoglobin A1c reduction at 48weeks is the primary outcome. Secondary outcomes include hypoglycemic events, diabetes medication use, weight, medication adherence, diabetes-related quality of life, and cost-effectiveness. We hypothesize that WM/SMA will be non-inferior to standard SMA for glycemic control, and will reduce hypoglycemia, diabetes medication use, and weight relative to standard SMA, while also improving quality of life and costs. Jump Start targets two common problems that are closely related but infrequently managed together: diabetes and obesity. By focusing on diet and weight loss as the primary means to control diabetes, this intervention may improve several meaningful patient-centered outcomes related to diabetes. Copyright © 2017. Published by Elsevier Inc.

  20. Contribution of family social support to the metabolic control of people with diabetes mellitus: A randomized controlled clinical trial.

    Science.gov (United States)

    Gomes, Lilian Cristiane; Coelho, Anna Claudia Martins; Gomides, Danielle Dos Santos; Foss-Freitas, Maria Cristina; Foss, Milton César; Pace, Ana Emilia

    2017-08-01

    This randomized controlled clinical trial aimed to evaluate the contribution of family social support to the clinical/metabolic control of people with type 2 diabetes mellitus. Diabetes mellitus is a chronic disease that requires continuous care in order for individuals to reach glycemic control, the primordial goal of treatment. Family social support is essential to the development of care skills and their maintenance. However, there are few studies that investigate the contribution of family social support to diabetes control. The study was developed between June 2011 and May 2013, and included 164 people who were randomized using simple randomization. The intervention group differed from the control group in that it included a family caregiver, who was recognized by the patient as a source of social support. The educational interventions received by people with diabetes mellitus were used as the basis of the education provided through telephone calls to patients' family members and caregivers, and their purpose was to encourage dialogue between the patients and their relatives about the topics related to diabetes. Regarding the clinical impact, the results showed that there was a greater reduction in blood pressure and glycated hemoglobin in the intervention group than in the control group, showing a positive effect on the control of the disease. Families should be incorporated into the care of people with diabetes mellitus and especially in health care programs, in particular those that can promote different forms of social support to strengthen the bond between family members. Copyright © 2017 Elsevier Inc. All rights reserved.

  1. Random-walk simulation of selected aspects of dissipative collisions

    International Nuclear Information System (INIS)

    Toeke, J.; Gobbi, A.; Matulewicz, T.

    1984-11-01

    Internuclear thermal equilibrium effects and shell structure effects in dissipative collisions are studied numerically within the framework of the model of stochastic exchanges by applying the random-walk technique. Effective blocking of the drift through the mass flux induced by the temperature difference, while leaving the variances of the mass distributions unaltered is found possible, provided an internuclear potential barrier is present. Presence of the shell structure is found to lead to characteristic correlations between the consecutive exchanges. Experimental evidence for the predicted effects is discussed. (orig.)

  2. Application of random effects to the study of resource selection by animals.

    Science.gov (United States)

    Gillies, Cameron S; Hebblewhite, Mark; Nielsen, Scott E; Krawchuk, Meg A; Aldridge, Cameron L; Frair, Jacqueline L; Saher, D Joanne; Stevens, Cameron E; Jerde, Christopher L

    2006-07-01

    1. Resource selection estimated by logistic regression is used increasingly in studies to identify critical resources for animal populations and to predict species occurrence. 2. Most frequently, individual animals are monitored and pooled to estimate population-level effects without regard to group or individual-level variation. Pooling assumes that both observations and their errors are independent, and resource selection is constant given individual variation in resource availability. 3. Although researchers have identified ways to minimize autocorrelation, variation between individuals caused by differences in selection or available resources, including functional responses in resource selection, have not been well addressed. 4. Here we review random-effects models and their application to resource selection modelling to overcome these common limitations. We present a simple case study of an analysis of resource selection by grizzly bears in the foothills of the Canadian Rocky Mountains with and without random effects. 5. Both categorical and continuous variables in the grizzly bear model differed in interpretation, both in statistical significance and coefficient sign, depending on how a random effect was included. We used a simulation approach to clarify the application of random effects under three common situations for telemetry studies: (a) discrepancies in sample sizes among individuals; (b) differences among individuals in selection where availability is constant; and (c) differences in availability with and without a functional response in resource selection. 6. We found that random intercepts accounted for unbalanced sample designs, and models with random intercepts and coefficients improved model fit given the variation in selection among individuals and functional responses in selection. Our empirical example and simulations demonstrate how including random effects in resource selection models can aid interpretation and address difficult assumptions

  3. Diabetes risk reduction in overweight first degree relatives of type 2 diabetes patients: Effects of a low-intensive lifestyle education program (DiAlert) A randomized controlled trial

    NARCIS (Netherlands)

    Heideman, W.H.; de Wit, M.; Middelkoop, B.J.C.; Nierkens, V.; Stronks, K.; Verhoeff, A.P.; Snoek, F.J.

    2015-01-01

    Objectives: To test the efficacy of a low-intensive lifestyle education program (DiAlert) for overweight first degree relatives of type 2 diabetes patients aimed at reducing diabetes risk. Methods: Overweight first degree relatives of type 2 diabetes patients were randomly assigned to the DiAlert

  4. Diabetes risk reduction in overweight first degree relatives of type 2 diabetes patients: Effects of a low-intensive lifestyle education program (DiAlert) A randomized controlled trial

    NARCIS (Netherlands)

    Heideman, W.H.; de Wit, M.; Middelkoop, B.J.C.; Nierkens, V.; Stronks, K.; Verhoeff, A.P.; Snoek, F.J.

    2015-01-01

    Objectives To test the efficacy of a low-intensive lifestyle education program (DiAlert) for overweight first degree relatives of type 2 diabetes patients aimed at reducing diabetes risk. Methods Overweight first degree relatives of type 2 diabetes patients were randomly assigned to the DiAlert

  5. Diabetes risk reduction in overweight first degree relatives of type 2 diabetes patients: effects of a low-intensive lifestyle education program (DiAlert) A randomized controlled trial

    NARCIS (Netherlands)

    Heideman, Wieke H.; de Wit, Maartje; Middelkoop, Barend J. C.; Nierkens, Vera; Stronks, Karien; Verhoeff, Arnoud P.; Snoek, Frank J.

    2015-01-01

    To test the efficacy of a low-intensive lifestyle education program (DiAlert) for overweight first degree relatives of type 2 diabetes patients aimed at reducing diabetes risk. Overweight first degree relatives of type 2 diabetes patients were randomly assigned to the DiAlert intervention (N=45) or

  6. Reduction of microalbuminuria by using losartan in normotensive patients with type 2 diabetes mellitus: A randomized controlled trial

    International Nuclear Information System (INIS)

    Agha, Adnan; Amer, Wasim; Anwar, Eram; Bashir, Kaukab

    2009-01-01

    Type 2 diabetes mellitus (T2DM) is a worldwide pandemic that may lead to diabetic kidney disease (DKD), a complication which is the single most important and globally prevalent cause of chronic kidney disease. Microalbuminuria has been shown to be an early indicator of DKD and data suggest that angiotensin receptor blockers (ARBs) reduce urinary albumin excretion and retard the progression of renal disease in hypertensive T2DM patients. However, the effects of ARBs on preventing microalbuminuria and ensuing DKD in normotensive patients with T2DM is yet to be fully established. The objective of this study is to assess the anti-microalbuminuric effects of losartan therapy versus placebo in normotensive T2DM patients. This randomized single blinded controlled trial was performed at the Diabetic Clinic, Jinnah Hospital, Lahore over a period of 10 months. A total of 361 normotensive patients with T2DM and microalbuminuria were selected; of them, 171 patients were randomly allocated to the test group and 190 enrolled into the control group. The patients in the test group were started on losartan 50 mg/day for a six month period while those in the control group were put on vitamin B-12 500 mcg/day. The patients as well as the primary attending physicians/lab evaluators were blinded to the study. All study patients were followed up on a monthly basis. Quantitative microalbuminuria was tested at the beginning and at the end of the study. Out of the 171 patients in the test group, 149 (87.1%) had significant reduction of albuminuria by > 30% of their baseline (mean 101.9 +- 21.7 baseline and, 47.5 + - 12.9 post-therapy). The corresponding values for albuminuria in the 190 patients in the control group was mean 104.7 +- 26.3 baseline and post 6-month mean 103.9 +- 22.9, with P< 0.0001. The anti-albuminuric effect of losartan was reversible as seen on re-checking the urinary albumin two months after discontinuation of treatment. Our study shows that losartan was well tolerated

  7. Perceptions of similarity and response to selected comparison targets in type 2 diabetes.

    Science.gov (United States)

    Arigo, Danielle; Smyth, Joshua M; Suls, Jerry M

    2015-01-01

    Social comparisons (i.e. self-evaluations relative to others) may affect motivation for diabetes self-care behaviours. Comparisons can have either positive or negative effects, but it is not clear what differentiates these responses. This study tested the effect of a patient's perceived similarity to a comparison target on motivation for self-care. Individuals with type 2 diabetes (n = 180, MA1c = 7.59%) selected to read one of four brief descriptions of a patient with diabetes. Participants rated their motivation for self-care behaviours prior and subsequent to reading and reported the extent to which they focused on similarities between the self and the selected patient while reading. Perceived similarity moderated the effect of selection on motivation for self-care (p = .01, η2 = .06). Increased motivation was observed if participants focused on similarities with patients 'doing better' (i.e. high coping effectiveness/low symptom severity) and decreased motivation if they focused on similarities with patients 'doing worse' (low coping effectiveness/high symptom severity). Providing social comparison information in diabetes management (and perhaps other chronic diseases) may improve motivation for self-care among some patients. A subset of patients, however, may benefit from guidance to focus on similarities with certain targets.

  8. Interference-aware random beam selection schemes for spectrum sharing systems

    KAUST Repository

    Abdallah, Mohamed; Qaraqe, Khalid; Alouini, Mohamed-Slim

    2012-01-01

    users. In this work, we develop interference-aware random beam selection schemes that provide enhanced performance for the secondary network under the condition that the interference observed by the receivers of the primary network is below a

  9. Assessing the accuracy and stability of variable selection methods for random forest modeling in ecology

    Science.gov (United States)

    Random forest (RF) modeling has emerged as an important statistical learning method in ecology due to its exceptional predictive performance. However, for large and complex ecological datasets there is limited guidance on variable selection methods for RF modeling. Typically, e...

  10. Size- and charge selectivity of glomerular filtration in Type 1 (insulin-dependent) diabetic patients with and without albuminuria

    DEFF Research Database (Denmark)

    Deckert, T; Kofoed-Enevoldsen, A; Vidal, P

    1993-01-01

    Albuminuria is the first clinical event in the development of diabetic nephropathy. We assessed glomerular charge- and size selectivity in 51 patients with Type 1 (insulin-dependent) diabetes mellitus of juvenile onset and 11 healthy individuals. Patients were allocated to five groups. The urinary...... techniques and tubular protein reabsorption by excretion of beta 2-microglobulin. Charge selectivity was estimated from the IgG/IgG4 selectivity index. Size selectivity was measured by dextran clearance. Dextran was measured by refractive index detection after fractionation (2 A fractions in the range 26...... macromolecular pathways in the development of diabetic nephropathy....

  11. Practical Telemedicine for Veterans with Persistently Poor Diabetes Control: A Randomized Pilot Trial.

    Science.gov (United States)

    Crowley, Matthew J; Edelman, David; McAndrew, Ann T; Kistler, Susan; Danus, Susanne; Webb, Jason A; Zanga, Joseph; Sanders, Linda L; Coffman, Cynthia J; Jackson, George L; Bosworth, Hayden B

    2016-05-01

    Telemedicine-based diabetes management improves outcomes versus clinic care but is seldom implemented by healthcare systems. In order to advance telemedicine-based management as a practical option for veterans with persistent poorly controlled diabetes mellitus (PPDM) despite clinic-based care, we evaluated a comprehensive telemedicine intervention that we specifically designed for delivery using existing Veterans Health Administration (VHA) clinical staffing and equipment. We conducted a 6-month randomized trial among 50 veterans with PPDM; all maintained hemoglobin A1c (HbA1c) levels continuously >9.0% for >1 year despite clinic-based management. Participants received usual care or a telemedicine intervention combining telemonitoring, medication management, self-management support, and depression management; existing VHA clinical staff delivered the intervention. Using linear mixed models, we examined HbA1c, diabetes self-care (measured by the Self-Care Inventory-Revised questionnaire), depression, and blood pressure. At baseline, the model-estimated common HbA1c intercept was 10.5%. By 6 months, estimated HbA1c had improved by 1.3% for intervention participants and 0.3% for usual care (estimated difference, -1.0%, 95% confidence interval [CI], -2.0%, 0.0%; p = 0.050). Intervention participants' diabetes self-care (estimated difference, 7.0; 95% CI, 0.1, 14.0; p = 0.047), systolic blood pressure (-7.7 mm Hg; 95% CI, -14.8, -0.6; p = 0.035), and diastolic blood pressure (-5.6 mm Hg; 95% CI, -9.9, -1.2; p = 0.013) were improved versus usual care by 6 months. Depressive symptoms were similar between groups. A comprehensive telemedicine intervention improved outcomes among veterans with PPDM despite clinic-based care. Because we specifically designed this intervention with scalability in mind, it may represent a practical, real-world strategy to reduce the burden of poor diabetes control among veterans.

  12. The Comparative Effectiveness of Diabetes Prevention Strategies to Reduce Postpartum Weight Retention in Women With Gestational Diabetes Mellitus: The Gestational Diabetes' Effects on Moms (GEM) Cluster Randomized Controlled Trial.

    Science.gov (United States)

    Ferrara, Assiamira; Hedderson, Monique M; Brown, Susan D; Albright, Cheryl L; Ehrlich, Samantha F; Tsai, Ai-Lin; Caan, Bette J; Sternfeld, Barbara; Gordon, Nancy P; Schmittdiel, Julie A; Gunderson, Erica P; Mevi, Ashley A; Herman, William H; Ching, Jenny; Crites, Yvonne; Quesenberry, Charles P

    2016-01-01

    To compare the effectiveness of diabetes prevention strategies addressing postpartum weight retention for women with gestational diabetes mellitus (GDM) delivered at the health system level: mailed recommendations (usual care) versus usual care plus a Diabetes Prevention Program (DPP)-derived lifestyle intervention. This study was a cluster randomized controlled trial of 44 medical facilities (including 2,280 women with GDM) randomized to intervention or usual care. The intervention included mailed gestational weight gain recommendations plus 13 telephone sessions between 6 weeks and 6 months postpartum. Primary outcomes included the following: proportion meeting the postpartum goals of 1) reaching pregravid weight if pregravid BMI Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

  13. The mathematics of random mutation and natural selection for multiple simultaneous selection pressures and the evolution of antimicrobial drug resistance.

    Science.gov (United States)

    Kleinman, Alan

    2016-12-20

    The random mutation and natural selection phenomenon act in a mathematically predictable behavior, which when understood leads to approaches to reduce and prevent the failure of the use of these selection pressures when treating infections and cancers. The underlying principle to impair the random mutation and natural selection phenomenon is to use combination therapy, which forces the population to evolve to multiple selection pressures simultaneously that invoke the multiplication rule of probabilities simultaneously as well. Recently, it has been seen that combination therapy for the treatment of malaria has failed to prevent the emergence of drug-resistant variants. Using this empirical example and the principles of probability theory, the derivation of the equations describing this treatment failure is carried out. These equations give guidance as to how to use combination therapy for the treatment of cancers and infectious diseases and prevent the emergence of drug resistance. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  14. Efficacy of Cellular Therapy for Diabetic Foot Ulcer: A Meta-Analysis of Randomized Controlled Clinical Trials.

    Science.gov (United States)

    Zhang, Ye; Deng, Hong; Tang, Zhouping

    2017-12-01

    Diabetes mellitus is a widely spread chronic disease with growing incidence worldwide, and diabetic foot ulcer is one of the most serious complications of diabetes. Cellular therapy has shown promise in the management of diabetic foot ulcer in many preclinical experiments and clinical researches. Here, we performed a meta-analysis to evaluate the efficacy and safety of cellular therapy in the management of diabetic foot ulcer. We systematically searched PubMed, MEDLINE, EMBASE, and Cochrane Library databases from inception to May 2017 for randomized controlled trials assessing the efficacy of cellular therapy in diabetic foot ulcer, and a meta-analysis was conducted. A total of 6 randomized controlled clinical trials involving 241 individuals were included in this meta-analysis. The results suggested that cellular therapy could help accelerating the healing of diabetic foot ulcer, presented as higher ankle-brachial index (mean difference = 0.17, 95% confidence interval [CI] = 0.11 to 0.23), higher transcutaneous oxygen pressure (standardized mean difference [SMD] = 1.43; 95% CI, 1.09- to 1.78), higher ulcer healing rate (relative risk [RR] = 1.78; 95% CI, 1.41 to 2.25), higher amputation-free survival (RR = 1.25; 95% CI, 1.11 to 1.40), and lower scale of pain (SMD = -1.69; 95% CI, -2.05 to -1.33). Furthermore, cellular therapy seemed to be safe, with no serious complications and low risk of short-term slight complications. Cellular therapy could accelerate the rate of diabetic foot ulcer healing and may be more efficient than standard therapy for diabetic foot treatment.

  15. Acceptance sampling using judgmental and randomly selected samples

    Energy Technology Data Exchange (ETDEWEB)

    Sego, Landon H.; Shulman, Stanley A.; Anderson, Kevin K.; Wilson, John E.; Pulsipher, Brent A.; Sieber, W. Karl

    2010-09-01

    We present a Bayesian model for acceptance sampling where the population consists of two groups, each with different levels of risk of containing unacceptable items. Expert opinion, or judgment, may be required to distinguish between the high and low-risk groups. Hence, high-risk items are likely to be identifed (and sampled) using expert judgment, while the remaining low-risk items are sampled randomly. We focus on the situation where all observed samples must be acceptable. Consequently, the objective of the statistical inference is to quantify the probability that a large percentage of the unsampled items in the population are also acceptable. We demonstrate that traditional (frequentist) acceptance sampling and simpler Bayesian formulations of the problem are essentially special cases of the proposed model. We explore the properties of the model in detail, and discuss the conditions necessary to ensure that required samples sizes are non-decreasing function of the population size. The method is applicable to a variety of acceptance sampling problems, and, in particular, to environmental sampling where the objective is to demonstrate the safety of reoccupying a remediated facility that has been contaminated with a lethal agent.

  16. Associations among comorbid anxiety, psychiatric symptomatology, and diabetic control in a population with serious mental illness and diabetes: Findings from an interventional randomized controlled trial.

    Science.gov (United States)

    Aftab, Awais; Bhat, Chetan; Gunzler, Douglas; Cassidy, Kristin; Thomas, Charles; McCormick, Richard; Dawson, Neal V; Sajatovic, Martha

    2018-05-01

    Objective Serious mental illness and type II diabetes mellitus have a high comorbidity, and both have a higher prevalence of anxiety disorders compared to the general population. Targeted Training in Illness Management is a group-based self-management training approach which targets serious mental illness and type II diabetes mellitus concurrently. This analysis examines data from a randomized controlled trial of Targeted Training in Illness Management intervention to examine the impact of comorbid anxiety on baseline psychiatric symptomatology and diabetic control, and on longitudinal treatment outcomes. Methods We conducted secondary analyses on data from a prospective, 60-week, randomized controlled trial testing Targeted Training in Illness Management versus treatment as usual in 200 individuals with serious mental illness and diabetes. Primary outcomes included measures related to serious mental illness symptoms, functional status, general health status, and diabetes control. Measures were compared between those participants with anxiety disorders versus those without anxiety at baseline as well as over time using linear mixed effects analyses. Results Forty seven percent of the participants had one or more anxiety disorders. At baseline, those with an anxiety diagnosis had higher illness severity, depressive, and other psychiatric symptomatology and disability. Diabetic control (HbA1c) was not significantly different at baseline. In the longitudinal analyses, no significant mean slope differences over time (group-by-time interaction effect) between those with anxiety diagnoses and those without in treatment as usual group were found for primary outcomes. Within the Targeted Training in Illness Management arm, those with anxiety disorders had significantly greater improvement in mental health functioning. Those with anxiety comorbidity in the Targeted Training in Illness Management group demonstrated significantly lower HbA1c levels compared to no anxiety

  17. Outcomes of combined cardiovascular risk factor management strategies in type 2 diabetes: the ACCORD randomized trial.

    Science.gov (United States)

    Margolis, Karen L; O'Connor, Patrick J; Morgan, Timothy M; Buse, John B; Cohen, Robert M; Cushman, William C; Cutler, Jeffrey A; Evans, Gregory W; Gerstein, Hertzel C; Grimm, Richard H; Lipkin, Edward W; Narayan, K M Venkat; Riddle, Matthew C; Sood, Ajay; Goff, David C

    2014-06-01

    To compare effects of combinations of standard and intensive treatment of glycemia and either blood pressure (BP) or lipids in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. ACCORD enrolled 10,251 type 2 diabetes patients aged 40-79 years at high risk for cardiovascular disease (CVD) events. Participants were randomly assigned to hemoglobin A1c goals of risk of the primary outcome was lower in the groups intensively treated for glycemia (hazard ratio [HR] 0.67; 95% CI 0.50-0.91), BP (HR 0.74; 95% CI 0.55-1.00), or both (HR 0.71; 95% CI 0.52-0.96) compared with combined standard BP and glycemia treatment. For secondary outcomes, MI was significantly reduced by intensive glycemia treatment and stroke by intensive BP treatment; most other HRs were neutral or favored intensive treatment groups. In the lipid trial, the general pattern of results showed no evidence of benefit of intensive regimens (whether single or combined) compared with combined standard lipid and glycemia treatment. The mortality HR was 1.33 (95% CI 1.02-1.74) in the standard lipid/intensive glycemia group compared with the standard lipid/standard glycemia group. In the ACCORD BP trial, compared with combined standard treatment, intensive BP or intensive glycemia treatment alone improved major CVD outcomes, without additional benefit from combining the two. In the ACCORD lipid trial, neither intensive lipid nor glycemia treatment produced an overall benefit, but intensive glycemia treatment increased mortality. © 2014 by the American Diabetes Association.

  18. 40 CFR 761.308 - Sample selection by random number generation on any two-dimensional square grid.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Sample selection by random number... § 761.79(b)(3) § 761.308 Sample selection by random number generation on any two-dimensional square... area created in accordance with paragraph (a) of this section, select two random numbers: one each for...

  19. A randomized controlled trial to prevent glycemic relapse in longitudinal diabetes care: Study protocol (NCT00362193

    Directory of Open Access Journals (Sweden)

    Davis Dianne

    2006-10-01

    Full Text Available Abstract Background Diabetes is a common disease with self-management a key aspect of care. Large prospective trials have shown that maintaining glycated hemoglobin less than 7% greatly reduces complications but translating this level of control into everyday clinical practice can be difficult. Intensive improvement programs are successful in attaining control in patients with type 2 diabetes, however, many patients experience glycemic relapse once returned to routine care. This early relapse is, in part, due to decreased adherence in self-management behaviors. Objective This paper describes the design of the Glycemic Relapse Prevention study. The purpose of this study is to determine the optimal frequency of maintenance intervention needed to prevent glycemic relapse. The primary endpoint is glycemic relapse, which is defined as glycated hemoglobin greater than 8% and an increase of 1% from baseline. Methods The intervention consists of telephonic contact by a nurse practitioner with a referral to a dietitian if indicated. This intervention was designed to provide early identification of self-care problems, understanding the rationale behind the self-care lapse and problem solve to find a negotiated solution. A total of 164 patients were randomized to routine care (least intensive, routine care with phone contact every three months (moderate intensity or routine care with phone contact every month (most intensive. Conclusion The baseline patient characteristics are similar across the treatment arms. Intervention fidelity analysis showed excellent reproducibility. This study will provide insight into the important but poorly understood area of glycemic relapse prevention.

  20. A randomized, controlled clinical trial of honey-impregnated dressing for treating diabetic foot ulcer

    International Nuclear Information System (INIS)

    Imran, M.

    2015-01-01

    To investigate the effect of Beri-honey-impregnated dressing on diabetic foot ulcer and compare it with normal saline dressing. Study Design: A randomized, controlled trial. Place and Duration of Study: Sughra Shafi Medical Complex, Narowal, Pakistan and Bhatti International Trust (BIT) Hospital, Affiliated with Central Park Medical College, Lahore, from February 2006 to February 2010. Methodology: Patients with Wagner's grade 1 and 2 ulcers were enrolled. Those patients were divided in two groups; group A (n=179) treated with honey dressing and group B (n=169) treated with normal saline dressing. Outcome measures were calculated in terms of proportion of wounds completely healed (primary outcome), wound healing time, and deterioration of wounds. Patients were followed-up for a maximum of 120 days. Results: One hundred and thirty six wounds (75.97%) out of 179 were completely healed with honey dressing and 97 (57.39%) out of 169 wtih saline dressing (p=0.001). The median wound healing time was 18.00 (6 - 120) days (Median with IQR) in group A and 29.00 (7 - 120) days (Median with IQR) in group B (p < 0.001). Conclusion: The present results showed that honey is an effective dressing agent instead of conventional dressings, in treating patients of diabetic foot ulcer. (author)

  1. Obesity indices and haemodynamic response to exercise in obese diabetic hypertensive patients: Randomized controlled trial.

    Science.gov (United States)

    Abdelaal, Ashraf Abdelaal Mohamed; Mohamad, Mohamad Ali

    2015-01-01

    Obesity, diabetes and hypertension are major worldwide interconnected problems. The aim of this study was to investigate body mass index (BMI), waist circumference (WC), systolic and diastolic blood pressure (SBP and DPB) responses to circuit weight training (CWT) or aerobic exercise training (AET) in obese diabetic hypertensive patients (ODHP). Fifty-nine ODHP were randomly assigned into CWT, AET and control groups. Either CWT or AET was performed thrice weekly for 12 weeks. Variables were evaluated pre-training (evaluation-1), after 3 months (evaluation-2) and 1 month post-training cessation (evaluation-3). At evaluation-2, BMI, WC, SBP, DBP mean values and percentages of decrease were 31.56±1.48 (9.23%), 104±5.97 (6.2%), 141±2.2 (3.09%), 91.2±1.24 (2.98%) and 32.09±1.21 (7.11%), 107.66±3.92 (3.07%), 138.3±1.17 (4.79%), 88.05±1.05 (6.02%) for CWT and AET groups respectively (Pobesity indices, AET is still the best intervention to lower blood pressure in ODHP, for a more extended period of time. Copyright © 2014 Asian Oceanian Association for the Study of Obesity. Published by Elsevier Ltd. All rights reserved.

  2. Glomerular size- and charge selectivity in type 2 (non-insulin-dependent) diabetic patients with diabetic nephropathy

    DEFF Research Database (Denmark)

    Gall, M A; Rossing, P; Kofoed-Enevoldsen, A

    1994-01-01

    In an attempt to evaluate the mechanisms of proteinuria in diabetic kidney disease, we measured the renal clearances of albumin, total IgG, and IgG4 in 20 male Type 2 (non-insulin-dependent) diabetic patients with diabetic glomerulosclerosis (biopsy proven), in 10 male Type 2 diabetic patients...

  3. A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes

    DEFF Research Database (Denmark)

    Hod, Moshe; Mathiesen, Elisabeth R; Jovanovič, Lois

    2014-01-01

    OBJECTIVE: This randomized controlled trial aimed to compare the efficacy and safety of insulin detemir (IDet) with neutral protamine Hagedorn (NPH), both with insulin aspart, in pregnant women with type 1 diabetes. The perinatal and obstetric pregnancy outcomes are presented. METHODS: Subjects w...

  4. Improving Diabetes Care and Health Measures among Hispanics Using Community Health Workers: Results from a Randomized Controlled Trial

    Science.gov (United States)

    Babamoto, Kenneth S.; Sey, Kwa A.; Camilleri, Angela J.; Karlan, Vicki J.; Catalasan, Joana; Morisky, Donald E.

    2009-01-01

    The increasing prevalence of diabetes and obesity, growing health disparities, and shortage of bilingual and culturally trained health care professionals underscore the role of trained community health workers (CHWs) to provide economically sustainable and culturally relevant services. This prospective randomized design evaluated the relative…

  5. Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial.

    Science.gov (United States)

    Mash, Bob; Levitt, Naomi; Steyn, Krisela; Zwarenstein, Merrick; Rollnick, Stephen

    2012-12-24

    Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33% have been recorded in Cape Town. Previous studies show that quality of care and health outcomes are poor. The development of an effective education programme should impact on self-care, lifestyle change and adherence to medication; and lead to better control of diabetes, fewer complications and better quality of life. Pragmatic cluster randomized controlled trialParticipants: Type 2 diabetic patients attending 45 public sector community health centres in Cape TownInterventions: The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style. The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room. To evaluate the effectiveness of the group diabetes education programmeOutcomes: diabetes self-care activities, 5% weight loss, 1% reduction in HbA1c. self-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c, mean total cholesterol, quality of lifeRandomisation: Computer generated random numbersBlinding: Patients, health promoters and research assistants could not be blinded to the health centre's allocationNumbers randomized: Seventeen health centres (34 in total) will be randomly assigned to either control or intervention groups. A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80% to detect the primary outcomes with 5% precision. Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570. The study will inform policy makers and managers of the district health system, particularly in low to middle income countries, if this programme can be implemented more widely. Pan African Clinical Trial Registry PACTR201205000380384.

  6. Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial

    Directory of Open Access Journals (Sweden)

    Mash Bob

    2012-12-01

    Full Text Available Abstract Background Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33% have been recorded in Cape Town. Previous studies show that quality of care and health outcomes are poor. The development of an effective education programme should impact on self-care, lifestyle change and adherence to medication; and lead to better control of diabetes, fewer complications and better quality of life. Methods Trial design: Pragmatic cluster randomized controlled trial Participants: Type 2 diabetic patients attending 45 public sector community health centres in Cape Town Interventions: The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style. The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room. Objective: To evaluate the effectiveness of the group diabetes education programme Outcomes: Primary outcomes: diabetes self-care activities, 5% weight loss, 1% reduction in HbA1c. Secondary outcomes: self-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c, mean total cholesterol, quality of life Randomisation: Computer generated random numbers Blinding: Patients, health promoters and research assistants could not be blinded to the health centre’s allocation Numbers randomized: Seventeen health centres (34 in total will be randomly assigned to either control or intervention groups. A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80% to detect the primary outcomes with 5% precision. Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570. Discussion The study will inform policy makers and managers of the district health system, particularly in low to middle income countries, if this programme can

  7. Technology-Intensified Diabetes Education Study (TIDES) in African Americans with type 2 diabetes: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Williams, Joni S; Lynch, Cheryl P; Knapp, Rebecca G; Egede, Leonard E

    2014-11-25

    Compared to American Whites, African Americans have a higher prevalence of type 2 diabetes mellitus (T2DM), experiencing poorer metabolic control and greater risks for complications and death. Patient-level factors, such as diabetes knowledge, self-management skills, empowerment, and perceived control, account for >90% of the variance observed in outcomes between these racial groups. There is strong evidence that self-management interventions that include telephone-delivered diabetes education and skills training are effective at improving metabolic control in diabetes. Web-based home telemonitoring systems in conjunction with active care management are also effective ways to lower glycosylated hemoglobin A1c values when compared to standard care, and provide feedback to patients; however, there are no studies in African Americans with poorly controlled T2DM that examine the use of technology-based feedback to tailor or augment diabetes education and skills training. This study provides a unique opportunity to address this gap in the literature. We describe an ongoing 4-year randomized clinical trial, which will test the efficacy of a technology-intensified diabetes education and skills training (TIDES) intervention in African Americans with poorly controlled T2DM. Two hundred male and female AfricanAmerican participants, 21 years of age or older and with a glycosylated hemoglobin A1c level ≥ 8%, will be randomized into one of two groups for 12 weeks of telephone interventions: (1) TIDES intervention group or (2) a usual-care group. Participants will be followed for 12 months to ascertain the effect of the interventions on glycemic control. Our primary hypothesis is that, among African Americans with poorly controlled T2DM, patients randomized to the TIDES intervention will have significantly greater reduction in glycosylated hemoglobin A1c at 12 months of follow-up compared to the usual-care group. Results from this study will add to the current literature

  8. Metformin versus insulin in gestational diabetes mellitus: a meta-analysis of randomized clinical trials.

    Science.gov (United States)

    Zhu, B; Zhang, L; Fan, Y Y; Wang, L; Li, X G; Liu, T; Cao, Y S; Zhao, Z G

    2016-05-01

    Metformin is widely used in treatment of type 2 diabetes. However, whether it is safe for use in pregnancy is controversial. A search for relevant studies were performed using PubMed (1948-2014), Embase (1974-2014), the Web of knowledge (1950-2014), and the Cochrane database, included all randomized control trials published in English. Eight RCTs (1712 patients with gestational diabetes mellitus) were retrieved; of those 853 patients were given metformin, and 859 patients were given insulin. Our results showed that metformin does not increase risk of prematurity (RR = 1.26; 95 % CI [0.89, 1.79], P = 0.19). In addition, metformin can either decrease the total weight gain [MD = -1.49, 95 % CI (-2.66, -0.31), P = 0.01] or weight gain after randomization [MD = -1.23, 95 % CI (-1.75, -0.71), P metformin also significantly decreased the risk of neonatal hypoglycemia [RR = 0.58, 95 % CI (0.43, 0.78), P = 0.0003] and admission rates to neonatal intensive care units [RR = 0.74, 95 % CI (0.61, 0.89), P = 0.002]. No other adverse effects were observed, such as hyperbilirubinaemia [RR = 0.83, 95 % CI (0.64, 1.08), P = 0.16], large for gestational age [RR = 0.85, 95 % CI (0.68, 1.05), P = 0.14], small for gestational age [RR = 0.92, 95 % CI (0.61, 1.39), P = 0.69], macrosomia [RR = 0.75, 95 % CI (0.54, 1.03), P = 0.07] or respiratory distress syndrome [RR = 0.88, 95 % CI (0.55, 1.41), P = 0.6]. Metformin may be beneficial in treating gestational diabetes. However, even more studies are needed to provide more evidence for the future use of metformin.

  9. Combined Interval Training and Post-exercise Nutrition in Type 2 Diabetes: A Randomized Control Trial

    Directory of Open Access Journals (Sweden)

    Monique E. Francois

    2017-07-01

    Full Text Available Background: High-intensity interval training (HIIT can improve several aspects of cardiometabolic health. Previous studies have suggested that adaptations to exercise training can be augmented with post-exercise milk or protein consumption, but whether this nutritional strategy can impact the cardiometabolic adaptations to HIIT in type 2 diabetes is unknown.Objective: To determine if the addition of a post-exercise milk or protein beverage to a high-intensity interval training (HIIT intervention improves cardiometabolic health in individuals with type 2 diabetes.Design: In a proof-of-concept, double-blind clinical trial 53 adults with uncomplicated type 2 diabetes were randomized to one of three nutritional beverages (500 mL skim-milk, macronutrient control, or flavored water placebo consumed after exercise (3 days/week during a 12 week low-volume HIIT intervention. HIIT involved 10 X 1-min high-intensity intervals separated by 1-min low-intensity recovery periods. Two sessions per week were cardio-based (at ~90% of heart rate max and one session involved resistance-based exercises (at RPE of 5–6; CR-10 scale in the same interval pattern. Continuous glucose monitoring (CGM, glycosylated hemoglobin (HbA1c, body composition (dual-energy X-ray absorptiometry, cardiorespiratory fitness (V˙O2peak, blood pressure, and endothelial function (%FMD were measured before and after the intervention.Results: There were significant main effects of time (all p < 0.05 but no difference between groups (Interaction: all p > 0.71 for CGM 24-h mean glucose (−0.5 ± 1.1 mmol/L, HbA1c (−0.2 ± 0.4%, percent body fat (−0.8 ± 1.6%, and lean mass (+1.1 ± 2.8 kg. Similarly, V˙O2peak (+2.5 ± 1.6 mL/kg/min and %FMD (+1.4 ± 1.9% were increased, and mean arterial blood pressure reduced (−6 ± 7 mmHg, after 12 weeks of HIIT (all p < 0.01 with no difference between beverage groups (Interaction: all p > 0.11.Conclusion: High-intensity interval training is a

  10. Combined Interval Training and Post-exercise Nutrition in Type 2 Diabetes: A Randomized Control Trial.

    Science.gov (United States)

    Francois, Monique E; Durrer, Cody; Pistawka, Kevin J; Halperin, Frank A; Chang, Courtney; Little, Jonathan P

    2017-01-01

    Background: High-intensity interval training (HIIT) can improve several aspects of cardiometabolic health. Previous studies have suggested that adaptations to exercise training can be augmented with post-exercise milk or protein consumption, but whether this nutritional strategy can impact the cardiometabolic adaptations to HIIT in type 2 diabetes is unknown. Objective: To determine if the addition of a post-exercise milk or protein beverage to a high-intensity interval training (HIIT) intervention improves cardiometabolic health in individuals with type 2 diabetes. Design: In a proof-of-concept, double-blind clinical trial 53 adults with uncomplicated type 2 diabetes were randomized to one of three nutritional beverages (500 mL skim-milk, macronutrient control, or flavored water placebo) consumed after exercise (3 days/week) during a 12 week low-volume HIIT intervention. HIIT involved 10 X 1-min high-intensity intervals separated by 1-min low-intensity recovery periods. Two sessions per week were cardio-based (at ~90% of heart rate max) and one session involved resistance-based exercises (at RPE of 5-6; CR-10 scale) in the same interval pattern. Continuous glucose monitoring (CGM), glycosylated hemoglobin (HbA 1c ), body composition (dual-energy X-ray absorptiometry), cardiorespiratory fitness ([Formula: see text]), blood pressure, and endothelial function (%FMD) were measured before and after the intervention. Results: There were significant main effects of time (all p 0.71) for CGM 24-h mean glucose (-0.5 ± 1.1 mmol/L), HbA 1c (-0.2 ± 0.4%), percent body fat (-0.8 ± 1.6%), and lean mass (+1.1 ± 2.8 kg). Similarly, [Formula: see text] (+2.5 ± 1.6 mL/kg/min) and %FMD (+1.4 ± 1.9%) were increased, and mean arterial blood pressure reduced (-6 ± 7 mmHg), after 12 weeks of HIIT (all p 0.11). Conclusion: High-intensity interval training is a potent stimulus for improving several important metabolic and cardiovascular risk factors in type 2 diabetes. The benefits

  11. Community-based randomized controlled trial of diabetes prevention study for high-risk individuals of type 2 diabetes: lifestyle intervention using web-based system.

    Science.gov (United States)

    Cha, Seon-Ah; Lim, Sun-Young; Kim, Kook-Rye; Lee, Eun-Young; Kang, Borami; Choi, Yoon-Hee; Yoon, Kun-Ho; Ahn, Yu-Bae; Lee, Jin-Hee; Ko, Seung-Hyun

    2017-05-05

    The trend of increasing numbers of patients with type 2 diabetes emphasizes the need for active screening of high-risk individuals and intensive lifestyle modification (LSM). The community-based Korean Diabetes Prevention Study (C-KDPS) is a randomized controlled clinical trial to prevent type 2 diabetes by intensive LSM using a web-based program. The two public healthcare centers in Korea are involved, and 420 subjects are being recruited for 6 months and will be followed up for 22 months. The participants are allocated randomly to intensive LSM (18 individual sessions for 24 weeks) and usual care (control group). The major goals of the C-KDPS lifestyle intervention program are: 1) a minimum of 5-7% loss of initial body weight in 6 months and maintenance of this weight loss, 2) increased physical activity (≥ 150 min/week of moderate intensity activity), 3) balanced healthy eating, and 4) quitting smoking and alcohol with stress management. The web-based program includes education contents, video files, visit schedules, and inter-communicable keeping track sites. Primary outcomes are the diagnoses of newly developed diabetes. A 75-g oral glucose tolerance test with hemoglobin A1c level determination and cardiovascular risk factor assessment is scheduled at 6, 12, 18, and 22 months. Active screening of high-risk individuals and an effective LSM program are an essential prerequisite for successful diabetes prevention. We hope that our C-KDPS program can reduce the incidence of newly developed type 2 diabetes and be implemented throughout the country, merging community-based public healthcare resources and a web-based system. Clinical Research Information Service (CRIS), Republic of Korea (No. KCT0001981 ). Date of registration; July 28, 2016.

  12. Community-based randomized controlled trial of diabetes prevention study for high-risk individuals of type 2 diabetes: lifestyle intervention using web-based system

    Directory of Open Access Journals (Sweden)

    Seon-Ah Cha

    2017-05-01

    Full Text Available Abstract Background The trend of increasing numbers of patients with type 2 diabetes emphasizes the need for active screening of high-risk individuals and intensive lifestyle modification (LSM. Methods/design The community-based Korean Diabetes Prevention Study (C-KDPS is a randomized controlled clinical trial to prevent type 2 diabetes by intensive LSM using a web-based program. The two public healthcare centers in Korea are involved, and 420 subjects are being recruited for 6 months and will be followed up for 22 months. The participants are allocated randomly to intensive LSM (18 individual sessions for 24 weeks and usual care (control group. The major goals of the C-KDPS lifestyle intervention program are: 1 a minimum of 5–7% loss of initial body weight in 6 months and maintenance of this weight loss, 2 increased physical activity (≥ 150 min/week of moderate intensity activity, 3 balanced healthy eating, and 4 quitting smoking and alcohol with stress management. The web-based program includes education contents, video files, visit schedules, and inter-communicable keeping track sites. Primary outcomes are the diagnoses of newly developed diabetes. A 75-g oral glucose tolerance test with hemoglobin A1c level determination and cardiovascular risk factor assessment is scheduled at 6, 12, 18, and 22 months. Discussion Active screening of high-risk individuals and an effective LSM program are an essential prerequisite for successful diabetes prevention. We hope that our C-KDPS program can reduce the incidence of newly developed type 2 diabetes and be implemented throughout the country, merging community-based public healthcare resources and a web-based system. Trial registration Clinical Research Information Service (CRIS, Republic of Korea (No. KCT0001981 . Date of registration; July 28, 2016.

  13. Comparison of low- and high-carbohydrate diets for type 2 diabetes management: a randomized trial.

    Science.gov (United States)

    Tay, Jeannie; Luscombe-Marsh, Natalie D; Thompson, Campbell H; Noakes, Manny; Buckley, Jonathan D; Wittert, Gary A; Yancy, William S; Brinkworth, Grant D

    2015-10-01

    Few well-controlled studies have comprehensively examined the effects of very-low-carbohydrate diets on type 2 diabetes (T2D). We compared the effects of a very-low-carbohydrate, high-unsaturated fat, low-saturated fat (LC) diet with a high-carbohydrate, low-fat (HC) diet on glycemic control and cardiovascular disease risk factors in T2D after 52 wk. In this randomized controlled trial that was conducted in an outpatient research clinic, 115 obese adults with T2D [mean ± SD age: 58 ± 7 y; body mass index (in kg/m(2)): 34.6 ± 4.3; glycated hemoglobin (HbA1c): 7.3 ± 1.1%; duration of diabetes: 8 ± 6 y] were randomly assigned to consume either a hypocaloric LC diet [14% of energy as carbohydrate (carbohydrate fasting blood glucose, glycemic variability assessed with use of 48-h continuous glucose monitoring, diabetes medication, weight, blood pressure, and lipids assessed at baseline, 24, and 52 wk. Both groups achieved similar completion rates (LC diet: 71%; HC diet: 65%) and mean (95% CI) reductions in weight [LC diet: -9.8 kg (-11.7, -7.9 kg); HC diet: -10.1 kg (-12.0, -8.2 kg)], blood pressure [LC diet: -7.1 (-10.6, -3.7)/-6.2 (-8.2, -4.1) mm Hg; HC diet: -5.8 (-9.4, -2.2)/-6.4 (-8.4, -4.3) mm Hg], HbA1c [LC diet: -1.0% (-1.2%, -0.7%); HC diet: -1.0% (-1.3%, -0.8%)], fasting glucose [LC diet: -0.7 mmol/L (-1.3, -0.1 mmol/L); HC diet: -1.5 mmol/L (-2.1, -0.8 mmol/L)], and LDL cholesterol [LC diet: -0.1 mmol/L (-0.3, 0.1 mmol/L); HC diet: -0.2 mmol/L (-0.4, 0.03 mmol/L)] (P-diet effect ≥ 0.10). Compared with the HC-diet group, the LC-diet group achieved greater mean (95% CI) reductions in the diabetes medication score [LC diet: -0.5 arbitrary units (-0.7, -0.4 arbitrary units); HC diet: -0.2 arbitrary units (-0.4, -0.06 arbitrary units); P = 0.02], glycemic variability assessed by measuring the continuous overall net glycemic action-1 [LC diet: -0.5 mmol/L (-0.6, -0.3 mmol/L); HC diet: -0.05 mmol/L (-0.2, -0.1 mmol/L); P = 0.003], and triglycerides [LC diet

  14. Hypoglycemic effect of triphala on selected non insulin dependent Diabetes mellitus subjects

    OpenAIRE

    Rajan, Sowmya S.; Antony, Seema

    2008-01-01

    Modern life style is characterized by high stress, increased automation, junk food consumption and sedentary life style which have lead to the incidence of Diabetes. The study involved selection of NIDDM subjects who were supplemented with Triphala powder called, The Three Myrobalans ( Terminalia bellirica - Belliric myrobalan, Terminalia chebula -Inknut, Embilica officinalis - Indian gooseberry) for a period of 45 days. Statistical evaluation of the blood profile showed significant reduction...

  15. Effectiveness and cost-effectiveness of knowledge transfer and behavior modification interventions in type 2 diabetes mellitus patients--the INDICA study: a cluster randomized controlled trial.

    Science.gov (United States)

    Ramallo-Fariña, Yolanda; García-Pérez, Lidia; Castilla-Rodríguez, Iván; Perestelo-Pérez, Lilisbeth; Wägner, Ana María; de Pablos-Velasco, Pedro; Domínguez, Armando Carrillo; Cortés, Mauro Boronat; Vallejo-Torres, Laura; Ramírez, Marcos Estupiñán; Martín, Pablo Pedrianes; García-Puente, Ignacio; Salinero-Fort, Miguel Ángel; Serrano-Aguilar, Pedro Guillermo

    2015-04-09

    Type 2 diabetes mellitus is a chronic disease whose health outcomes are related to patients and healthcare professionals' decision-making. The Diabetes Intervention study in the Canary Islands (INDICA study) aims to evaluate the effectiveness and cost-effectiveness of educational interventions supported by new technology decision tools for type 2 diabetes patients and primary care professionals in the Canary Islands. The INDICA study is an open, community-based, multicenter, clinical controlled trial with random allocation by clusters to one of three interventions or to usual care. The setting is primary care where physicians and nurses are invited to participate. Patients with diabetes diagnosis, 18-65 years of age, and regular users of mobile phone were randomly selected. Patients with severe comorbidities were excluded. The clusters are primary healthcare practices with enough professionals and available places to provide the intervention. The calculated sample size was 2,300 patients. Patients in group 1 are receiving an educational group program of eight sessions every 3 months led by trained nurses and monitored by means of logs and a web-based platform and tailored semi-automated SMS for continuous support. Primary care professionals in group 2 are receiving a short educational program to update their diabetes knowledge, which includes a decision support tool embedded into the electronic clinical record and a monthly feedback report of patients' results. Group 3 is receiving a combination of the interventions for patients and professionals. The primary endpoint is the change in HbA1c in 2 years. Secondary endpoints are cardiovascular risk factors, macrovascular and microvascular diabetes complications, quality of life, psychological outcomes, diabetes knowledge, and healthcare utilization. Data is being collected from interviews, questionnaires, clinical examinations, and records. Generalized linear mixed models with repeated time measurements will be used

  16. Metformin compared with insulin in the management of gestational diabetes mellitus: a randomized clinical trial.

    Science.gov (United States)

    Niromanesh, Shirin; Alavi, Azin; Sharbaf, Fatemeh Rahimi; Amjadi, Nooshin; Moosavi, Sanaz; Akbari, Soheila

    2012-12-01

    To evaluate the effect of metformin and insulin in glycemic control and compare pregnancy outcome in women with gestational diabetes mellitus (GDM). This randomized controlled trial was conducted in GDM women with singleton pregnancy and gestational age between 20 and 34 weeks who did not achieve glycemic control on diet were assigned randomly to receive either metformin (n=80) or insulin (n=80). The primary outcomes were maternal glycemic control and birth weight. The secondary outcomes were neonatal and obstetric complications. Two groups were comparable regarding the maternal characteristics. Two groups were similar in mean FBS (P=0.68) and postprandial measurements (P=0.87) throughout GDM treatment. The neonates of metformin group had less rate of birth weight centile >90 than insulin group (RR: 0.5, 95% CI: 0.3-0.9, P=0.012). Maternal weight gain was reduced in the metformin group (P0.05). In metformin group 14% of women needed to supplemental insulin to achieve euglycemia. Metformin is an effective and safe alternative treatment to insulin for women with GDM. This study does not show significant risk of maternal or neonatal adverse outcome with the use of metformin. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  17. [Chromium supplementation in patients with type 2 diabetes and high risk of type 2 diabetes: a meta-analysis of randomized controlled trials].

    Science.gov (United States)

    San Mauro-Martin, Ismael; Ruiz-León, Ana María; Camina-Martín, María Alicia; Garicano-Vilar, Elena; Collado-Yurrita, Luis; Mateo-Silleras, Beatriz de; Redondo Del Río, María De Paz

    2016-02-16

    Chromium is an essential trace mineral for carbohydrate and lipid metabolism, which is currently prescribed to control diabetes mellitus. Results of previous systematic reviews and meta-analyses of chromium supplementation and metabolic profiles in diabetes have been inconsistent. The objective of this meta-analysis was to assess the effects on metabolic profiles and safety of chromium supplementation in type 2 diabetes mellitus and cholesterol. Literature searches in PubMed, Scopus and Web of Science were made by use of related terms-keywords and randomized clinical trials during the period of 2000-2014. Thirteen trials fulfilled the inclusion criteria and were included in this systematic review. Total doses of Cr supplementation and brewer's yeast ranged from 42 to 1,000 μg/day, and duration of supplementation ranged from 30 to 120 days. The analysis indicated that there was a significant effect of chromium supplementation in diabetics on fasting plasma glucose with a weighted average effect size of -29.26 mg/dL, p = 0.01, CI 95% = -52.4 to -6.09; and on total cholesterol with a weighted average effect size of -6.7 mg/dL, p = 0.01, CI 95% = -11.88 to -1.53. The available evidence suggests favourable effects of chromium supplementation on glycaemic control in patients with diabetes.

  18. The Diabetes Manual trial protocol – a cluster randomized controlled trial of a self-management intervention for type 2 diabetes [ISRCTN06315411

    Directory of Open Access Journals (Sweden)

    Dale Jeremy

    2006-07-01

    Full Text Available Abstract Background The Diabetes Manual is a type 2 diabetes self-management programme based upon the clinically effective 'Heart Manual'. The 12 week programme is a complex intervention theoretically underpinned by self-efficacy theory. It is a one to one intervention meeting United Kingdom requirements for structured diabetes-education and is delivered within routine primary care. Methods/design In a two-group cluster randomized controlled trial, GP practices are allocated by computer minimisation to an intervention group or a six-month deferred intervention group. We aim to recruit 250 participants from 50 practices across central England. Eligibility criteria are adults able to undertake the programme with type 2 diabetes, not taking insulin, with HbA1c over 8% (first 12 months and following an agreed protocol change over 7% (months 13 to 18. Following randomisation, intervention nurses receive two-day training and delivered the Diabetes Manual programme to participants. Deferred intervention nurses receive the training following six-month follow-up. Primary outcome is HbA1c with total and HDL cholesterol; blood pressure, body mass index; self-efficacy and quality of life as additional outcomes. Primary analysis is between-group HbA1c differences at 6 months powered to give 80% power to detect a difference in HbA1c of 0.6%. A 12 month cohort analysis will assess maintenance of effect and assess relationship between self-efficacy and outcomes, and a qualitative study is running alongside. Discussion This trial incorporates educational and psychological diabetes interventions into a single programme and assesses both clinical and psychosocial outcomes. The trial will increase our understanding of intervention transferability between conditions, those diabetes related health behaviours that are more or less susceptible to change through efficacy enhancing mechanisms and how this impacts on clinical outcomes.

  19. Evaluation of empowerment model on indicators of metabolic control in patients with type 2 diabetes, a randomized clinical trial study.

    Science.gov (United States)

    Ebrahimi, Hossein; Sadeghi, Mahdi; Amanpour, Farzaneh; Vahedi, Hamid

    2016-04-01

    Diabetes education is a major subject in achieving optimal glycemic control. Effective empowerment approach can be beneficial for improving patients' health. The aim of this study was to evaluate the effect of empowerment model on indicators of metabolic control in patients with type 2 diabetes. a randomized controlled trial of 103 patients with type 2 diabetes were randomly assigned to either the intervention (empowerment approach training) or the control group (conventional training) 2014. Empowerment approach training were performed for the experimental group for eight weeks. Data collection tool included demographic information form and indicators of metabolic control checklist. Analysis was performed by one-way analysis of variance, chi-square test, paired t-test, independent t-test and multiple linear regression. Before the intervention, two groups were homogeneous in terms of demographic variables, glycosylated hemoglobin (HbA1C), and other indicators of metabolic control. After the intervention, average HbA1C and other metabolic indicators except for LDL showed significant differences in the experimental group compared to the control group. study results indicated the positive effects of applying the empowerment model on the metabolic control indicators. Therefore, applying this model is recommended to nurses and the relevant authorities in order to improve clinical outcomes in diabetic patients. Copyright © 2015 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

  20. An enhanced PSO-DEFS based feature selection with biometric authentication for identification of diabetic retinopathy

    Directory of Open Access Journals (Sweden)

    Umarani Balakrishnan

    2016-11-01

    Full Text Available Recently, automatic diagnosis of diabetic retinopathy (DR from the retinal image is the most significant research topic in the medical applications. Diabetic macular edema (DME is the major reason for the loss of vision in patients suffering from DR. Early identification of the DR enables to prevent the vision loss and encourage diabetic control activities. Many techniques are developed to diagnose the DR. The major drawbacks of the existing techniques are low accuracy and high time complexity. To overcome these issues, this paper proposes an enhanced particle swarm optimization-differential evolution feature selection (PSO-DEFS based feature selection approach with biometric authentication for the identification of DR. Initially, a hybrid median filter (HMF is used for pre-processing the input images. Then, the pre-processed images are embedded with each other by using least significant bit (LSB for authentication purpose. Simultaneously, the image features are extracted using convoluted local tetra pattern (CLTrP and Tamura features. Feature selection is performed using PSO-DEFS and PSO-gravitational search algorithm (PSO-GSA to reduce time complexity. Based on some performance metrics, the PSO-DEFS is chosen as a better choice for feature selection. The feature selection is performed based on the fitness value. A multi-relevance vector machine (M-RVM is introduced to classify the 13 normal and 62 abnormal images among 75 images from 60 patients. Finally, the DR patients are further classified by M-RVM. The experimental results exhibit that the proposed approach achieves better accuracy, sensitivity, and specificity than the existing techniques.

  1. Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) study: Methodology and baseline characteristics of a randomized controlled trial evaluating an occupation-based diabetes management intervention for young adults.

    Science.gov (United States)

    Pyatak, Elizabeth A; Carandang, Kristine; Vigen, Cheryl; Blanchard, Jeanine; Sequeira, Paola A; Wood, Jamie R; Spruijt-Metz, Donna; Whittemore, Robin; Peters, Anne L

    2017-03-01

    This paper describes the study protocol used to evaluate the Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) intervention and reports on baseline characteristics of recruited participants. REAL Diabetes is an activity-based intervention designed to address the needs of young adults diagnosed with type 1 (T1D) or type 2 diabetes (T2D) from low socioeconomic status or racial/ethnic minority backgrounds. The REAL intervention incorporates tailored delivery of seven content modules addressing various dimensions of health and well-being as they relate to diabetes, delivered by a licensed occupational therapist. In this pilot randomized controlled trial, participants are assigned to the REAL Diabetes intervention or an attention control condition. The study's primary recruitment strategies included in-person recruitment at diabetes clinics, mass mailings to clinic patients, and social media advertising. Data collection includes baseline and 6-month assessments of primary outcomes, secondary outcomes, and hypothesized mediators of intervention effects, as well as ongoing process evaluation assessment to ensure study protocol adherence and intervention fidelity. At baseline, participants (n=81) were 51% female, 78% Latino, and on average 22.6years old with an average HbA1c of 10.8%. A majority of participants (61.7%) demonstrated clinically significant diabetes distress and 27.2% reported symptoms consistent with major depressive disorder. Compared to participants with T1D, participants with T2D had lower diabetes-related self-efficacy and problem-solving skills. Compared to participants recruited at clinics, participants recruited through other strategies had greater diabetes knowledge but weaker medication adherence. Participants in the REAL study demonstrate clinically significant medical and psychosocial needs. Copyright © 2017 Elsevier Inc. All rights reserved.

  2. A Team-Based Online Game Improves Blood Glucose Control in Veterans With Type 2 Diabetes: A Randomized Controlled Trial.

    Science.gov (United States)

    Kerfoot, B Price; Gagnon, David R; McMahon, Graham T; Orlander, Jay D; Kurgansky, Katherine E; Conlin, Paul R

    2017-09-01

    Rigorous evidence is lacking whether online games can improve patients' longer-term health outcomes. We investigated whether an online team-based game delivering diabetes self-management education (DSME) to patients via e-mail or mobile application (app) can generate longer-term improvements in hemoglobin A 1c (HbA 1c ). Patients ( n = 456) on oral diabetes medications with HbA 1c ≥58 mmol/mol were randomly assigned between a DSME game (with a civics booklet) and a civics game (with a DSME booklet). The 6-month games sent two questions twice weekly via e-mail or mobile app. Participants accrued points based on performance, with scores posted on leaderboards. Winning teams and individuals received modest financial rewards. Our primary outcome measure was HbA 1c change over 12 months. DSME game patients had significantly greater HbA 1c reductions over 12 months than civics game patients (-8 mmol/mol [95% CI -10 to -7] and -5 mmol/mol [95% CI -7 to -3], respectively; P = 0.048). HbA 1c reductions were greater among patients with baseline HbA 1c >75 mmol/mol: -16 mmol/mol [95% CI -21 to -12] and -9 mmol/mol [95% CI -14 to -5] for DSME and civics game patients, respectively; P = 0.031. Patients with diabetes who were randomized to an online game delivering DSME demonstrated sustained and meaningful HbA 1c improvements. Among patients with poorly controlled diabetes, the DSME game reduced HbA 1c by a magnitude comparable to starting a new diabetes medication. Online games may be a scalable approach to improve outcomes among geographically dispersed patients with diabetes and other chronic diseases. © 2017 by the American Diabetes Association.

  3. Efficacy of an education course delivered to community health workers in diabetes control: A randomized clinical trial.

    Science.gov (United States)

    de Souza, Camila Furtado; Dalzochio, Mériane Boeira; Zucatti, Alessandra Teixeira Netto; De Nale, Rosana; de Almeida, Marília Tavares; Gross, Jorge Luiz; Leitão, Cristiane Bauermann

    2017-08-01

    Community health workers are community members who provide education and care for patients for a broad range of health issues, including diabetes mellitus. However, few community health workers are trained for diabetes education and little is known about the effectiveness of their interventions. The aim of this study is to evaluate the effect of a diabetes education program delivered to community health workers in improving the metabolic control of patients with type 2 diabetes mellitus. Eight community health workers, providing care for 118 patients, were randomized in two groups to receive a 1-month diabetes education program (intervention, patients n = 62) or an education course in other health issues (control, patients n = 56). Each community health worker was responsible for transmitting the acquired knowledge to patients. Primary outcome was changed in HbA1C 3 months after the intervention. PARTICIPANTS: Mean age was 61 ± 11 years, 35% were men and 62% were whites. HbA1c levels reduced in both groups (intervention: 9.1 ± 2.2 vs. 7.9 ± 1.9%; control: 9.1 ± 2.1 vs. 8.4 ± 2.5%, p patients' follow-up, but it was similar in intervention and control groups. The diabetes mellitus education course delivered to community health workers was able to improve patients' lipid profile.

  4. Translating U-500R Randomized Clinical Trial Evidence to the Practice Setting: A Diabetes Educator/Expert Prescriber Team Approach.

    Science.gov (United States)

    Bergen, Paula M; Kruger, Davida F; Taylor, April D; Eid, Wael E; Bhan, Arti; Jackson, Jeffrey A

    2017-06-01

    Purpose The purpose of this article is to provide recommendations to the diabetes educator/expert prescriber team for the use of human regular U-500 insulin (U-500R) in patients with severely insulin-resistant type 2 diabetes, including its initiation and titration, by utilizing dosing charts and teaching materials translated from a recent U-500R clinical trial. Conclusions Clinically relevant recommendations and teaching materials for the optimal use and management of U-500R in clinical practice are provided based on the efficacy and safety results of and lessons learned from the U-500R clinical trial by Hood et al, current standards of practice, and the authors' clinical expertise. This trial was the first robustly powered, randomized, titration-to-target trial to compare twice-daily and three-times-daily U-500R dosing regimens. Modifications were made to the initiation and titration dosing algorithms used in this trial to simplify dosing strategies for the clinical setting and align with current glycemic targets recommended by the American Diabetes Association. Leveraging the expertise, resources, and patient interactions of the diabetes educator who can provide diabetes self-management education and support in collaboration with the multidisciplinary diabetes team is strongly recommended to ensure patients treated with U-500R receive the timely and comprehensive care required to safely and effectively use this highly concentrated insulin.

  5. Pirfenidone Accelerates Wound Healing in Chronic Diabetic Foot Ulcers: A Randomized, Double-Blind Controlled Trial

    Directory of Open Access Journals (Sweden)

    Luz E. Gasca-Lozano

    2017-01-01

    Full Text Available Background. Diabetic foot ulcers are one disabling complication of diabetes mellitus. Pirfenidone (PFD is a potent modulator of extracellular matrix. Modified diallyl disulfide oxide (M-DDO is an antimicrobial and antiseptic agent. Aim. To evaluate efficacy of topical PFD + M-DDO in a randomized, double-blind trial versus ketanserin in the treatment of noninfected chronic DFU. Methods. Patients received PFD + M-DDO or ketanserin for 6 months. Relative ulcer volume (RUV was measured every month; biopsies were taken at baseline and months 1 and 2 for histopathology and gene expression analysis for COL-1α, COL-4, KGF, VEGF, ACTA2 (α-SMA, elastin, fibronectin, TGF-β1, TGF-β3, HIF-1α, and HIF-1β. Results. Reduction of median RUV in the PFD + M-DDO group was 62%, 89.8%, and 99.7% at months 1–3 and 100% from months 4 to 6. Ketanserin reduced RUV in 38.4%, 56%, 60.8%, 94%, 94.8%, and 100% from the first to the sixth month, respectively. Healing score improved 4.5 points with PFD + M-DDO and 1.5 points with ketanserin compared to basal value. Histology analysis revealed few inflammatory cells and organized/ordered collagen fiber bundles in PFD + M-DDO. Expression of most genes was increased with PFD + M-DDO; 43.8% of ulcers were resolved using PFD + M-DDO and 23.5% with ketanserin. Conclusion. PFD + M-DDO was more effective than ketanserin in RUV reduction.

  6. The role of telenursing in the management of Diabetes Type 1: A randomized controlled trial.

    Science.gov (United States)

    Kotsani, Konstantia; Antonopoulou, Vasiliki; Kountouri, Aikaterini; Grammatiki, Maria; Rapti, Eleni; Karras, Spyridon; Trakatelli, Christina; Tsaklis, Panagiotis; Kazakos, Kiriakos; Kotsa, Kalliopi

    2018-04-01

    Diabetes Mellitus type 1 (T1DM) is a chronic disease that requires patients' self-monitoring and self-management to achieve glucose targets and prevent complications. Telenursing implicates technology in the interaction of a specialized nurse with patients with chronic diseases in order to provide personalized care and support. To evaluate the effect of telenursing on T1DM patients' compliance with glucose self-monitoring and glycemic control. Randomized controlled study. Outpatient Department of Diabetes, Endocrinology and Metabolism of a University Hospital in Northern Greece. Ninety-four T1DM patients were recruited and randomized in two groups by a random number generator. The intervention group (N = 48) was provided with telenursing services. A specialized nurse made a weekly contact via telephone motivating patients to frequently measure blood glucose and adopt a healthy lifestyle. The control group (N = 46) received standard diabetes advice and care in the clinic. The primary outcome was the effect of the intervention in glucose control and glucose variability. The secondary outcome was the effect on frequency of self-monitoring. SPSS 20.0 was used for data analysis. The two groups did not differ in age, sex, physical activity or initial HbA1c. In the intervention group, blood glucose significantly decreased at the end of the study in all predefined measurements, compared to control group: morning (93.18 ± 13.30 mg/dl vs. 105.17 ± 13.74 mg/dl, p < 0.005), pre-prandial (114.76 ± 9.54 mg/dl vs. 120.84 ± 4.05 mg/dl, p < 0.005), post-prandial (193.35 ± 25.36 mg/dl vs. 207.84 ± 18.80 mg/dl, p < 0.005), and HbA1c decreased significantly over time in the intervention group (8.3 ± 0.6% at the beginning of the study vs. 7.8 ± 1% at the end of the study, p = 0.03). In the intervention group there were also fewer omitted glucose measurements than in the control group. Patients in the

  7. Process Evaluation of the Type 2 Diabetes Mellitus PULSE Program Randomized Controlled Trial: Recruitment, Engagement, and Overall Satisfaction.

    Science.gov (United States)

    Aguiar, Elroy J; Morgan, Philip J; Collins, Clare E; Plotnikoff, Ronald C; Young, Myles D; Callister, Robin

    2017-07-01

    Men are underrepresented in weight loss and type 2 diabetes mellitus (T2DM) prevention studies. To determine the effectiveness of recruitment, and acceptability of the T2DM Prevention Using LifeStyle Education (PULSE) Program-a gender-targeted, self-administered intervention for men. Men (18-65 years, high risk for T2DM) were randomized to intervention ( n = 53) or wait-list control groups ( n = 48). The 6-month PULSE Program intervention focused on weight loss, diet, and exercise for T2DM prevention. A process evaluation questionnaire was administered at 6 months to examine recruitment and selection processes, and acceptability of the intervention's delivery and content. Associations between self-monitoring and selected outcomes were assessed using Spearman's rank correlation. A pragmatic recruitment and online screening process was effective in identifying men at high risk of T2DM (prediabetes prevalence 70%). Men reported the trial was appealing because it targeted weight loss, T2DM prevention, and getting fit, and because it was perceived as "doable" and tailored for men. The intervention was considered acceptable, with men reporting high overall satisfaction (83%) and engagement with the various components. Adherence to self-monitoring was poor, with only 13% meeting requisite criteria. However, significant associations were observed between weekly self-monitoring of weight and change in weight ( r s = -.47, p = .004) and waist circumference ( r s = -.38, p = .026). Men reported they would have preferred more intervention contact, for example, by phone or email. Gender-targeted, self-administered lifestyle interventions are feasible, appealing, and satisfying for men. Future studies should explore the effects of additional non-face-to-face contact on motivation, accountability, self-monitoring adherence, and program efficacy.

  8. Social comparisons in adults with type 2 diabetes: Patients' reasons for target selection.

    Science.gov (United States)

    Arigo, Danielle; Cornell, Max; Smyth, Joshua M

    2018-07-01

    To examine reasons for selecting a social comparison target (i.e. a specific other for relative self-evaluation), and their influence on affect and motivation for self-care, in type 2 diabetes (T2DM). Adults with T2DM (n = 180, M A1c  = 7.6%) chose to read about one of four targets. Participants rated five reasons for their choice (strongly disagree - strongly agree), and rated affect and self-care motivation before and after reading. To boost confidence in my ability to manage diabetes was rated highest overall (ps motivation (p motivation only among those who chose better-off targets (p = 0.01). Patients' reasons for a particular comparison are associated with short-term changes in affect and self-care motivation, and warrant greater empirical and clinical attention.

  9. Health benefits of Tai Chi for older patients with type 2 diabetes: The “Move It for Diabetes Study” – A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Tracey Tsang

    2007-10-01

    Full Text Available Tracey Tsang1, Rhonda Orr1, Paul Lam2, Elizabeth J Comino3, Maria Fiatarone Singh11School of Exercise and Sport Science, Faculty of Health Sciences, University of Sydney, Lidcombe, NSW, Australia; 2School of Public Health and Community Medicine, University of New South Wales, Sydney, NSW, Australia; 3The University of NSW Research Centre for Primary Health Care and Equity, University of New South Wales, Sydney, NSW, AustraliaAbstract: Older adults with type 2 diabetes have mobility impairment and reduced fitness. This study aimed to test the efficacy of the “Tai Chi for Diabetes” form, developed to address health-related problems in diabetes, including mobility and physical function. Thirty-eight older adults with stable type 2 diabetes were randomized to Tai Chi or sham exercise, twice a week for 16 weeks. Outcomes included gait, balance, musculoskeletal and cardiovascular fitness, self-reported activity and quality of life. Static and dynamic balance index (−5.8 ± 14.2; p = 0.03 and maximal gait speed (6.2 ± 11.6%; p = 0.005 improved over time, with no significant group effects. There were no changes in other measures. Non-specific effects of exercise testing and/or study participation such as outcome expectation, socialization, the Hawthorne effect, or unmeasured changes in health status or compliance with medical treatment may underlie the modest improvements in gait and balance observed in this sham-exercise-controlled trial. This Tai Chi form, although developed specifically for diabetes, may not have been of sufficient intensity, frequency, or duration to effect positive changes in many aspects of physiology or health status relevant to older people with diabetes.Keywords: Tai Chi, Type 2 diabetes, physical function

  10. Childhood adiposity and risk of type 1 diabetes: A Mendelian randomization study.

    Directory of Open Access Journals (Sweden)

    J C Censin

    2017-08-01

    Full Text Available The incidence of type 1 diabetes (T1D is increasing globally. One hypothesis is that increasing childhood obesity rates may explain part of this increase, but, as T1D is rare, intervention studies are challenging to perform. The aim of this study was to assess this hypothesis with a Mendelian randomization approach that uses genetic variants as instrumental variables to test for causal associations.We created a genetic instrument of 23 single nucleotide polymorphisms (SNPs associated with childhood adiposity in children aged 2-10 years. Summary-level association results for these 23 SNPs with childhood-onset (<17 years T1D were extracted from a meta-analysis of genome-wide association study with 5,913 T1D cases and 8,828 reference samples. Using inverse-variance weighted Mendelian randomization analysis, we found support for an effect of childhood adiposity on T1D risk (odds ratio 1.32, 95% CI 1.06-1.64 per standard deviation score in body mass index [SDS-BMI]. A sensitivity analysis provided evidence of horizontal pleiotropy bias (p = 0.04 diluting the estimates towards the null. We therefore applied Egger regression and multivariable Mendelian randomization methods to control for this type of bias and found evidence in support of a role of childhood adiposity in T1D (odds ratio in Egger regression, 2.76, 95% CI 1.40-5.44. Limitations of our study include that underlying genes and their mechanisms for most of the genetic variants included in the score are not known. Mendelian randomization requires large sample sizes, and power was limited to provide precise estimates. This research has been conducted using data from the Early Growth Genetics (EGG Consortium, the Genetic Investigation of Anthropometric Traits (GIANT Consortium, the Tobacco and Genetics (TAG Consortium, and the Social Science Genetic Association Consortium (SSGAC, as well as meta-analysis results from a T1D genome-wide association study.This study provides genetic support for a

  11. Single-donor islet transplantation in type 1 diabetes: patient selection and special considerations

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    Tatum JA

    2017-02-01

    Full Text Available Jacob A Tatum,* Max O Meneveau,* Kenneth L Brayman Department of Surgery, Division of Transplantation, The University of Virginia Health System, Charlottesville, VA, USA *These authors contributed equally to this work. Abstract: Type 1 diabetes mellitus is an autoimmune disorder of the endocrine pancreas that currently affects millions of people in the United States. Although the disease can be managed with exogenous insulin administration, the ultimate cure for the condition lies in restoring a patient’s ability to produce their own insulin. Islet cell allotransplantation provides a means of endogenous insulin production. Though far from perfected, islet transplants are now a proven treatment for type 1 diabetics. However, proper patient selection is critical for achieving optimal outcomes. Given the shortage of transplantable organs, selecting appropriate candidates for whom the procedure will be of greatest benefit is essential. Although many of those who receive islets do not retain insulin independence, grafts do play a significant role in preventing hypoglycemic episodes that can be quite detrimental to quality of life and potentially fatal. Additionally, islet transplant requires lifelong immunosuppression. Antibodies, both preformed and following islet infusion, may play important roles in graft outcomes. Finally, no procedure is without inherent risk and islet transfusions can have serious consequences for recipients’ livers in the form of both vascular and metabolic complications. Therefore, patient-specific factors that should be taken into account before islet transplantation include aims of therapy, sensitization, and potential increased risk for hepatic and portal-venous sequelae. Keywords: islet transplantation, diabetes mellitus type 1, brittle diabetes, single donor, patient

  12. Metoprolol compared to carvedilol deteriorates insulin-stimulated endothelial function in patients with type 2 diabetes - a randomized study

    DEFF Research Database (Denmark)

    Kveiborg, Britt; Hermann, Thomas S; Major-Pedersen, Atheline

    2010-01-01

    -stimulated endothelial function in patients with type 2 diabetes. METHOD: 24 patients with type 2 diabetes were randomized to receive either 200 mg metoprolol succinate or 50 mg carvedilol daily. Endothelium-dependent vasodilation was assessed by using venous occlusion plethysmography with increasing doses of intra......AIM: Studies of beta blockade in patients with type 2 diabetes have shown inferiority of metoprolol treatment compared to carvedilol on indices of insulin resistance. The aim of this study was to examine the effect of metoprolol versus carvedilol on endothelial function and insulin...... with metoprolol, the percentage change in forearm blood-flow was 60.19% +/- 17.89 (at the highest serotonin dosages) before treatment and -33.80% +/- 23.38 after treatment (p = 0.007). Treatment with carvedilol did not change insulin-stimulated endothelial function. Endothelium-dependent vasodilation without...

  13. A double-blind, randomized, placebo-controlled clinical trial on benfotiamine treatment in patients with diabetic nephropathy.

    Science.gov (United States)

    Alkhalaf, Alaa; Klooster, Astrid; van Oeveren, Willem; Achenbach, Ulrike; Kleefstra, Nanne; Slingerland, Robbert J; Mijnhout, G Sophie; Bilo, Henk J G; Gans, Reinold O B; Navis, Gerjan J; Bakker, Stephan J L

    2010-07-01

    To investigate the effect of benfotiamine on urinary albumin excretion (UAE) and the tubular damage marker kidney injury molecule-1 (KIM-1) in patients with type 2 diabetes and nephropathy. Patients with type 2 diabetes and UAE equivalent to 15-300 mg/24 h, despite ACE inhibitors (ACE-Is) or angiotensin receptor blockers (ARBs), were randomly assigned to 12 weeks of benfotiamine (900 mg/day) (n = 39) or placebo (n = 43). Compared with placebo, benfotiamine treatment resulted in significant improvement of thiamine status (P Benfotiamine treatment did not significantly decrease 24-h UAE or 24-h KIM-1 excretion. In patients with type 2 diabetes and nephropathy, high-dose benfotiamine treatment for 12 weeks in addition to ACE-Is or ARBs did not reduce UAE or KIM-1 excretion, despite improvement of thiamine status.

  14. A randomized clinical trial with two doses of an enteral diabetes-specific suplements in elderly patients with diabetes mellitus type 2.

    Science.gov (United States)

    de Luis, D A; Izaola, O; de la Fuente, B; Terroba, M C; Cuellar, L; Cabezas, G

    2013-06-01

    The aim of our study was to investigate whether two different daily doses of a high monounsaturated fatty acid (MUFA) specific diabetes enteral formula could improve nutritional variables as well as metabolic parameters. We conducted a randomized, open-label, multicenter, parallel group study. 27 patients with diabetes mellitus type 2 with recent weight loss were randomized to one of two study groups: group 1 (two cans per day) and group 2 (three cans per day) for a ten week period. A significative decrease of HbA1c was detected in both groups. The decrease 0.98% (confidence interval 95% 0.19-1.88) was higher in group 2 than group 1 0.60% (confidence interval 95% 0.14-1.04). A significant increase of weight, body mass index, fat mass, albumin, prealbumin and transferrin was observed in both groups without statistical differences in this improvement between both groups. The increase of weight 4.59kg (confidence interval 95% 1.71-9.49) was higher in group 2 than group 1 1.46% (confidence interval 95% 0.39-2.54). Gastrointestinal tolerance (diarrhea episodes) with both formulas was good, without statistical differences (7.60% vs 7.14%: ns). A high monounsaturated fatty acid diabetes-specific supplement improved HbA1c and nutritional status. These improvements were higher with three supplements than with two per day.

  15. Impact of the «Conversation Map™» tools on understanding of diabetes by Spanish patients with type 2 diabetes mellitus: a randomized, comparative study.

    Science.gov (United States)

    Penalba, Maite; Moreno, Luis; Cobo, Amelia; Reviriego, Jesús; Rodríguez, Angel; Cleall, Simon; Reaney, Matthew

    2014-12-01

    This paper presents results from the Spanish subpopulation of a study comparing Conversation Maps™ (CM)-based education with regular care (RC) in type 2 diabetes mellitus (T2DM). Adult patients with T2DM who were considered as not demonstrating ideal disease management were randomly assigned to CM or RC with assessments following (Visit 2), and at follow-up 6 months after (Visit 3), the final CM session. The primary endpoint was diabetes knowledge at Visit 3. 310 patients were randomised to receive CM education (n=148) or RC (n=162). Median knowledge scores were ranked significantly higher in the CM group than the RC group at Visit 2 and Visit 3 (p<0.001). No significant differences in clinical and other outcomes were identified between the interventions, except satisfaction with care (p<0.001, Visit 2; p=0.055, Visit 3) and perception of goal attainment (p<0.001 and p = 0.046, respectively) that were both higher in the CM group. In these patients from Spain, CM was superior to RC in terms of diabetes knowledge 6 months after education was completed, suggesting that CM should be considered for use in patients requiring diabetes education. Copyright © 2014 SEEN. Published by Elsevier Espana. All rights reserved.

  16. Metformin versus Insulin in the Management of Pre-Gestational Diabetes Mellitus in Pregnancy and Gestational Diabetes Mellitus at the Korle Bu Teaching Hospital: A Randomized Clinical Trial.

    Science.gov (United States)

    Beyuo, Titus; Obed, Samuel Amenyi; Adjepong-Yamoah, Kenneth Kweku; Bugyei, Kwasi Agyei; Oppong, Samuel Antwi; Marfoh, Kissinger

    2015-01-01

    To determine if metformin monotherapy or metformin in combination with insulin is equally effective as insulin monotherapy at glycemic control in diabetes mellitus in pregnancy among Ghanaians. This was a study involving 104 pregnant women with type 2 diabetes mellitus (T2DM) or gestational diabetes mellitus (GDM) at 20-30 weeks gestation. Participants were randomized into metformin and insulin treatment groups. Starting dose of metformin was 500 mg once a day and increased gradually over two (2) weeks, to meet glycemic targets. Insulin was added if targets could not be reached on metformin alone at maximum doses. Total daily dose of premixed insulin at initiation was calculated as 0.3 IU/kg body weight and titrated upwards to achieve glycemic control. Glycemic profile monitoring was done every two weeks. The two hour post prandial blood glucose (2HPG) levels were significantly lower in the metformin group than the insulin group (p= 0.004). The findings of this study suggest that metformin monotherapy is effective in achieving glycemic targets in the management of diabetes in pregnancy. It is more effective than insulin in lowering the 2HPG level. Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12614000942651.

  17. Metformin versus Insulin in the Management of Pre-Gestational Diabetes Mellitus in Pregnancy and Gestational Diabetes Mellitus at the Korle Bu Teaching Hospital: A Randomized Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Titus Beyuo

    Full Text Available To determine if metformin monotherapy or metformin in combination with insulin is equally effective as insulin monotherapy at glycemic control in diabetes mellitus in pregnancy among Ghanaians.This was a study involving 104 pregnant women with type 2 diabetes mellitus (T2DM or gestational diabetes mellitus (GDM at 20-30 weeks gestation. Participants were randomized into metformin and insulin treatment groups. Starting dose of metformin was 500 mg once a day and increased gradually over two (2 weeks, to meet glycemic targets. Insulin was added if targets could not be reached on metformin alone at maximum doses. Total daily dose of premixed insulin at initiation was calculated as 0.3 IU/kg body weight and titrated upwards to achieve glycemic control. Glycemic profile monitoring was done every two weeks.The two hour post prandial blood glucose (2HPG levels were significantly lower in the metformin group than the insulin group (p= 0.004.The findings of this study suggest that metformin monotherapy is effective in achieving glycemic targets in the management of diabetes in pregnancy. It is more effective than insulin in lowering the 2HPG level.Australian New Zealand Clinical Trials Registry (ANZCTR ACTRN12614000942651.

  18. Tinospora cordifolia stem supplementation in diabetic dyslipidemia: an open labelled randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kuhu Roy

    2015-08-01

    Full Text Available Background: Medicinal plants are powerful health promoting nutritional agents. Among the vast library of medicinal plants Tinospora cordifolia (Willd. has been meagrely explored. It belongs to the family Menispermaceae and is a rich source of alkaloid and terpenes. It has hepatoprotective, antioxidant, immunostimulatory, hyperlipidemic, anticancer and antidiabetic properties. The stem contains berberine, palmatine, tembetarine, magnoflorine, tinosporin, tinocordifolin. The stem starch is highly nutritive and digestive. In modern medicine it is called the magical rejuvenating herb owing to its properties to cure many diseases. The stem contains higher alkaloid content than the leaves because of which it is approved for medicinal usage. With a host of phytochemical properties present in the stem, it may hold potential to manage dyslipidemia and dysglycemia, which otherwise has been proven only in pre-clinical studies. Objective: To study the impact of tinospora cordifolia stem supplementation on the glycemic and lipemic profile of subjects with diabetic dyslipidemia. Methods: Type 2 diabetics with dyslipidemia on oral hypoglycemic agents were enrolled. Baseline data on medical history, family history of lifestyle diseases, duration of diabetes diagnosis, drug profile, anthropometric data, dietary data and physical activity data was obtained along with a fasting blood sample for estimating high sensitivity C reactive protein (hs-CRP, hepatic, renal, lipid profile and glycated hemoglobin. The participants were randomized into either of the two groups; intervention group (n=29 received 250mg of encapsulated mature stem of tinospora cordifolia pre meal twice a day along with prescribed dyslipidemic agent and control group (n=30 only on dyslipidemic agents for a period of 60 days. After 60 days all the parameters were re-assessed to analyse the impact of the intervention. Results: Majority of the subjects in both the arms were in the 50-60 years age

  19. Prognostic interaction patterns in diabetes mellitus II: A random-matrix-theory relation

    Science.gov (United States)

    Rai, Aparna; Pawar, Amit Kumar; Jalan, Sarika

    2015-08-01

    We analyze protein-protein interactions in diabetes mellitus II and its normal counterpart under the combined framework of random matrix theory and network biology. This disease is the fifth-leading cause of death in high-income countries and an epidemic in developing countries, affecting around 8 % of the total adult population in the world. Treatment at the advanced stage is difficult and challenging, making early detection a high priority in the cure of the disease. Our investigation reveals specific structural patterns important for the occurrence of the disease. In addition to the structural parameters, the spectral properties reveal the top contributing nodes from localized eigenvectors, which turn out to be significant for the occurrence of the disease. Our analysis is time-efficient and cost-effective, bringing a new horizon in the field of medicine by highlighting major pathways involved in the disease. The analysis provides a direction for the development of novel drugs and therapies in curing the disease by targeting specific interaction patterns instead of a single protein.

  20. Liver glycogen in type 2 diabetic mice is randomly branched as enlarged aggregates with blunted glucose release.

    Science.gov (United States)

    Besford, Quinn Alexander; Zeng, Xiao-Yi; Ye, Ji-Ming; Gray-Weale, Angus

    2016-02-01

    Glycogen is a vital highly branched polymer of glucose that is essential for blood glucose homeostasis. In this article, the structure of liver glycogen from mice is investigated with respect to size distributions, degradation kinetics, and branching structure, complemented by a comparison of normal and diabetic liver glycogen. This is done to screen for differences that may result from disease. Glycogen α-particle (diameter ∼ 150 nm) and β-particle (diameter ∼ 25 nm) size distributions are reported, along with in vitro γ-amylase degradation experiments, and a small angle X-ray scattering analysis of mouse β-particles. Type 2 diabetic liver glycogen upon extraction was found to be present as large loosely bound, aggregates, not present in normal livers. Liver glycogen was found to aggregate in vitro over a period of 20 h, and particle size is shown to be related to rate of glucose release, allowing a structure-function relationship to be inferred for the tissue specific distribution of particle types. Application of branching theories to small angle X-ray scattering data for mouse β-particles revealed these particles to be randomly branched polymers, not fractal polymers. Together, this article shows that type 2 diabetic liver glycogen is present as large aggregates in mice, which may contribute to the inflexibility of interconversion between glucose and glycogen in type 2 diabetes, and further that glycogen particles are randomly branched with a size that is related to the rate of glucose release.

  1. Ebselen does not improve oxidative stress and vascular function in patients with diabetes: a randomized, crossover trial.

    Science.gov (United States)

    Beckman, Joshua A; Goldfine, Allison B; Leopold, Jane A; Creager, Mark A

    2016-12-01

    Oxidative stress is a key driver of vascular dysfunction in diabetes mellitus. Ebselen is a glutathione peroxidase mimetic. A single-site, randomized, double-masked, placebo-controlled, crossover trial was carried out in 26 patients with type 1 or type 2 diabetes to evaluate effects of high-dose ebselen (150 mg po twice daily) administration on oxidative stress and endothelium-dependent vasodilation. Treatment periods were in random order of 4 wk duration, with a 4-wk washout between treatments. Measures of oxidative stress included nitrotyrosine, plasma 8-isoprostanes, and the ratio of reduced to oxidized glutathione. Vascular ultrasound of the brachial artery and plethysmographic measurement of blood flow were used to assess flow-mediated and methacholine-induced endothelium-dependent vasodilation of conduit and resistance vessels, respectively. Ebselen administration did not affect parameters of oxidative stress or conduit artery or forearm arteriolar vascular function compared with placebo treatment. There was no difference in outcome by diabetes type. Ebselen, at the dose and duration evaluated, does not improve the oxidative stress profile, nor does it affect endothelium-dependent vasodilation in patients with diabetes mellitus. Copyright © 2016 the American Physiological Society.

  2. Non-random mating for selection with restricted rates of inbreeding and overlapping generations

    NARCIS (Netherlands)

    Sonesson, A.K.; Meuwissen, T.H.E.

    2002-01-01

    Minimum coancestry mating with a maximum of one offspring per mating pair (MC1) is compared with random mating schemes for populations with overlapping generations. Optimum contribution selection is used, whereby $\\\\\\\\Delta F$ is restricted. For schemes with $\\\\\\\\Delta F$ restricted to 0.25% per

  3. Applications of random forest feature selection for fine-scale genetic population assignment.

    Science.gov (United States)

    Sylvester, Emma V A; Bentzen, Paul; Bradbury, Ian R; Clément, Marie; Pearce, Jon; Horne, John; Beiko, Robert G

    2018-02-01

    Genetic population assignment used to inform wildlife management and conservation efforts requires panels of highly informative genetic markers and sensitive assignment tests. We explored the utility of machine-learning algorithms (random forest, regularized random forest and guided regularized random forest) compared with F ST ranking for selection of single nucleotide polymorphisms (SNP) for fine-scale population assignment. We applied these methods to an unpublished SNP data set for Atlantic salmon ( Salmo salar ) and a published SNP data set for Alaskan Chinook salmon ( Oncorhynchus tshawytscha ). In each species, we identified the minimum panel size required to obtain a self-assignment accuracy of at least 90% using each method to create panels of 50-700 markers Panels of SNPs identified using random forest-based methods performed up to 7.8 and 11.2 percentage points better than F ST -selected panels of similar size for the Atlantic salmon and Chinook salmon data, respectively. Self-assignment accuracy ≥90% was obtained with panels of 670 and 384 SNPs for each data set, respectively, a level of accuracy never reached for these species using F ST -selected panels. Our results demonstrate a role for machine-learning approaches in marker selection across large genomic data sets to improve assignment for management and conservation of exploited populations.

  4. 40 CFR 761.306 - Sampling 1 meter square surfaces by random selection of halves.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Sampling 1 meter square surfaces by...(b)(3) § 761.306 Sampling 1 meter square surfaces by random selection of halves. (a) Divide each 1 meter square portion where it is necessary to collect a surface wipe test sample into two equal (or as...

  5. The Effects of 6 Isocaloric Meals Pattern on Blood Lipid Profile, Glucose, Hemoglobin A1c, Insulin and Malondialdehyde in Type 2 Diabetic Patients: A Randomized Clinical Trial

    OpenAIRE

    Moosa Salehi; Asma Kazemi; Jafar Hasan Zadeh

    2014-01-01

    Background: The present clinical trial study aims at investigating the effect of daily energy intake in 6 isocaloric meals in comparison with the current meal pattern (3 meals and 2 small snacks per day) on type 2 diabetes risk markers in diabetes during 3-month period. Methods: Eighty four type 2 diabetes patients were randomly divided into 6 isocaloric meal diet or a balanced diet (3 meals and 2 snacks previous meal pattern). The planned reduced calorie diets for both groups were identi...

  6. Undiagnosed Diabetes and Pre-Diabetes in Health Disparities.

    Directory of Open Access Journals (Sweden)

    Susan P Fisher-Hoch

    Full Text Available Globally half of all diabetes mellitus is undiagnosed. We sought to determine the extent and characteristics of undiagnosed type 2 diabetes mellitus and pre-diabetes in Mexican Americans residing in the United States. This disadvantaged population with 50% lifetime risk of diabetes is a microcosm of the current pandemic. We accessed baseline data between 2004 and 2014 from 2,838 adults recruited to our Cameron County Hispanic Cohort (CCHC; a two-stage randomly selected 'Framingham-like' cohort of Mexican Americans on the US Mexico border with severe health disparities. We examined prevalence, risk factors and metabolic health in diagnosed and undiagnosed diabetes and pre-diabetes. Two thirds of this Mexican American population has diabetes or pre-diabetes. Diabetes prevalence was 28.0%, nearly half undiagnosed, and pre-diabetes 31.6%. Mean BMI among those with diabetes was 33.5 kg/m2 compared with 29.0 kg/m2 for those without diabetes. Significant risk factors were low income and educational levels. Most with diabetes had increased waist/hip ratio. Lack of insurance and access to health services played a decisive role in failure to have diabetes diagnosed. Participants with undiagnosed diabetes and pre-diabetes had similar measures of poor metabolic health similar but generally not as severe as those with diagnosed diabetes. More than 50% of a minority Mexican American population in South Texas has diabetes or pre-diabetes and is metabolically unhealthy. Only a third of diabetes cases were diagnosed. Sustained efforts are imperative to identify, diagnose and treat individuals in underserved communities.

  7. Intensive multifactorial treatment modifies the effect of family history of diabetes on glycaemic control in people with Type 2 diabetes: a post hoc analysis of the ADDITION-Denmark randomized controlled trial.

    Science.gov (United States)

    Eliraqi, G M; Vistisen, D; Lauritzen, T; Sandbaek, A; Jørgensen, M E; Faerch, K

    2015-08-01

    To investigate whether intensive multifactorial treatment can reverse the predisposed adverse phenotype of people with Type 2 diabetes who have a family history of diabetes. Data from the randomized controlled trial ADDITION-Denmark were used. A total of 1441 newly diagnosed patients with diabetes (598 with family history of diabetes) were randomized to intensive treatment or routine care. Family history of diabetes was defined as having one parent and/or sibling with diabetes. Linear mixed-effects models were used to assess the changes in risk factors (BMI, waist circumference, blood pressure, lipids and HbA1c ) after 5 years of follow-up in participants with and without a family history of diabetes. An interaction term between family history of diabetes and treatment group was included in the models to test for a modifying effect of the intervention. All analyses were adjusted for age, sex, baseline value of the risk factor and general practice (random effect). At baseline, participants with a family history of diabetes were younger and had a 1.1 mmol/mol (0.1%) higher HbA1c concentration at the time of diagnosis than those without a family history of diabetes. Family history of diabetes modified the effect of the intervention on changes in HbA1c levels. In the group receiving routine care, participants with a family history of diabetes experienced an improvement in HbA1c concentration that was 3.3 mmol/mol (0.3%) lower than the improvement found in those without a family history of diabetes after 5 years of follow-up. In the intensive treatment group, however, there was no difference in HbA1c concentrations between participants with and without a family history of diabetes after 5 years of treatment. Intensive treatment of diabetes may partly remove the adverse effects of family history of diabetes on glycaemic control. The effect of this improvement on long-term diabetic complications warrants further investigation. © 2015 The Authors. Diabetic Medicine

  8. Hebbian Learning in a Random Network Captures Selectivity Properties of the Prefrontal Cortex

    Science.gov (United States)

    Lindsay, Grace W.

    2017-01-01

    Complex cognitive behaviors, such as context-switching and rule-following, are thought to be supported by the prefrontal cortex (PFC). Neural activity in the PFC must thus be specialized to specific tasks while retaining flexibility. Nonlinear “mixed” selectivity is an important neurophysiological trait for enabling complex and context-dependent behaviors. Here we investigate (1) the extent to which the PFC exhibits computationally relevant properties, such as mixed selectivity, and (2) how such properties could arise via circuit mechanisms. We show that PFC cells recorded from male and female rhesus macaques during a complex task show a moderate level of specialization and structure that is not replicated by a model wherein cells receive random feedforward inputs. While random connectivity can be effective at generating mixed selectivity, the data show significantly more mixed selectivity than predicted by a model with otherwise matched parameters. A simple Hebbian learning rule applied to the random connectivity, however, increases mixed selectivity and enables the model to match the data more accurately. To explain how learning achieves this, we provide analysis along with a clear geometric interpretation of the impact of learning on selectivity. After learning, the model also matches the data on measures of noise, response density, clustering, and the distribution of selectivities. Of two styles of Hebbian learning tested, the simpler and more biologically plausible option better matches the data. These modeling results provide clues about how neural properties important for cognition can arise in a circuit and make clear experimental predictions regarding how various measures of selectivity would evolve during animal training. SIGNIFICANCE STATEMENT The prefrontal cortex is a brain region believed to support the ability of animals to engage in complex behavior. How neurons in this area respond to stimuli—and in particular, to combinations of stimuli (

  9. Amylase, Lipase, and Acute Pancreatitis in People With Type 2 Diabetes Treated With Liraglutide: Results From the LEADER Randomized Trial.

    Science.gov (United States)

    Steinberg, William M; Buse, John B; Ghorbani, Marie Louise Muus; Ørsted, David D; Nauck, Michael A

    2017-07-01

    To evaluate serum amylase and lipase levels and the rate of acute pancreatitis in patients with type 2 diabetes and high cardiovascular risk randomized to liraglutide or placebo and observed for 3.5-5.0 years. A total of 9,340 patients with type 2 diabetes were randomized to either liraglutide or placebo (median observation time 3.84 years). Fasting serum lipase and amylase were monitored. Acute pancreatitis was adjudicated in a blinded manner. Compared with the placebo group, liraglutide-treated patients had increases in serum lipase and amylase of 28.0% and 7.0%, respectively. Levels were increased at 6 months and then remained stable. During the study, 18 (0.4% [1.1 events/1,000 patient-years of observation] [PYO]) liraglutide-treated and 23 (0.5% [1.7 events/1,000 PYO]) placebo patients had acute pancreatitis confirmed by adjudication. Most acute pancreatitis cases occurred ≥12 months after randomization. Liraglutide-treated patients with prior history of pancreatitis ( n = 147) were not more likely to develop acute pancreatitis than similar patients in the placebo group ( n = 120). Elevations of amylase and lipase levels did not predict future risk of acute pancreatitis (positive predictive value pancreatitis among liraglutide-treated patients (regardless of previous history of pancreatitis) compared with the placebo group. Liraglutide was associated with increases in serum lipase and amylase, which were not predictive of an event of subsequent acute pancreatitis. © 2017 by the American Diabetes Association.

  10. Performance Evaluation of User Selection Protocols in Random Networks with Energy Harvesting and Hardware Impairments

    Directory of Open Access Journals (Sweden)

    Tan Nhat Nguyen

    2016-01-01

    Full Text Available In this paper, we evaluate performances of various user selection protocols under impact of hardware impairments. In the considered protocols, a Base Station (BS selects one of available Users (US to serve, while the remaining USs harvest the energy from the Radio Frequency (RF transmitted by the BS. We assume that all of the US randomly appear around the BS. In the Random Selection Protocol (RAN, the BS randomly selects a US to transmit the data. In the second proposed protocol, named Minimum Distance Protocol (MIND, the US that is nearest to the BS will be chosen. In the Optimal Selection Protocol (OPT, the US providing the highest channel gain between itself and the BS will be served. For performance evaluation, we derive exact and asymptotic closed-form expressions of average Outage Probability (OP over Rayleigh fading channels. We also consider average harvested energy per a US. Finally, Monte-Carlo simulations are then performed to verify the theoretical results.

  11. Mendelian randomization studies do not support a causal role for reduced circulating adiponectin levels in insulin resistance and type 2 diabetes

    NARCIS (Netherlands)

    H. Yaghootkar (Hanieh); C. Lamina (Claudia); R.A. Scott (Robert); Z. Dastani (Zari); M.-F. Hivert (Marie-France); L.L. Warren (Liling); A. Stancáková (Alena); S.G. Buxbaum (Sarah); L.-P. Lyytikäinen (Leo-Pekka); P. Henneman (Peter); Y. Wu (Ying); C.Y.Y. Cheung (Chloe); J.S. Pankow (James); A.U. Jackson (Anne); S. Gustafsson (Stefan); J.H. Zhao (Jing Hua); C. Ballantyne (Christie); W. Xie (Weijia); R.N. Bergman (Richard); M. Boehnke (Michael); F. El Bouazzaoui (Fatiha); F.S. Collins (Francis); S.H. Dunn (Sandra); J. Dupuis (Josée); N.G. Forouhi (Nita); C.J. Gillson (Christopher); A.T. Hattersley (Andrew); J. Hong (Jaeyoung); M. Kähönen (Mika); J. Kuusisto (Johanna); L. Kedenko (Lyudmyla); F. Kronenberg (Florian); A. Doria (Andrea); T.L. Assimes (Themistocles); E. Ferrannini (Ele); T. Hansen (Torben); K. Hao (Ke); H. Häring (Hans); J.W. Knowles (Joshua); C.M. Lindgren (Cecilia); J.J. Nolan (John); J. Paananen (Jussi); O. Pedersen (Oluf); T. Quertermous (Thomas); U. Smith (Ulf); T. Lehtimäki (Terho); C.-T. Liu (Ching-Ti); R.J.F. Loos (Ruth); M.I. McCarthy (Mark); A.D. Morris (Andrew); R.S. Vasan (Ramachandran Srini); T.D. Spector (Timothy); T.M. Teslovich (Tanya); J. Tuomilehto (Jaakko); J.A.P. Willems van Dijk (Ko); J. Viikari (Jorma); N. Zhu (Na); C. Langenberg (Claudia); E. Ingelsson (Erik); R.K. Semple (Robert); A. Sinaiko (Alan); C.N.A. Palmer (Colin); M. Walker (Mark); K.S.L. Lam (Karen); B. Paulweber (Bernhard); K.L. Mohlke (Karen); C.M. van Duijn (Cornelia); O. Raitakari (Olli); A. Bidulescu (Aurelian); N.J. Wareham (Nick); M. Laakso (Markku); D. Waterworth (Dawn); D.A. Lawlor (Debbie); J.B. Meigs (James); J.B. Richards (Brent); T.M. Frayling (Timothy)

    2013-01-01

    textabstractAdiponectin is strongly inversely associated with insulin resistance and type 2 diabetes, but its causal role remains controversial. We used a Mendelian randomization approach to test the hypothesis that adiponectin causally influences insulin resistance and type 2 diabetes. We used

  12. Basis and Design of a Randomized Clinical Trial to Evaluate the Effect of Levosulpiride on Retinal Alterations in Patients With Diabetic Retinopathy and Diabetic Macular Edema.

    Science.gov (United States)

    Robles-Osorio, Ma Ludivina; García-Franco, Renata; Núñez-Amaro, Carlos D; Mira-Lorenzo, Ximena; Ramírez-Neria, Paulina; Hernández, Wendy; López-Star, Ellery; Bertsch, Thomas; Martínez de la Escalera, Gonzalo; Triebel, Jakob; Clapp, Carmen

    2018-01-01

    Diabetic retinopathy (DR) and diabetic macular edema (DME) are potentially blinding, microvascular retinal diseases in people with diabetes mellitus. Preclinical studies support a protective role of the hormone prolactin (PRL) due to its ocular incorporation and conversion to vasoinhibins, a family of PRL fragments that inhibit ischemia-induced retinal angiogenesis and diabetes-derived retinal vasopermeability. Here, we describe the protocol of an ongoing clinical trial investigating a new therapy for DR and DME based on elevating the circulating levels of PRL with the prokinetic, dopamine D2 receptor blocker, levosulpiride. It is a prospective, randomized, double-blind, placebo-controlled trial enrolling male and female patients with type 2 diabetes having DME, non-proliferative DR (NPDR), proliferative DR (PDR) requiring vitrectomy, and DME plus standard intravitreal therapy with the antiangiogenic agent, ranibizumab. Patients are randomized to receive placebo (lactose pill, orally TID) or levosulpiride (75 mg/day orally TID) for 8 weeks (DME and NPDR), 1 week (the period before vitrectomy in PDR), or 12 weeks (DME plus ranibizumab). In all cases the study medication is taken on top of standard therapy for diabetes, blood pressure control, or other medical conditions. Primary endpoints in groups 1 and 2 (DME: placebo and levosulpiride), groups 3 and 4 (NPDR: placebo and levosulpiride), and groups 7 and 8 (DME plus ranibizumab: placebo and levosulpiride) are changes from baseline in visual acuity, retinal thickness assessed by optical coherence tomography, and retinal microvascular abnormalities evaluated by fundus biomicroscopy and fluorescein angiography. Changes in serum PRL levels and of PRL and vasoinhibins levels in the vitreous between groups 5 and 6 (PDR undergoing vitrectomy: placebo and levosulpiride) serve as proof of principle that PRL enters the eye to counteract disease progression. Secondary endpoints are changes during the follow-up of health

  13. Simulated Performance Evaluation of a Selective Tracker Through Random Scenario Generation

    DEFF Research Database (Denmark)

    Hussain, Dil Muhammad Akbar

    2006-01-01

    performance assessment. Therefore, a random target motion scenario is adopted. Its implementation in particular for testing the proposed selective track splitting algorithm using Kalman filters is investigated through a number of performance parameters which gives the activity profile of the tracking scenario......  The paper presents a simulation study on the performance of a target tracker using selective track splitting filter algorithm through a random scenario implemented on a digital signal processor.  In a typical track splitting filter all the observation which fall inside a likelihood ellipse...... are used for update, however, in our proposed selective track splitting filter less number of observations are used for track update.  Much of the previous performance work [1] has been done on specific (deterministic) scenarios. One of the reasons for considering the specific scenarios, which were...

  14. TEHRAN AIR POLLUTANTS PREDICTION BASED ON RANDOM FOREST FEATURE SELECTION METHOD

    Directory of Open Access Journals (Sweden)

    A. Shamsoddini

    2017-09-01

    Full Text Available Air pollution as one of the most serious forms of environmental pollutions poses huge threat to human life. Air pollution leads to environmental instability, and has harmful and undesirable effects on the environment. Modern prediction methods of the pollutant concentration are able to improve decision making and provide appropriate solutions. This study examines the performance of the Random Forest feature selection in combination with multiple-linear regression and Multilayer Perceptron Artificial Neural Networks methods, in order to achieve an efficient model to estimate carbon monoxide and nitrogen dioxide, sulfur dioxide and PM2.5 contents in the air. The results indicated that Artificial Neural Networks fed by the attributes selected by Random Forest feature selection method performed more accurate than other models for the modeling of all pollutants. The estimation accuracy of sulfur dioxide emissions was lower than the other air contaminants whereas the nitrogen dioxide was predicted more accurate than the other pollutants.

  15. Tehran Air Pollutants Prediction Based on Random Forest Feature Selection Method

    Science.gov (United States)

    Shamsoddini, A.; Aboodi, M. R.; Karami, J.

    2017-09-01

    Air pollution as one of the most serious forms of environmental pollutions poses huge threat to human life. Air pollution leads to environmental instability, and has harmful and undesirable effects on the environment. Modern prediction methods of the pollutant concentration are able to improve decision making and provide appropriate solutions. This study examines the performance of the Random Forest feature selection in combination with multiple-linear regression and Multilayer Perceptron Artificial Neural Networks methods, in order to achieve an efficient model to estimate carbon monoxide and nitrogen dioxide, sulfur dioxide and PM2.5 contents in the air. The results indicated that Artificial Neural Networks fed by the attributes selected by Random Forest feature selection method performed more accurate than other models for the modeling of all pollutants. The estimation accuracy of sulfur dioxide emissions was lower than the other air contaminants whereas the nitrogen dioxide was predicted more accurate than the other pollutants.

  16. Effect of Rebound Exercises and Circuit Training on Complications Associated with Type 2 Diabetes: Protocol for a Randomized Controlled Trial.

    Science.gov (United States)

    Kaka, Bashir; Maharaj, Sonill Sooknunan

    2018-05-07

    The incidence of type 2 diabetes mellitus, a chronic lifestyle disease, and its complications are on the rise. Exercise has been documented as being effective in the management of musculoskeletal pain, depression, and reduction of hyperglycemia in diabetic patients. However, there is no consensus regarding the types of exercise that reduce musculoskeletal pain and depression and improve quality of life as well as respiratory function among individuals with type 2 diabetes. The objective of this study is to determine the effects of rebound and circuit training on musculoskeletal pain, blood glucose level, cholesterol level, quality of life, depression, and respiratory parameters in patients with type 2 diabetes mellitus. A total of 70 participants are expected to be recruited in this single blind randomized controlled trial. Computer-generated random numbers will be used to randomize the participants into 3 groups, namely, the rebound exercise group, the circuit exercise group, and the control group. Measurements will be taken at baseline and at the end of the 8 weeks of the study. Participants' musculoskeletal pain will be assessed using the visual analog scale, quality of life will be assessed using the SF 12 Health Survey Questionnaire, depression using the Beck Depression Inventory, respiratory parameters using the spirometer, and biochemical parameters such as glucose level and cholesterol level using the glucometer. Data will be analyzed using descriptive statistics and inferential statistics of multivariate analysis of variance between the groups and paired t test within the group. Alpha will be set at .05. The results of this study will identify the effectiveness of rebound exercise and circuit training, compared with the control, in the management of type 2 diabetes mellitus and on quality of life, musculoskeletal pain, depression, glycemic control, cholesterol level, as well as improvement in respiratory function. Though different additional strategies

  17. Telemedicine for the Management of Glycemic Control and Clinical Outcomes of Type 1 Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Controlled Studies

    Directory of Open Access Journals (Sweden)

    Shaun W. H. Lee

    2017-05-01

    Full Text Available Importance: Telemedicine has been shown to be an efficient and effective means of providing care to patients with chronic disease especially in remote and undeserved regions, by improving access to care and reduce healthcare cost. However, the evidence surrounding its applicability in type 1 diabetes remains scarce and conflicting.Objective: To synthesize evidence and quantify the effectiveness of telemedicine interventions for the management of glycemic and clinical outcomes in type 1 diabetes patients, relative to comparator conditions.Data Sources: MEDLINE, EMBASE, Cochrane Library, Web of Science, PsycINFO, and CINAHL were searched for published articles since inception until December 2016.Study Selection: Original articles reporting the results of randomized controlled studies on the effectiveness of telemedicine in people with type 1 diabetes were included.Data Extraction and Synthesis: Two reviewers independently extracted data, assessed quality, and strength of evidence. Interventions were categorized based upon the telemedicine focus (monitoring, education, consultation, case-management, and peer mentoring.Main Outcome and Measure: Absolute change in glycosylated hemoglobin A1c (HbA1c from baseline to follow-up assessment.Results: A total of 38 studies described in 41 articles were identified. Positive effects on glycemic control were noted with studies examining telemedicine, with a mean reduction of 0.18% at the end of intervention. Studies with longer duration (>6 months who had recruited patients with a higher baseline HbA1c (≥9% were associated with larger effects. Telemedicine interventions that involve individualized assessments, audit with feedback and skill building were also more effective in improving glycemic control. However, no benefits were observed on blood pressure, lipids, weight, quality of life, and adverse events.Conclusions and Relevance: There is insufficient evidence to support telemedicine use for glycemic

  18. Effects of probiotics supplement in patients with type 2 diabetes mellitus: A meta-analysis of randomized trials.

    Science.gov (United States)

    Hu, Yi-Meng; Zhou, Feng; Yuan, Yin; Xu, Yan-Cheng

    2017-04-21

    To objectively evaluate the effects of probiotics supplement on glycemic control and lipid metabolism in patients with type 2 diabetes mellitus (T2DM). The randomized controlled trials (RCTs) with regard to the probiotics or synbiotics for the treatment of T2DM were collected through retrieving 5 databases from their establishment to March 2016. After study selection, quality assessment and data extraction were performed by 2 authors independently; and STATA software was used for statistical analysis. The level of evidence was evaluated by applying the GRADE system. Twelve RCTs involving 770 participants were enrolled. The results of the meta-analysis showed that probiotics could significantly reduce fasting blood glucose by -11.27mg/dL (95% CI -21.76 to -0.79; PProbiotics could significantly reduce HOMA-IR of T2DM patients (-1.05; 95% CI -1.52 to -0.59; Pprobiotics on total cholesterol (-8.49mg/dL; 95% CI -15.24 to -1.73; P=.014) and triglycerides (TG; -23.66mg/dL; 95% CI -40.26 to -7.05; Pprobiotics had stronger reduction effect on serum insulin concentration (-3.32μU/mL; 95% CI -5.89 to-0.75; P=.001) and TG (-25.94mg/dL; 95% CI -65.33 to 13.44; Pprobiotics can improve glucose control and lipid metabolism. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

  19. Prospective randomized controlled intervention trial: Comprehensive Yogic Breathing Improves Cardiac autonomic functions and Quality of life in Diabetes

    Directory of Open Access Journals (Sweden)

    V P Jyotsna

    2012-01-01

    Full Text Available Aims and Objectives: To assess the effect of Comprehensive Yogic Breathing Program on glycemic control, quality of life, and cardiac autonomic functions in diabetes. Material and Methods: This is a prospective randomized controlled intervention trial. Cardiac autonomic functions were assessed in 120 diabetics. Patients were randomized into two groups, one group receiving standard therapy for diabetes (n = 56 and the other group receiving standard therapy for diabetes and comprehensive yogic breathing program (n = 64. Standard therapy included advice on diet, walk, and oral antidiabetic drugs. Comprehensive yogic breathing program was an interactive session in which Sudarshan kriya yoga, a rhythmic cyclical breathing, preceded by Pranayam was taught under guidance of a certified teacher. Change in fasting, post prandial blood sugars, glycated hemoglobin, and quality of life were assessed. Cardiac autonomic function tests were done before and six months after intervention. Results: There was significant improvement in psychological (P = 0.006 and social domains (P = 0.04 and total quality of life (P = 0.02 in the group practicing comprehensive yogic breathing program as compared to the group following standard therapy alone. In the group following breathing program, the improvement in sympathetic cardiac autonomic functions was statistically significant (P = 0.01, while the change in the standard group was not significant (P = 0.17. When both parasympathetic and sympathetic cardiac autonomic functions were considered, there was a trend toward improvement in patients following comprehensive yogic breathing program (P = 0.07. In the standard therapy group, no change in cardiac autonomic functions was noted (P = 0.76. The parameters of glycemic control were comparable in both groups. Conclusion: There was significant improvement in quality of life and cardiac autonomic functions in the diabetes patients practicing comprehensive yogic breathing

  20. Continuous-Time Mean-Variance Portfolio Selection with Random Horizon

    International Nuclear Information System (INIS)

    Yu, Zhiyong

    2013-01-01

    This paper examines the continuous-time mean-variance optimal portfolio selection problem with random market parameters and random time horizon. Treating this problem as a linearly constrained stochastic linear-quadratic optimal control problem, I explicitly derive the efficient portfolios and efficient frontier in closed forms based on the solutions of two backward stochastic differential equations. Some related issues such as a minimum variance portfolio and a mutual fund theorem are also addressed. All the results are markedly different from those in the problem with deterministic exit time. A key part of my analysis involves proving the global solvability of a stochastic Riccati equation, which is interesting in its own right

  1. Continuous-Time Mean-Variance Portfolio Selection with Random Horizon

    Energy Technology Data Exchange (ETDEWEB)

    Yu, Zhiyong, E-mail: yuzhiyong@sdu.edu.cn [Shandong University, School of Mathematics (China)

    2013-12-15

    This paper examines the continuous-time mean-variance optimal portfolio selection problem with random market parameters and random time horizon. Treating this problem as a linearly constrained stochastic linear-quadratic optimal control problem, I explicitly derive the efficient portfolios and efficient frontier in closed forms based on the solutions of two backward stochastic differential equations. Some related issues such as a minimum variance portfolio and a mutual fund theorem are also addressed. All the results are markedly different from those in the problem with deterministic exit time. A key part of my analysis involves proving the global solvability of a stochastic Riccati equation, which is interesting in its own right.

  2. Gestational Diabetes Mellitus Can Be Prevented by Lifestyle Intervention: The Finnish Gestational Diabetes Prevention Study (RADIEL): A Randomized Controlled Trial.

    Science.gov (United States)

    Koivusalo, Saila B; Rönö, Kristiina; Klemetti, Miira M; Roine, Risto P; Lindström, Jaana; Erkkola, Maijaliisa; Kaaja, Risto J; Pöyhönen-Alho, Maritta; Tiitinen, Aila; Huvinen, Emilia; Andersson, Sture; Laivuori, Hannele; Valkama, Anita; Meinilä, Jelena; Kautiainen, Hannu; Eriksson, Johan G; Stach-Lempinen, Beata

    2016-01-01

    To assess whether gestational diabetes mellitus (GDM) can be prevented by a moderate lifestyle intervention in pregnant women who are at high risk for the disease. Two hundred ninety-three women with a history of GDM and/or a prepregnancy BMI of ≥30 kg/m(2) were enrolled in the study at lifestyle intervention reduced the incidence of GDM by 39% in high-risk pregnant women. These findings may have major health consequences for both the mother and the child. © 2016 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

  3. Causal Association of Overall Obesity and Abdominal Obesity with Type 2 Diabetes: A Mendelian Randomization Analysis.

    Science.gov (United States)

    Wang, Tao; Zhang, Rong; Ma, Xiaojing; Wang, Shiyun; He, Zhen; Huang, Yeping; Xu, Bo; Li, Yangyang; Zhang, Hong; Jiang, Feng; Bao, Yuqian; Hu, Cheng; Jia, Weiping

    2018-05-01

    This study aimed to compare the causal effect of overall obesity and abdominal obesity on type 2 diabetes among Chinese Han individuals. The causal relationship of BMI and waist-to-hip ratio (WHR) with the risk of glucose deterioration and glycemic traits was compared using two different genetic instruments based on 30 BMI loci and 6 WHR loci with Mendelian randomization (MR) in three prospective cohorts (n = 6,476). Each 1-SD genetically instrumented higher WHR was associated with a 65.7% higher risk of glucose deterioration (95% CI = 1.069-2.569, P = 0.024), whereas no significant association of BMI with glucose deterioration was observed. Furthermore, a causal relationship was found only between BMI and homeostatic model assessment β-cell function (HOMA-B) (β = 0.143, P = 0.001), and there was a nominal association with Stumvoll second-phase insulin secretion traits (β = 0.074, P = 0.022). The significance level did not persist in sensitivity analyses, except in the causal estimate of WHR on the Gutt index in MR-Egger (β = -0.379, P = 0.022) and the causal estimate of BMI on homeostatic model assessment β-cell function in weighted median MR (β = 0.128, P = 0.017). The data from this study support the potential causal relationship between abdominal obesity and hyperglycemia, which may be driven by aggravated insulin resistance, in contrast with the potential causal relationship between overall obesity and insulin secretion. © 2018 The Obesity Society.

  4. Management of diabetes by a healthcare team in a cardiology unit: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Maria Antonieta P. de Moraes

    2013-11-01

    Full Text Available OBJECTIVE: To assess the effectiveness of healthcare team guidance in the implementation of a glycemic control protocol in the non-intensive care unit of a cardiology hospital. METHODS: This was a randomized clinical trial comparing 9 months of intensive guidance by a healthcare team on a protocol for diabetes care (Intervention Group, n = 95 with 9 months of standard care (Control Group, n = 87. Clinicaltrials.gov: NCT01154413. RESULTS: The mean age of the patients was 61.7±10 years, and the mean glycated hemoglobin level was 71±23 mmol/mol (8.7±2.1%. The mean capillary glycemia during hospitalization was similar between the groups (9.8±2.9 and 9.1±2.4 mmol/l for the Intervention Group and Control Group, respectively, p = 0.078. The number of hypoglycemic episodes (p = 0.77, hyperglycemic episodes (47 vs. 50 in the Intervention Group and Control Group, p = 0.35, respectively, and the length of stay in the hospital were similar between the groups (p = 0.64. The amount of regular insulin administered was 0 (0-10 IU in the Intervention Group and 28 (7-56 IU in the Control Group (p<0.001, and the amount of NPH insulin administered was similar between the groups (p = 0.16. CONCLUSIONS: While guidance on a glycemic control protocol given by a healthcare team resulted in a modification of the therapeutic strategy, no changes in glycemic control, frequency of episodes of hypoglycemia and hyperglycemia, or hospitalization duration were observed.

  5. Implementation of foot thermometry plus mHealth to prevent diabetic foot ulcers: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Lazo-Porras, Maria; Bernabe-Ortiz, Antonio; Sacksteder, Katherine A; Gilman, Robert H; Malaga, German; Armstrong, David G; Miranda, J Jaime

    2016-04-19

    Diabetic foot neuropathy (DFN) is one of the most important complications of diabetes mellitus; its early diagnosis and intervention can prevent foot ulcers and the need for amputation. Thermometry, measuring the temperature of the feet, is a promising emerging modality for diabetic foot ulcer prevention. However, patient compliance with at-home monitoring is concerning. Delivering messages to remind patients to perform thermometry and foot care might be helpful to guarantee regular foot monitoring. This trial was designed to compare the incidence of diabetic foot ulcers (DFUs) between participants who receive thermometry alone and those who receive thermometry as well as mHealth (SMS and voice messaging) over a year-long study period. This is an evaluator-blinded, randomized, 12-month trial. Individuals with a diagnosis of type 2 diabetes mellitus, aged between 18-80 years, having a present dorsalis pedis pulse in both feet, are in risk group 2 or 3 using the diabetic foot risk classification system (as specified by the International Working Group on the Diabetic Foot), have an operating cell phone or a caregiver with an operating cell phone, and have the ability to provide informed consent will be eligible to participate in the study. Recruitment will be performed in diabetes outpatient clinics at two Ministry of Health tertiary hospitals in Lima, Peru. participants in both groups will receive education about foot care at the beginning of the study and they will be provided with a thermometry device (TempStat™). TempStat™ is a tool that captures a thermal image of the feet, which, depending on the temperature of the feet, shows different colors. In this study, if a participant notes a single yellow image or variance between one foot and the contralateral foot, they will be prompted to notify a nurse to evaluate their activity within the previous 2 weeks and make appropriate recommendations. In addition to thermometry, participants in the intervention arm

  6. Diabetes

    Science.gov (United States)

    ... you, discussing your symptoms, and going over your health history, your doctor may test for diabetes if he or she suspects you are at risk. To check for diabetes, your doctor may request the following tests: Fasting blood sugar test. This test is usually done ...

  7. Diabetes

    DEFF Research Database (Denmark)

    Damm, Peter; Mathiesen, Elisabeth R

    2015-01-01

    For >30 years, insulin has been the drug of choice for the medical treatment of gestational diabetes mellitus. However, the use of oral hypoglycaemic agents has increased during the past 1–2 decades, so a recent comparison of treatment with glibenclamide, metformin or insulin in women...... with gestational diabetes mellitus is highly relevant....

  8. A Comparison between Decision Tree and Random Forest in Determining the Risk Factors Associated with Type 2 Diabetes.

    Science.gov (United States)

    Esmaily, Habibollah; Tayefi, Maryam; Doosti, Hassan; Ghayour-Mobarhan, Majid; Nezami, Hossein; Amirabadizadeh, Alireza

    2018-04-24

    We aimed to identify the associated risk factors of type 2 diabetes mellitus (T2DM) using data mining approach, decision tree and random forest techniques using the Mashhad Stroke and Heart Atherosclerotic Disorders (MASHAD) Study program. A cross-sectional study. The MASHAD study started in 2010 and will continue until 2020. Two data mining tools, namely decision trees, and random forests, are used for predicting T2DM when some other characteristics are observed on 9528 subjects recruited from MASHAD database. This paper makes a comparison between these two models in terms of accuracy, sensitivity, specificity and the area under ROC curve. The prevalence rate of T2DM was 14% among these subjects. The decision tree model has 64.9% accuracy, 64.5% sensitivity, 66.8% specificity, and area under the ROC curve measuring 68.6%, while the random forest model has 71.1% accuracy, 71.3% sensitivity, 69.9% specificity, and area under the ROC curve measuring 77.3% respectively. The random forest model, when used with demographic, clinical, and anthropometric and biochemical measurements, can provide a simple tool to identify associated risk factors for type 2 diabetes. Such identification can substantially use for managing the health policy to reduce the number of subjects with T2DM .

  9. Mediterranean diet cools down the inflammatory milieu in type 2 diabetes: the MÉDITA randomized controlled trial.

    Science.gov (United States)

    Maiorino, Maria Ida; Bellastella, Giuseppe; Petrizzo, Michela; Scappaticcio, Lorenzo; Giugliano, Dario; Esposito, Katherine

    2016-12-01

    Mediterranean-style diets provide cardiovascular benefits and increase insulin sensitivity. There is little evidence that adherence to Mediterranean diet may influence the levels of the inflammatory milieu in type 2 diabetes. The aim of this study was to assess whether Mediterranean diet influences both C-reactive protein (CRP) and adiponectin in newly diagnosed type 2 diabetes, and whether adherence to Mediterranean diet affects their circulating levels. In a two-arm, single-center trial, 215 men and women with newly diagnosed type 2 diabetes were randomized to a Mediterranean diet (n = 108, 54 males and 54 females) or a low-fat diet (n = 107, 52 males and 55 females), with a total follow-up of 8.1 years. At baseline visit and at 1 year, body weight, HOMA index, CRP, and adiponectin and its fractions were assessed. Adherence to the diets was assessed by calculating the Mediterranean-diet score. At 1 year, CPR fell by 37 % and adiponectin rose by 43 % in the Mediterranean diet group, while remaining unchanged in the low-fat diet group. The pattern of adiponectin fractions (high and non-high molecular weight) showed a response similar to that of total adiponectin. Diabetic patients with the highest scores (6-9 points) of adherence to Mediterranean diet had lower circulating CRP level and higher circulating total adiponectin levels than the diabetic patients who scored Mediterranean diet cools down the inflammatory milieu of type 2 diabetes.

  10. Practice context affects efforts to improve diabetes care for primary care patients: a pragmatic cluster randomized trial.

    Science.gov (United States)

    Dickinson, L Miriam; Dickinson, W Perry; Nutting, Paul A; Fisher, Lawrence; Harbrecht, Marjie; Crabtree, Benjamin F; Glasgow, Russell E; West, David R

    2015-04-01

    Efforts to improve primary care diabetes management have assessed strategies across heterogeneous groups of patients and practices. However, there is substantial variability in how well practices implement interventions and achieve desired outcomes. To examine practice contextual features that moderate intervention effectiveness. Secondary analysis of data from a cluster randomized trial of three approaches for implementing the Chronic Care Model to improve diabetes care. Forty small to mid-sized primary care practices participated, with 522 clinician and staff member surveys. Outcomes were assessed for 822 established patients with a diagnosis of type 2 diabetes who had at least one visit to the practice in the 18 months following enrollment. The primary outcome was a composite measure of diabetes process of care, ascertained by chart audit, regarding nine quality measures from the American Diabetes Association Physician Recognition Program: HgA1c, foot exam, blood pressure, dilated eye exam, cholesterol, nephropathy screen, flu shot, nutrition counseling, and self-management support. Data from practices included structural and demographic characteristics and Practice Culture Assessment survey subscales (Change Culture, Work Culture, Chaos). Across the three implementation approaches, demographic/structural characteristics (rural vs. urban + .70(p = .006), +2.44(p Culture (high vs. low: -.86(p = .048), +1.71(p = .005), +.34(p = .22)), Work Culture (high vs. low: -.67(p = .18), +2.41(p Culture (high vs. low: -.24(p = .006), -.20(p = .0771), -.44(p = .0019) and Work Culture (high vs. low: +.56(p = .3160), -1.0(p = .008), -.25 (p = .0216) were associated with trajectories of change in diabetes process of care, either directly or differentially by study arm. This study supports the need for broader use of methodological approaches to better examine contextual effects on implementation and effectiveness of quality improvement interventions in primary care settings.

  11. Emergence of multilevel selection in the prisoner's dilemma game on coevolving random networks

    International Nuclear Information System (INIS)

    Szolnoki, Attila; Perc, Matjaz

    2009-01-01

    We study the evolution of cooperation in the prisoner's dilemma game, whereby a coevolutionary rule is introduced that molds the random topology of the interaction network in two ways. First, existing links are deleted whenever a player adopts a new strategy or its degree exceeds a threshold value; second, new links are added randomly after a given number of game iterations. These coevolutionary processes correspond to the generic formation of new links and deletion of existing links that, especially in human societies, appear frequently as a consequence of ongoing socialization, change of lifestyle or death. Due to the counteraction of deletions and additions of links the initial heterogeneity of the interaction network is qualitatively preserved, and thus cannot be held responsible for the observed promotion of cooperation. Indeed, the coevolutionary rule evokes the spontaneous emergence of a powerful multilevel selection mechanism, which despite the sustained random topology of the evolving network, maintains cooperation across the whole span of defection temptation values.

  12. A randomized clinical trial of diabetes self-management for Mexican Americans: Are there serendipitous health benefits for supporters of study participants?

    Directory of Open Access Journals (Sweden)

    Sharon A Brown

    2017-01-01

    Full Text Available Objectives: Studies of social support in diabetes have focused on the effects of support on the person with type 2 diabetes. We explored diabetes prevention effects of a culturally tailored diabetes self-management intervention in individuals without diabetes who were supporters of intervention participants. Methods: This is a secondary analysis of data from a randomized clinical trial that involved 256 Mexican Americans with diabetes. Each study participant designated a supporter—spouse, relative, friend—who attended intervention sessions and assisted participants in attaining effective diabetes self-management. Supporter’s glycosylated hemoglobin (A1C data were tracked for 1 year to determine diabetes conversion rates in supporters without diabetes at baseline. Results: Fewer individuals in the intervention group (n = 9 converted to an A1C above the 7% threshold, compared to the 1-year wait-listed control group (n = 16. We found a statistically significant difference (p = .021 at 12 months in the number of individuals whose A1C was ⩽8%, with fewer supporters above threshold in the intervention group (reduction of 48%. Supporters in the intervention group with prediabetes, based on baseline A1C, experienced a slight reduction in A1C, while control group supporters with prediabetes experienced an increase. Discussion: The results suggest that there are potential benefits for family members and other supporters of persons with diabetes who participated in diabetes self-management programs.

  13. Metformin in women with type 2 diabetes in pregnancy (MiTy): a multi-center randomized controlled trial.

    Science.gov (United States)

    Feig, Denice S; Murphy, Kellie; Asztalos, Elizabeth; Tomlinson, George; Sanchez, Johanna; Zinman, Bernard; Ohlsson, Arne; Ryan, Edmond A; Fantus, I George; Armson, Anthony B; Lipscombe, Lorraine L; Barrett, Jon F R

    2016-07-19

    The incidence of type 2 diabetes in pregnancy is rising and rates of serious adverse maternal and fetal outcomes remain high. Metformin is a biguanide that is used as first-line treatment for non-pregnant patients with type 2 diabetes. We hypothesize that metformin use in pregnancy, as an adjunct to insulin, will decrease adverse outcomes by reducing maternal hyperglycemia, maternal insulin doses, maternal weight gain and gestational hypertension/pre-eclampsia. In addition, since metformin crosses the placenta, metformin treatment of the fetus may have a direct beneficial effect on neonatal outcomes. Our aim is to compare the effectiveness of the addition of metformin to insulin, to standard care (insulin plus placebo) in women with type 2 diabetes in pregnancy. The MiTy trial is a multi-centre randomized trial currently enrolling pregnant women with type 2 diabetes, who are on insulin, between the ages of 18-45, with a gestational age of 6 weeks 0 days to 22 weeks 6 days. In this randomized, double-masked, parallel placebo-controlled trial, after giving informed consent, women are randomized to receive either metformin 1,000 mg twice daily or placebo twice daily. A web-based block randomization system is used to assign women to metformin or placebo in a 1:1 ratio, stratified for site and body mass index. The primary outcome is a composite neonatal outcome of pregnancy loss, preterm birth, birth injury, moderate/severe respiratory distress, neonatal hypoglycemia, or neonatal intensive care unit admission longer than 24 h. Secondary outcomes are large for gestational age, cord blood gas pH pregnancy, and duration of hospital stays. The trial aims to enroll 500 participants. The results of this trial will inform endocrinologists, obstetricians, family doctors, and other healthcare professionals caring for women with type 2 diabetes in pregnancy, as to the benefits of adding metformin to insulin in this high risk population. ClinicalTrials.gov Identifier: no

  14. Screening for diabetic retinopathy with or without a copayment in a randomized controlled trial: influence of the inverse care law.

    Science.gov (United States)

    Lian, Jin Xiao; McGhee, Sarah M; Gangwani, Rita A; Hedley, Anthony J; Lam, Cindy Lo Kuen; Yap, Maurice Keng Hung; Lai, Wico W; Chu, Daniel Wai Sing; Wong, David S H

    2013-06-01

    To examine whether the inverse care law operates in a screening program for diabetic retinopathy (DR) based on fee for service in Hong Kong. Randomized controlled trial. All those with type 1 or 2 diabetes from 2 clinics were recruited. Diabetic retinopathy screening with a small copayment versus free access in a publicly funded family medicine service. Uptake of screening and severity of DR detected. Association between these outcome variables and independent variables were determined using multivariate logistic regression models and reported as odds ratios (ORs). After randomization, 1387 subjects in the free group and 1379 subjects in the pay group were eligible for screening, and 94.9% (1316/1387) and 92.6% (1277/1379), respectively, agreed to participate in the study. The offer of screening was accepted by 94.8% (1247/1316) in the free group and 91.2% (1164/1277) in the pay group, and the final uptake ratios were 88.5% (1165/1316) and 82.4% (1052/1277), respectively (Pearson chi = 19.74, Plaw seems to operate in a preventive intervention when a relatively small copayment is applied. There is a case for making effective preventive services free of charge. The author(s) have no proprietary or commercial interest in any materials discussed in this article. Copyright © 2013 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

  15. Peer characteristics associated with improved glycemic control in a randomized controlled trial of a reciprocal peer support program for diabetes.

    Science.gov (United States)

    Kaselitz, Elizabeth; Shah, Megha; Choi, Hwajung; Heisler, Michele

    2018-01-01

    Objective In a secondary analysis of a randomized controlled trial of diabetes reciprocal peer support, we examined characteristics of peers associated with improvements in their partner's glycemic control. Methods A total of 102 adults with diabetes were randomized to the reciprocal peer support arm (vs. a nurse care management arm). The primary outcome was change in A1c over six months. Intermediate outcomes were insulin initiation and peer engagement. A number of baseline characteristics of peers were hypothesized to influence outcomes for their peer, and concordant characteristics of peer dyads were hypothesized that would influence outcomes for both peer partners. Results Improvement in A1c was associated with having a peer older than oneself ( P peers who reported poorer health at baseline had worse glycemic control at follow-up ( P peers had a more controlled self-regulation style were more likely to initiate insulin ( P peers whose partners were older and reported more diabetes distress at baseline supports the need for further research into the peer characteristics that lead to improved outcomes. This could allow for better matching and more effective partnerships.

  16. A Randomized Controlled Trial of Acceptance and Commitment Therapy for Type 2 Diabetes Management: The Moderating Role of Coping Styles.

    Science.gov (United States)

    Shayeghian, Zeinab; Hassanabadi, Hamidreza; Aguilar-Vafaie, Maria E; Amiri, Parisa; Besharat, Mohammad Ali

    2016-01-01

    Evidence of the efficacy of existing psychological interventions for self-management in diabetes is limited. The current study aimed at assessing the effects of group-based ACT on self-management of patients with T2DM, considering the moderating role of coping styles. One hundred and six patients with type 2 diabetes were randomly assigned either to the education alone (n = 53) or to a combination of education and group-based acceptance and commitment therapy (n = 53) over a period of 10 sessions. In each group, 50 participants completed a 3 month follow-up assessment. After 3 months, compared to patients who received education alone, those in the group-based acceptance and commitment therapy condition were more likely to use effective coping strategies, reported better diabetes self-care, and optimum glycated hemoglobin (HbA1C) levels in the target range. Consideration of the role of coping style for a more accurate evaluation of the effects of acceptance and commitment therapy may be a useful addition to services provided for patients with type 2 diabetes.

  17. Reduction of atherogenic risk in patients with type 2 diabetes by curcuminoid extract: a randomized controlled trial.

    Science.gov (United States)

    Chuengsamarn, Somlak; Rattanamongkolgul, Suthee; Phonrat, Benjaluck; Tungtrongchitr, Rungsunn; Jirawatnotai, Siwanon

    2014-02-01

    Curcumin is a phytocompound found in the root of turmeric, a common herbal ingredient in many Asian cuisines. The compound contains anti-inflammatory activity, which is mediated through an up-regulation of adiponectin and reduction of leptin. Consumption of curcumin was shown to prevent some deteriorative conditions caused by inflammation, such as ulcerative colitis, rheumatoid arthritis and esophagitis, and so on. Inflammation-associated cardiovascular conditions such as atherosclerosis are common in diabetes patients. The anti-inflammation effect of curcumin might be beneficial to prevent such condition in these patients. We aim to evaluate an antiatherosclerosis effect of curcumin in diabetes patients. Effects of curcumin on risk factors for atherosclerosis were investigated in a 6-month randomized, double-blinded and placebo-controlled clinical trial that included subjects diagnosed with type 2 diabetes. An atherosclerosis parameter, the pulse wave velocity, and other metabolic parameters in patients treated with placebo and curcumin were compared. Our results showed that curcumin intervention significantly reduced pulse wave velocity, increased level of serum adiponectin and decreased level of leptin. These results are associated with reduced levels of homeostasis model assessment-insulin resistance, triglyceride, uric acid, visceral fat and total body fat. In summary, a 6-month curcumin intervention in type 2 diabetic population lowered the atherogenic risks. In addition, the extract helped to improve relevant metabolic profiles in this high-risk population. Copyright © 2014 Elsevier Inc. All rights reserved.

  18. Metoprolol compared to carvedilol deteriorates insulin-stimulated endothelial function in patients with type 2 diabetes - a randomized study

    Directory of Open Access Journals (Sweden)

    Raunsø Jakob

    2010-05-01

    Full Text Available Abstract Aim Studies of beta blockade in patients with type 2 diabetes have shown inferiority of metoprolol treatment compared to carvedilol on indices of insulin resistance. The aim of this study was to examine the effect of metoprolol versus carvedilol on endothelial function and insulin-stimulated endothelial function in patients with type 2 diabetes. Method 24 patients with type 2 diabetes were randomized to receive either 200 mg metoprolol succinate or 50 mg carvedilol daily. Endothelium-dependent vasodilation was assessed by using venous occlusion plethysmography with increasing doses of intra-arterial infusions of the agonist serotonin. Insulin-stimulated endothelial function was assessed after co-infusion of insulin for sixty minutes. Vaso-reactivity studies were done before and after the two-month treatment period. Results Insulin-stimulated endothelial function was deteriorated after treatment with metoprolol, the percentage change in forearm blood-flow was 60.19% ± 17.89 (at the highest serotonin dosages before treatment and -33.80% ± 23.38 after treatment (p = 0.007. Treatment with carvedilol did not change insulin-stimulated endothelial function. Endothelium-dependent vasodilation without insulin was not changed in either of the two treatment groups. Conclusion This study shows that vascular insulin sensitivity was preserved during treatment with carvedilol while blunted during treatment with metoprolol in patients with type 2 diabetes. Trial registration Current Controlled Trials NCT00497003

  19. Effects of thai foot massage on balance performance in diabetic patients with peripheral neuropathy: a randomized parallel-controlled trial.

    Science.gov (United States)

    Chatchawan, Uraiwan; Eungpinichpong, Wichai; Plandee, Piyawan; Yamauchi, Junichiro

    2015-04-20

    BACKGROUND Peripheral neuropathy is the most common complications of diabetic patients and leads to loss of plantar cutaneous sensation, movement perception, and body balance. Thai foot massage is an alternative therapy to improve balance. Therefore, the purpose of this study was to investigate the effects of Thai foot massage on balance performance in diabetic patients with peripheral neuropathy. MATERIAL AND METHODS Sixty patients with type-2 diabetes were recruited and randomly assigned into either the Thai foot massage or control groups. The Thai foot massage group received a modified Thai traditional foot massage for 30 min, 3 days per week for 2 weeks. We measured timed up and go (TUG), one leg stance: OLS), the range of motion (ROM) of the foot, and foot sensation (SWMT) before treatment, after the first single session, and after the 2-week treatment. RESULTS After the single treatment session, only the Thai foot massage group showed a significant improvement in TUG. After the 2-week treatment, both Thai foot massage and control groups showed a significant improvement of TUG and OLS (Pfoot massage group showed better improvement in TUG than the control group (pfoot massage group also showed significant improvements in ROM and SWMT after the 2-week treatment. CONCLUSIONS The results of this study suggest that Thai foot massage is a viable alternative treatment for balance performance, ROM of the foot, and the foot sensation in diabetic patients with peripheral neuropathy.

  20. A web-based lifestyle intervention for women with recent gestational diabetes mellitus: a randomized controlled trial.

    Science.gov (United States)

    Nicklas, Jacinda M; Zera, Chloe A; England, Lucinda J; Rosner, Bernard A; Horton, Edward; Levkoff, Sue E; Seely, Ellen W

    2014-09-01

    To test the feasibility and effectiveness of a Web-based lifestyle intervention based on the Diabetes Prevention Program modified for women with recent gestational diabetes mellitus to reduce postpartum weight retention. We randomly allocated 75 women with recent gestational diabetes mellitus to either a Web-based lifestyle program (Balance after Baby) delivered over the first postpartum year or to a control group. Primary outcomes were change in body weight at 12 months from 1) first postpartum measured weight; and 2) self-reported prepregnancy weight. There were no significant differences in baseline characteristics between groups including age, body mass index, race, and income status. Women assigned to the Balance after Baby program (n=36, three lost to follow-up) lost a mean of 2.8 kg (95% confidence interval -4.8 to -0.7) from 6 weeks to 12 months postpartum, whereas the control group (n=39, one lost to follow-up) gained a mean of 0.5 kg (-1.4 to +2.4) (P=.022). Women in the intervention were closer to prepregnancy weight at 12 months postpartum (mean change -0.7 kg; -3.5 to +2.2) compared with women in the control arm (+4.0 kg; +1.3 to +6.8) (P=.035). A Web-based lifestyle modification program for women with recent gestational diabetes mellitus decreased postpartum weight retention. ClinicalTrials.gov, www.clinicaltrials.gov, NCT01158131. I.

  1. Short term supplementation of dietary antioxidants selectively regulates the inflammatory responses during early cutaneous wound healing in diabetic mice

    Directory of Open Access Journals (Sweden)

    Park Na-Young

    2011-11-01

    Full Text Available Abstract Background Diabetic foot ulcers are serious complications for diabetic patients, yet the precise mechanism that underlines the treatment of these diabetic complications remains unclear. We hypothesized that dietary antioxidant supplementation with vitamin C, combined either with vitamin E or with vitamin E and NAC, improves delayed wound healing through modulation of blood glucose levels, oxidative stress, and inflammatory response. Methods Diabetes was induced by administration of alloxan monohydrate. Mice were divided into 4 groups; CON (non-diabetic control mice fed AIN 93 G purified rodent diet, DM (diabetic mice fed AIN 93 G purified rodent diet, VCE (diabetic mice fed 0.5% vitamin C and 0.5% vitamin E supplemented diet, and Comb (diabetic mice fed 0.5% vitamin C, 0.5% vitamin E, and 2.5% NAC supplemented diet. After 10 days of dietary antioxidant supplementation, cutaneous full-thickness excisional wounds were performed, and the rate of wound closure was examined. TBARS as lipid peroxidation products and vitamin E levels were measured in the liver. Expression levels of oxidative stress and inflammatory response related proteins were measured in the cutaneous wound site. Results Dietary antioxidant supplementation improved blood glucose levels and wound closure rate and increased liver vitamin E, but not liver TBARS levels in the diabetic mice as compared to those of the CON. In addition, dietary antioxidant supplementation modulated the expression levels of pIκBα, HO-1, CuZnSOD, iNOS and COX-2 proteins in the diabetic mice. Conclusions These findings demonstrated that delayed wound healing is associated with an inflammatory response induced by hyperglycaemia, and suggests that dietary antioxidant supplementation may have beneficial effects on wound healing through selective modulation of blood glucose levels, oxidative stress, and inflammatory response.

  2. Topology-selective jamming of fully-connected, code-division random-access networks

    Science.gov (United States)

    Polydoros, Andreas; Cheng, Unjeng

    1990-01-01

    The purpose is to introduce certain models of topology selective stochastic jamming and examine its impact on a class of fully-connected, spread-spectrum, slotted ALOHA-type random access networks. The theory covers dedicated as well as half-duplex units. The dominant role of the spatial duty factor is established, and connections with the dual concept of time selective jamming are discussed. The optimal choices of coding rate and link access parameters (from the users' side) and the jamming spatial fraction are numerically established for DS and FH spreading.

  3. Random drift versus selection in academic vocabulary: an evolutionary analysis of published keywords.

    Directory of Open Access Journals (Sweden)

    R Alexander Bentley

    Full Text Available The evolution of vocabulary in academic publishing is characterized via keyword frequencies recorded in the ISI Web of Science citations database. In four distinct case-studies, evolutionary analysis of keyword frequency change through time is compared to a model of random copying used as the null hypothesis, such that selection may be identified against it. The case studies from the physical sciences indicate greater selection in keyword choice than in the social sciences. Similar evolutionary analyses can be applied to a wide range of phenomena; wherever the popularity of multiple items through time has been recorded, as with web searches, or sales of popular music and books, for example.

  4. Random drift versus selection in academic vocabulary: an evolutionary analysis of published keywords.

    Science.gov (United States)

    Bentley, R Alexander

    2008-08-27

    The evolution of vocabulary in academic publishing is characterized via keyword frequencies recorded in the ISI Web of Science citations database. In four distinct case-studies, evolutionary analysis of keyword frequency change through time is compared to a model of random copying used as the null hypothesis, such that selection may be identified against it. The case studies from the physical sciences indicate greater selection in keyword choice than in the social sciences. Similar evolutionary analyses can be applied to a wide range of phenomena; wherever the popularity of multiple items through time has been recorded, as with web searches, or sales of popular music and books, for example.

  5. Selected Factors Determining a Way of Coping with Stress in Type 2 Diabetic Patients

    Directory of Open Access Journals (Sweden)

    Anna Beata Sobol-Pacyniak

    2014-01-01

    Full Text Available Objectives. The aim of the study was to examine factors which determine stress coping styles in type 2 diabetic (T2D patients, with regard to selected demographic variables, clinical diabetes-related variables and selected psychical variables (anxiety level and assessment of depressive disorders. Methods. 50 T2D patients, aged 59.9 ± 10.2 years were assessed by Coping Inventory for Stressful Situations (CISS, Spielberger State-Trait Anxiety Inventory (STAI, and Beck Depression Inventory (BDI. In the statistical analysis simple and multivariable logistic regression models were used. Results. Variables significantly increasing the selection risk of stress coping style different from preferred task-oriented strategy in a simple logistic regression model are: hypoglycemia within three months prior to the research: odds ratio (OR = 6.86 (95% confidence interval (CI 1.25–37.61, taking antidepressants or neuroleptics: OR =15.42 (95% CI 2.42–98.33, severe depression in Beck’s scale: OR = 84.00 (95% CI 6.51–1083.65, high state-anxiety level: OR = 9.60 (95% CI 1.08–85.16, and high trait-anxiety level: OR = 18.40 (95%CI 2.96–114.31, but in a multivariable model, diagnosed depression is the strongest factor: OR = 32.38 (95% CI 4.94–212.13. Conclusions. In T2D patients, the strategy to cope with stress appears to be mostly influenced by psychical predisposition.

  6. Effect of adjunct metformin treatment in patients with type-1 diabetes and persistent inadequate glycaemic control. A randomized study

    DEFF Research Database (Denmark)

    Lund, S.S.; Tarnow, L.; Astrup, A.S.

    2008-01-01

    BACKGROUND: Despite intensive insulin treatment, many patients with type-1 diabetes (T1DM) have longstanding inadequate glycaemic control. Metformin is an oral hypoglycaemic agent that improves insulin action in patients with type-2 diabetes. We investigated the effect of a one-year treatment...... with metformin versus placebo in patients with T1DM and persistent poor glycaemic control. METHODOLOGY/PRINCIPAL FINDINGS: One hundred patients with T1DM, preserved hypoglycaemic awareness and HaemoglobinA(1c) (HbA(1c)) > or = 8.5% during the year before enrolment entered a one-month run-in on placebo treatment....... Thereafter, patients were randomized (baseline) to treatment with either metformin (1 g twice daily) or placebo for 12 months (double-masked). Patients continued ongoing insulin therapy and their usual outpatient clinical care. The primary outcome measure was change in HbA(1c) after one year of treatment...

  7. Natural selection and type 2 diabetes-associated mortality in an isolated indigenous community in the valley of Oaxaca, southern Mexico.

    Science.gov (United States)

    Little, Bertis B; Peña Reyes, Maria Eugenia; Malina, Robert M

    2017-03-01

    This study tests the hypothesis that natural selection is associated with type 2 diabetes (T2D)-associated mortality and fertility in a rural isolated Zapotec community in the Valley of Oaxaca, southern Mexico. Mortality data and related demographic and genealogic information were linked with data for fertility, prereproductive mortality and family history of mortality attributed to T2D. Physician verified T2D mortality (n = 27) between 1980 and 2009 and imputed T2D (n = 70) from cardiovascular mortality (68% random sample) and renal failure (44% random sample). Bootstrapping was used to obtain a robust variance estimate in survival analysis and multivariate analysis of variance. Estimated maximum natural selection by Crow's Index occurred circa 1930 and was relaxed after this time in the study population. Cox-regression survival analysis of T2D mortality with covariates (family history of T2D, cardiovascular disease, renal failure) indicated a significant hazard ratio (HR = 5.95, 95% CI: 1.38-25.67, p natural selection decreased, and favored offspring survival of non-T2D descedants. The results indicated statistically significant directional selection against T2D and imputed T2D to this population isolate. © 2016 Wiley Periodicals, Inc.

  8. Monitoring and discussing health-related quality of life in adolescents with type 1 diabetes improve psychosocial well-being: a randomized controlled trial

    NARCIS (Netherlands)

    de Wit, M.; Delemarre-van d Waal, H.A.; Bokma, J.A.; Haasnoot, K.; Houdijk, M.C.; Gemke, R.J.B.J.; Snoek, F.J.

    2008-01-01

    OBJECTIVE - To test the effects of monitoring and discussing of health-related quality of life (HRQoL) in adolescents with type 1 diabetes in a multicenter randomized controlled trial. RESEARCH DESIGN AND METHODS - Four centers were randomly assigned to the HRQoL intervention (46 adolescents) or

  9. Maternal Efficacy and Safety Outcomes in a Randomized, Controlled Trial Comparing Insulin Detemir With NPH Insulin in 310 Pregnant Women With Type 1 Diabetes

    DEFF Research Database (Denmark)

    Mathiesen, Elisabeth R; Hod, Moshe; Ivanisevic, Marina

    2012-01-01

    OBJECTIVE This randomized, controlled noninferiority trial aimed to compare the efficacy and safety of insulin detemir (IDet) versus neutral protamine Hagedorn (NPH) (both with prandial insulin aspart) in pregnant women with type 1 diabetes. RESEARCH DESIGN AND METHODS Patients were randomized an...

  10. [Optimizing the managment of patients with diabetes mellitus: selected clinical trials from the 2004 Congress of the American Diabetes Association].

    Science.gov (United States)

    Scheen, A J; Radermecker, R P; Philips, J C

    2004-06-01

    The 64th scientific congress of the American Diabetes Association had a special session devoted to the presentation of the results from three clinical trials: 1) the first multicentre international trial of pancreatic islet transplantation according to the so-called Edmonton protocol with the primary endpoint of restoring insulin independence in type 1 diabetic patients; 2) three pivotal studies of 30 weeks testing both the efficacy and safety of exenatide (exendin-4), a new insulin secretagogue that is a long-acting analogue of glucagon-like peptide-1, in patients with type 2 diabetes treated with either metformin, or a sulfonylurea, or a metformin-sulfonylurea combination; and 3) the "Collaborative AtoRvastatin Diabetes Study" (CARDS), a placebo-controlled primary prevention trial of cardiovascular complications using atorvastatin 10 mg in 2 838 at risk patients with type 2 diabetes. The main results and conclusions of these trials are briefly presented as they open new perspectives in the management of patients with type 1 or type 2 diabetes mellitus.

  11. Diabetes

    Science.gov (United States)

    ... including: Blurry vision Excess thirst Fatigue Frequent urination Hunger Weight loss Because type 2 diabetes develops slowly, ... must be authorized in writing by ADAM Health Solutions. About MedlinePlus Site Map FAQs Customer Support Get ...

  12. Diabetes

    Data.gov (United States)

    Allegheny County / City of Pittsburgh / Western PA Regional Data Center — These datasets provide de-identified insurance data for diabetes. The data is provided by three managed care organizations in Allegheny County (Gateway Health Plan,...

  13. A Meta-Analysis of Randomized Controlled Trials of Yiqi Yangyin Huoxue Method in Treating Diabetic Nephropathy

    Directory of Open Access Journals (Sweden)

    Jiao Ying Ou

    2016-01-01

    Full Text Available Objective. The purpose of this systematic review is to evaluate the evidence of Yiqi Yangyin Huoxue Method for diabetic nephropathy. Methods. 11 electronic databases, through September 2015, were searched to identify randomized controlled trials of Yiqi Yangyin Huoxue Method for diabetic nephropathy. The quality of the included trials was assessed using the Jadad scale. Results. 26 randomized controlled trials were included in our review. Of all the included trials, most of them were considered as high quality. The aggregated results suggested that Yiqi Yangyin Huoxue Method is beneficial to diabetic nephropathy in bringing down the microalbuminuria (SMD = −0.98, 95% CI −1.22 to −0.74, serum creatinine (SMD = −0.56, 95% CI −0.93 to −0.20, beta-2 microglobulin (MD = 0.06, 95% CI 0.01 to 0.12, fasting plasma glucose (MD = −0.35, 95% CI −0.62 to −0.08, and 2-hour postprandial blood glucose (MD = 1.13, 95% CI 0.07 to 2.20, but not in decreasing blood urea nitrogen (SMD = −0.72, 95% CI −1.47 to 0.02 or 2-hour postprandial blood glucose (SMD = −0.48, 95% CI −1.01 to 0.04. Conclusions. Yiqi Yangyin Huoxue Method should be a valid complementary and alternative therapy in the management of diabetic nephropathy, especially in improving UAER, serum creatinine, fasting blood glucose, and beta-2 microglobulin. However, more studies with long follow-up are warrant to confirm the current findings.

  14. Community-based participatory research to design a faith-enhanced diabetes prevention program: The Better Me Within randomized trial.

    Science.gov (United States)

    Kitzman, Heather; Dodgen, Leilani; Mamun, Abdullah; Slater, J Lee; King, George; Slater, Donna; King, Alene; Mandapati, Surendra; DeHaven, Mark

    2017-11-01

    Reducing obesity positively impacts diabetes and cardiovascular risk; however, evidence-based lifestyle programs, such as the diabetes prevention program (DPP), show reduced effectiveness in African American (AA) women. In addition to an attenuated response to lifestyle programs, AA women also demonstrate high rates of obesity, diabetes, and cardiovascular disease. To address these disparities, enhancements to evidence-based lifestyle programs for AA women need to be developed and evaluated with culturally relevant and rigorous study designs. This study describes a community-based participatory research (CBPR) approach to design a novel faith-enhancement to the DPP for AA women. A long-standing CBPR partnership designed the faith-enhancement from focus group data (N=64 AA adults) integrating five components: a brief pastor led sermon, memory verse, in class or take-home faith activity, promises to remember, and scripture and prayer integrated into participant curriculum and facilitator materials. The faith components were specifically linked to weekly DPP learning objectives to strategically emphasize behavioral skills with religious principles. Using a CBPR approach, the Better Me Within trial was able to enroll 12 churches, screen 333 AA women, and randomize 221 (M age =48.8±11.2; M BMI =36.7±8.4; 52% technical or high school) after collection of objective eligibility measures. A prospective, randomized, nested by church, design will be used to evaluate the faith-enhanced DPP as compared to a standard DPP on weight, diabetes and cardiovascular risk, over a 16-week intervention and 10-month follow up. This study will provide essential data to guide enhancements to evidence-based lifestyle programs for AA women who are at high risk for chronic disease. Copyright © 2017 Elsevier Inc. All rights reserved.

  15. Fuzzy Random λ-Mean SAD Portfolio Selection Problem: An Ant Colony Optimization Approach

    Science.gov (United States)

    Thakur, Gour Sundar Mitra; Bhattacharyya, Rupak; Mitra, Swapan Kumar

    2010-10-01

    To reach the investment goal, one has to select a combination of securities among different portfolios containing large number of securities. Only the past records of each security do not guarantee the future return. As there are many uncertain factors which directly or indirectly influence the stock market and there are also some newer stock markets which do not have enough historical data, experts' expectation and experience must be combined with the past records to generate an effective portfolio selection model. In this paper the return of security is assumed to be Fuzzy Random Variable Set (FRVS), where returns are set of random numbers which are in turn fuzzy numbers. A new λ-Mean Semi Absolute Deviation (λ-MSAD) portfolio selection model is developed. The subjective opinions of the investors to the rate of returns of each security are taken into consideration by introducing a pessimistic-optimistic parameter vector λ. λ-Mean Semi Absolute Deviation (λ-MSAD) model is preferred as it follows absolute deviation of the rate of returns of a portfolio instead of the variance as the measure of the risk. As this model can be reduced to Linear Programming Problem (LPP) it can be solved much faster than quadratic programming problems. Ant Colony Optimization (ACO) is used for solving the portfolio selection problem. ACO is a paradigm for designing meta-heuristic algorithms for combinatorial optimization problem. Data from BSE is used for illustration.

  16. Effect of candesartan on microalbuminuria and albumin excretion rate in diabetes: three randomized trials

    DEFF Research Database (Denmark)

    Bilous, Rudy; Chaturvedi, Nish; Sjølie, Anne Katrin

    2009-01-01

    BACKGROUND: Microalbuminuria in diabetes is strongly predictive of nephropathy, end-stage renal disease, and premature cardiovascular morbidity and mortality. Effective preventive therapies are therefore a clinical priority. OBJECTIVE: To determine whether the angiotensin-receptor blocker candesa...

  17. From Protocols to Publications: A Study in Selective Reporting of Outcomes in Randomized Trials in Oncology

    Science.gov (United States)

    Raghav, Kanwal Pratap Singh; Mahajan, Sminil; Yao, James C.; Hobbs, Brian P.; Berry, Donald A.; Pentz, Rebecca D.; Tam, Alda; Hong, Waun K.; Ellis, Lee M.; Abbruzzese, James; Overman, Michael J.

    2015-01-01

    Purpose The decision by journals to append protocols to published reports of randomized trials was a landmark event in clinical trial reporting. However, limited information is available on how this initiative effected transparency and selective reporting of clinical trial data. Methods We analyzed 74 oncology-based randomized trials published in Journal of Clinical Oncology, the New England Journal of Medicine, and The Lancet in 2012. To ascertain integrity of reporting, we compared published reports with their respective appended protocols with regard to primary end points, nonprimary end points, unplanned end points, and unplanned analyses. Results A total of 86 primary end points were reported in 74 randomized trials; nine trials had greater than one primary end point. Nine trials (12.2%) had some discrepancy between their planned and published primary end points. A total of 579 nonprimary end points (median, seven per trial) were planned, of which 373 (64.4%; median, five per trial) were reported. A significant positive correlation was found between the number of planned and nonreported nonprimary end points (Spearman r = 0.66; P < .001). Twenty-eight studies (37.8%) reported a total of 65 unplanned end points; 52 (80.0%) of which were not identified as unplanned. Thirty-one (41.9%) and 19 (25.7%) of 74 trials reported a total of 52 unplanned analyses involving primary end points and 33 unplanned analyses involving nonprimary end points, respectively. Studies reported positive unplanned end points and unplanned analyses more frequently than negative outcomes in abstracts (unplanned end points odds ratio, 6.8; P = .002; unplanned analyses odd ratio, 8.4; P = .007). Conclusion Despite public and reviewer access to protocols, selective outcome reporting persists and is a major concern in the reporting of randomized clinical trials. To foster credible evidence-based medicine, additional initiatives are needed to minimize selective reporting. PMID:26304898

  18. Randomized controlled trial using bosentan to enhance the impact of exercise training in subjects with type 2 diabetes mellitus.

    Science.gov (United States)

    Schreuder, Tim H A; Duncker, Dirk J; Hopman, Maria T E; Thijssen, Dick H J

    2014-11-01

    In type 2 diabetes patients, endothelin (ET) receptor blockade may enhance blood flow responses to exercise training. The combination of exercise training and ET receptor blockade may represent a more potent stimulus than training alone to improve vascular function, physical fitness and glucose homeostasis. We assessed the effect of an 8 week exercise training programme combined with either ET blockade or placebo on vasculature, fitness and glucose homeostasis in people with type 2 diabetes. In a double-blind randomized controlled trial, brachial endothelium-dependent and ‑independent dilatation (using flow-mediated dilatation and glyceryl trinitrate, respectively), glucose homeostasis (using Homeostasis Model Assessment for Insulin Resistance (HOMA-IR)) and physical fitness (maximal cycling test) were assessed in 18 men with type 2 diabetes (60 ± 6 years old). Subjects underwent an 8 week exercise training programme, with half of the subjects receiving ET receptor blockade (bosentan) and the other half a placebo, followed by reassessment of the tests above. Exercise training improved physical fitness to a similar extent in both groups, but we did not detect changes in vascular function in either group. This study suggests that there is no adaptation in brachial and femoral artery endothelial function after 8 weeks of training in type 2 diabetes patients. Endothelin receptor blockade combined with exercise training does not additionally alter conduit artery endothelial function or physical fitness in type 2 diabetes. © 2014 The Authors. Experimental Physiology © 2014 The Physiological Society.

  19. Ultrasound therapy for recalcitrant diabetic foot ulcers: results of a randomized, double-blind, controlled, multicenter study.

    Science.gov (United States)

    Ennis, William J; Foremann, Phil; Mozen, Neal; Massey, Joi; Conner-Kerr, Teresa; Meneses, Patricio

    2005-08-01

    An estimated 15% of patients with diabetes will develop a foot ulcer sometime in their life, making them 30 to 40 times more likely to undergo amputation due to a non-healing foot ulcer than the non-diabetic population. To determine the safety and efficacy of a new, non-contact, kilohertz ultrasound therapy for the healing of recalcitrant diabetic foot ulcers - as well as to evaluate the impact on total closure and quantitative bacterial cultures and the effect on healing of various levels of sharp/surgical debridement - a randomized, double-blinded, sham-controlled, multicenter study was conducted in hospital-based and private wound care clinics. Patients (55 met criteria for efficacy analysis) received standard of care, which included products that provide a moist environment, offloading diabetic shoes and socks, debridement, wound evaluation, and measurement. The "therapy" was either active 40 KHz ultrasound delivered by a saline mist or a "sham device" which delivered a saline mist without the use of ultrasound. After 12 weeks of care, the proportion of wounds healed (defined as complete epithelialization without drainage) in the active ultrasound therapy device group was significantly higher than that in the sham control group (40.7% versus 14.3%, P = 0.0366, Fisher's exact test). The ultrasound treatment was easy to use and no difference in the number and type of adverse events between the two treatment groups was noted. Of interest, wounds were debrided at baseline followed by a quantitative culture biopsy. The results of these cultures demonstrated a significant bioburden (greater than 10(5)) in the majority of cases, despite a lack of clinical signs of infection. Compared to control, this therapeutic modality was found to increase the healing rate of recalcitrant, diabetic foot ulcers.

  20. A low-fat vegan diet and a conventional diabetes diet in the treatment of type 2 diabetes: a randomized, controlled, 74-wk clinical trial1234

    Science.gov (United States)

    Barnard, Neal D; Cohen, Joshua; Jenkins, David JA; Turner-McGrievy, Gabrielle; Gloede, Lise; Green, Amber; Ferdowsian, Hope

    2009-01-01

    Background: Low-fat vegetarian and vegan diets are associated with weight loss, increased insulin sensitivity, and improved cardiovascular health. Objective: We compared the effects of a low-fat vegan diet and conventional diabetes diet recommendations on glycemia, weight, and plasma lipids. Design: Free-living individuals with type 2 diabetes were randomly assigned to a low-fat vegan diet (n = 49) or a diet following 2003 American Diabetes Association guidelines (conventional, n = 50) for 74 wk. Glycated hemoglobin (Hb A1c) and plasma lipids were assessed at weeks 0, 11, 22, 35, 48, 61, and 74. Weight was measured at weeks 0, 22, and 74. Results: Weight loss was significant within each diet group but not significantly different between groups (−4.4 kg in the vegan group and −3.0 kg in the conventional diet group, P = 0.25) and related significantly to Hb A1c changes (r = 0.50, P = 0.001). Hb A1c changes from baseline to 74 wk or last available values were −0.34 and −0.14 for vegan and conventional diets, respectively (P = 0.43). Hb A1c changes from baseline to last available value or last value before any medication adjustment were −0.40 and 0.01 for vegan and conventional diets, respectively (P = 0.03). In analyses before alterations in lipid-lowering medications, total cholesterol decreased by 20.4 and 6.8 mg/dL in the vegan and conventional diet groups, respectively (P = 0.01); LDL cholesterol decreased by 13.5 and 3.4 mg/dL in the vegan and conventional groups, respectively (P = 0.03). Conclusions: Both diets were associated with sustained reductions in weight and plasma lipid concentrations. In an analysis controlling for medication changes, a low-fat vegan diet appeared to improve glycemia and plasma lipids more than did conventional diabetes diet recommendations. Whether the observed differences provide clinical benefit for the macro- or microvascular complications of diabetes remains to be established. This trial was registered at clinicaltrials

  1. A low-fat vegan diet and a conventional diabetes diet in the treatment of type 2 diabetes: a randomized, controlled, 74-wk clinical trial.

    Science.gov (United States)

    Barnard, Neal D; Cohen, Joshua; Jenkins, David J A; Turner-McGrievy, Gabrielle; Gloede, Lise; Green, Amber; Ferdowsian, Hope

    2009-05-01

    Low-fat vegetarian and vegan diets are associated with weight loss, increased insulin sensitivity, and improved cardiovascular health. We compared the effects of a low-fat vegan diet and conventional diabetes diet recommendations on glycemia, weight, and plasma lipids. Free-living individuals with type 2 diabetes were randomly assigned to a low-fat vegan diet (n = 49) or a diet following 2003 American Diabetes Association guidelines (conventional, n = 50) for 74 wk. Glycated hemoglobin (Hb A(1c)) and plasma lipids were assessed at weeks 0, 11, 22, 35, 48, 61, and 74. Weight was measured at weeks 0, 22, and 74. Weight loss was significant within each diet group but not significantly different between groups (-4.4 kg in the vegan group and -3.0 kg in the conventional diet group, P = 0.25) and related significantly to Hb A(1c) changes (r = 0.50, P = 0.001). Hb A(1c) changes from baseline to 74 wk or last available values were -0.34 and -0.14 for vegan and conventional diets, respectively (P = 0.43). Hb A(1c) changes from baseline to last available value or last value before any medication adjustment were -0.40 and 0.01 for vegan and conventional diets, respectively (P = 0.03). In analyses before alterations in lipid-lowering medications, total cholesterol decreased by 20.4 and 6.8 mg/dL in the vegan and conventional diet groups, respectively (P = 0.01); LDL cholesterol decreased by 13.5 and 3.4 mg/dL in the vegan and conventional groups, respectively (P = 0.03). Both diets were associated with sustained reductions in weight and plasma lipid concentrations. In an analysis controlling for medication changes, a low-fat vegan diet appeared to improve glycemia and plasma lipids more than did conventional diabetes diet recommendations. Whether the observed differences provide clinical benefit for the macro- or microvascular complications of diabetes remains to be established. This trial was registered at clinicaltrials.gov as NCT00276939.

  2. Optimization of the Dutch Matrix Test by Random Selection of Sentences From a Preselected Subset

    Directory of Open Access Journals (Sweden)

    Rolph Houben

    2015-04-01

    Full Text Available Matrix tests are available for speech recognition testing in many languages. For an accurate measurement, a steep psychometric function of the speech materials is required. For existing tests, it would be beneficial if it were possible to further optimize the available materials by increasing the function’s steepness. The objective is to show if the steepness of the psychometric function of an existing matrix test can be increased by selecting a homogeneous subset of recordings with the steepest sentence-based psychometric functions. We took data from a previous multicenter evaluation of the Dutch matrix test (45 normal-hearing listeners. Based on half of the data set, first the sentences (140 out of 311 with a similar speech reception threshold and with the steepest psychometric function (≥9.7%/dB were selected. Subsequently, the steepness of the psychometric function for this selection was calculated from the remaining (unused second half of the data set. The calculation showed that the slope increased from 10.2%/dB to 13.7%/dB. The resulting subset did not allow the construction of enough balanced test lists. Therefore, the measurement procedure was changed to randomly select the sentences during testing. Random selection may interfere with a representative occurrence of phonemes. However, in our material, the median phonemic occurrence remained close to that of the original test. This finding indicates that phonemic occurrence is not a critical factor. The work highlights the possibility that existing speech tests might be improved by selecting sentences with a steep psychometric function.

  3. Improving detection and initial management of gestational diabetes through the primary level of care in Morocco: protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Utz, Bettina; Assarag, Bouchra; Essolbi, Amina; Barkat, Amina; El Ansari, Nawal; Fakhir, Bouchra; Delamou, Alexandre; De Brouwere, Vincent

    2017-06-19

    Morocco is facing a growing prevalence of diabetes and according to latest figures of the World Health Organization, already 12.4% of the population are affected. A similar prevalence has been reported for gestational diabetes (GDM) and although it is not yet high on the national agenda, immediate and long-term complications threaten the health of mothers and future generations. A situational analysis on GDM conducted in 2015 revealed difficulties in access to screening and delays in receiving appropriate care. This implementation study has as objective to evaluate a decentralized GDM detection and management approach through the primary level of care and assess its potential for scaling up. We will conduct a hybrid effectiveness-implementation research using a cluster randomized controlled trial design in two districts of Morocco. Using the health center as unit of randomization we randomly selected 20 health centers with 10 serving as intervention and 10 as control facilities. In the intervention arm, providers will screen pregnant women attending antenatal care for GDM by capillary glucose testing during antenatal care. Women tested positive will receive nutritional counselling and will be followed up through the health center. In the control facilities, screening and initial management of GDM will follow standard practice. Primary outcome will be birthweight with weight gain during pregnancy, average glucose levels and pregnancy outcomes including mode of delivery, presence or absence of obstetric or newborn complications and the prevalence of GDM at health center level as secondary outcomes. Furthermore we will assess the quality of life /care experienced by the women in both arms. Qualitative methods will be applied to evaluate the feasibility of the intervention at primary level and its adoption by the health care providers. In Morocco, gestational diabetes screening and its initial management is fragmented and coupled with difficulties in access and

  4. Using Random Forests to Select Optimal Input Variables for Short-Term Wind Speed Forecasting Models

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    Hui Wang

    2017-10-01

    Full Text Available Achieving relatively high-accuracy short-term wind speed forecasting estimates is a precondition for the construction and grid-connected operation of wind power forecasting systems for wind farms. Currently, most research is focused on the structure of forecasting models and does not consider the selection of input variables, which can have significant impacts on forecasting performance. This paper presents an input variable selection method for wind speed forecasting models. The candidate input variables for various leading periods are selected and random forests (RF is employed to evaluate the importance of all variable as features. The feature subset with the best evaluation performance is selected as the optimal feature set. Then, kernel-based extreme learning machine is constructed to evaluate the performance of input variables selection based on RF. The results of the case study show that by removing the uncorrelated and redundant features, RF effectively extracts the most strongly correlated set of features from the candidate input variables. By finding the optimal feature combination to represent the original information, RF simplifies the structure of the wind speed forecasting model, shortens the training time required, and substantially improves the model’s accuracy and generalization ability, demonstrating that the input variables selected by RF are effective.

  5. Evidence of changes in renal charge selectivity in patients with type 1 (insulin-dependent) diabetes mellitus

    DEFF Research Database (Denmark)

    Kverneland, A; Feldt-Rasmussen, B; Vidal, P

    1986-01-01

    in plasma and urine was determined by a specific, sensitive and highly reproducible chromatographic procedure. In diabetic patients with normal urinary albumin excretion, the selectivity index was increased three-fold compared with that of non-diabetic subjects (2 p less than 0.01). A significant...... clearance of non-glycated plasma albumin/clearance of glycated plasma albumin in 38 patients with Type 1 diabetes mellitus. The two albumin molecules differed slightly in charge, non-enzymatic glycated albumin being more anionic at physiological pH compared with unmodified plasma albumin. Glycated albumin...... patients with increased albumin excretion rate had a significantly lower selectivity index compared with patients with normal albumin excretion (2 p less than 0.01). A significant negative correlation (r = 0.85, 2 p less than 0.001, exponential curve fit) was seen between urinary albumin excretion...

  6. From Protocols to Publications: A Study in Selective Reporting of Outcomes in Randomized Trials in Oncology.

    Science.gov (United States)

    Raghav, Kanwal Pratap Singh; Mahajan, Sminil; Yao, James C; Hobbs, Brian P; Berry, Donald A; Pentz, Rebecca D; Tam, Alda; Hong, Waun K; Ellis, Lee M; Abbruzzese, James; Overman, Michael J

    2015-11-01

    The decision by journals to append protocols to published reports of randomized trials was a landmark event in clinical trial reporting. However, limited information is available on how this initiative effected transparency and selective reporting of clinical trial data. We analyzed 74 oncology-based randomized trials published in Journal of Clinical Oncology, the New England Journal of Medicine, and The Lancet in 2012. To ascertain integrity of reporting, we compared published reports with their respective appended protocols with regard to primary end points, nonprimary end points, unplanned end points, and unplanned analyses. A total of 86 primary end points were reported in 74 randomized trials; nine trials had greater than one primary end point. Nine trials (12.2%) had some discrepancy between their planned and published primary end points. A total of 579 nonprimary end points (median, seven per trial) were planned, of which 373 (64.4%; median, five per trial) were reported. A significant positive correlation was found between the number of planned and nonreported nonprimary end points (Spearman r = 0.66; P medicine, additional initiatives are needed to minimize selective reporting. © 2015 by American Society of Clinical Oncology.

  7. Effects of supervised exercise on lipid profiles and blood pressure control in people with type 2 diabetes mellitus: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Hayashino, Yasuaki; Jackson, Jeffrey L; Fukumori, Norio; Nakamura, Fumiaki; Fukuhara, Shunichi

    2012-12-01

    Our study's purpose was to perform a systematic review to assess the effect of supervised exercise interventions on lipid profiles and blood pressure control. We searched electronic databases and selected studies that evaluated the effect of supervised exercise intervention on cardiovascular risk factors in adult people with type 2 diabetes. We used random effect models to derive weighted mean differences of exercise on lipid profiles and blood pressure control. Forty-two RCTs (2808 subjects) met inclusion criteria and are included in our meta-analysis. Structured exercise was associated with a change in systolic blood pressure (SBP) of -2.42 mmHg (95% CI, -4.39 to -0.45 mmHg), diastolic blood pressure (DBP) of -2.23 mmHg (95% CI, -3.21 to -1.25 mmHg), high-density lipoprotein cholesterol (HDL-C) of 0.04 mmol/L (95% CI, 0.02-0.07 mmol/L), and low-density lipoprotein cholesterol (LDL-C) of -0.16 mmol/L (95% CI, -0.30 to -0.01 mmol/L). Heterogeneity was partially explained by age, dietary co-intervention and the duration and intensity of the exercise. Supervised exercise is effective in improving blood pressure control, lowering LDL-C, and elevating HDL-C levels in people with diabetes. Physicians should recommend exercise for their adult patients with diabetes who can safely do so. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  8. Effect of Behavioral Intervention on Dilated Fundus Examination Rates in Older African American Individuals With Diabetes Mellitus: A Randomized Clinical Trial.

    Science.gov (United States)

    Weiss, David M; Casten, Robin J; Leiby, Benjamin E; Hark, Lisa A; Murchison, Ann P; Johnson, Deiana; Stratford, Shayla; Henderer, Jeffrey; Rovner, Barry W; Haller, Julia A

    2015-09-01

    African American individuals are at high risk of diabetes mellitus and diabetic retinopathy but have suboptimal rates of dilated fundus examinations (DFEs). Early intervention is crucial for the prevention of diabetic retinopathy in this high-risk population. To test the efficacy of behavioral activation for diabetic retinopathy prevention on rates of DFEs in older African American individuals with diabetes mellitus. Masked randomized clinical trial at 2 urban medical centers from October 1, 2010, to May 31, 2014. Participants included 206 African American individuals 65 years and older with diabetes mellitus who had not obtained a DFE in the preceding 12 months. Participants were randomized to either behavioral activation for diabetic retinopathy prevention, a behavioral intervention designed to provide education, facilitate identifying and addressing health care barriers, and promote goal setting to improve rates of DFEs, or supportive therapy, a control condition. The primary outcome was medical documentation of a DFE at 6 months' follow-up. Secondary outcomes included the Risk Perceptions and Risk Knowledge Survey of Diabetes Mellitus, Diabetes Self-Care Inventory, Patient Health Questionnaire 9, and National Eye Institute Vision Function Questionnaire 25 scores and hemoglobin A1c levels. More participants in the behavioral activation for diabetic retinopathy prevention group (87.9%) obtained a DFE compared with those in the supportive therapy group (34.1%) by the 6-month follow-up assessment (P diabetic retinopathy prevention group were 2.5 times more likely to obtain a DFE compared with those in the supportive therapy group (risk ratio = 2.58; 95% CI, 1.91-3.48; P Knowledge Survey of Diabetes Mellitus or National Eye Institute Vision Function Questionnaire 25 composite scores; however, both groups had improved adherence to diabetes mellitus self-care behaviors from baseline to 6-month follow-up. Behavioral activation for diabetic retinopathy

  9. On theoretical models of gene expression evolution with random genetic drift and natural selection.

    Directory of Open Access Journals (Sweden)

    Osamu Ogasawara

    2009-11-01

    Full Text Available The relative contributions of natural selection and random genetic drift are a major source of debate in the study of gene expression evolution, which is hypothesized to serve as a bridge from molecular to phenotypic evolution. It has been suggested that the conflict between views is caused by the lack of a definite model of the neutral hypothesis, which can describe the long-run behavior of evolutionary change in mRNA abundance. Therefore previous studies have used inadequate analogies with the neutral prediction of other phenomena, such as amino acid or nucleotide sequence evolution, as the null hypothesis of their statistical inference.In this study, we introduced two novel theoretical models, one based on neutral drift and the other assuming natural selection, by focusing on a common property of the distribution of mRNA abundance among a variety of eukaryotic cells, which reflects the result of long-term evolution. Our results demonstrated that (1 our models can reproduce two independently found phenomena simultaneously: the time development of gene expression divergence and Zipf's law of the transcriptome; (2 cytological constraints can be explicitly formulated to describe long-term evolution; (3 the model assuming that natural selection optimized relative mRNA abundance was more consistent with previously published observations than the model of optimized absolute mRNA abundances.The models introduced in this study give a formulation of evolutionary change in the mRNA abundance of each gene as a stochastic process, on the basis of previously published observations. This model provides a foundation for interpreting observed data in studies of gene expression evolution, including identifying an adequate time scale for discriminating the effect of natural selection from that of random genetic drift of selectively neutral variations.

  10. Xuezhikang Capsule for Type 2 Diabetes with Hyperlipemia: A Systematic Review and Meta-Analysis of Randomized Clinical Trails

    Directory of Open Access Journals (Sweden)

    Min Li

    2015-01-01

    Full Text Available Objective. To evaluate the efficacy and safety of Xuezhikang capsule treating type 2 diabetes with hyperlipidemia. Methods. We searched six databases to identify relevant studies published before January 2015. Two review authors independently extracted data and assessed the Cochrane risk of bias tool. We resolved disagreements with this assessment through discussion and a decision was achieved by consensus. Results. We included 21 studies (1548 participants. Treatment courses were at least 8 weeks. Overall, the risk of bias of included trials was unclear. Among them, 16 studies could conduct meta-analysis. The result showed that compared with routine group (5 studies, Xuezhikang group had more effect on decreasing TC, TG, LDL-C, and rising HDL-C. However, compared with statins group (11 studies, Xuezhikang group has less effect on decreasing TC, TG, and rising HDL-C. Meanwhile, two groups had no statistical differences of LDL-C level. Conclusion. Xuezhikang capsule may be effective for treating type 2 diabetes with hyperlipemia. Our findings should be considered cautiously due to unclear risk of bias of the included studies and low methodological quality. Therefore, more strictly designed large-scale randomized clinical trials are needed to evaluate the efficacy of Xuezhikang capsule in type 2 diabetes with hyperlipemia.

  11. Long-Term Effects of Goshajinkigan in Prevention of Diabetic Complications: A Randomized Open-Labeled Clinical Trial

    Directory of Open Access Journals (Sweden)

    K. Watanabe

    2014-01-01

    Full Text Available Objective. This clinical trial was designed to investigate whether goshajinkigan reduces the onset of diabetic complications or not. Materials and Methods. A total of 332 type 2 diabetic mellitus patients were registered from 9 clinical centers from March 2000 to August 2007. Patients were randomly assigned to take goshajinkigan extract powder, 2.5 grams for 3 times a day or no kampo therapy, additionally to the regular treatment. The primary endpoints were the onset of macrovascular diseases or progression of nephropathy or retinopathy. Statistical analysis was performed by the intention-to-treat method. Results. After 5 years of observation, 116 patients were submitted to analysis. Among them, no macrovascular events were observed in both groups. Although 43 participants had upstaging of retinopathy or nephropathy in total, there was no significant difference between goshajinkigan group and control group. Deterioration of ankle reflex was suppressed in goshajinkigan group. Also glycated hemoglobin, and fasting plasma glucose were decreased in the goshajinkigan group. Conclusion. Although the power of analysis was too low to demonstrate any effects of goshajinkigan on the progression of macrovascular diseases, retinopathy or nephropathy, goshajinkigan may be beneficial for diabetic neuropathy and glycemic control.

  12. The Impact of a Cultural Lifestyle Intervention on Metabolic Parameters After Gestational Diabetes Mellitus A Randomized Controlled Trial.

    Science.gov (United States)

    Zilberman-Kravits, Dana; Meyerstein, Naomi; Abu-Rabia, Yones; Wiznitzer, Arnon; Harman-Boehm, Ilana

    2018-06-01

    The prevalence of type 2 diabetes in Israel is increasing in all ethnic groups but most markedly in the Bedouin population. We aimed to assess the effects of a lifestyle change intervention on risk markers for type 2 diabetes after gestational diabetes mellitus (GDM). One hundred eighty Jewish and Bedouin post-GDM women were randomly assigned to a lifestyle intervention group (IG) or a control group (CG) starting 3-4 months after delivery. The IG participated in healthy lifestyle sessions led by a dietician and a sports instructor for 24 months after delivery. The IG participants had three individual 45-min counseling sessions and four 90-min group meetings (10 women each). The dietary and exercise recommendations were culturally adapted. The primary outcome of the study was HOMA-IR. We monitored clinical and chemical biomarkers 1 and 2 years after delivery. After 1 and 2 years of intervention, the metabolic measures improved substantially. The intervention reduced the insulin, glucose and HOMA-IR levels in the IG compared with those in the CG (p < 0.001). This novel culturally tailored lifestyle intervention program significantly improved the metabolic and morphometric indices measured 1 and 2 years after delivery. These results highlight and underscore the importance of effective lifestyle change education following GDM.

  13. Randomized nutrition education intervention to improve carbohydrate counting in adolescents with type 1 diabetes study: is more intensive education needed?

    Science.gov (United States)

    Spiegel, Gail; Bortsov, Andrey; Bishop, Franziska K; Owen, Darcy; Klingensmith, Georgeanna J; Mayer-Davis, Elizabeth J; Maahs, David M

    2012-11-01

    Youth with type 1 diabetes do not count carbohydrates accurately, yet it is an important strategy in blood glucose control. The study objective was to determine whether a nutrition education intervention would improve carbohydrate counting accuracy and glycemic control. We conducted a randomized, controlled nutrition intervention trial that was recruited from February 2009 to February 2010. Youth (12 to 18 years of age, n = 101) with type 1 diabetes were screened to identify those with poor carbohydrate counting accuracy, using a previously developed carbohydrate counting accuracy test covering commonly consumed foods and beverage items presented in six mixed meals and two snacks. All participants (n = 66, age = 15 ± 3 years, 41 male, diabetes duration = 6 ± 4 years, hemoglobin A1c [HbA1c] = 8.3% ± 1.1%) were randomized to the control or intervention group at the baseline visit. The intervention group attended a 90-minute class with a registered dietitian/certified diabetes educator and twice kept 3-day food records, which were used to review carbohydrate counting progress. Carbohydrate counting accuracy (measured as described) and HbA1c were evaluated at baseline and 3 months to determine the effectiveness of the intervention. t Tests, Spearman correlations, and repeated measures models were used. At baseline, carbohydrate content was over- and underestimated in 16 and 5 of 29 food items, respectively. When foods were presented as mixed meals, participants either significantly over- or underestimated 10 of the 9 meals and 4 snacks. After 3 months of follow-up, HbA1c decreased in both the intervention and control groups by -0.19% ± 0.12% (P = 0.12) and -0.08% ± 0.11% (P = 0.51), respectively; however, the overall intervention effect was not statistically significant for change in HbA1c or carbohydrate counting accuracy. More intensive intervention might be required to improve adolescents' carbohydrate counting accuracy and nutrition management of type 1

  14. Effect of fruit restriction on glycemic control in patients with type 2 diabetes--a randomized trial.

    Science.gov (United States)

    Christensen, Allan S; Viggers, Lone; Hasselström, Kjeld; Gregersen, Søren

    2013-03-05

    Medical nutrition therapy is recognized as an important treatment option in type 2 diabetes. Most guidelines recommend eating a diet with a high intake of fiber-rich food including fruit. This is based on the many positive effects of fruit on human health. However some health professionals have concerns that fruit intake has a negative impact on glycemic control and therefore recommend restricting the fruit intake. We found no studies addressing this important clinical question. The objective was to investigate whether an advice to reduce the intake of fruit to patients with type 2 diabetes affects HbA1c, bodyweight, waist circumference and fruit intake. This was an open randomized controlled trial with two parallel groups. The primary outcome was a change in HbA1c during 12 weeks of intervention. Participants were randomized to one of two interventions; medical nutrition therapy + advice to consume at least two pieces of fruit a day (high-fruit) or medical nutrition therapy + advice to consume no more than two pieces of fruit a day (low-fruit). All participants had two consultations with a registered dietitian. Fruit intake was self-reported using 3-day fruit records and dietary recalls. All assessments were made by the "intention to treat" principle. The study population consisted of 63 men and women with newly diagnosed type 2 diabetes. All patients completed the trial. The high-fruit group increased fruit intake with 125 grams (CI 95%; 78 to 172) and the low-fruit group reduced intake with 51 grams (CI 95%; -18 to -83). HbA1c decreased in both groups with no difference between the groups (diff.: 0.19%, CI 95%; -0.23 to 0.62). Both groups reduced body weight and waist circumference, however there was no difference between the groups. A recommendation to reduce fruit intake as part of standard medical nutrition therapy in overweight patients with newly diagnosed type 2 diabetes resulted in eating less fruit. It had however no effect on HbA1c, weight loss or waist

  15. Intensive Treat-to-Target Statin Therapy in High-Risk Japanese Patients With Hypercholesterolemia and Diabetic Retinopathy: Report of a Randomized Study.

    Science.gov (United States)

    Itoh, Hiroshi; Komuro, Issei; Takeuchi, Masahiro; Akasaka, Takashi; Daida, Hiroyuki; Egashira, Yoshiki; Fujita, Hideo; Higaki, Jitsuo; Hirata, Ken-Ichi; Ishibashi, Shun; Isshiki, Takaaki; Ito, Sadayoshi; Kashiwagi, Atsunori; Kato, Satoshi; Kitagawa, Kazuo; Kitakaze, Masafumi; Kitazono, Takanari; Kurabayashi, Masahiko; Miyauchi, Katsumi; Murakami, Tomoaki; Murohara, Toyoaki; Node, Koichi; Ogawa, Susumu; Saito, Yoshihiko; Seino, Yoshihiko; Shigeeda, Takashi; Shindo, Shunya; Sugawara, Masahiro; Sugiyama, Seigo; Terauchi, Yasuo; Tsutsui, Hiroyuki; Ueshima, Kenji; Utsunomiya, Kazunori; Yamagishi, Masakazu; Yamazaki, Tsutomu; Yo, Shoei; Yokote, Koutaro; Yoshida, Kiyoshi; Yoshimura, Michihiro; Yoshimura, Nagahisa; Nakao, Kazuwa; Nagai, Ryozo

    2018-06-01

    Diabetes is associated with high risk of cardiovascular (CV) events, particularly in patients with dyslipidemia and diabetic complications. We investigated the incidence of CV events with intensive or standard lipid-lowering therapy in patients with hypercholesterolemia, diabetic retinopathy, and no history of coronary artery disease (treat-to-target approach). In this multicenter, prospective, randomized, open-label, blinded end point study, eligible patients were randomly assigned (1:1) to intensive statin therapy targeting LDL cholesterol (LDL-C) targeting LDL-C 100-120 mg/dL ( n = 2,524). Mean follow-up was 37 ± 13 months. LDL-C at 36 months was 76.5 ± 21.6 mg/dL in the intensive group and 104.1 ± 22.1 mg/dL in the standard group ( P target strategy in high-risk patients deserves further investigation. © 2018 by the American Diabetes Association.

  16. Randomized control trial for the assessment of the anti-albuminuric effects of topiroxostat in hyperuricemic patients with diabetic nephropathy (the ETUDE study).

    Science.gov (United States)

    Kato, Sawako; Ando, Masahiko; Mizukoshi, Toshihiro; Nagata, Takanobu; Katsuno, Takayuki; Kosugi, Tomoki; Tsuboi, Naotake; Maruyama, Shoichi

    2016-05-01

    Proteinuria is an established risk factor for diabetic nephropathy. Recent studies indicate that some xanthine oxidase inhibitors have a renoprotective effect. The aim of this study was to assess whether topiroxostat reduces albuminuria in hyperuricemic patients with diabetic nephropathy and overt proteinuria. The ETUDE study is an ongoing 24-week, multicenter, open-label, randomized (1:1), parallel group study involving hyperuricemic patients with diabetic nephropathy (estimated glomerular filtration rate [eGFR] ≥ 20 mL/min/1.73 m(2)) and overt proteinuria (0.3 ≤ urine protein to creatinine ratio (UPCR) ETUDE trial is the first randomized controlled study of topiroxostat in hyperuricemic patients with diabetic nephropathy and overt proteinuria. We will clarify the pleiotropic function of topiroxostat including an anti-albumiuric effect as well as its effects on safely decreasing serum uric acid levels.

  17. Selective Insulin Resistance and the Development of Cardiovascular Diseases in Diabetes: The 2015 Edwin Bierman Award Lecture

    Science.gov (United States)

    Park, Kyoungmin; Li, Qian

    2016-01-01

    The Edwin Bierman Award Lecture is presented in honor of the memory of Edwin L. Bierman, MD, an exemplary scientist, mentor, and leader in the field of diabetes, obesity, hyperlipidemia, and atherosclerosis. The award and lecture recognizes a leading scientist in the field of macrovascular complications and contributing risk factors in diabetes. George L. King, MD, of the Section of Vascular Cell Biology and Complications, Dianne Nunnally Hoppes Laboratory for Diabetes Complications, Joslin Diabetes Center, Harvard Medical School, Boston, MA, received the prestigious award at the American Diabetes Association’s 75th Scientific Sessions, 5–9 June 2015, in Boston, MA. He presented the Edwin Bierman Award Lecture, “Selective Insulin Resistance and the Development of Cardiovascular Disease in Diabetes,” on Sunday, 7 June 2015. This review is focused on the factors and potential mechanisms that are causing various cardiovascular pathologies. In diabetes, insulin’s actions on the endothelium and other vascular cells have significant influence on systemic metabolisms and the development of cardiovascular pathologies. Our studies showed that insulin receptors on the endothelium are important for insulin transport across the endothelial barrier and mediate insulin’s actions in muscle, heart, fat, and the brain. Insulin actions on the vascular cells are mediated by two pathways involving the actions of either IRS/PI3K/Akt or Grb/Shc/MAPK. Insulin’s activation of IRS/PI3K/Akt results in mostly antiatherogenic actions, as this pathway induces activation of eNOS, the expressions of HO-1 and VEGF, and the reduction of VCAM-1. In contrast, insulin’s activation of the Grb/Shc/MAPK pathway mediates the expressions of ET-1 and PAI-1 and migration and proliferation of contractile cells, which have proatherogenic actions. Elevated levels of glucose, free fatty acids, and inflammatory cytokines due to diabetes and insulin resistance selectively inhibit insulin

  18. The impact of a daily smartphone-based feedback system among women with gestational diabetes on compliance, glycemic control, satisfaction, and pregnancy outcome: a randomized controlled trial.

    Science.gov (United States)

    Miremberg, Hadas; Ben-Ari, Tal; Betzer, Tal; Raphaeli, Hagit; Gasnier, Rose; Barda, Giulia; Bar, Jacob; Weiner, Eran

    2018-04-01

    Patient compliance and tight glycemic control have been demonstrated to improve outcome in pregnancies complicated by gestational diabetes mellitus. The use of advanced technological tools, including smartphone-based platforms, to improve medical care and outcomes has been demonstrated in various fields of medicine, but only a few small studies were performed with gestational diabetes mellitus patients. We aimed to study the impact of introducing a smartphone-based daily feedback and communication platform between gestational diabetes mellitus patients and their physicians, on patient compliance, glycemic control, pregnancy outcome, and patient satisfaction. This is a prospective, single-center, randomized controlled trial. Newly diagnosed gestational diabetes mellitus patients presenting to our multidisciplinary diabetes-in-pregnancy clinic were randomized to: (1) routine biweekly prenatal clinic care (control group); or (2) additional daily detailed feedback on their compliance and glycemic control from the clinic team via an application installed on their smartphone (smartphone group). The primary outcome was patient compliance defined as the actual blood glucose measurements/instructed measurements ×100. The secondary outcomes included diabetes-control parameters, pregnancy, and neonatal outcomes. The study was adequately powered to detect a 20% difference in patient compliance, based on a preliminary phase that demonstrated 70% baseline compliance to glucose measurements. A total of 120 newly diagnosed gestational diabetes mellitus patients were analyzed. The 2 groups did not differ in terms of age, parity, education, body mass index, family history, maternal comorbidities, oral glucose tolerance test values, and hemoglobin A1C at randomization. The smartphone group demonstrated higher level of compliance (84 ± 0.16% vs 66 ± 0.28%, P diabetes mellitus patients and the multidisciplinary diabetes-in-pregnancy clinic team improved patient compliance and

  19. Renoprotective effects of topiroxostat for hyperuremic patients with overt diabetic nephropathy study (ETUDE Study): A prospective, randomized, multicenter clinical trial.

    Science.gov (United States)

    Mizukoshi, Toshihiro; Kato, Sawako; Ando, Masahiko; Sobajima, Hiroshi; Ohashi, Norimi; Naruse, Tomohiko; Saka, Yosuke; Shimizu, Hideaki; Nagata, Takanobu; Maruyama, Shoichi

    2017-10-09

    We aimed to evaluate the anti-albuminuric effects of topiroxostat in Japanese hyperuricemic patients with diabetic nephropathy. In this 24-week, multicenter, open-label, randomized (1:1) trial, we assigned hyperuricemic patients with diabetic nephropathy (estimated glomerular filtration rate ≥ 20 mL/min/1.73m 2 ) and overt proteinuria (0.3 ≤ urine protein to creatinine ratio (UPCR) <3.5 g/g Cr) to either high dose (160 mg daily) or low dose (40 mg daily) topiroxostat. The primary endpoint was the change in albuminuria indicated by urine albumin-to-creatinine ratio (UACR) from the baseline at the final time point. A total of 80 patients underwent randomization. The changes in UACR after 24 weeks of treatment (or at the final time point if patients failed to reach 24 weeks) relative to the baseline were -122 mg/gCr (95% CI: -5.1 to -240.1, P = 0.041) in patients treated with high dose, while treatment with low dose topiroxostat could not show significant reduction (P = 0.067). In the linear mixed model including baseline albuminuria, eGFR, age, and sex as covariates, the decreases in UACR were still significant from baseline to 12 weeks by 228.7 ± 83.2 mg/gCr (P = 0.0075) in the high dose group. The adverse-event profile during this study was not different between the groups. Topiroxostat 160 mg daily reduced albuminuria in patients with diabetic nephropathy. (Funded by Sanwa Kagaku Kenkyusho; Trial registration, UMIN000015403). This article is protected by copyright. All rights reserved.

  20. Benfotiamine in the treatment of diabetic polyneuropathy--a three-week randomized, controlled pilot study (BEDIP study).

    Science.gov (United States)

    Haupt, E; Ledermann, H; Köpcke, W

    2005-02-01

    The aim of the study was to evaluate the efficacy of benfotiamine administered over three weeks (allithiamine; a lipid-soluble vitamin B1 prodrug with high bioavailability) to patients with diabetic polyneuropathy in a randomized, placebo-controlled, double-blind, two-center pilot study. Forty inpatients (23 male, 18 female, age range 18 - 70 years) with a history of type 1 or 2 diabetes and polyneuropathy of not longer than two years, were included in the study. Twenty Patients received two 50 mg benfotiamine tablets four times daily and 20 patients received placebo over the three-week study period. Two clinical units were involved with 10 patients receiving placebo and 10 patients benfotiamine in each. The neuropathy score according to Katzenwadel et al. [1987] was used to evaluate symptoms of polyneuropathy, vibration perception threshold and both the physician's and the patient's own assessment were documented. A statistically significant (p = 0.0287) improvement in the neuropathy score was observed in the group given active drug when compared to the placebo-treated controls. There was no statistically significant change observed in the tuning fork test. The most pronounced effect on complaints was a decrease in pain (p = 0.0414). More patients in the benfotiamine-treated group than in the placebo group considered their clinical condition to have improved (p = 0.052). No side effects attributable to benfotiamine were observed. The differences between the groups cannot be attributed to a change in metabolic parameters since there were no significant alterations in the HbA1 levels and blood sugar profiles. The body mass index of the two groups did not differ. This pilot investigation (BEDIP Study) has confirmed the results of two earlier randomized controlled trials and has provided further evidence for the beneficial effects of benfotiamine in patients with diabetic neuropathy.

  1. Mobile Health Technology (mDiab) for the Prevention of Type 2 Diabetes: Protocol for a Randomized Controlled Trial.

    Science.gov (United States)

    Muralidharan, Shruti; Mohan, Viswanathan; Anjana, Ranjit Mohan; Jena, Sidhant; Tandon, Nikhil; Allender, Steven; Ranjani, Harish

    2017-12-12

    The prevalence of type 2 diabetes is increasing in epidemic proportions in low- and middle-income countries. There is an urgent need for novel methods to tackle the increasing incidence of diabetes. The ubiquity of mobile phone use and access to Internet makes mobile health (mHealth) technology a viable tool to prevent and manage diabetes. The objective of this randomized controlled trial is to implement and evaluate the feasibility, cost-effectiveness, and sustainability of a reality television-based lifestyle intervention program. This intervention program is delivered via a mobile phone app (mDiab) to approximately 1500 Android smartphone users who are adults at a high risk for type 2 diabetes from three cities in India, namely, Chennai, Bengaluru, and New Delhi. The mDiab intervention would be delivered via a mobile phone app along with weekly coach calls for 12 weeks. Each participant will go through a maintenance phase of 6 to 8 months post intervention. Overall, there would be 3 testing time points in the study: baseline, post intervention, and the end of follow-up. The app will enable individuals to track their weight, physical activity, and diet alongside weekly video lessons on type 2 diabetes prevention. The study outcomes are weight loss (primary measure of effectiveness); improvement in cardiometabolic risk factors (ie, waist circumference, blood pressure, glucose, insulin, and lipids); and improvement in physical activity, quality of life, and dietary habits. Sustainability will be assessed through focus group discussions. If successful, mDiab can be used as a model for translational and implementation research in the use of mHealth technology for diabetes prevention and may be further expanded for the prevention of other noncommunicable diseases such as hypertension and cardiovascular diseases. Clinical Trials Registry of India CTRI/2015/07/006011 http://ctri.nic.in/Clinicaltrials/pdf_generate.php? trialid=11841 (Archived by WebCite at http

  2. Assessing the accuracy and stability of variable selection methods for random forest modeling in ecology.

    Science.gov (United States)

    Fox, Eric W; Hill, Ryan A; Leibowitz, Scott G; Olsen, Anthony R; Thornbrugh, Darren J; Weber, Marc H

    2017-07-01

    Random forest (RF) modeling has emerged as an important statistical learning method in ecology due to its exceptional predictive performance. However, for large and complex ecological data sets, there is limited guidance on variable selection methods for RF modeling. Typically, either a preselected set of predictor variables are used or stepwise procedures are employed which iteratively remove variables according to their importance measures. This paper investigates the application of variable selection methods to RF models for predicting probable biological stream condition. Our motivating data set consists of the good/poor condition of n = 1365 stream survey sites from the 2008/2009 National Rivers and Stream Assessment, and a large set (p = 212) of landscape features from the StreamCat data set as potential predictors. We compare two types of RF models: a full variable set model with all 212 predictors and a reduced variable set model selected using a backward elimination approach. We assess model accuracy using RF's internal out-of-bag estimate, and a cross-validation procedure with validation folds external to the variable selection process. We also assess the stability of the spatial predictions generated by the RF models to changes in the number of predictors and argue that model selection needs to consider both accuracy and stability. The results suggest that RF modeling is robust to the inclusion of many variables of moderate to low importance. We found no substantial improvement in cross-validated accuracy as a result of variable reduction. Moreover, the backward elimination procedure tended to select too few variables and exhibited numerous issues such as upwardly biased out-of-bag accuracy estimates and instabilities in the spatial predictions. We use simulations to further support and generalize results from the analysis of real data. A main purpose of this work is to elucidate issues of model selection bias and instability to ecologists interested in

  3. Periodontal treatment to improve glycaemic control in diabetic patients: study protocol of the randomized, controlled DIAPERIO trial.

    Science.gov (United States)

    Vergnes, Jean-Noel; Arrivé, Elise; Gourdy, Pierre; Hanaire, Hélène; Rigalleau, Vincent; Gin, Henri; Sédarat, Cyril; Dorignac, Georges; Bou, Christophe; Sixou, Michel; Nabet, Cathy

    2009-08-02

    Periodontitis is a common, chronic inflammatory disease caused by gram-negative bacteria leading to destruction of tissues supporting the teeth. Epidemiological studies have consistently shown increased frequency, extent and severity of periodontitis among diabetic adults. More recently, some controlled clinical trials have also suggested that periodontal treatment could improve glycaemic control in diabetic patients. However current evidence does not provide sufficient information on which to confidently base any clinical recommendations. The main objective of this clinical trial is to assess whether periodontal treatment could lead to a decrease in glycated haemoglobin levels in metabolically unbalanced diabetic patients suffering from chronic periodontitis. The DIAPERIO trial is an open-label, 13-week follow-up, randomized, controlled trial. The total target sample size is planned at 150 participants, with a balanced (1:1) treatment allocation (immediate treatment vs delayed treatment). Periodontal treatment will include full mouth non-surgical scaling and root planing, systemic antibiotherapy, local antiseptics (chlorhexidine 0.12%) and oral health instructions. The primary outcome will be the difference in change of HbA1c between the two groups after the 13-weeks' follow-up. Secondary outcomes will be the difference in change of fructosamine levels and quality of life between the two groups. The DIAPERIO trial will provide insight into the question of whether periodontal treatment could lead to an improvement in glycaemic control in metabolically unbalanced diabetic patients suffering from periodontitis. The results of this trial will help to provide evidence-based recommendations for clinicians and a draft framework for designing national health policies. Current Controlled Trials ISRCTN15334496.

  4. Effects of probiotic yogurt consumption on lipid profile in type 2 diabetic patients: A randomized controlled clinical trial.

    Science.gov (United States)

    Mohamadshahi, Majid; Veissi, Masoud; Haidari, Fatemeh; Javid, Ahmad Zare; Mohammadi, Fatemeh; Shirbeigi, Esmat

    2014-06-01

    Alteration in plasma lipid and lipoprotein profile has been documented in diabetic patients. The purpose of this study was to compare the effect of probiotic and conventional yogurt on lipid profile in type 2 diabetes mellitus patients. A total of 44 patients with type 2 diabetes aged 30-60 years old who had low density lipoprotein cholesterol (LDL-c) ≥100 mg/dl enrolled in this randomized, double - blind controlled trial and were assigned to two intervention and control groups. The subjects in the intervention group consumed 300 g/d probiotic yogurt containing Lactobacillus acidophilus La-5 and Bifidobacterium lactis Bb-12 and subjects in the control group consumed 300 g/d conventional yogurt for 8 weeks. Anthropometric indices, dietary intake, and serum lipid profile were evaluated at the beginning and end of the intervention. Independent-sample t-test, paired sample t-test, ANCOVA, and repeated measures were used for statistical analysis. The consumption of probiotic yogurt caused significant decrease in LDL-c/high density lipoprotein cholesterol (HDL-c) ratio (3.13 ± 1.00-2.07 ± 0.71, P = 0.016). The levels of HDL-c were increased significantly (43.66 ± 6.80-50.42 ± 6.64, P = 0.023) in the intervention group postintervention. However, there were no significant differences in triglyceride and total cholesterol levels between two groups postintervention (P consumption may be used as an alternative prevention approach and treatment method to improve dyslipidemia in patients with type 2 diabetes.

  5. Liver fat is reduced by an isoenergetic MUFA diet in a controlled randomized study in type 2 diabetic patients.

    Science.gov (United States)

    Bozzetto, Lutgarda; Prinster, Anna; Annuzzi, Giovanni; Costagliola, Lucia; Mangione, Anna; Vitelli, Alessandra; Mazzarella, Raffaella; Longobardo, Margaret; Mancini, Marcello; Vigorito, Carlo; Riccardi, Gabriele; Rivellese, Angela A

    2012-07-01

    To evaluate the effects of qualitative dietary changes and the interaction with aerobic exercise training on liver fat content independent of weight loss in patients with type 2 diabetes. With use of a factorial 2 × 2 randomized parallel-group design, 37 men and 8 women, aged 35-70 years, with type 2 diabetes in satisfactory blood glucose control on diet or diet plus metformin treatment were assigned to one of the following groups for an 8-week period: 1) high-carbohydrate/high-fiber/low-glycemic index diet (CHO/fiber group), 2) high-MUFA diet (MUFA group), 3) high-carbohydrate/high-fiber/low-glycemic index diet plus physical activity program (CHO/fiber+Ex group), and 4) high-MUFA diet plus physical activity program (MUFA+Ex group). Before and after intervention, hepatic fat content was measured by (1)H NMR. Dietary compliance was optimal and body weight remained stable in all groups. Liver fat content decreased more in MUFA (-29%) and MUFA+Ex (-25%) groups than in CHO/fiber (-4%) and CHO/fiber+Ex groups (-6%). Two-way repeated-measures ANOVA, including baseline values as covariate, showed a significant effect on liver fat content for diet (P = 0.006), with no effects for exercise training (P = 0.789) or diet-exercise interaction (P = 0.712). An isocaloric diet enriched in MUFA compared with a diet higher in carbohydrate and fiber was associated with a clinically relevant reduction of hepatic fat content in type 2 diabetic patients independent of an aerobic training program and should be considered for the nutritional management of hepatic steatosis in people with type 2 diabetes.

  6. Effect of a Brown Rice Based Vegan Diet and Conventional Diabetic Diet on Glycemic Control of Patients with Type 2 Diabetes: A 12-Week Randomized Clinical Trial.

    Science.gov (United States)

    Lee, Yu-Mi; Kim, Se-A; Lee, In-Kyu; Kim, Jung-Guk; Park, Keun-Gyu; Jeong, Ji-Yun; Jeon, Jae-Han; Shin, Ji-Yeon; Lee, Duk-Hee

    2016-01-01

    Several intervention studies have suggested that vegetarian or vegan diets have clinical benefits, particularly in terms of glycemic control, in patients with type 2 diabetes (T2D); however, no randomized controlled trial has been conducted in Asians who more commonly depend on plant-based foods, as compared to Western populations. Here, we aimed to compare the effect of a vegan diet and conventional diabetic diet on glycemic control among Korean individuals. Participants diagnosed with T2D were randomly assigned to follow either a vegan diet (excluding animal-based food including fish; n = 46) or a conventional diet recommended by the Korean Diabetes Association 2011 (n = 47) for 12 weeks. HbA1c levels were measured at weeks 0, 4, and 12, and the primary study endpoint was the change in HbA1c levels over 12 weeks. The mean HbA1c levels at weeks 0, 4, and 12 were 7.7%, 7.2%, and 7.1% in the vegan group, and 7.4%, 7.2%, and 7.2% in the conventional group, respectively. Although both groups showed significant reductions in HbA1C levels, the reductions were larger in the vegan group than in the conventional group (-0.5% vs. -0.2%; p-for-interaction = 0.017). When only considering participants with high compliance, the difference in HbA1c level reduction between the groups was found to be larger (-0.9% vs. -0.3%). The beneficial effect of vegan diets was noted even after adjusting for changes in total energy intake or waist circumference over the 12 weeks. Both diets led to reductions in HbA1c levels; however, glycemic control was better with the vegan diet than with the conventional diet. Thus, the dietary guidelines for patients with T2D should include a vegan diet for the better management and treatment. However, further studies are needed to evaluate the long-term effects of a vegan diet, and to identify potential explanations of the underlying mechanisms. CRiS KCT0001771.

  7. Effect of a Brown Rice Based Vegan Diet and Conventional Diabetic Diet on Glycemic Control of Patients with Type 2 Diabetes: A 12-Week Randomized Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Yu-Mi Lee

    Full Text Available Several intervention studies have suggested that vegetarian or vegan diets have clinical benefits, particularly in terms of glycemic control, in patients with type 2 diabetes (T2D; however, no randomized controlled trial has been conducted in Asians who more commonly depend on plant-based foods, as compared to Western populations. Here, we aimed to compare the effect of a vegan diet and conventional diabetic diet on glycemic control among Korean individuals.Participants diagnosed with T2D were randomly assigned to follow either a vegan diet (excluding animal-based food including fish; n = 46 or a conventional diet recommended by the Korean Diabetes Association 2011 (n = 47 for 12 weeks. HbA1c levels were measured at weeks 0, 4, and 12, and the primary study endpoint was the change in HbA1c levels over 12 weeks.The mean HbA1c levels at weeks 0, 4, and 12 were 7.7%, 7.2%, and 7.1% in the vegan group, and 7.4%, 7.2%, and 7.2% in the conventional group, respectively. Although both groups showed significant reductions in HbA1C levels, the reductions were larger in the vegan group than in the conventional group (-0.5% vs. -0.2%; p-for-interaction = 0.017. When only considering participants with high compliance, the difference in HbA1c level reduction between the groups was found to be larger (-0.9% vs. -0.3%. The beneficial effect of vegan diets was noted even after adjusting for changes in total energy intake or waist circumference over the 12 weeks.Both diets led to reductions in HbA1c levels; however, glycemic control was better with the vegan diet than with the conventional diet. Thus, the dietary guidelines for patients with T2D should include a vegan diet for the better management and treatment. However, further studies are needed to evaluate the long-term effects of a vegan diet, and to identify potential explanations of the underlying mechanisms.CRiS KCT0001771.

  8. Randomized and double-blinded pilot clinical study of the safety and anti-diabetic efficacy of the Rauvolfia-Citrus tea, as used in Nigerian Traditional Medicine

    DEFF Research Database (Denmark)

    Campbell-Tofte, Joan I A; Mølgaard, Per; Josefsen, Knud

    2011-01-01

    The aim of this randomized and double blinded pilot clinical trial was to investigate the anti-diabetic efficacy of the Rauvolfia-Citrus (RC) tea in humans. We have earlier shown that a combination of calorie-restriction and chronic administration of the RC tea to the genetic diabetic (BKS-db) mice...... resulted in the normalization of blood sugar, reduction in lipid accumulated in the mice eyes and prevention of the degeneration of the otherwise brittle BKS-db pancreas. The tea is made by boiling foliage of Rauvolfia vomitoria and fruits of Citrus aurantium and is used to treat diabetes in Nigerian folk...

  9. 167: CRITICALLY APPRAISE OF THE REPORTING QUALITY OF RANDOMIZED CONTROLLED TRIALS ARTICLES IN THE FIELD OF DIABETES IN MEDICAL GUIDELINES IN IRAN

    Science.gov (United States)

    Aletaha, Azadeh; Baradaran, Hamid Reza; Soltani, Akbar; Ramezani, Amir

    2017-01-01

    Background and aims To determine the quality of randomized controlled clinical trial reports in diabetes research in Iran and their presence in domestic and foreign credible guidelines which can imply whether randomized controlled trial articles in the field of diabetes are of good quality or not with respect to their high level of received citations, quality and credibility. Method We included RCTs conducted on Diabetes mellitus in Iran. Animal studies, educational, interventions, and non-randomized trials were excluded. This was a bibliographic study examining published journal articles involving RCTs in diabetes research from Iranian authors. A systematic search of ten databases(ISI Web of science, Scopus, PubMed, Science Direct, The Cochrane Library, Taylor & Francis Online, Biomed Central, EBSCO, ProQuest and OVID)were undertaken from July 2004–2014. We excluded duplicated publications reporting the same groups of participants and intervention two independent reviewers identify all eligible articles specifically designed data extraction form. Two reviewers assessed the quality of reporting by CONSORT 2010 (Consolidated Standards of Reporting Trials) checklist statement and also evaluate each article with Scientometry tools in 260 valid English diabetes guidelines. Result Overall, we included 185 RCTs on diabetes mellitus, One hundred and eight five (185) studies were included and appraised. Half of them (55.7%) were published in Iranian journals. Most (89.7%) were parallel RCTs, and being performed on type2 diabetic patients (77.8%). Less than half of the CONSORT items (43.2%) were reported in studies, totally. The reporting of randomization and blinding were poor. A few studies 15.1% mentioned the method of random sequence generation and strategy of allocation concealment. And only 34.8% of trials report how blinding was applied. From 185 articles, twelve articles (10%) are presented in 260 Guidelines. Conclusion The reporting quality of abstracts of RCTs

  10. The effects of probiotic supplements on insulin resistance in gestational diabetes mellitus: a double-blind randomized controlled trial.

    Science.gov (United States)

    Kijmanawat, Athasit; Panburana, Panyu; Reutrakul, Sirimon; Tangshewinsirikul, Chayada

    2018-05-20

    To evaluate the effect of probiotic supplements on insulin resistance in pregnant women with diet-controlled gestational diabetes mellitus. A randomized, double-blind, placebo-controlled trial was conducted between June 2016 and February 2017. Pregnant women with diet-controlled gestational diabetes mellitus were enrolled in the study at 24-28 weeks of gestation and randomized to receive either probiotic supplements containing Bifidobacterium and Lactobacillus or placebo daily for four consecutive weeks. Primary outcomes were mean differences in insulin resistance (HOMA-IR), fasting insulin and fasting plasma glucose between the two groups. Secondary outcomes were changes in maternal weight after the intervention. Data from 28 patients in the probiotic group and 29 in the placebo group were analyzed. The changes in metabolic parameters after randomization indicated significant improvement in glucose metabolism in the probiotic group compared to the placebo group, including fasting plasma glucose (0.68 ± 5.88 vs. 4.620 ± 7.78 mg/dL, mean difference, MD, -3.94 mg/dL (95% CI -7.62, -0.27), p-value 0.034), fasting plasma insulin (1.11 ± 1.71 vs. 3.77 ± 1.70 mIU/L, MD -2.67 mIU/L (95%CI -3.57, -1.76), p-value 0.001) and HOMA-IR (0.25 ± 0.37 vs. 0.89 ± 0.46, MD -0.63 (95% CI -0.86, -0.41), p-value 0.001). Weight gain during randomization was similar between the two groups. Four weeks of probiotic supplements in women with diet-controlled gestational diabetes in the late second- and early third-trimester lowered fasting glucose and increased insulin sensitivity. Probiotic supplements may be considered as an adjunct treatment for glycemic control in these patients. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  11. Effects of nordic walking and exercise in type 2 diabetes mellitus: a randomized controlled trial

    DEFF Research Database (Denmark)

    Gram, Bibi; Christensen, Robin; Christiansen, Christian

    2010-01-01

    Both Nordic walking and Exercise on Prescription have potential as elements in the management of type 2 diabetes mellitus. These programs are recommended, but their effectiveness has not yet been established. The aim was to evaluate the efficacy of these 2 interventions compared with standard...

  12. Spinal cord stimulation in patients with painful diabetic neuropathy: A multicentre randomized clinical trial

    NARCIS (Netherlands)

    de Vos, Cecilia Cecilia Clementine; Meier, Kaare; Brocades Zaalberg, Paul; Nijhuis, Harold J.A.; Duyvendak, Wim; Vesper, Jan; Enggaard, Thomas P.; Lenders, Mathieu W.P.M.

    2014-01-01

    Painful diabetic neuropathy (PDN) is a peripheral neuropathic pain condition that is often difficult to relieve. Spinal cord stimulation (SCS) is a proven effective therapy for various types of mixed neuropathic conditions, yet effectiveness of SCS treatment for PDN is not well established. To our

  13. Resist diabetes: A randomized clinical trial for resistance training maintenance in adults with prediabetes.

    Directory of Open Access Journals (Sweden)

    Brenda M Davy

    Full Text Available To determine whether a social cognitive theory (SCT-based intervention improves resistance training (RT maintenance and strength, and reduces prediabetes prevalence.Sedentary, overweight/obese (BMI: 25-39.9 kg/m2 adults aged 50-69 (N = 170 with prediabetes participated in the 15-month trial. Participants completed a supervised 3-month RT (2×/wk phase and were randomly assigned (N = 159 to one of two 6-month maintenance conditions: SCT or standard care. Participants continued RT at a self-selected facility. The final 6-month period involved no contact. Assessments occurred at baseline and months 3, 9, and 15. The SCT faded-contact intervention consisted of nine tailored transition (i.e., supervised training to training alone and nine follow-up sessions. Standard care involved six generic follow-up sessions. Primary outcomes were prevalence of normoglycemia and muscular strength.The retention rate was 76%. Four serious adverse events were reported. After 3 months of RT, 34% of participants were no longer prediabetic. This prevalence of normoglycemia was maintained through month 15 (30%, with no group difference. There was an 18% increase in the odds of being normoglycemic for each % increase in fat-free mass. Increases in muscular strength were evident at month 3 and maintained through month 15 (P<0.001, which represented improvements of 21% and 14% for chest and leg press, respectively. Results did not demonstrate a greater reduction in prediabetes prevalence in the SCT condition.Resistance training is an effective, maintainable strategy for reducing prediabetes prevalence and increasing muscular strength. Future research which promotes RT initiation and maintenance in clinical and community settings is warranted.ClinicalTrials.gov NCT01112709.

  14. Resist diabetes: A randomized clinical trial for resistance training maintenance in adults with prediabetes.

    Science.gov (United States)

    Davy, Brenda M; Winett, Richard A; Savla, Jyoti; Marinik, Elaina L; Baugh, Mary Elizabeth; Flack, Kyle D; Halliday, Tanya M; Kelleher, Sarah A; Winett, Sheila G; Williams, David M; Boshra, Soheir

    2017-01-01

    To determine whether a social cognitive theory (SCT)-based intervention improves resistance training (RT) maintenance and strength, and reduces prediabetes prevalence. Sedentary, overweight/obese (BMI: 25-39.9 kg/m2) adults aged 50-69 (N = 170) with prediabetes participated in the 15-month trial. Participants completed a supervised 3-month RT (2×/wk) phase and were randomly assigned (N = 159) to one of two 6-month maintenance conditions: SCT or standard care. Participants continued RT at a self-selected facility. The final 6-month period involved no contact. Assessments occurred at baseline and months 3, 9, and 15. The SCT faded-contact intervention consisted of nine tailored transition (i.e., supervised training to training alone) and nine follow-up sessions. Standard care involved six generic follow-up sessions. Primary outcomes were prevalence of normoglycemia and muscular strength. The retention rate was 76%. Four serious adverse events were reported. After 3 months of RT, 34% of participants were no longer prediabetic. This prevalence of normoglycemia was maintained through month 15 (30%), with no group difference. There was an 18% increase in the odds of being normoglycemic for each % increase in fat-free mass. Increases in muscular strength were evident at month 3 and maintained through month 15 (Pprediabetes prevalence in the SCT condition. Resistance training is an effective, maintainable strategy for reducing prediabetes prevalence and increasing muscular strength. Future research which promotes RT initiation and maintenance in clinical and community settings is warranted. ClinicalTrials.gov NCT01112709.

  15. Analysis and applications of a frequency selective surface via a random distribution method

    International Nuclear Information System (INIS)

    Xie Shao-Yi; Huang Jing-Jian; Yuan Nai-Chang; Liu Li-Guo

    2014-01-01

    A novel frequency selective surface (FSS) for reducing radar cross section (RCS) is proposed in this paper. This FSS is based on the random distribution method, so it can be called random surface. In this paper, the stacked patches serving as periodic elements are employed for RCS reduction. Previous work has demonstrated the efficiency by utilizing the microstrip patches, especially for the reflectarray. First, the relevant theory of the method is described. Then a sample of a three-layer variable-sized stacked patch random surface with a dimension of 260 mm×260 mm is simulated, fabricated, and measured in order to demonstrate the validity of the proposed design. For the normal incidence, the 8-dB RCS reduction can be achieved both by the simulation and the measurement in 8 GHz–13 GHz. The oblique incidence of 30° is also investigated, in which the 7-dB RCS reduction can be obtained in a frequency range of 8 GHz–14 GHz. (condensed matter: electronic structure, electrical, magnetic, and optical properties)

  16. Selective oropharyngeal decontamination versus selective digestive decontamination in critically ill patients: a meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Zhao D

    2015-07-01

    Full Text Available Di Zhao,1,* Jian Song,2,* Xuan Gao,3 Fei Gao,4 Yupeng Wu,2 Yingying Lu,5 Kai Hou1 1Department of Neurosurgery, The First Hospital of Hebei Medical University, 2Department of Neurosurgery, 3Department of Neurology, The Second Hospital of Hebei Medical University, 4Hebei Provincial Procurement Centers for Medical Drugs and Devices, 5Department of Neurosurgery, The Second Hospital of Hebei Medical University, Shijiazhuang People’s Republic of China *These authors contributed equally to this work Background: Selective digestive decontamination (SDD and selective oropharyngeal decontamination (SOD are associated with reduced mortality and infection rates among patients in intensive care units (ICUs; however, whether SOD has a superior effect than SDD remains uncertain. Hence, we conducted a meta-analysis of randomized controlled trials (RCTs to compare SOD with SDD in terms of clinical outcomes and antimicrobial resistance rates in patients who were critically ill. Methods: RCTs published in PubMed, Embase, and Web of Science were systematically reviewed to compare the effects of SOD and SDD in patients who were critically ill. Outcomes included day-28 mortality, length of ICU stay, length of hospital stay, duration of mechanical ventilation, ICU-acquired bacteremia, and prevalence of antibiotic-resistant Gram-negative bacteria. Results were expressed as risk ratio (RR with 95% confidence intervals (CIs, and weighted mean differences (WMDs with 95% CIs. Pooled estimates were performed using a fixed-effects model or random-effects model, depending on the heterogeneity among studies. Results: A total of four RCTs involving 23,822 patients met the inclusion criteria and were included in this meta-analysis. Among patients whose admitting specialty was surgery, cardiothoracic surgery (57.3% and neurosurgery (29.7% were the two main types of surgery being performed. Pooled results showed that SOD had similar effects as SDD in day-28 mortality (RR =1

  17. Geography and genography: prediction of continental origin using randomly selected single nucleotide polymorphisms

    Directory of Open Access Journals (Sweden)

    Ramoni Marco F

    2007-03-01

    Full Text Available Abstract Background Recent studies have shown that when individuals are grouped on the basis of genetic similarity, group membership corresponds closely to continental origin. There has been considerable debate about the implications of these findings in the context of larger debates about race and the extent of genetic variation between groups. Some have argued that clustering according to continental origin demonstrates the existence of significant genetic differences between groups and that these differences may have important implications for differences in health and disease. Others argue that clustering according to continental origin requires the use of large amounts of genetic data or specifically chosen markers and is indicative only of very subtle genetic differences that are unlikely to have biomedical significance. Results We used small numbers of randomly selected single nucleotide polymorphisms (SNPs from the International HapMap Project to train naïve Bayes classifiers for prediction of ancestral continent of origin. Predictive accuracy was tested on two independent data sets. Genetically similar groups should be difficult to distinguish, especially if only a small number of genetic markers are used. The genetic differences between continentally defined groups are sufficiently large that one can accurately predict ancestral continent of origin using only a minute, randomly selected fraction of the genetic variation present in the human genome. Genotype data from only 50 random SNPs was sufficient to predict ancestral continent of origin in our primary test data set with an average accuracy of 95%. Genetic variations informative about ancestry were common and widely distributed throughout the genome. Conclusion Accurate characterization of ancestry is possible using small numbers of randomly selected SNPs. The results presented here show how investigators conducting genetic association studies can use small numbers of arbitrarily

  18. Random forest variable selection in spatial malaria transmission modelling in Mpumalanga Province, South Africa

    Directory of Open Access Journals (Sweden)

    Thandi Kapwata

    2016-11-01

    Full Text Available Malaria is an environmentally driven disease. In order to quantify the spatial variability of malaria transmission, it is imperative to understand the interactions between environmental variables and malaria epidemiology at a micro-geographic level using a novel statistical approach. The random forest (RF statistical learning method, a relatively new variable-importance ranking method, measures the variable importance of potentially influential parameters through the percent increase of the mean squared error. As this value increases, so does the relative importance of the associated variable. The principal aim of this study was to create predictive malaria maps generated using the selected variables based on the RF algorithm in the Ehlanzeni District of Mpumalanga Province, South Africa. From the seven environmental variables used [temperature, lag temperature, rainfall, lag rainfall, humidity, altitude, and the normalized difference vegetation index (NDVI], altitude was identified as the most influential predictor variable due its high selection frequency. It was selected as the top predictor for 4 out of 12 months of the year, followed by NDVI, temperature and lag rainfall, which were each selected twice. The combination of climatic variables that produced the highest prediction accuracy was altitude, NDVI, and temperature. This suggests that these three variables have high predictive capabilities in relation to malaria transmission. Furthermore, it is anticipated that the predictive maps generated from predictions made by the RF algorithm could be used to monitor the progression of malaria and assist in intervention and prevention efforts with respect to malaria.

  19. Distribution of orientation selectivity in recurrent networks of spiking neurons with different random topologies.

    Science.gov (United States)

    Sadeh, Sadra; Rotter, Stefan

    2014-01-01

    Neurons in the primary visual cortex are more or less selective for the orientation of a light bar used for stimulation. A broad distribution of individual grades of orientation selectivity has in fact been reported in all species. A possible reason for emergence of broad distributions is the recurrent network within which the stimulus is being processed. Here we compute the distribution of orientation selectivity in randomly connected model networks that are equipped with different spatial patterns of connectivity. We show that, for a wide variety of connectivity patterns, a linear theory based on firing rates accurately approximates the outcome of direct numerical simulations of networks of spiking neurons. Distance dependent connectivity in networks with a more biologically realistic structure does not compromise our linear analysis, as long as the linearized dynamics, and hence the uniform asynchronous irregular activity state, remain stable. We conclude that linear mechanisms of stimulus processing are indeed responsible for the emergence of orientation selectivity and its distribution in recurrent networks with functionally heterogeneous synaptic connectivity.

  20. Interference-aware random beam selection schemes for spectrum sharing systems

    KAUST Repository

    Abdallah, Mohamed

    2012-10-19

    Spectrum sharing systems have been recently introduced to alleviate the problem of spectrum scarcity by allowing secondary unlicensed networks to share the spectrum with primary licensed networks under acceptable interference levels to the primary users. In this work, we develop interference-aware random beam selection schemes that provide enhanced performance for the secondary network under the condition that the interference observed by the receivers of the primary network is below a predetermined/acceptable value. We consider a secondary link composed of a transmitter equipped with multiple antennas and a single-antenna receiver sharing the same spectrum with a primary link composed of a single-antenna transmitter and a single-antenna receiver. The proposed schemes select a beam, among a set of power-optimized random beams, that maximizes the signal-to-interference-plus-noise ratio (SINR) of the secondary link while satisfying the primary interference constraint for different levels of feedback information describing the interference level at the primary receiver. For the proposed schemes, we develop a statistical analysis for the SINR statistics as well as the capacity and bit error rate (BER) of the secondary link.

  1. Joint random beam and spectrum selection for spectrum sharing systems with partial channel state information

    KAUST Repository

    Abdallah, Mohamed M.

    2013-11-01

    In this work, we develop joint interference-aware random beam and spectrum selection scheme that provide enhanced performance for the secondary network under the condition that the interference observed at the primary receiver is below a predetermined acceptable value. We consider a secondary link composed of a transmitter equipped with multiple antennas and a single-antenna receiver sharing the same spectrum with a set of primary links composed of a single-antenna transmitter and a single-antenna receiver. The proposed schemes jointly select a beam, among a set of power-optimized random beams, as well as the primary spectrum that maximizes the signal-to-interference-plus-noise ratio (SINR) of the secondary link while satisfying the primary interference constraint. In particular, we consider the case where the interference level is described by a q-bit description of its magnitude, whereby we propose a technique to find the optimal quantizer thresholds in a mean square error (MSE) sense. © 2013 IEEE.

  2. Joint random beam and spectrum selection for spectrum sharing systems with partial channel state information

    KAUST Repository

    Abdallah, Mohamed M.; Sayed, Mostafa M.; Alouini, Mohamed-Slim; Qaraqe, Khalid A.

    2013-01-01

    In this work, we develop joint interference-aware random beam and spectrum selection scheme that provide enhanced performance for the secondary network under the condition that the interference observed at the primary receiver is below a predetermined acceptable value. We consider a secondary link composed of a transmitter equipped with multiple antennas and a single-antenna receiver sharing the same spectrum with a set of primary links composed of a single-antenna transmitter and a single-antenna receiver. The proposed schemes jointly select a beam, among a set of power-optimized random beams, as well as the primary spectrum that maximizes the signal-to-interference-plus-noise ratio (SINR) of the secondary link while satisfying the primary interference constraint. In particular, we consider the case where the interference level is described by a q-bit description of its magnitude, whereby we propose a technique to find the optimal quantizer thresholds in a mean square error (MSE) sense. © 2013 IEEE.

  3. 'Huang Qi Elixir' for proteinuria in patients with diabetic nephropathy: a study protocol for a randomized controlled pilot trial.

    Science.gov (United States)

    Tu, Xiang; Liu, Fang; Jordan, James B; Ye, Xue Feng; Fu, Ping; Wang, Fei; Zhong, Sen

    2013-07-18

    Diabetic nephropathy (DN) is the major complication of diabetes; proteinuria is the hall mark of DN. Currently, the treatment for proteinuria is mainly limited to angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs). According to Traditional Chinese Medicine (TCM) theory, Chinese medicinals 'securing essence and tonifying the kidney' may be appropriate for proteinuria. The most promising Chinese medicinals and formulae are introduced in the present study to form a potent formula for DN proteinuria. To make oral administration convenient, the formula will be processed in the form of granules. A randomized, multi-center pilot trial will be conducted. Forty eight participants with DN will be randomly assigned to one of four treatment groups: 1. A granule group, at 10 grams, three times daily (G10 group, n = 12); 2. A granule group, at 20 grams, three times daily (G20 group, n = 12); 3. A decoction group (D group, n = 12); and 4. An irbesartan group (Aprovel group, n = 12).The following outcome measures will be used: the percentage change of the albumin-to-creatinine ratio; and the changes in serum creatinine, glomerular filtration rate, fasting plasma glucose and hemoglobulin from baseline to the end of the trial. It is notable that most published clinical trials which assessed the efficacy of TCM on DN were of poor methodology and, therefore, their results have been invalidated. It is necessary to carry out well-designed clinical trials to provide sound evidence. The present trial is a study with potentially great value, for it will provide the parameters for future randomized, placebo-controlled, clinical trials with large sample sizes. The trial is registered on the Chinese Clinical Trial Registry: ChiCTR-TRC-12002718 (http://www.chictr.org/cn/proj/show.aspx?proj=3820).

  4. The effectiveness of peer health coaching in improving glycemic control among low-income patients with diabetes: protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Chen Ellen

    2011-04-01

    Full Text Available Abstract Background Although self-management support improves diabetes outcomes, it is not consistently provided in health care settings strained for time and resources. One proposed solution to personnel and funding shortages is to utilize peer coaches, patients trained to provide diabetes education and support to other patients. Coaches share similar experiences about living with diabetes and are able to reach patients within and beyond the health care setting. Given the limited body of evidence that demonstrates peer coaching significantly improves chronic disease care, this present study examines the impact of peer coaching delivered in a primary care setting on diabetes outcomes. Methods/Design The aim of this multicenter, randomized control trial is to evaluate the effectiveness of utilizing peer coaches to improve clinical outcomes and self-management skills in low-income patients with poorly controlled diabetes. A total of 400 patients from six primary health centers based in San Francisco that serve primarily low-income populations will be randomized to receive peer coaching (n = 200 or usual care (n = 200 over 6 months. Patients in the peer coach group receive coaching from patients with diabetes who are trained and mentored as peer coaches. The primary outcome is change in HbA1c. Secondary outcomes include change in: systolic blood pressure, body mass index (BMI, LDL cholesterol, diabetes self-care activities, medication adherence, diabetes-related quality of life, diabetes self-efficacy, and depression. Clinical values (HbA1c, LDL cholesterol and blood pressure and self-reported diabetes self-efficacy and self-care activities are measured at baseline and after 6 months for patients and coaches. Peer coaches are also assessed at 12 months. Discussion Patients with diabetes, who are trained as peer health coaches, are uniquely poised to provide diabetes self management support and education to patients. This study is designed to

  5. mHealth Technology and Nurse Health Coaching to Improve Health in Diabetes: Protocol for a Randomized Controlled Trial.

    Science.gov (United States)

    Miyamoto, Sheridan; Dharmar, Madan; Fazio, Sarina; Tang-Feldman, Yajarayma; Young, Heather M

    2018-02-15

    Chronic diseases, including diabetes mellitus, are the leading cause of mortality and disability in the United States. Current solutions focus primarily on diagnosis and pharmacological treatment, yet there is increasing evidence that patient-centered models of care are more successful in improving and addressing chronic disease outcomes. The objective of this clinical trial is to evaluate the impact of a mobile health (mHealth) enabled nurse health coaching intervention on self-efficacy among adults with type-2 diabetes mellitus. A randomized controlled trial was conducted at an academic health system in Northern California. A total of 300 participants with type-2 diabetes were scheduled to be enrolled through three primary care clinics. Participants were randomized to either usual care or intervention. All participants received training on use of the health system patient portal. Participants in the intervention arm received six scheduled health-coaching telephone calls with a registered nurse and were provided with an activity tracker and mobile application that integrated data into the electronic health record (EHR) to track their daily activity and health behavior decisions. All participants completed a baseline survey and follow-up surveys at 3 and 9 months. Primary and secondary outcomes include diabetes self-efficacy, hemoglobin A 1c (HbA 1c ), and quality of life measures. Data collection for this trial, funded by the Patient-Centered Outcomes Research Institute, will be completed by December 2017. Results from the trial will be available mid-2018. This protocol details a patient-centered intervention using nurse health coaching, mHealth technologies, and integration of patient-generated data into the EHR. The aim of the intervention is to enhance self-efficacy and health outcomes by providing participants with a mechanism to track daily activity by offering coaching support to set reasonable and attainable health goals, and by creating a complete feedback

  6. Rationale, Design, and Baseline Characteristics of the Utopia Trial for Preventing Diabetic Atherosclerosis Using an SGLT2 Inhibitor: A Prospective, Randomized, Open-Label, Parallel-Group Comparative Study.

    Science.gov (United States)

    Katakami, Naoto; Mita, Tomoya; Yoshii, Hidenori; Shiraiwa, Toshihiko; Yasuda, Tetsuyuki; Okada, Yosuke; Umayahara, Yutaka; Kaneto, Hideaki; Osonoi, Takeshi; Yamamoto, Tsunehiko; Kuribayashi, Nobuichi; Maeda, Kazuhisa; Yokoyama, Hiroki; Kosugi, Keisuke; Ohtoshi, Kentaro; Hayashi, Isao; Sumitani, Satoru; Tsugawa, Mamiko; Ohashi, Makoto; Taki, Hideki; Nakamura, Tadashi; Kawashima, Satoshi; Sato, Yasunori; Watada, Hirotaka; Shimomura, Iichiro

    2017-10-01

    Sodium-glucose co-transporter-2 (SGLT2) inhibitors are anti-diabetic agents that improve glycemic control with a low risk of hypoglycemia and ameliorate a variety of cardiovascular risk factors. The aim of the ongoing study described herein is to investigate the preventive effects of tofogliflozin, a potent and selective SGLT2 inhibitor, on the progression of atherosclerosis in subjects with type 2 diabetes (T2DM) using carotid intima-media thickness (IMT), an established marker of cardiovascular disease (CVD), as a marker. The Study of Using Tofogliflozin for Possible better Intervention against Atherosclerosis for type 2 diabetes patients (UTOPIA) trial is a prospective, randomized, open-label, blinded-endpoint, multicenter, and parallel-group comparative study. The aim was to recruit a total of 340 subjects with T2DM but no history of apparent CVD at 24 clinical sites and randomly allocate these to a tofogliflozin treatment group or a conventional treatment group using drugs other than SGLT2 inhibitors. As primary outcomes, changes in mean and maximum IMT of the common carotid artery during a 104-week treatment period will be measured by carotid echography. Secondary outcomes include changes in glycemic control, parameters related to β-cell function and diabetic nephropathy, the occurrence of CVD and adverse events, and biochemical measurements reflecting vascular function. This is the first study to address the effects of SGLT2 inhibitors on the progression of carotid IMT in subjects with T2DM without a history of CVD. The results will be available in the very near future, and these findings are expected to provide clinical data that will be helpful in the prevention of diabetic atherosclerosis and subsequent CVD. Kowa Co., Ltd. UMIN000017607.

  7. Effect of Sugar-Free and Regular Toothpaste on Salivary Glucose and pH among Type 2 Diabetes- A Randomized Crossover Trial.

    Science.gov (United States)

    Kapadia, Junaid; Dodamani, Arun; Baviskar, Priya; Karibasappa, G N; Pathak, Parag; Bezalwar, Abhishek

    2017-07-01

    Diabetes is one of the most prevalent diseases of mankind having general as well as oral health manifestations. Also, there is an increase of salivary glucose level in diabetic, inducing saccharolytic bacteria in saliva which can have adverse effects on oral tissue. To assess and compare the effect of sugar-free toothpaste on salivary glucose and pH among Type 2 diabetic and non-diabetic individuals. A randomized controlled-crossover study was carried out on 30 Type 2 diabetic (Group A) and 45 non-diabetic (Group B) subjects. In first half of study, subjects in Group A and Group B were intervened with sugar-free and regular toothpaste respectively. Salivary glucose and pH was assessed before and after brushing at interval of one week for a period of four weeks. In second half, toothpastes were switched over between the groups, after sufficient washout period. Salivary glucose and pH were assessed again in the same manner for both the groups. The data was subjected to paired t-test and unpaired t-test for intragroup and intergroup comparison respectively. Salivary glucose level was significantly reduced and salivary pH was increased significantly (psalivary glucose level and salivary pH level on diabetes and non-diabetes population.

  8. Herbal Therapies for Type 2 Diabetes Mellitus: Chemistry, Biology, and Potential Application of Selected Plants and Compounds

    Directory of Open Access Journals (Sweden)

    Cicero L. T. Chang

    2013-01-01

    Full Text Available Diabetes mellitus has been recognized since antiquity. It currently affects as many as 285 million people worldwide and results in heavy personal and national economic burdens. Considerable progress has been made in orthodox antidiabetic drugs. However, new remedies are still in great demand because of the limited efficacy and undesirable side effects of current orthodox drugs. Nature is an extraordinary source of antidiabetic medicines. To date, more than 1200 flowering plants have been claimed to have antidiabetic properties. Among them, one-third have been scientifically studied and documented in around 460 publications. In this review, we select and discuss blood glucose-lowering medicinal herbs that have the ability to modulate one or more of the pathways that regulate insulin resistance, β-cell function, GLP-1 homeostasis, and glucose (reabsorption. Emphasis is placed on phytochemistry, anti-diabetic bioactivities, and likely mechanism(s. Recent progress in the understanding of the biological actions, mechanisms, and therapeutic potential of compounds and extracts of plant origin in type 2 diabetes is summarized. This review provides a source of up-to-date information for further basic and clinical research into herbal therapy for type 2 diabetes. Emerging views on therapeutic strategies for type 2 diabetes are also discussed.

  9. Effects of pistachio nut supplementation on blood glucose in patients with type 2 diabetes: a randomized crossover trial.

    Science.gov (United States)

    Parham, Mahmoud; Heidari, Saeide; Khorramirad, Ashraf; Hozoori, Mohammad; Hosseinzadeh, Fatemeh; Bakhtyari, Lida; Vafaeimanesh, Jamshid

    2014-01-01

    Diabetes is a chronic, potentially debilitating, and often fatal disease. Dietary strategies to reduce postprandial glycemia are important in the prevention and treatment of diabetes. Nuts are rich in mono- and polyunsaturated fatty acids, which may reduce hyperglycemia and improve metabolism. To evaluate the effectiveness of pistachio nut supplementation on glycemic and inflammatory measures in patients with type 2 diabetes. In this double-blind, randomized, placebo-controlled, crossover trial, 48 diabetic patients were equally assigned to groups A and B. Patients in group A received a snack of 25 g pistachio nuts twice a day for 12 weeks and group B received a control meal without nuts. After 12 weeks of intervention, the patients had an 8-week washout. Then the groups were displaced, and group B received the same amount of pistachios for 12 weeks. With respect to the total change in variables over both phases, there was a marked decrease in HbA1c (-0.4%) and fasting blood glucose (FBG) concentrations (-16 mg/dl) in the pistachio group compared with the control group (p ≤ 0.001 for both). There was no overall significant change in BMI, blood pressure, HOMA-IR, and C-reactive protein (CRP) concentrations. Analysis of the two phases separately showed a decrease in FBG by 14 mg/dl and in HbA1c by 0.45% in the treatment group (A) after 12 weeks, while no significant differences were seen in group B (control group). In the second phase, FBG decreased from 151.36 ± 39.22 to 137.28 ± 28.65 mg/dl (-14 mg/dl) and HbA1c decreased from 7.42 ± 0.97 to 7.15 ± 0.68 mg/dl (-0.28%, p = 0.013 and p = 0.033, respectively) in the pistachio group (B). Pistachio consumption reduced systolic blood pressure (p = 0.007), BMI (p = 0.011), and CRP (p = 0.002) in patients from the treatment groups, but not insulin resistance. Dietary consumption of pistachio nuts as a snack has beneficial effects on glycemic control, blood pressure, obesity, and inflammation markers in diabetic

  10. Combined Interval Training and Post-exercise Nutrition in Type 2 Diabetes: A Randomized Control Trial

    OpenAIRE

    Francois, Monique E.; Durrer, Cody; Pistawka, Kevin J.; Halperin, Frank A.; Chang, Courtney; Little, Jonathan P.

    2017-01-01

    Background: High-intensity interval training (HIIT) can improve several aspects of cardiometabolic health. Previous studies have suggested that adaptations to exercise training can be augmented with post-exercise milk or protein consumption, but whether this nutritional strategy can impact the cardiometabolic adaptations to HIIT in type 2 diabetes is unknown. Objective: To determine if the addition of a post-exercise milk or protein beverage to a high-intensity interval training (HIIT) interv...

  11. Determination of Efficacy of Reflexology in Managing Patients with Diabetic Neuropathy: A Randomized Controlled Clinical Trial

    OpenAIRE

    Dalal, Krishna; Maran, V. Bharathi; Pandey, Ravindra M.; Tripathi, Manjari

    2014-01-01

    Background. The restricted usage of existing pharmacological methods which do not seem to provide the treatment of diabetic neuropathy may lead to exploring the efficacy of a complementary therapy. In this context, this paper was devoted to evaluate the efficacy of foot reflexology. This health science works on the hypothesis that the dysfunctional states of body parts could be identified by observing certain skin features and be rectified by stimulating certain specific areas mapped on feet....

  12. Examining the impact of genetic testing for type 2 diabetes on health behaviors: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Voils Corrine I

    2012-08-01

    Full Text Available Abstract Background We describe the study design, procedures, and development of the risk counseling protocol used in a randomized controlled trial to evaluate the impact of genetic testing for diabetes mellitus (DM on psychological, health behavior, and clinical outcomes. Methods/Design Eligible patients are aged 21 to 65 years with body mass index (BMI ≥27 kg/m2 and no prior diagnosis of DM. At baseline, conventional DM risk factors are assessed, and blood is drawn for possible genetic testing. Participants are randomized to receive conventional risk counseling for DM with eye disease counseling or with genetic test results. The counseling protocol was pilot tested to identify an acceptable graphical format for conveying risk estimates and match the length of the eye disease to genetic counseling. Risk estimates are presented with a vertical bar graph denoting risk level with colors and descriptors. After receiving either genetic counseling regarding risk for DM or control counseling on eye disease, brief lifestyle counseling for prevention of DM is provided to all participants. Discussion A standardized risk counseling protocol is being used in a randomized trial of 600 participants. Results of this trial will inform policy about whether risk counseling should include genetic counseling. Trial registration ClinicalTrials.gov Identifier NCT01060540

  13. Treatment selection in a randomized clinical trial via covariate-specific treatment effect curves.

    Science.gov (United States)

    Ma, Yunbei; Zhou, Xiao-Hua

    2017-02-01

    For time-to-event data in a randomized clinical trial, we proposed two new methods for selecting an optimal treatment for a patient based on the covariate-specific treatment effect curve, which is used to represent the clinical utility of a predictive biomarker. To select an optimal treatment for a patient with a specific biomarker value, we proposed pointwise confidence intervals for each covariate-specific treatment effect curve and the difference between covariate-specific treatment effect curves of two treatments. Furthermore, to select an optimal treatment for a future biomarker-defined subpopulation of patients, we proposed confidence bands for each covariate-specific treatment effect curve and the difference between each pair of covariate-specific treatment effect curve over a fixed interval of biomarker values. We constructed the confidence bands based on a resampling technique. We also conducted simulation studies to evaluate finite-sample properties of the proposed estimation methods. Finally, we illustrated the application of the proposed method in a real-world data set.

  14. Integrated Behavior Therapy for Selective Mutism: a randomized controlled pilot study.

    Science.gov (United States)

    Bergman, R Lindsey; Gonzalez, Araceli; Piacentini, John; Keller, Melody L

    2013-10-01

    To evaluate the feasibility, acceptability, and preliminary efficacy of a novel behavioral intervention for reducing symptoms of selective mutism and increasing functional speech. A total of 21 children ages 4 to 8 with primary selective mutism were randomized to 24 weeks of Integrated Behavior Therapy for Selective Mutism (IBTSM) or a 12-week Waitlist control. Clinical outcomes were assessed using blind independent evaluators, parent-, and teacher-report, and an objective behavioral measure. Treatment recipients completed a three-month follow-up to assess durability of treatment gains. Data indicated increased functional speaking behavior post-treatment as rated by parents and teachers, with a high rate of treatment responders as rated by blind independent evaluators (75%). Conversely, children in the Waitlist comparison group did not experience significant improvements in speaking behaviors. Children who received IBTSM also demonstrated significant improvements in number of words spoken at school compared to baseline, however, significant group differences did not emerge. Treatment recipients also experienced significant reductions in social anxiety per parent, but not teacher, report. Clinical gains were maintained over 3 month follow-up. IBTSM appears to be a promising new intervention that is efficacious in increasing functional speaking behaviors, feasible, and acceptable to parents and teachers. Copyright © 2013 Elsevier Ltd. All rights reserved.

  15. Two-year Randomized Clinical Trial of Self-etching Adhesives and Selective Enamel Etching.

    Science.gov (United States)

    Pena, C E; Rodrigues, J A; Ely, C; Giannini, M; Reis, A F

    2016-01-01

    The aim of this randomized, controlled prospective clinical trial was to evaluate the clinical effectiveness of restoring noncarious cervical lesions with two self-etching adhesive systems applied with or without selective enamel etching. A one-step self-etching adhesive (Xeno V(+)) and a two-step self-etching system (Clearfil SE Bond) were used. The effectiveness of phosphoric acid selective etching of enamel margins was also evaluated. Fifty-six cavities were restored with each adhesive system and divided into two subgroups (n=28; etch and non-etch). All 112 cavities were restored with the nanohybrid composite Esthet.X HD. The clinical effectiveness of restorations was recorded in terms of retention, marginal integrity, marginal staining, caries recurrence, and postoperative sensitivity after 3, 6, 12, 18, and 24 months (modified United States Public Health Service). The Friedman test detected significant differences only after 18 months for marginal staining in the groups Clearfil SE non-etch (p=0.009) and Xeno V(+) etch (p=0.004). One restoration was lost during the trial (Xeno V(+) etch; p>0.05). Although an increase in marginal staining was recorded for groups Clearfil SE non-etch and Xeno V(+) etch, the clinical effectiveness of restorations was considered acceptable for the single-step and two-step self-etching systems with or without selective enamel etching in this 24-month clinical trial.

  16. Results of the northern Manhattan diabetes community outreach project: a randomized trial studying a community health worker intervention to improve diabetes care in Hispanic adults.

    Science.gov (United States)

    Palmas, Walter; Findley, Sally E; Mejia, Miriam; Batista, Milagros; Teresi, Jeanne; Kong, Jian; Silver, Stephanie; Fleck, Elaine M; Luchsinger, Jose A; Carrasquillo, Olveen

    2014-04-01

    OBJECTIVE The Northern Manhattan Diabetes Community Outreach Project evaluated whether a community health worker (CHW) intervention improved clinically relevant markers of diabetes care in adult Hispanics. RESEARCH DESIGN AND METHODS Participants were adult Hispanics, ages 35-70 years, with recent hemoglobin A1c (A1C) ≥8% (≥64 mmol/mol), from a university-affiliated network of primary care practices in northern Manhattan (New York City, NY). They were randomized to a 12-month CHW intervention (n = 181), or enhanced usual care (educational materials mailed at 4-month intervals, preceded by phone calls, n = 179). The primary outcome was A1C at 12 months; the secondary outcomes were systolic blood pressure (SBP), diastolic blood pressure, and LDL-cholesterol levels. RESULTS There was a nonsignificant trend toward improvement in A1C levels in the intervention group (from unadjusted mean A1C of 8.77 to 8.40%), as compared with usual care (from 8.58 to 8.53%) (P = 0.131). There was also a nonsignificant trend toward an increase in SBP and LDL cholesterol in the intervention arm. Intervention fidelity, measured as the number of contacts in the intervention arm (visits, phone contacts, group support, and nutritional education), showed a borderline association with greater A1C reduction (P = 0.054). When assessed separately, phone contacts were associated with greater A1C reduction (P = 0.04). CONCLUSIONS The trend toward A1C reduction with the CHW intervention failed to achieve statistical significance. Greater intervention fidelity may achieve better glycemic control, and more accessible treatment models, such as phone-based interventions, may be more efficacious in socioeconomically disadvantaged populations.

  17. Lifestyle modifications in the development of diabetes mellitus and metabolic syndrome in Chinese women who had gestational diabetes mellitus: a randomized interventional trial.

    Science.gov (United States)

    Shek, Noel Wan Man; Ngai, Cora Suk Wai; Lee, Chin Peng; Chan, Jane Yuk Chun; Lao, Terence Tzu Hsi

    2014-02-01

    To study whether lifestyle intervention can reduce the development of type II diabetes mellitus (DM) and metabolic syndrome (MS) among Chinese women who had gestational diabetes mellitus (GDM). A prospective randomized controlled interventional trial of 450 women who had GDM and impaired glucose tolerance (IGT) postpartum. Advice on diet and exercise was given to the intervention group and reinforced in each follow-up visit. Women in both arms were followed for 36 months. Blood pressure and anthropometry were measured at each visit and blood tests were repeated. Fewer women in the intervention group developed DM (15 versus 19 %) but this was not statistically significant, and there was a lower incidence of DM among women over 40 years old. No difference was found in fasting glucose, insulin and homeostasis model assessment (HOMA) index. Both systolic and diastolic blood pressures, and triglyceride level, were lower but the significance was inconsistent among visits. BMI and percentage body fat were also significantly lower in the later visits. There was no difference in waist-hip ratio and basal metabolic rate. Our results demonstrate a trend towards lower incidence of type II DM within 3 years postpartum in GDM women given lifestyle advice, which also potentially offers protection against development of MS, in terms of lower blood pressure and triglyceride level. Women over 40 years old are more likely to benefit. Future studies should address ways to maximize compliance to lifestyle intervention as its potential benefits can be undermined by challenges of motherhood.

  18. Diabetes mellitus and abnormal glucose tolerance development after gestational diabetes: A three-year, prospective, randomized, clinical-based, Mediterranean lifestyle interventional study with parallel groups.

    Science.gov (United States)

    Pérez-Ferre, Natalia; Del Valle, Laura; Torrejón, Maria José; Barca, Idoya; Calvo, María Isabel; Matía, Pilar; Rubio, Miguel A; Calle-Pascual, Alfonso L

    2015-08-01

    Women with prior gestational diabetes mellitus (GDM) have a high risk of developing type 2 diabetes mellitus (DM2) in later life. The study aim was to evaluate the efficacy of a lifestyle intervention for the prevention of glucose disorders (impaired fasting glucose, impaired glucose tolerance or DM2) in women with prior GDM. A total of 260 women with prior GDM who presented with normal fasting plasma glucose at six to twelve weeks postpartum were randomized into two groups: a Mediterranean lifestyle intervention group (n = 130) who underwent an educational program on nutrition and a monitored physical activity program and a control group (n = 130) with a conventional follow-up. A total of 237 women completed the three-year follow-up (126 in the intervention group and 111 in the control group). Their glucose disorders rates, clinical and metabolic changes and rates of adherence to the Mediterranean lifestyle were analyzed. Less women in the intervention group (42.8%) developed glucose disorders at the end of the three-year follow-up period compared with the control group (56.75%), p Lifestyle intervention was effective for the prevention of glucose disorders in women with prior GDM. Body weight gain and an unhealthy fat intake pattern were found to be the most predictive factors for the development of glucose disorders. Current Controlled trials: ISRCTN24165302. http://www.controlled-trials.com/isrctn/pf/24165302. Copyright © 2014 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  19. The Effect of a Vegetarian vs Conventional Hypocaloric Diabetic Diet on Thigh Adipose Tissue Distribution in Subjects with Type 2 Diabetes: A Randomized Study.

    Science.gov (United States)

    Kahleova, Hana; Klementova, Marta; Herynek, Vit; Skoch, Antonin; Herynek, Stepan; Hill, Martin; Mari, Andrea; Pelikanova, Terezie

    2017-07-01

    The aim of our study was to compare the effects of a vegetarian and a conventional diet on thigh adipose tissue distribution in subjects with type 2 diabetes (T2D). Seventy-four subjects with T2D were randomly assigned to either follow a vegetarian diet (V, n = 37) or a control group who followed an isocaloric conventional anti-diabetic diet (C, n = 37). Both diets were calorie restricted (-500 kcal/day). To measure insulin sensitivity, the hyperinsulinemic (1 mU.kg -1 .min -1 ) isoglycemic clamp was conducted. β-Cell function was assessed using a mathematical model after a test meal. Magnetic resonance imaging of the thigh was performed. All subjects were examined at 0, 3, and 6 months. Statistical analyses were performed using repeated measures analysis of variance and a multivariate regression model. Greater reduction was observed in total leg area in V (-13.6 cm 2 [95% confidence interval [CI], -14.2 to -12.9] in V vs -9.9 cm 2 [95% CI, -10.6 to -9.2] in C; Gxt p diets (Gxt, p = 0.64). Subfascial fat was reduced only in response to a vegetarian diet (-0.82 [95% CI, -1.13 to -0.55] cm 2 in V vs -0.44 [95% CI, -0.78 to +0.02] cm 2 in C; Gxt, p = 0.04). The reduction in intramuscular fat tended to be greater in response to a vegetarian diet (-1.78 [95% CI, -2.26 to -1.27] cm 2 in V vs -0.57 [95% CI, -1.06 to -0.09] cm 2 in C; Gxt, p = 0.12). Changes in subcutaneous and subfascial fat correlated with changes in glycated hemoglobin (HbA1c), fasting plasma glucose, and β-cell insulin sensitivity. After adjustment for changes in body mass index (BMI), correlations remained significant for changes in fasting plasma glucose and β-cell insulin sensitivity and with changes in triglycerides. Our data indicate the importance of both subcutaneous and subfascial fat in relationship to glucose and lipid metabolism. BMI , body mass index; C , control group; FPG , fasting plasma glucose; Gxt , interaction between group and time; HbA1c , glycated hemoglobin; MCR

  20. [Level of selected antibacterial tear proteins in children with diabetes type 1].

    Science.gov (United States)

    Moll, Agnieszka; Wyka, Krystyna; Młynarski, Wojciech; Niwald, Anna

    2011-01-01

    Antibacterial immunity in diabetes is impaired, which increases the risk of general and local infections. The aim of the study was to evaluate non-specific local antibacterial immunity based on lactoferrin and lysozyme concentration in tears in children with diabetes type 1. Children at the age of 10-18 years old were studied. Group 1. consisted of children without diabetes, group 2. included patients with new onset of diabetes and group 3. consisted of children with decade-long diabetes. Among all patients tears were collected from inferior coniunctival fornix with hematocrit glass capillaries in purpose to measure lactoferrin and lysozyme concentration. ELISA method was used in laboratory testing. Level of lactoferrin did not differ significantly among all groups. Concentration of lysozyme was statistically lower in group with decade-long diabetes (group 3.) compared to patients without diabetes. Mild correlation between lactoferrin and lysozyme levels was seen in individual patients in whole group of probands together. Diabetes type 1 in children is associated with significant changes in concentration of tear proteins, which contribute to antibacterial immunity.

  1. Efficacy of vildagliptin for prevention of postpartum diabetes in women with a recent history of insulin-requiring gestational diabetes: A phase II, randomized, double-blind, placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Sandra Hummel

    2018-03-01

    Full Text Available Objective: Women with insulin-requiring gestational diabetes mellitus (GDM are at high risk of developing diabetes within a few years postpartum. We implemented this phase II study to test the hypothesis that vildagliptin, a dipeptidyl peptidase-4 inhibitor, is superior to placebo in terms of reducing the risk of postpartum diabetes. Methods: Women with insulin-requiring GDM were randomized to either placebo or 50 mg vildagliptin twice daily for 24 months followed by a 12-month observation period (EudraCT: 2007-000634-39. Both groups received lifestyle counseling. The primary efficacy outcomes were the diagnosis of diabetes (American Diabetes Association (ADA criteria or impaired fasting glucose (IFG/impaired glucose tolerance (IGT. Results: Between 2008 and 2015, 113 patients (58 vildagliptin, 55 placebo were randomized within 2.2–10.4 (median 8.6 months after delivery. At the interim analysis, nine diabetic events and 28 IFG/IGT events had occurred. Fifty-two women withdrew before completing the treatment phase. Because of the low diabetes rate, the study was terminated. Lifestyle adherence was similar in both groups. At 24 months, the cumulative probability of postpartum diabetes was 3% and 5% (hazard ratio: 1.03; 95% confidence interval: 0.15–7.36 and IFG/IGT was 43% and 22% (hazard ratio: 0.55; 95% confidence interval: 0.26–1.19 in the placebo and vildagliptin groups, respectively. Vildagliptin was well tolerated with no unexpected adverse events. Conclusions: The study did not show significant superiority of vildagliptin over placebo in terms of reducing the risk of postpartum diabetes. However, treatment was safe and suggested some improvements in glycemic control, insulin resistance, and β-cell function. The study identified critical issues in performing clinical trials in the early postpartum period in women with GDM hampering efficacy assessments. With this knowledge, we have set a basis for which properly powered trials could

  2. Childhood BMI and Adult Type 2 Diabetes, Coronary Artery Diseases, Chronic Kidney Disease, and Cardiometabolic Traits: A Mendelian Randomization Analysis.

    Science.gov (United States)

    Geng, Tingting; Smith, Caren E; Li, Changwei; Huang, Tao

    2018-05-01

    To test the causal effect of childhood BMI on adult cardiometabolic diseases using a Mendelian randomization analysis. We used 15 single nucleotide polymorphisms as instrumental variables for childhood BMI to test the causal effect of childhood BMI on cardiometabolic diseases using summary-level data from consortia. We found that a 1-SD increase in childhood BMI (kg/m 2 ) was associated with an 83% increase in risk of type 2 diabetes (odds ratio [OR] 1.83 [95% CI 1.46, 2.30]; P = 2.5 × 10 -7 ) and a 28% increase in risk of coronary artery disease (CAD) (OR 1.28 [95% CI 1.17, 1.39]; P = 2.1 × 10 -8 ) at the Bonferroni-adjusted level of significance ( P BMI was associated with a 0.587-SD increase in adulthood BMI (kg/m 2 ), a 0.062-SD increase in hip circumference (cm), a 0.602-SD increase in waist circumference (cm), a 0.111 pmol/L increase in log fasting insulin, a 0.068 increase in log-transformed HOMA of ß-cell function (%), a 0.126 increase in log-transformed HOMA of insulin resistance (%), and a 0.109-SD increase in triglyceride (mg/dL) but a 0.138-SD decrease in HDL (mg/dL) in adults at the Bonferroni-adjusted level of significance ( P BMI was associated with increased risk of type 2 diabetes and CAD in adult life. These results provide evidence supportive of a causal association between childhood BMI and these outcomes. © 2018 by the American Diabetes Association.

  3. Effect of custom-made footwear on foot ulcer recurrence in diabetes: a multicenter randomized controlled trial.

    Science.gov (United States)

    Bus, Sicco A; Waaijman, Roelof; Arts, Mark; de Haart, Mirjam; Busch-Westbroek, Tessa; van Baal, Jeff; Nollet, Frans

    2013-12-01

    Custom-made footwear is the treatment of choice to prevent foot ulcer recurrence in diabetes. This footwear primarily aims to offload plantar regions at high ulcer risk. However, ulcer recurrence rates are high. We assessed the effect of offloading-improved custom-made footwear and the role of footwear adherence on plantar foot ulcer recurrence. We randomly assigned 171 neuropathic diabetic patients with a recently healed plantar foot ulcer to custom-made footwear with improved and subsequently preserved offloading (∼20% peak pressure relief by modifying the footwear) or to usual care (i.e., nonimproved custom-made footwear). Primary outcome was plantar foot ulcer recurrence in 18 months. Secondary outcome was ulcer recurrence in patients with an objectively measured adherence of ≥80% of steps taken. On the basis of intention-to-treat, 33 of 85 patients (38.8%) with improved footwear and 38 of 86 patients (44.2%) with usual care had a recurrent ulcer (relative risk -11%, odds ratio 0.80 [95% CI 0.44-1.47], P = 0.48). Ulcer-free survival curves were not significantly different between groups (P = 0.40). In the 79 patients (46% of total group) with high adherence, 9 of 35 (25.7%) with improved footwear and 21 of 44 (47.8%) with usual care had a recurrent ulcer (relative risk -46%, odds ratio 0.38 [0.15-0.99], P = 0.045). Offloading-improved custom-made footwear does not significantly reduce the incidence of plantar foot ulcer recurrence in diabetes compared with custom-made footwear that does not undergo such improvement, unless it is worn as recommended.

  4. Metformin versus insulin treatment in gestational diabetes in pregnancy in a developing country: a randomized control trial.

    Science.gov (United States)

    Ainuddin, Jahanara; Karim, Nasim; Hasan, Anjum Ara; Naqvi, Sanower Ali

    2015-02-01

    To compare treatment with metformin alone, metformin plus insulin and insulin alone in women with gestational diabetes (GDM). A total of 150 gestational diabetic patients who fulfilled the eligibility criteria were included in this prospective randomized control open labeled study. A risk factor based screening was done followed by a GCT and then local GTT criteria from antenatal clinics. They were initially divided into two groups with odd numbers assigned to metformin treatment and even numbers to insulin treatment. Metformin and/or insulin treatment was given and target blood sugar levels aimed at FBS ≤ 100 mg/dl and postprandial levels ≤ 126 mg/dl. Supplemental insulin was added to metformin treatment group to maintain the glycemic targets if required. Patients were followed until delivery and maternal fetal outcomes and pharmacotherapeutic characteristics were recorded on a performa. Less maternal weight gain was found in the metformin treated groups (9.8 ± 1.5 kg [metformin alone] vs. 9.8 ± 1.4 kg [metformin plus insulin] vs. 12.5 ± 1.1 kg [insulin alone] P metformin treated groups. There were no perinatal deaths in the study. Mean birth weight was significantly less in metformin treated groups (3.4 ± 0.4 kg vs. 3.3 ± 0.5 kg vs. 3.7 ± 0.5 kg P metformin groups. 42.7% of patients required supplemental insulin (mean dose of 13.6 ± 2 units) in the metformin group. Mean gestational age at which insulin was added was 31.8 ± 5.9 weeks. Metformin is an effective and cheap treatment option for women with gestational diabetes with or without supplemental insulin. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  5. Can chronic disease management programs for patients with type 2 diabetes reduce productivity-related indirect costs of the disease? Evidence from a randomized controlled trial.

    Science.gov (United States)

    Adepoju, Omolola E; Bolin, Jane N; Ohsfeldt, Robert L; Phillips, Charles D; Zhao, Hongwei; Ory, Marcia G; Forjuoh, Samuel N

    2014-04-01

    The objective was to assess the impacts of diabetes self-management programs on productivity-related indirect costs of the disease. Using an employer's perspective, this study estimated the productivity losses associated with: (1) employee absence on the job, (2) diabetes-related disability, (3) employee presence on the job, and (4) early mortality. Data were obtained from electronic medical records and survey responses of 376 adults aged ≥18 years who were enrolled in a randomized controlled trial of type 2 diabetes self-management programs. All study participants had uncontrolled diabetes and were randomized into one of 4 study arms: personal digital assistant (PDA), chronic disease self-management program (CDSMP), combined PDA and CDSMP, and usual care (UC). The human-capital approach was used to estimate lost productivity resulting from 1, 2, 3, and 4 above, which are summed to obtain total productivity loss. Using robust regression, total productivity loss was modeled as a function of the diabetes self-management programs and other identified demographic and clinical characteristics. Compared to subjects in the UC arm, there were no statistically significant differences in productivity losses among persons undergoing any of the 3 diabetes management interventions. Males were associated with higher productivity losses (+$708/year; Pmanagement programs examined in this trial affect indirect productivity losses.

  6. Fluorine-Directed Glycosylation Enables the Stereocontrolled Synthesis of Selective SGLT2 Inhibitors for Type II Diabetes.

    Science.gov (United States)

    Sadurní, Anna; Kehr, Gerald; Ahlqvist, Marie; Wernevik, Johan; Sjögren, Helena Peilot; Kankkonen, Cecilia; Knerr, Laurent; Gilmour, Ryan

    2018-02-26

    Inhibition of the sodium-glucose co-transporters (SGLT1 and SGLT2) is a validated strategy to address the increasing prevalence of type II diabetes mellitus. However, achieving selective inhibition of human SGLT1 or SGLT2 remains challenging. Orally available small molecule drugs based on the d-glucose core of the natural product Gliflozin have proven to be clinically effective in this regard, effectively impeding glucose reabsorption. Herein, we disclose the influence of molecular editing with fluorine at the C2 position of the pyranose ring of Phlorizin analogues Remogliflozin Etabonate and Dapagliflozin (Farxiga ® ) to concurrently direct β-selective glycosylation, as is required for biological efficacy, and enhance aspects of the physicochemical profile. Given the abundance of glycosylated pharmaceuticals in diabetes therapy that contain a β-configured d-glucose nucleus, it is envisaged that this strategy may prove to be expansive. © 2018 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

  7. The use of low output laser therapy to accelerate healing of diabetic foot ulcers: a randomized prospective controlled trial

    Science.gov (United States)

    Naidu, S. V. L. G.; Subapriya, S.; Yeoh, C. N.; Soosai, S.; Shalini, V.; Harwant, S.

    2005-11-01

    The aim of this study was to assess the effects of low output laser therapy as an adjuvant treatment in grade 1 diabetic foot ulcers. Methods: Sixteen patients were randomly divided equally into two groups. Group A had daily dressing only, while group B had low output laser therapy instituted five days a week in addition to daily dressing. Serial measurement of the ulcer was done weekly using digital photography and analyzed. Results: The rate of healing in group A was 10.42 mm2/week, and in group B was 66.14mm2/week. The difference in the rate of healing was statistically significant, pdiabetic ulcer healing by six times in a six week period.

  8. Selecting Optimal Parameters of Random Linear Network Coding for Wireless Sensor Networks

    DEFF Research Database (Denmark)

    Heide, J; Zhang, Qi; Fitzek, F H P

    2013-01-01

    This work studies how to select optimal code parameters of Random Linear Network Coding (RLNC) in Wireless Sensor Networks (WSNs). With Rateless Deluge [1] the authors proposed to apply Network Coding (NC) for Over-the-Air Programming (OAP) in WSNs, and demonstrated that with NC a significant...... reduction in the number of transmitted packets can be achieved. However, NC introduces additional computations and potentially a non-negligible transmission overhead, both of which depend on the chosen coding parameters. Therefore it is necessary to consider the trade-off that these coding parameters...... present in order to obtain the lowest energy consumption per transmitted bit. This problem is analyzed and suitable coding parameters are determined for the popular Tmote Sky platform. Compared to the use of traditional RLNC, these parameters enable a reduction in the energy spent per bit which grows...

  9. Benchmarking is associated with improved quality of care in type 2 diabetes: the OPTIMISE randomized, controlled trial.

    Science.gov (United States)

    Hermans, Michel P; Elisaf, Moses; Michel, Georges; Muls, Erik; Nobels, Frank; Vandenberghe, Hans; Brotons, Carlos

    2013-11-01

    To assess prospectively the effect of benchmarking on quality of primary care for patients with type 2 diabetes by using three major modifiable cardiovascular risk factors as critical quality indicators. Primary care physicians treating patients with type 2 diabetes in six European countries were randomized to give standard care (control group) or standard care with feedback benchmarked against other centers in each country (benchmarking group). In both groups, laboratory tests were performed every 4 months. The primary end point was the percentage of patients achieving preset targets of the critical quality indicators HbA1c, LDL cholesterol, and systolic blood pressure (SBP) after 12 months of follow-up. Of 4,027 patients enrolled, 3,996 patients were evaluable and 3,487 completed 12 months of follow-up. Primary end point of HbA1c target was achieved in the benchmarking group by 58.9 vs. 62.1% in the control group (P = 0.398) after 12 months; 40.0 vs. 30.1% patients met the SBP target (P benchmarking group. The percentage of patients achieving all three targets at month 12 was significantly larger in the benchmarking group than in the control group (12.5 vs. 8.1%; P benchmarking was shown to be an effective tool for increasing achievement of critical quality indicators and potentially reducing patient cardiovascular residual risk profile.

  10. Chinese Medicinal Formula (MHGWT for Relieving Diabetic Neuropathic Pain: A Randomized, Double-Blind, Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Chia-I Tsai

    2013-01-01

    Full Text Available Objective. To investigate the effects of modified Hungqi Guizhi Wuwu Tang (MHGWT, a formula that comprises Chinese medicinal herbs, in relieving neuropathic pain in diabetics. Method. Between March 2008 and April 2009, 112 participants were randomly assigned to either the MHGWT group, whose members received MHGWT (n=56, or the control group, whose members received a placebo (n=56. Diabetic neuropathic pain (DNP was rated using the 15-item Short-Form Brief Pain Inventory (SF-BPI, the 17-item Short-Form McGill Pain Questionnaire (SF-MPQ, the 13-item Modified Michigan Neuropathy Screening Instrument (MMNSI, and the 36-item “SF-36.” Nerve conduction studies (NCSs were performed before and after treatment. Results. After 12 weeks of treatment, the SF-MPQ and SF-BPI scores of the MHGWT group were significantly (P0.05 reduced, and no significant difference in NCS level was observed between the groups (P>0.05. Conclusions. MHGWT shows promise in relieving DNP and deserves further investigation.

  11. Effects of Minocycline on Urine Albumin, Interleukin-6, and Osteoprotegerin in Patients with Diabetic Nephropathy: A Randomized Controlled Pilot Trial

    Science.gov (United States)

    Wang, Ying; Tong, Lili; Pak, Youngju; Andalibi, Ali; LaPage, Janine A.; Adler, Sharon G.

    2016-01-01

    Background We tested minocycline as an anti-proteinuric adjunct to renin-angiotensin-aldosterone system inhibitors (RAASi) in diabetic nephropathy (DN) and measured urinary biomarkers to evaluate minocycline’s biological effects. Methods Design: Prospective, single center, randomized, placebo-controlled, intention-to-treat pilot trial. Inclusion. Type 2 diabetes/DN; Baseline creatinine clearance > 30 mL/min; proteinuria ≥ 1.0 g/day; Age ≥30 years; BP minocycline patients (6 month P:Cr ÷ Baseline P:Cr, 0.85 vs. 0.92) was not significant (p = 0.27). Creatinine clearance did not differ in the 2 groups. Urine IL-6:Cr (p = 0.03) and osteoprotegerin/Cr (p = 0.046) decrements were significant. Minocycline modified the relationship between urine IL-6 and proteinuria, suggesting a protective biological effect. Conclusions Although the decline in U P:Cr in minocycline patients was not statistically significant, the significant differences in urine IL-6 and osteoprotegerin suggest that minocycline may confer cytoprotection in patients with DN, providing a rationale for further study. Trial Registration Clinicaltrials.gov NCT01779089 PMID:27019421

  12. A pilot randomized, controlled trial of metformin versus insulin in women with type 2 diabetes mellitus during pregnancy.

    Science.gov (United States)

    Refuerzo, Jerrie S; Gowen, Rose; Pedroza, Claudia; Hutchinson, Maria; Blackwell, Sean C; Ramin, Susan

    2015-02-01

    Few studies support oral diabetic treatment in pregnant women with type 2 diabetes mellitus (T2DM). The objective of this study was to compare the effects of metformin versus insulin on achieving glycemic control and improving maternal and neonatal outcomes in pregnant women with T2DM. A pilot randomized, controlled trial was conducted of metformin versus insulin for the treatment of T2DM during pregnancy. The primary outcome was glycemic control measured with hemoglobin A1c metformin and 11 received insulin. All women in both groups achieved glycemic control by delivery (HgbA1c: metformin 5.96 ± 5.88 vs. insulin 6.34 ± 0.92%). There were similar rates of cesarean delivery, birth weights, neonatal intensive care unit admissions, respiratory distress syndrome, and neonatal dextrose treatment between groups. There was one case of fetal macrosomia in the insulin group, one case of shoulder dystocia in the metformin group and no cases of failed metformin therapy. In this pilot study, glycemic control was achieved in women who received metformin and insulin. Larger studies are needed to determine whether metformin can be considered a reasonable alternative to insulin in pregnant women with T2DM. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  13. Implications of structural genomics target selection strategies: Pfam5000, whole genome, and random approaches

    Energy Technology Data Exchange (ETDEWEB)

    Chandonia, John-Marc; Brenner, Steven E.

    2004-07-14

    The structural genomics project is an international effort to determine the three-dimensional shapes of all important biological macromolecules, with a primary focus on proteins. Target proteins should be selected according to a strategy which is medically and biologically relevant, of good value, and tractable. As an option to consider, we present the Pfam5000 strategy, which involves selecting the 5000 most important families from the Pfam database as sources for targets. We compare the Pfam5000 strategy to several other proposed strategies that would require similar numbers of targets. These include including complete solution of several small to moderately sized bacterial proteomes, partial coverage of the human proteome, and random selection of approximately 5000 targets from sequenced genomes. We measure the impact that successful implementation of these strategies would have upon structural interpretation of the proteins in Swiss-Prot, TrEMBL, and 131 complete proteomes (including 10 of eukaryotes) from the Proteome Analysis database at EBI. Solving the structures of proteins from the 5000 largest Pfam families would allow accurate fold assignment for approximately 68 percent of all prokaryotic proteins (covering 59 percent of residues) and 61 percent of eukaryotic proteins (40 percent of residues). More fine-grained coverage which would allow accurate modeling of these proteins would require an order of magnitude more targets. The Pfam5000 strategy may be modified in several ways, for example to focus on larger families, bacterial sequences, or eukaryotic sequences; as long as secondary consideration is given to large families within Pfam, coverage results vary only slightly. In contrast, focusing structural genomics on a single tractable genome would have only a limited impact in structural knowledge of other proteomes: a significant fraction (about 30-40 percent of the proteins, and 40-60 percent of the residues) of each proteome is classified in small

  14. Anti-hyperglycaemic effects of herbal porridge made of Scoparia dulcis leaf extract in diabetics - a randomized crossover clinical trial.

    Science.gov (United States)

    Senadheera, Senadheera Pathirannehelage Anuruddhika Subhashinie; Ekanayake, Sagarika; Wanigatunge, Chandanie

    2015-11-19

    Leaf extracts of Scoparia dulcis, is used as a herbal remedy by diabetics worldwide. Fresh Scoparia dulcis porridge elicited a low glycaemic index (GI) and anti-hyperglycaemic effects when fed to diabetic Wistar rats. Commercially produced Scoparia dulcis porridge (SDC) elicited medium GI. Present study was aimed at studying the anti-diabetic effects of consumption of commercially produced S. dulcis porridge. A randomized crossover clinical trial with type 2 diabetic patients (n = 35) on medication, with mild and moderate diabetes [fasting blood glucose (FBG) 126-300 mg/dL, age 35-70 years] was conducted. Within the first three months (study period 1) group 1 was the test and group 2 was the control. Following a wash-out period, the two groups were crossed over (study period 2: group 1 - control; group 2 - test). Test group consumed commercially produced SDC for 3 days/week for three months and the control group any other food. At the onset and end of each study period glucose measurements [Fasting Blood Glucose (FBG), HbA1c], lipid measurements (total cholesterol, HDL-C, LDL-C, triglycerides, cholesterol ratios), toxicity parameters (liver enzymes, creatinine, CRP, eGFR) were analyzed by enzyme assay kit methods using a KONELAB 20XT auto analyzer. Significances between groups were analyzed by one way ANOVA (normal distribution) and Mann Whitney test (if the values were not normally distributed). Within group comparisons were carried out by Bonferroni post hoc test. During the crossover clinical trial HbA1c of group 1 decreased from 7.9 ± 0.5 to 6.5 ± 0.3 (p = 0.003) while HbA1c of group 2 decreased from 7.0 ± 0.3to 6.7 ± 0.3 while in the test group. Therefore, both test groups (1 and 2) elicited a decrease in HbA1c compared to respective control groups. Both test groups elicited a non significant decrease in FBG following the intervention (group 1 - from 174 ± 14 to 160 ± 10 mg/dL; group 2 - from 183 ± 13 to 160 ± 7 mg/dL). No significant differences (p >0

  15. Day-ahead load forecast using random forest and expert input selection

    International Nuclear Information System (INIS)

    Lahouar, A.; Ben Hadj Slama, J.

    2015-01-01

    Highlights: • A model based on random forests for short term load forecast is proposed. • An expert feature selection is added to refine inputs. • Special attention is paid to customers behavior, load profile and special holidays. • The model is flexible and able to handle complex load signal. • A technical comparison is performed to assess the forecast accuracy. - Abstract: The electrical load forecast is getting more and more important in recent years due to the electricity market deregulation and integration of renewable resources. To overcome the incoming challenges and ensure accurate power prediction for different time horizons, sophisticated intelligent methods are elaborated. Utilization of intelligent forecast algorithms is among main characteristics of smart grids, and is an efficient tool to face uncertainty. Several crucial tasks of power operators such as load dispatch rely on the short term forecast, thus it should be as accurate as possible. To this end, this paper proposes a short term load predictor, able to forecast the next 24 h of load. Using random forest, characterized by immunity to parameter variations and internal cross validation, the model is constructed following an online learning process. The inputs are refined by expert feature selection using a set of if–then rules, in order to include the own user specifications about the country weather or market, and to generalize the forecast ability. The proposed approach is tested through a real historical set from the Tunisian Power Company, and the simulation shows accurate and satisfactory results for one day in advance, with an average error exceeding rarely 2.3%. The model is validated for regular working days and weekends, and special attention is paid to moving holidays, following non Gregorian calendar

  16. Repeated Remote Ischemic Conditioning Effect on Ankle-brachial Index in Diabetic Patients - A Randomized Control Trial

    Directory of Open Access Journals (Sweden)

    Najmeh Shahvazian

    2017-01-01

    Full Text Available Background: Remote ischemic preconditioning (RIPC is a phenomenon where a short period of ischemia in one organ protects against further ischemia in the other organs. We hypothesized that RIPC occurring in diabetic patients with ankle brachial index (ABI between 0.70 and 0.90 were included with peripheral arterial disease, would make the better coronary flow resulted in the increasing ABI. Materials and Methods: This randomized clinical trial study was done in the Afshar Cardiovascular Hospital in Yazd between 2013 and 2014. Sixty participants were randomly divided into two groups (intervention and control groups. The intervention group was undergoing RIPC, and the control group was tested without RIPC. RIPC was stimulated by giving three cycles of 5 min of ischemia followed by 5 min of reperfusion of both upper arms using a blood pressure cuff inflated to 200 mm Hg (n = 30. This was compared with no RIPC group which consisted of placing a deflated blood pressure cuff on the upper limbs (n = 30. Results: The mean of ABI level before intervention in the RIPC and control group group was 0.82 ± 0.055 and 0.83 ± 0.0603 (P = 0.347 respectively, with no significant difference. It was 0.86 ± 0.066 in the RIPC group compared the control 0.83 ± 0.0603 (P = 0.046. So levels of ABI were greater after intervention in the RIPC group. The mean of ABI level increase from 0.82 ± 0.05 to 0.86 ± 0.06 in RIPC group (P = 0.008. So the intervention group showed a significant increase in ABI. Conclusions: RIPC through using a simple, noninvasive technique, composing three cycles of 5 min-ischemia of both upper arms, showing a significant increase in ABI level in diabetic patients.

  17. Effect of Volume of Fluid Resuscitation on Metabolic Normalization in Children Presenting in Diabetic Ketoacidosis: A Randomized Controlled Trial.

    Science.gov (United States)

    Bakes, Katherine; Haukoos, Jason S; Deakyne, Sara J; Hopkins, Emily; Easter, Josh; McFann, Kim; Brent, Alison; Rewers, Arleta

    2016-04-01

    The optimal rate of fluid administration in pediatric diabetic ketoacidosis (DKA) is unknown. Our aim was to determine whether the volume of fluid administration in children with DKA influences the rate of metabolic normalization. We performed a randomized controlled trial conducted in a tertiary pediatric emergency department from December 2007 until June 2010. The primary outcome was time to metabolic normalization; secondary outcomes were time to bicarbonate normalization, pH normalization, overall length of hospital treatment, and adverse outcomes. Children between 0 and 18 years of age were eligible if they had type 1 diabetes mellitus and DKA. Patients were randomized to receive intravenous (IV) fluid at low volume (10 mL/kg bolus + 1.25 × maintenance rate) or high volume (20 mL/kg bolus + 1.5 × maintenance rate) (n = 25 in each). After adjusting for initial differences in bicarbonate levels, time to metabolic normalization was significantly faster in the higher-volume infusion group compared to the low-volume infusion group (hazard ratio [HR] = 2.0; 95% confidence interval [CI] 1.0-3.9; p = 0.04). Higher-volume IV fluid infusion appeared to hasten, to a greater extent, normalization of pH (HR = 2.5; 95% CI 1.2-5.0; p = 0.01) than normalization of serum bicarbonate (HR = 1.2; 95% CI 0.6-2.3; p = 0.6). The length of hospital treatment HR (0.8; 95% CI 0.4-1.5; p = 0.5) and time to discharge HR (0.8; 95% CI 0.4-1.5; p = 0.5) did not differ between treatment groups. Higher-volume fluid infusion in the treatment of pediatric DKA patients significantly shortened metabolic normalization time, but did not change overall length of hospital treatment. ClinicalTrials.gov ID NCT01701557. Copyright © 2016 Elsevier Inc. All rights reserved.

  18. Design and methods for a randomized clinical trial of a diabetes self-management intervention for low-Income Latinos: Latinos en Control

    Directory of Open Access Journals (Sweden)

    Lemon Stephenie C

    2009-12-01

    Full Text Available Abstract Background US Latinos have greater prevalence of type 2 diabetes (diabetes, uncontrolled diabetes and diabetes co-morbidities compared to non-Latino Whites. They also have lower literacy levels and are more likely to live in poverty. Interventions are needed to improve diabetes control among low-income Latinos. Methods and design This randomized clinical trial tested the efficacy of a culturally- and literacy-tailored diabetes self-management intervention (Latinos en Control on glycemic control among low-income Latinos with diabetes, compared to usual care (control. Participants were recruited from five community health centers (CHCs in Massachusetts. The theory-based intervention included an intensive phase of 12 weekly sessions and a follow-up maintenance phase of 8 monthly sessions. Assessments occurred at baseline, and at 4 and 12 months. The primary outcome was glycosylated hemoglobin (HbA1c. Secondary outcomes were self-management behaviors, weight, lipids and blood pressure. Additional outcomes included diabetes knowledge, self-efficacy, depression and quality of life. The study was designed for recruitment of 250 participants (estimated 20% dropout rate to provide 90% power for detecting a 7% or greater change in HbA1c between the intervention and control groups. This is a difference in change of HbA1c of 0.5 to 0.6%. Discussion Low-income Latinos bear a great burden of uncontrolled diabetes and are an understudied population. Theory-based interventions that are tailored to the needs of this high-risk population have potential for improving diabetes self-management and reduce health disparities. This article describes the design and methods of a theory driven intervention aimed at addressing this need. Trial registration http://www.clinicaltrials.gov # NCT00848315

  19. The Effect of Group Discussion-based Education on Self-management of Adults with Type 2 Diabetes Mellitus Compared with Usual Care: A Randomized Control Trial.

    Science.gov (United States)

    Habibzadeh, Hosein; Sofiani, Akbar; Alilu, Leyla; Gillespie, Mark

    2017-11-01

    We sought to determine the effect of group discussion-based education on the self-management capability of patients with type 2 diabetes in Iran. This randomized control trial was conducted on 90 patients with type 2 diabetes. Participants were allocated randomly into one of two groups; intervention and control. The intervention group received the group discussion-based education while the control group received routine care only. The Lin's self-management questionnaire was completed at baseline and three months post-intervention. Statistical analysis, including the use of independent t -test, identified that in comparison to the control group, significant increases were observed in the scores of self-organization ( t =11.24, p health experts ( t = 7.31, p diet ( t = 5.22, p diabetes.

  20. Are glucose levels, glucose variability and autonomic control influenced by inspiratory muscle exercise in patients with type 2 diabetes? Study protocol for a randomized controlled trial.

    Science.gov (United States)

    Schein, Aso; Correa, Aps; Casali, Karina Rabello; Schaan, Beatriz D

    2016-01-20

    Physical exercise reduces glucose levels and glucose variability in patients with type 2 diabetes. Acute inspiratory muscle exercise has been shown to reduce these parameters in a small group of patients with type 2 diabetes, but these results have yet to be confirmed in a well-designed study. The aim of this study is to investigate the effect of acute inspiratory muscle exercise on glucose levels, glucose variability, and cardiovascular autonomic function in patients with type 2 diabetes. This study will use a randomized clinical trial crossover design. A total of 14 subjects will be recruited and randomly allocated to two groups to perform acute inspiratory muscle loading at 2 % of maximal inspiratory pressure (PImax, placebo load) or 60 % of PImax (experimental load). Inspiratory muscle training could be a novel exercise modality to be used to decrease glucose levels and glucose variability. ClinicalTrials.gov NCT02292810 .

  1. Duloxetine in the long-term management of diabetic peripheral neuropathic pain: An open-label, 52-week extension of a randomized controlled clinical trial.

    Science.gov (United States)

    Wernicke, Joachim F; Raskin, Joel; Rosen, Amy; Pritchett, Yili L; D'Souza, Deborah N; Iyengar, Smriti; Knopp, Kelly; Le, Trong K

    2006-09-01

    Duloxetine hydrochloride, a selective serotonin (5-HT) and norepinephrine (NE) reuptake inhibitor, is relatively balanced in its affinity for both 5-HT and NE reuptake inhibition and is the first US Food and Drug Administration-approved prescription drug for the management of diabetic peripheral neuropathic pain (DPNP). The aim of this study was to determine whether management of DPNP with duloxetine interferes with the treatment of diabetes. It also examined the tolerability of long-term exposure to duloxetine with regard to the progression of diabetic complications, and assessed the impact of DPNP management with duloxetine versus routine care. This was a 52-week, multicenter, re-randomized, open-label extension of a parallel, double-blind, randomized, placebo-controlled, acute (12-week) study. Patients who completed the duloxetine or placebo acute treatment period were randomly reassigned in a 2:1 ratio to treatment with duloxetine 60 mg BID or routine care for an additional 52 weeks. The study included male and female outpatients aged ≥18 years with a diagnosis of DPNP caused by type 1 or type 2 diabetes. Over the course of the 52-week study, visits were scheduled on the following weeks (of the extension phase of the study): 1 (via phone only), 2, 4, 8, 12, 20, 28, 40, and 52. Tolerability was assessed by review and analyses of discontinuation rates, adverse events (AEs), laboratory data, vital signs, electrocardiographic results, concomitant medications, and diabetic complications. Treatment-emergent AEs (TEAEs) were defined as AEs that appeared during therapy (were not present at baseline) or were exacerbated during treatment. Data on AEs and concomitant medications were collected at every visit. Data on blood pressure, heart rate, and significant hypoglycemic events were collected at every visit starting from week 2. Fasting clinical chemistry and electrolyte group laboratory assessments were done at every visit, starting from week 4. Electrocardiographic

  2. Evaluation of quality improvement performance in the Community Diabetes Education (CoDE) program for uninsured Mexican Americans: results of a randomized controlled trial.

    Science.gov (United States)

    Prezio, Elizabeth A; Balasubramanian, Bijal A; Shuval, Kerem; Cheng, Dunlei; Kendzor, Darla E; Culica, Dan

    2014-01-01

    The objective of this article is to quantify quality improvement using data from a randomized controlled trial that tested the effectiveness of a community health worker in the primary role of diabetes educator in a clinic serving uninsured Mexican Americans. The intervention group received 7 hours of diabetes education/case management in excess of usual medical care. Of 16 process and outcome measures evaluated, the intervention group was significantly more likely to have received a dilated retinal examination, and 53% achieved a hemoglobin A1c below 7% compared with 38% of the control group participants. Composite quality measures were similar in magnitude with published practice-based benchmarks at study conclusion. This suggests that the overall diabetes care delivered in this clinic serving uninsured patients was comparable to the levels of excellence achieved in other primary care settings. Quantitative measurements of quality improvement can inform health policy regarding the relative effectiveness of diabetes interventions.

  3. Results From a European Multicenter Randomized Trial of Physical Activity and/or Healthy Eating to Reduce the Risk of Gestational Diabetes Mellitus

    DEFF Research Database (Denmark)

    Simmons, David; Jelsma, Judith G M; Galjaard, Sander

    2015-01-01

    OBJECTIVE: Ways to prevent gestational diabetes mellitus (GDM) remain unproven. We compared the impact of three lifestyle interventions (healthy eating [HE], physical activity [PA], and both HE and PA [HE+PA]) on GDM risk in a pilot multicenter randomized trial. RESEARCH DESIGN AND METHODS...

  4. Sensor-augmented pump therapy lowers HbA(1c) in suboptimally controlled Type 1 diabetes; a randomized controlled trial

    NARCIS (Netherlands)

    Hermanides, J.; Nørgaard, K.; Bruttomesso, D.; Mathieu, C.; Frid, A.; Dayan, C. M.; Diem, P.; Fermon, C.; Wentholt, I. M. E.; Hoekstra, J. B. L.; DeVries, J. H.

    2011-01-01

    To investigate the efficacy of sensor-augmented pump therapy vs. multiple daily injection therapy in patients with suboptimally controlled Type 1 diabetes. In this investigator-initiated multi-centre trial (the Eurythmics Trial) in eight outpatient centres in Europe, we randomized 83 patients with

  5. Field-based random sampling without a sampling frame: control selection for a case-control study in rural Africa.

    Science.gov (United States)

    Crampin, A C; Mwinuka, V; Malema, S S; Glynn, J R; Fine, P E

    2001-01-01

    Selection bias, particularly of controls, is common in case-control studies and may materially affect the results. Methods of control selection should be tailored both for the risk factors and disease under investigation and for the population being studied. We present here a control selection method devised for a case-control study of tuberculosis in rural Africa (Karonga, northern Malawi) that selects an age/sex frequency-matched random sample of the population, with a geographical distribution in proportion to the population density. We also present an audit of the selection process, and discuss the potential of this method in other settings.

  6. Effects of aerobic exercise on selected physiological parameters and quality of life in patients with type 2 diabetes mellitus

    Directory of Open Access Journals (Sweden)

    Bello AI

    2011-10-01

    Full Text Available Ajediran I Bello1, Emmanuel Owusu-Boakye1, Babatunde OA Adegoke2, David N Adjei3 1Department of Physiotherapy, School of Allied Health Sciences, College of Health Sciences, Accra, University of Ghana, Accra, Ghana; 2Department of Physiotherapy, College of Medicine, University of Ibadan, Ibadan, Nigeria; 3Department of Medical Laboratory Sciences, School of Allied Health Sciences, College of Health Sciences, University of Ghana, Accra, Ghana Background: The aim of this study was to evaluate the effects of an 8-week aerobic exercise program on physiological parameters and quality of life in patients with type 2 diabetes mellitus. Methods: Patients attending a diabetes clinic participated in this randomized control trial. They were randomly assigned to an intervention or control group by ballot. The intervention group, in addition to regular conventional treatment, received individually prescribed aerobic exercise for 30 minutes, at 50%–75% of maximum heart rate three times weekly. Main outcome measures included fasting blood sugar, glycosylated hemoglobin (HbA1c, high-density lipoprotein, low-density lipoprotein, and a World Health Organization quality of life questionnaire (WHOQoL-BREF. Data analysis involved paired and unpaired t-tests and mixed-design two-way analysis of variance. Results: Eighteen patients with type 2 diabetes and of mean age 46.22 ± 9.79 years participated in the study. Mean duration since onset of diabetes in the intervention and control groups was 4.44 ± 3.33 years and 3.92 ± 2.66 years, respectively. Both groups were similar for duration since onset, baseline physiological parameters, and quality of life. Within-group comparison did not show any significant differences (P > 0.05 for HbA1c, fasting blood sugar, low-density lipoprotein, or high-density lipoprotein. The intervention group improved significantly (P < 0.05 in their postexercise quality of life compared with baseline. Between-group comparison did not show

  7. Assessing the Effect of High Performance Inulin Supplementation via KLF5 mRNA Expression in Adults with Type 2 Diabetes: A Randomized Placebo Controlled Clinical Trail.

    Science.gov (United States)

    Ghavami, Abed; Roshanravan, Neda; Alipour, Shahriar; Barati, Meisam; Mansoori, Behzad; Ghalichi, Faezeh; Nattagh-Eshtivan, Elyas; Ostadrahimi, Alireza

    2018-03-01

    Purpose: The worldwide prevalence of metabolic disorders such as diabetes is increasing rapidly. Currently, the complications of diabetes are the major health concern. The aim of this study was to investigate the effect of high performance (HP) inulin supplementation on glucose homeostasis via KLF5 mRNA expression in adults with type 2 diabetes. Methods: In the present clinical trial conducted for a duration of 6 weeks, 46 volunteers diabetic patients referring to diabetes clinic in Tabriz, Iran, were randomly assigned into intervention (n= 23, consuming 10 gr/d HP inulin) and control groups (n= 23, consuming 10 gr/ d starch). We assessed glycemic and anthropometric indices, blood lipids and plasmatic level of miR-375 as well as KLF5 mRNA expression before and after the intervention. Results: Findings indicated that inulin supplementation significantly decreased fasting plasma glucose (FPG) in comparison to the placebo group (Pinulin supplementation resulted in significant decrease in KLF5 mRNA expression in peripheral blood mononuclear cells (PBMCs) (Fold change: 0.61± 0.11; P-value= 0.001) and significant increase in plasmatic level of miR-375 (Fold change: 3.75± 0.70; P-value=0.004). Conclusion: Considering the improvements of FPG level in diabetic patients, it seems that HP inulin supplementation may be beneficial in controlling diabetes via the expression of some genes. However, further studies are needed to achieve concise conclusions.

  8. Psychosocial and Clinical Outcomes of a Cognitive Behavioral Therapy for Asians and Pacific Islanders with Type 2 Diabetes: A Randomized Clinical Trial.

    Science.gov (United States)

    Inouye, Jillian; Li, Dongmei; Davis, James; Arakaki, Richard

    2015-11-01

    Asian Americans and Pacific Islanders are twice as likely to be diagnosed with type 2 diabetes compared to Caucasians. The objective was to determine the effect of cognitive behavioral therapy on quality of life, general health perceptions, depressive symptoms, and glycemia in Asians and Pacific Islanders with type 2 diabetes. The design was a randomized controlled clinical trial comparing cognitive behavioral therapy to diabetes education and support for six weekly sessions. Participants were recruited from two endocrinology practices; 207 were enrolled. The cognitive behavioral therapy group was provided self-management tools which included biofeedback, breathing exercises, and stress relievers, while the diabetes education and support group included diabetes education and group discussions. Assessments of psychosocial and clinical outcomes were obtained before and after sessions and 12 months PostSession. Differences between the two groups were examined using linear mixed-effects models with linear contrasts. The cognitive behavioral therapy group had improved depressive symptom scores from PreSession to EndSession compared to the diabetes education and support group (P < .03), but the improvement did not extend to 12 months PostSession. Similar results were observed with misguided support scores in the Multidimensional Diabetes Questionnaire (P < .03) and susceptibility in health beliefs (P < .01), but no significant differences in HbA1c improvement were found between the two groups. Both interventions improved outcomes from baseline but were not sustained for 1 year.

  9. Minimal improvement of nurses' motivational interviewing skills in routine diabetes care one year after training: a cluster randomized trial.

    Science.gov (United States)

    Jansink, Renate; Braspenning, Jozé; Laurant, Miranda; Keizer, Ellen; Elwyn, Glyn; Weijden, Trudy van der; Grol, Richard

    2013-03-28

    The effectiveness of nurse-led motivational interviewing (MI) in routine diabetes care in general practice is inconclusive. Knowledge about the extent to which nurses apply MI skills and the factors that affect the usage can help to understand the black box of this intervention. The current study compared MI skills of trained versus non-trained general practice nurses in diabetes consultations. The nurses participated in a cluster randomized trial in which a comprehensive program (including MI training) was tested on improving clinical parameters, lifestyle, patients' readiness to change lifestyle, and quality of life. Fifty-eight general practices were randomly assigned to usual care (35 nurses) or the intervention (30 nurses). The ratings of applying 24 MI skills (primary outcome) were based on five consultation recordings per nurse at baseline and 14 months later. Two judges evaluated independently the MI skills and the consultation characteristics time, amount of nurse communication, amount of lifestyle discussion and patients' readiness to change. The effect of the training on the MI skills was analysed with a multilevel linear regression by comparing baseline and the one-year follow-up between the interventions with usual care group. The overall effect of the consultation characteristics on the MI skills was studied in a multilevel regression analyses. At one year follow up, it was demonstrated that the nurses improved on 2 of the 24 MI skills, namely, "inviting the patient to talk about behaviour change" (mean difference=0.39, p=0.009), and "assessing patient's confidence in changing their lifestyle" (mean difference=0.28, p=0.037). Consultation time and the amount of lifestyle discussion as well as the patients' readiness to change health behaviour was associated positively with applying MI skills. The maintenance of the MI skills one year after the training program was minimal. The question is whether the success of MI to change unhealthy behaviour must be

  10. Minimal improvement of nurses’ motivational interviewing skills in routine diabetes care one year after training: a cluster randomized trial

    Science.gov (United States)

    2013-01-01

    Background The effectiveness of nurse-led motivational interviewing (MI) in routine diabetes care in general practice is inconclusive. Knowledge about the extent to which nurses apply MI skills and the factors that affect the usage can help to understand the black box of this intervention. The current study compared MI skills of trained versus non-trained general practice nurses in diabetes consultations. The nurses participated in a cluster randomized trial in which a comprehensive program (including MI training) was tested on improving clinical parameters, lifestyle, patients’ readiness to change lifestyle, and quality of life. Methods Fifty-eight general practices were randomly assigned to usual care (35 nurses) or the intervention (30 nurses). The ratings of applying 24 MI skills (primary outcome) were based on five consultation recordings per nurse at baseline and 14 months later. Two judges evaluated independently the MI skills and the consultation characteristics time, amount of nurse communication, amount of lifestyle discussion and patients’ readiness to change. The effect of the training on the MI skills was analysed with a multilevel linear regression by comparing baseline and the one-year follow-up between the interventions with usual care group. The overall effect of the consultation characteristics on the MI skills was studied in a multilevel regression analyses. Results At one year follow up, it was demonstrated that the nurses improved on 2 of the 24 MI skills, namely, “inviting the patient to talk about behaviour change” (mean difference=0.39, p=0.009), and “assessing patient’s confidence in changing their lifestyle” (mean difference=0.28, p=0.037). Consultation time and the amount of lifestyle discussion as well as the patients’ readiness to change health behaviour was associated positively with applying MI skills. Conclusions The maintenance of the MI skills one year after the training program was minimal. The question is whether

  11. Three-Year Outcomes of Bariatric Surgery vs Lifestyle Intervention for Type 2 Diabetes Mellitus Treatment: A Randomized Clinical Trial.

    Science.gov (United States)

    Courcoulas, Anita P; Belle, Steven H; Neiberg, Rebecca H; Pierson, Sheila K; Eagleton, Jessie K; Kalarchian, Melissa A; DeLany, James P; Lang, Wei; Jakicic, John M

    2015-10-01

    Questions remain about the role and durability of bariatric surgery for type 2 diabetes mellitus (T2DM). To compare the remission of T2DM following surgical and nonsurgical treatments. In this 3-arm randomized clinical trial conducted at the University of Pittsburgh Medical Center from October 1, 2009, to June 26, 2014, in Pittsburgh, Pennsylvania, outcomes were assessed 3 years after treating 61 obese participants aged 25 to 55 years with T2DM. Analysis was conducted with an intent-to-treat population. Participants were randomized to either an intensive lifestyle weight loss intervention for 1 year followed by a low-level lifestyle intervention for 2 years or surgical treatments (Roux-en-Y gastric bypass [RYGB] or laparoscopic adjustable gastric banding [LAGB]) followed by low-level lifestyle intervention in years 2 and 3. Primary end points were partial and complete T2DM remission and secondary end points included diabetes medications and weight change. Body mass index (calculated as weight in kilograms divided by height in meters squared) was less than 35 for 26 participants (43%), 50 (82%) were women, and 13 (21%) were African American. Mean (SD) values were 100.5 (13.7) kg for weight, 47.3 (6.6) years for age, 7.8% (1.9%) for hemoglobin A1c level, and 171.3 (72.5) mg/dL for fasting plasma glucose level. Partial or complete T2DM remission was achieved by 40% (n = 8) of RYGB, 29% (n = 6) of LAGB, and no intensive lifestyle weight loss intervention participants (P = .004). The use of diabetes medications was reduced more in the surgical groups than the lifestyle intervention-alone group, with 65% of RYGB, 33% of LAGB, and none of the intensive lifestyle weight loss intervention participants going from using insulin or oral medication at baseline to no medication at year 3 (P lifestyle treatment at 5.7% (2.4%) (P lifestyle intervention resulted in more disease remission than did lifestyle intervention alone. clinicaltrials.gov Identifier: NCT

  12. Prevention of Gestational Diabetes: Design of a Cluster-Randomized Controlled Trial and One-Year Follow-Up

    Directory of Open Access Journals (Sweden)

    Mansikkamäki Kirsi

    2010-08-01

    Full Text Available Abstract Background Annual prevalence of gestational diabetes mellitus (GDM is 12.5% among Finnish pregnant women. The prevalence is expected to rise with the increasing overweight among women before pregnancy. Physical activity and diet are both known to have favourable effects on insulin resistance and possibly on the risk of GDM. We aimed to investigate, whether GDM can be prevented by counseling on diet, physical activity and gestational weight gain during pregnancy. Methods/Design A cluster-randomized controlled trial was conducted in 14 municipalities in the southern part of Finland. Pairwise randomization was performed in order to take into account socioeconomic differences. Recruited women were at 8-12 weeks' gestation and fulfilled at least one of the following criteria: body mass index ≥ 25 kg/m2, history of earlier gestational glucose intolerance or macrosomic newborn (> 4500 g, age ≥ 40 years, first or second degree relative with history of type 1 or 2 diabetes. Main exclusion criterion was pathological oral glucose tolerance test (OGTT at 8-12 weeks' gestation. The trial included one counseling session on physical activity at 8-12 weeks' gestation and one for diet at 16-18 weeks' gestation, and three to four booster sessions during other routine visits. In the control clinics women received usual care. Information on height, weight gain and other gestational factors was obtained from maternity cards. Physical activity, dietary intake and quality of life were followed by questionnaires during pregnancy and at 1-year postpartum. Blood samples for lipid status, hormones, insulin and OGTT were taken at 8-12 and 26-28 weeks' gestation and 1 year postpartum. Workability and return to work were elicited by a questionnaire at 1- year postpartum. Linkage to the national birth register of years 2007-2009 will provide information on perinatal complications and GDM incidence among the non-participants of the study. Cost

  13. Clinical, microbial, and immune responses observed in patients with diabetes after treatment for gingivitis: a three-month randomized clinical trial.

    Science.gov (United States)

    Raslan, Suzane A; Cortelli, Jose R; Costa, Fernando O; Aquino, Davi R; Franco, Gilson C N; Cota, Luis O M; Gargioni-Filho, Antonio; Cortelli, Sheila C

    2015-04-01

    Although patients with diabetes are frequently affected by periodontitis, only a few investigations have focused on gingivitis in this at-risk population. This randomized placebo-controlled clinical trial compared the response to a gingivitis treatment protocol that combined mechanical procedures and daily use of an essential oil (EO) mouthrinse between patients with and without diabetes. The whole-mouth periodontal probing depth (PD), gingival index (GI), and plaque index (PI) were monitored in gingivitis cases among systemically healthy patients (n = 60) or those with diabetes (n = 60) at baseline and 3 months after treatment. Levels of Porphyromonas gingivalis, Tannerella forsythia, Aggregatibacter actinomycetemcomitans, and total bacterial load were determined by a real-time polymerase chain reaction in intrasulci plaque samples. The volume of gingival crevicular fluid (GCF) was quantified, and interleukin-1β (IL-1β) levels were determined in GCF samples. After a full-mouth ultrasonic debridement, patients were randomly assigned to an EO or a placebo rinse for 90 days (40 mL/day). The data were analyzed through repeated-measures analysis of variance and multiple comparisons Tukey tests (P diabetes group. Diabetes impaired GI and reduced GCF volume. PD, bacterial levels, and IL-1β improved similarly in both systemic conditions. The adjunctive use of EO provided greater reductions of PI, GI, total bacterial load, T. forsythia, A. actinomycetemcomitans, and GCF volume. Response to gingivitis treatment in patients with diabetes can slightly differ from that in patients without diabetes. Daily use of an EO mouthrinse after ultrasonic debridement benefited patients with and without diabetes.

  14. DIABETES, DEPRESSION, AND DEATH: A RANDOMIZED CONTROLLED TRIAL OF A DEPRESSION TREATMENT PROGRAM FOR OLDER ADULTS BASED IN PRIMARY CARE (PROSPECT)

    Science.gov (United States)

    Bogner, Hillary R; Morales, Knashawn H; Post, Edward P; Bruce, Martha L

    2009-01-01

    OBJECTIVE Our a priori hypothesis was that depressed patients with diabetes in practices implementing a depression management program would have a decreased risk of mortality compared to depressed patients with diabetes in usual care practices. RESEARCH DESIGN AND METHODS Multi-site practice-randomized controlled trial PROSPECT (Prevention of Suicide in Primary Care Elderly: Collaborative Trial) with patient recruitment from 5/99-8/01 and supplemented with a search of the National Death Index. Twenty primary care practices participated from New York City, Philadelphia, and Pittsburgh. In all, 584 participants who were identified though a two-stage, age-stratified (60-74; 75+) depression screening of randomly sampled patients and were classified as depressed with complete information on diabetes status are included in these analyses. Of all the 584 participants, 123 (21.2%) reported a history of diabetes. A depression care manager worked with primary care physicians to provide algorithm-based care. Vital status was assessed at 5 years. RESULTS After a median follow-up of 52.0 months, 110 depressed patients had died. Depressed patients with diabetes in the Intervention Condition were less likely to have died during the 5-year follow-up interval than were depressed persons with diabetes in Usual Care after accounting for baseline differences among patients (adjusted hazard ratio 0.49, 95% CI [0.24, 0.98]). CONCLUSIONS Older depressed primary care patients with diabetes in practices implementing depression care management were less likely to die over the course of a 5-year interval than were depressed patients with diabetes in usual care practices. PMID:17717284

  15. Brief Computer-Delivered Intervention to Increase Parental Monitoring in Families of African American Adolescents with Type 1 Diabetes: A Randomized Controlled Trial.

    Science.gov (United States)

    Ellis, Deborah A; Idalski Carcone, April; Ondersma, Steven J; Naar-King, Sylvie; Dekelbab, Bassem; Moltz, Kathleen

    2017-06-01

    African American adolescents with type 1 diabetes (T1D) are at elevated risk for poor diabetes management and metabolic control. Parental supervision and monitoring of adolescent diabetes management have been shown to promote better diabetes management among adolescents, but parents typically decrease their oversight during the transition to independent diabetes care. The purpose of the study was to conduct a randomized clinical trial to test the feasibility and efficacy of a three-session, computer-delivered motivational intervention (The 3Ms) to promote increased parental monitoring among primary caregivers of young African American adolescents with T1D. The intervention was brief and optimized for delivery during routine diabetes clinic visits. Sixty-seven adolescents with T1D aged 11-14 and their primary caregiver were randomly assigned to one of three arms: adolescent and parent motivational intervention (Arm 1), adolescent control and parent motivational intervention (Arm 2), or adolescent and parent control (Arm 3). Intervention effects were assessed 1 month after intervention completion. Parents in Arm 1 and Arm 2 had significant increases in knowledge of the importance of monitoring adolescents' diabetes care. Parents in Arm 2 also had trend to significant increases in direct observation and monitoring of adolescent diabetes care, and adolescents in Arm 2 had significant improvements in glycemic control. Findings from the present study provide preliminary support for the efficacy of a brief, computer-delivered parenting intervention for improving family management practices and adolescent health outcomes among African American adolescents with T1D and their caregivers.

  16. Effectiveness of Green Tea in a Randomized Human Cohort: Relevance to Diabetes and Its Complications

    Directory of Open Access Journals (Sweden)

    Naushad Ali Toolsee

    2013-01-01

    Full Text Available Epidemiological studies have argued that green tea could mitigate diabetes and its complications. This study investigated the phytophenolic profile of Mauritian green tea and its antioxidant propensity. The effect of green tea on the risk factors: waist-hip ratio, glucose level, arterial pressure, antioxidant status, and alanine aminotransferase (ALT in prediabetics was assessed. The experimental group consumed 3 cups of green tea daily for 14 weeks followed by a 2-week washout period. The control group followed a water regimen. Green tea contained high level of phenolics related to its antioxidant power. Green tea suppressed waist-hip ratio of women from a significant increase and suppressed mean arterial pressure of men and women from a significant decrease after week 14. It reduced ALT level in women by 13.0% (P<0.1 while increasing the antioxidant potential of men and women sera by 2.7% (P<0.1 and 5.1% (P<0.1. The study timescale may have been too short to enable demonstration of effects on fasting plasma glucose and HbA1c outcomes. Green tea regimen could form part of a healthy lifestyle that might ameliorate features of metabolic syndrome and subsequent risks for diabetes and its complications. This trial is registered with ClinicalTrials.gov NCT01248143.

  17. Efficacy and safety of empagliflozin in type 2 diabetes mellitus: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Devi, R; Mali, Ghanshyam; Chakraborty, Indrani; Unnikrishnan, Mazhuvancherry Kesavan; Abdulsalim, Suhaj

    2017-04-01

    The prevalence of diabetes has increased in the recent decades and optimum glycemic control is required to reduce morbidity and mortality. We meta-analyzed randomized controlled trials in order to assess the efficacy and safety of empagliflozin compared to placebo in type 2 diabetes mellitus patients. We included double-blind, placebo controlled trials of empagliflozin that evaluated glycemic efficacy and safety (10 mg or 25 mg) either as monotherapy or as add-on to existing diabetes pharmacotherapy. The results demonstrated significant improvements in HbA1c (SMD -0.929%, 95 % CI -1.064 to -0.793, for 10 mg and -1.064%, 95 % CI -1.184 to -0.944, for 25 mg) and FPG (SMD -0.929%, 95 % CI -1.064 to -0.793, for 10 mg and -1.064%, 95 % CI -1.184 to -0.944, for 25 mg) with empagliflozin monotherapy (n = 609) compared to placebo. Significant improvements in HbA1c [SMD -1.582%, 95% CI -2.164 to -1.000, for 10 mg (n = 1079) and -1.668%, 95% CI -2.260 to -1.077, for 25 mg (n = 1070)] and FPG [SMD -0.865 mmol/L, 95 % CI -1.309 to -0.420, for 10 mg (n = 854) and -0.996 mmol/L, 95% CI -1.456 to -0.536, for 25 mg (n = 854)] were also observed in empagliflozin add-on therapy trials. Reductions in blood pressure and body weight were also seen in both monotherapy and add-on therapy. Empagliflozin was associated with increased risk of hypoglycemia, genital and urinary tract infections (OR 1.043, 2.814, 1.119 respectively). This meta-analysis shows empagliflozin is safe and effective for the treatment of T2DM along with existing diabetes pharmacotherapy.

  18. Effect of an Intensive Lifestyle Intervention on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial.

    Science.gov (United States)

    Johansen, Mette Yun; MacDonald, Christopher Scott; Hansen, Katrine Bagge; Karstoft, Kristian; Christensen, Robin; Pedersen, Maria; Hansen, Louise Seier; Zacho, Morten; Wedell-Neergaard, Anne-Sophie; Nielsen, Signe Tellerup; Iepsen, Ulrik Wining; Langberg, Henning; Vaag, Allan Arthur; Pedersen, Bente Klarlund; Ried-Larsen, Mathias

    2017-08-15

    It is unclear whether a lifestyle intervention can maintain glycemic control in patients with type 2 diabetes. To test whether an intensive lifestyle intervention results in equivalent glycemic control compared with standard care and, secondarily, leads to a reduction in glucose-lowering medication in participants with type 2 diabetes. Randomized, assessor-blinded, single-center study within Region Zealand and the Capital Region of Denmark (April 2015-August 2016). Ninety-eight adult participants with non-insulin-dependent type 2 diabetes who were diagnosed for less than 10 years were included. Participants were randomly assigned (2:1; stratified by sex) to the lifestyle group (n = 64) or the standard care group (n = 34). All participants received standard care with individual counseling and standardized, blinded, target-driven medical therapy. Additionally, the lifestyle intervention included 5 to 6 weekly aerobic training sessions (duration 30-60 minutes), of which 2 to 3 sessions were combined with resistance training. The lifestyle participants received dietary plans aiming for a body mass index of 25 or less. Participants were followed up for 12 months. Primary outcome was change in hemoglobin A1c (HbA1c) from baseline to 12-month follow-up, and equivalence was prespecified by a CI margin of ±0.4% based on the intention-to-treat population. Superiority analysis was performed on the secondary outcome reductions in glucose-lowering medication. Among 98 randomized participants (mean age, 54.6 years [SD, 8.9]; women, 47 [48%]; mean baseline HbA1c, 6.7%), 93 participants completed the trial. From baseline to 12-month follow-up, the mean HbA1c level changed from 6.65% to 6.34% in the lifestyle group and from 6.74% to 6.66% in the standard care group (mean between-group difference in change of -0.26% [95% CI, -0.52% to -0.01%]), not meeting the criteria for equivalence (P = .15). Reduction in glucose-lowering medications occurred in 47 participants (73

  19. Will Mobile Diabetes Education Teams (MDETs in primary care improve patient care processes and health outcomes? Study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Gucciardi Enza

    2012-09-01

    Full Text Available Abstract Background There is evidence to suggest that delivery of diabetes self-management support by diabetes educators in primary care may improve patient care processes and patient clinical outcomes; however, the evaluation of such a model in primary care is nonexistent in Canada. This article describes the design for the evaluation of the implementation of Mobile Diabetes Education Teams (MDETs in primary care settings in Canada. Methods/design This study will use a non-blinded, cluster-randomized controlled trial stepped wedge design to evaluate the Mobile Diabetes Education Teams' intervention in improving patient clinical and care process outcomes. A total of 1,200 patient charts at participating primary care sites will be reviewed for data extraction. Eligible patients will be those aged ≥18, who have type 2 diabetes and a hemoglobin A1c (HbA1c of ≥8%. Clusters (that is, primary care sites will be randomized to the intervention and control group using a block randomization procedure within practice size as the blocking factor. A stepped wedge design will be used to sequentially roll out the intervention so that all clusters eventually receive the intervention. The time at which each cluster begins the intervention is randomized to one of the four roll out periods (0, 6, 12, and 18 months. Clusters that are randomized into the intervention later will act as the control for those receiving the intervention earlier. The primary outcome measure will be the difference in the proportion of patients who achieve the recommended HbA1c target of ≤7% between intervention and control groups. Qualitative work (in-depth interviews with primary care physicians, MDET educators and patients; and MDET educators’ field notes and debriefing sessions will be undertaken to assess the implementation process and effectiveness of the MDET intervention. Trial registration ClinicalTrials.gov NCT01553266

  20. Structural Alteration of Gut Microbiota during the Amelioration of Human Type 2 Diabetes with Hyperlipidemia by Metformin and a Traditional Chinese Herbal Formula: a Multicenter, Randomized, Open Label Clinical Trial.

    Science.gov (United States)

    Tong, Xiaolin; Xu, Jia; Lian, Fengmei; Yu, Xiaotong; Zhao, Yufeng; Xu, Lipeng; Zhang, Menghui; Zhao, Xiyan; Shen, Jian; Wu, Shengping; Pang, Xiaoyan; Tian, Jiaxing; Zhang, Chenhong; Zhou, Qiang; Wang, Linhua; Pang, Bing; Chen, Feng; Peng, Zhiping; Wang, Jing; Zhen, Zhong; Fang, Chao; Li, Min; Chen, Limei; Zhao, Liping

    2018-05-22

    Accumulating evidence implicates gut microbiota as promising targets for the treatment of type 2 diabetes mellitus (T2DM). With a randomized clinical trial, we tested the hypothesis that alteration of gut microbiota may be involved in the alleviation of T2DM with hyperlipidemia by metformin and a specifically designed herbal formula (AMC). Four hundred fifty patients with T2DM and hyperlipidemia were randomly assigned to either the metformin- or AMC-treated group. After 12 weeks of treatment, 100 patients were randomly selected from each group and assessed for clinical improvement. The effects of the two drugs on the intestinal microbiota were evaluated by analyzing the V3 and V4 regions of the 16S rRNA gene by Illumina sequencing and multivariate statistical methods. Both metformin and AMC significantly alleviated hyperglycemia and hyperlipidemia and shifted gut microbiota structure in diabetic patients. They significantly increased a coabundant group represented by Blautia spp., which significantly correlated with the improvements in glucose and lipid homeostasis. However, AMC showed better efficacies in improving homeostasis model assessment of insulin resistance (HOMA-IR) and plasma triglyceride and also exerted a larger effect on gut microbiota. Furthermore, only AMC increased the coabundant group represented by Faecalibacterium spp., which was previously reported to be associated with the alleviation of T2DM in a randomized clinical trial. Metformin and the Chinese herbal formula may ameliorate type 2 diabetes with hyperlipidemia via enriching beneficial bacteria, such as Blautia and Faecalibacterium spp. IMPORTANCE Metabolic diseases such as T2DM and obesity have become a worldwide public health threat. Accumulating evidence indicates that gut microbiota can causatively arouse metabolic diseases, and thus the gut microbiota serves as a promising target for disease control. In this study, we evaluated the role of gut microbiota during improvements in

  1. Modified random hinge transport mechanics and multiple scattering step-size selection in EGS5

    International Nuclear Information System (INIS)

    Wilderman, S.J.; Bielajew, A.F.

    2005-01-01

    The new transport mechanics in EGS5 allows for significantly longer electron transport step sizes and hence shorter computation times than required for identical problems in EGS4. But as with all Monte Carlo electron transport algorithms, certain classes of problems exhibit step-size dependencies even when operating within recommended ranges, sometimes making selection of step-sizes a daunting task for novice users. Further contributing to this problem, because of the decoupling of multiple scattering and continuous energy loss in the dual random hinge transport mechanics of EGS5, there are two independent step sizes in EGS5, one for multiple scattering and one for continuous energy loss, each of which influences speed and accuracy in a different manner. Further, whereas EGS4 used a single value of fractional energy loss (ESTEPE) to determine step sizes at all energies, to increase performance by decreasing the amount of effort expended simulating lower energy particles, EGS5 permits the fractional energy loss values which are used to determine both the multiple scattering and continuous energy loss step sizes to vary with energy. This results in requiring the user to specify four fractional energy loss values when optimizing computations for speed. Thus, in order to simplify step-size selection and to mitigate step-size dependencies, a method has been devised to automatically optimize step-size selection based on a single material dependent input related to the size of problem tally region. In this paper we discuss the new transport mechanics in EGS5 and describe the automatic step-size optimization algorithm. (author)

  2. Does Kindness Matter? Diabetes, Depression, and Self-Compassion: A Selective Review and Research Agenda.

    Science.gov (United States)

    Friis, Anna M; Consedine, Nathan S; Johnson, Malcolm H

    2015-11-01

    Depression and severe psychological distress are frequently comorbid with diabetes and are associated with reduced adherence to medication and healthy lifestyle regimens, poorer glycemic control, and increased complications. The mixed success of existing treatments for depression in diabetes patients suggests a need for supplementary approaches to this common problem. This article reviews recent evidence for the benefits of self-compassion in chronically ill patients, suggesting its utility as a clinical tool for improving self-care, depression, and glycemic control in diabetes. Possible physical and psychological pathways by which self-compassion may promote better outcomes in diabetes patients are considered, with particular attention given to reductions in negative self-judgment and improved motivation to undertake self-care.

  3. Metformin as a prophylactic treatment of gestational diabetes in pregnant patients with pregestational insulin resistance: A randomized study.

    Science.gov (United States)

    Valdés, Enrique; Sepúlveda-Martínez, Alvaro; Candia, Paula; Abusada, Nancy; Orellana, Rodrigo; Manukian, Bárbara; Cuellar, Eduardo

    2018-01-01

    We aimed to assess the use of metformin (MTF) in the prevention of gestational diabetes mellitus (GDM) in patients with pregestational insulin resistance (PIR). A double blind, multicenter, randomized trial was carried out in patients with a history of PIR and pregestational MTF treatment. Groups were allocated either to MTF 1700 mg/day or placebo. Patients were recruited between 12 +0 and 15 +6  gestational weeks, and treatment was extended until week 36. A multiple logistic regression analysis was applied to determine the relation between the use of metformin and the development of GDM. One hundred and forty one patients were randomized (68 patients in the MTF group and 73 in the placebo group). A total of 30 patients withdrew from the study during follow-up. Administration of MTF was not associated with a decrease in the incidence of GDM as compared to placebo (37.5% vs 25.4%, respectively; P = 0.2). Moreover, MTF administration was associated with a significant increase in drug intolerance as compared to placebo (14.3% vs 1.8%, respectively; P = 0.02). The use of MTF is not effective in prevention of GDM in populations with PIR. The use of MTF shows a significantly higher frequency of drug intolerance than placebo. © 2017 Japan Society of Obstetrics and Gynecology.

  4. Static magnetic field therapy for symptomatic diabetic neuropathy: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Weintraub, Michael I; Wolfe, Gil I; Barohn, Richard A; Cole, Steven P; Parry, Gareth J; Hayat, Ghazala; Cohen, Jeffrey A; Page, Jeffrey C; Bromberg, Mark B; Schwartz, Sherwyn L

    2003-05-01

    To determine if constant wearing of multipolar, static magnetic (450G) shoe insoles can reduce neuropathic pain and quality of life (QOL) scores in symptomatic diabetic peripheral neuropathy (DPN). Randomized, placebo-control, parallel study. Forty-eight centers in 27 states. Three hundred seventy-five subjects with DPN stage II or III were randomly assigned to wear constantly magnetized insoles for 4 months; the placebo group wore similar, unmagnetized device. Nerve conduction and/or quantified sensory testing were performed serially. Daily visual analog scale scores for numbness or tingling and burning and QOL issues were tabulated over 4 months. Secondary measures included nerve conduction changes, role of placebo, and safety issues. Analysis of variance (ANOVA), analysis of covariance (ANCOVA), and chi-square analysis were performed. There were statistically significant reductions during the third and fourth months in burning (mean change for magnet treatment, -12%; for sham, -3%; P<.05, ANCOVA), numbness and tingling (magnet, -10%; sham, +1%; P<.05, ANCOVA), and exercise-induced foot pain (magnet, -12%; sham, -4%; P<.05, ANCOVA). For a subset of patients with baseline severe pain, statistically significant reductions occurred from baseline through the fourth month in numbness and tingling (magnet, -32%; sham, -14%; P<.01, ANOVA) and foot pain (magnet, -41%; sham, -21%; P<.01, ANOVA). Static magnetic fields can penetrate up to 20mm and appear to target the ectopic firing nociceptors in the epidermis and dermis. Analgesic benefits were achieved over time.

  5. Knowledge, attitude and practice of type 2 diabetic patients of selected outreach clinic, Dharan, Nepal

    OpenAIRE

    Chitrakala Nepal; Pallavi Vyas; Richha Bhattarai; Bishwanath Acharya; Kanchan Thapa; Jenesh Singh Shrestha; Robin Maskey; Sanjib K. Sharma

    2017-01-01

    Background and Objectives: The burden of type 2 Diabetes Mellitus continues to rise and constitutes a real threat especially in the developing world. A cross sectional study was carried out to determine knowledge, attitude and practices regarding lifestyle modifications on type 2 Diabetes Mellitus. Methods: Face to face interview was carried out using structured questionnaire among 89 of patients. The data was analyzed using SPSS16. Results: The study showed that majority of participants was ...

  6. Long-Term Pioglitazone Treatment for Patients With Nonalcoholic Steatohepatitis and Prediabetes or Type 2 Diabetes Mellitus: A Randomized Trial.

    Science.gov (United States)

    Cusi, Kenneth; Orsak, Beverly; Bril, Fernando; Lomonaco, Romina; Hecht, Joan; Ortiz-Lopez, Carolina; Tio, Fermin; Hardies, Jean; Darland, Celia; Musi, Nicolas; Webb, Amy; Portillo-Sanchez, Paola

    2016-09-06

    The metabolic defects of nonalcoholic steatohepatitis (NASH) and prediabetes or type 2 diabetes mellitus (T2DM) seem to be specifically targeted by pioglitazone. However, information about its long-term use in this population is limited. To determine the efficacy and safety of long-term pioglitazone treatment in patients with NASH and prediabetes or T2DM. Randomized, double-blind, placebo-controlled trial. (ClinicalTrials.gov: NCT00994682). University hospital. Patients (n = 101) with prediabetes or T2DM and biopsy-proven NASH were recruited from the general population and outpatient clinics. All patients were prescribed a hypocaloric diet (500-kcal/d deficit from weight-maintaining caloric intake) and then randomly assigned to pioglitazone, 45 mg/d, or placebo for 18 months, followed by an 18-month open-label phase with pioglitazone treatment. The primary outcome was a reduction of at least 2 points in the nonalcoholic fatty liver disease activity score in 2 histologic categories without worsening of fibrosis. Secondary outcomes included other histologic outcomes, hepatic triglyceride content measured by magnetic resonance and proton spectroscopy, and metabolic parameters. Among patients randomly assigned to pioglitazone, 58% achieved the primary outcome (treatment difference, 41 percentage points [95% CI, 23 to 59 percentage points]) and 51% had resolution of NASH (treatment difference, 32 percentage points [CI, 13 to 51 percentage points]) (P < 0.001 for each). Pioglitazone treatment also was associated with improvement in individual histologic scores, including the fibrosis score (treatment difference, -0.5 [CI, -0.9 to 0.0]; P = 0.039); reduced hepatic triglyceride content from 19% to 7% (treatment difference, -7 percentage points [CI, -10 to -4 percentage points]; P < 0.001); and improved adipose tissue, hepatic, and muscle insulin sensitivity (P < 0.001 vs. placebo for all). All 18-month metabolic and histologic improvements persisted over 36 months of

  7. Interval-walking training for the treatment of type 2 diabetes: a randomized, controlled trial

    DEFF Research Database (Denmark)

    Karstoft, Kristian; Winding, Kamilla; Knudsen, Sine H.

    Formål: To evaluate the feasibility of free-living walking training in type 2 diabetes patients, and to investigate the effects of interval-walking training (IWT) versus continuous-walking training (CWT) upon self reported health, physical fitness, body composition and glycemic control. Metoder...... alternated 3-min repetitions at low and high intensity. Before and after the 4-month intervention, the following variables were measured: Self-reported health, Physical fitness (VO2max), body composition, and glycemic control (fasting glucose, HbA1c, oral glucose tolerance test, continuous glucose monitoring...... [CGM]). Resultater: Training adherence was high (89 + 4%), and training energy expenditure and mean intensity were comparable between training groups. Nine and four of the subjects reported “Improved Health” in the IWT and CWT group, respectively. VO2max increased 16.1 + 3.7% in the IWT group (P

  8. Effectiveness of cognitive-behavioural therapy on glycaemic control and psychological outcomes in adults with diabetes mellitus: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Uchendu, C; Blake, H

    2017-03-01

    Diabetes is a chronic progressive condition presenting physical, social and psychological challenges that increase the risk of comorbid mental health problems. Cognitive-behavioural therapy (CBT) is effective in treating a variety of psychological disorders, and may potentially improve glycaemic control and psychological outcomes in diabetes. This systematic review and meta-analysis aims to establish the effectiveness of CBT on glycaemic control and comorbid diabetes-related distress, depression, anxiety and quality of life in the short, medium and longer term among adults with diabetes. An electronic search was conducted in PubMed, Embase, MEDLINE, PsycINFO, CINAHL, Web of Knowledge, Cochrane Central Register of Controlled Trials and references in reviews. Twelve randomized controlled trials (RCTs) were identified that evaluated the effectiveness of CBT on at least one of: glycaemic control, diabetes-related distress, anxiety, depression or quality of life in adults with Type 1 or Type 2 diabetes. The Cochrane Risk of Bias Tool and Review Manager version 5.3 were used for risk of bias assessment and meta-analysis, respectively. CBT is effective in reducing short-term and medium-term glycaemic control, although no significant effect was found for long-term glycaemic control. CBT improved short- and medium-term anxiety and depression, and long-term depression. Mixed results were found for diabetes-related distress and quality of life. CBT is beneficial in improving depression for adults with diabetes. It may have benefits for improving glycaemic control and other aspects of psychological health, although the findings are inconclusive. © 2016 Diabetes UK.

  9. The Effects of a Mobile Phone Application on Quality of Life in Patients With Type 1 Diabetes Mellitus: A Randomized Controlled Trial.

    Science.gov (United States)

    Drion, Iefke; Pameijer, Loes R; van Dijk, Peter R; Groenier, Klaas H; Kleefstra, Nanne; Bilo, Henk J G

    2015-05-11

    The combination of an increasing prevalence of diabetes mellitus and more people having access to smartphones creates opportunities for patient care. This study aims to investigate whether the use of the Diabetes Under Control (DBEES) mobile phone application, a digital diabetes diary, results in a change in quality of life for patients with type 1 diabetes mellitus (T1DM) compared with the standard paper diary. In this randomized controlled open-label trial, 63 patients with T1DM having access to a smartphone were assigned to the intervention group using the DBEES application (n = 31) or the control group using the standard paper diary (n = 32). Primary outcome was the change in quality of life, as measured by the RAND-36 questionnaire, between both groups. Secondary outcomes included diabetes-related distress (PAID), HbA1c, frequency of self-monitoring blood glucose, and the usability of the diabetes application (SUS). Patients had a median age (IQR) of 33 (21) years, diabetes duration of 17 (16) years, and an HbA1c of 62 ± 16 mmol/mol. No significant differences in the QOL, using the RAND-36, within and between both groups were observed after 3 months. Glycemic control, diabetes-related emotional distress, and frequency of self-monitoring of blood glucose remained within and between groups. Users reviewed the usability of DBEES with a 72 ± 20, on a range of 0-100. The use of the DBEES application in the management of patients with T1DM for 3 months yields no alterations in quality of life compared to the standard paper diary. © 2015 Diabetes Technology Society.

  10. Effects of a Multicomponent Life-Style Intervention on Weight, Glycemic Control, Depressive Symptoms, and Renal Function in Low-Income, Minority Patients With Type 2 Diabetes: Results of the Community Approach to Lifestyle Modification for Diabetes Randomized Controlled Trial.

    Science.gov (United States)

    Moncrieft, Ashley E; Llabre, Maria M; McCalla, Judith Rey; Gutt, Miriam; Mendez, Armando J; Gellman, Marc D; Goldberg, Ronald B; Schneiderman, Neil

    2016-09-01

    Few interventions have combined life-style and psychosocial approaches in the context of Type 2 diabetes management. The purpose of this study was to determine the effect of a multicomponent behavioral intervention on weight, glycemic control, renal function, and depressive symptoms in a sample of overweight/obese adults with Type 2 diabetes and marked depressive symptoms. A sample of 111 adults with Type 2 diabetes were randomly assigned to a 1-year intervention (n = 57) or usual care (n = 54) in a parallel groups design. Primary outcomes included weight, glycosylated hemoglobin, and Beck Depression Inventory II score. Estimated glomerular filtration rate served as a secondary outcome. All measures were assessed at baseline and 6 and 12 months after randomization by assessors blind to randomization. Latent growth modeling was used to examine intervention effects on each outcome. The intervention resulted in decreased weight (mean [M] = 0.322 kg, standard error [SE] = 0.124 kg, p = .010) and glycosylated hemoglobin (M = 0.066%, SE = 0.028%, p = .017), and Beck Depression Inventory II scores (M = 1.009, SE = 0.226, p diabetes. This study is registered at Clinicaltrials.gov ID: NCT01739205.

  11. The adverse effect of selective cyclooxygenase-2 inhibitor on random skin flap survival in rats.

    Directory of Open Access Journals (Sweden)

    Haiyong Ren

    Full Text Available BACKGROUND: Cyclooxygenase-2(COX-2 inhibitors provide desired analgesic effects after injury or surgery, but evidences suggested they also attenuate wound healing. The study is to investigate the effect of COX-2 inhibitor on random skin flap survival. METHODS: The McFarlane flap model was established in 40 rats and evaluated within two groups, each group gave the same volume of Parecoxib and saline injection for 7 days. The necrotic area of the flap was measured, the specimens of the flap were stained with haematoxylin-eosin(HE for histologic analysis. Immunohistochemical staining was performed to analyse the level of VEGF and COX-2 . RESULTS: 7 days after operation, the flap necrotic area ratio in study group (66.65 ± 2.81% was significantly enlarged than that of the control group(48.81 ± 2.33%(P <0.01. Histological analysis demonstrated angiogenesis with mean vessel density per mm(2 being lower in study group (15.4 ± 4.4 than in control group (27.2 ± 4.1 (P <0.05. To evaluate the expression of COX-2 and VEGF protein in the intermediate area II in the two groups by immunohistochemistry test .The expression of COX-2 in study group was (1022.45 ± 153.1, and in control group was (2638.05 ± 132.2 (P <0.01. The expression of VEGF in the study and control groups were (2779.45 ± 472.0 vs (4938.05 ± 123.6(P <0.01.In the COX-2 inhibitor group, the expressions of COX-2 and VEGF protein were remarkably down-regulated as compared with the control group. CONCLUSION: Selective COX-2 inhibitor had adverse effect on random skin flap survival. Suppression of neovascularization induced by low level of VEGF was supposed to be the biological mechanism.

  12. Efficacy and Safety of Multiple Doses of Exenatide Once-Monthly Suspension in Patients With Type 2 Diabetes: A Phase II Randomized Clinical Trial.

    Science.gov (United States)

    Wysham, Carol H; MacConell, Leigh; Hardy, Elise

    2016-10-01

    This study investigated the efficacy and safety of multiple exenatide once-monthly suspension (QMS) doses of exenatide-containing microspheres in Miglyol referenced against the clinical dose of exenatide once-weekly (QW) microspheres in aqueous solution. In this phase II, randomized, controlled, single-blind study, 121 adults (∼30/arm) with type 2 diabetes and HbA1c 7.1-11.0% (54-97 mmol/mol) were randomized 1:1:1:1 to subcutaneous exenatide QW 2 mg (self-administered) or exenatide QMS 5, 8, or 11 mg (caregiver-administered) for 20 weeks. The primary end point was change in HbA1c. At baseline, mean age was 50 years, HbA1c was 8.5% (69 mmol/mol), fasting plasma glucose (FPG) was 184 mg/dL, and body weight was 98 kg. At week 20, mean ± SD HbA1c reductions were -1.54% ± 1.26% with exenatide QW and -1.29% ± 1.07%, -1.31% ± 1.66%, and -1.45% ± 0.93% with exenatide QMS 5, 8, and 11 mg, respectively (evaluable population: n = 110). There were no significant differences in HbA1c reductions among the exenatide QMS doses. FPG reductions were -34 ± 48 mg/dL with exenatide QW and -25 ± 43, -30 ± 52, and -49 ± 49 mg/dL with exenatide QMS 5, 8, and 11 mg, respectively. Weight decreased with all treatments. For exenatide QMS, nausea (16.7-23.3%) and headache (16.7-26.7%) were the most common adverse events. No major or minor hypoglycemia occurred. All doses of exenatide QMS resulted in efficacy and tolerability profiles consistent with exenatide QW. These results combined with pharmacokinetic and pharmacodynamic modeling could inform dose selection for further development. © 2016 by the American Diabetes Association.

  13. One step versus two step approach for gestational diabetes screening: systematic review and meta-analysis of the randomized trials.

    Science.gov (United States)

    Saccone, Gabriele; Caissutti, Claudia; Khalifeh, Adeeb; Meltzer, Sara; Scifres, Christina; Simhan, Hyagriv N; Kelekci, Sefa; Sevket, Osman; Berghella, Vincenzo

    2017-12-03

    To compare both the prevalence of gestational diabetes mellitus (GDM) as well as maternal and neonatal outcomes by either the one-step or the two-step approaches. Electronic databases were searched from their inception until June 2017. We included all randomized controlled trials (RCTs) comparing the one-step with the two-step approaches for the screening and diagnosis of GDM. The primary outcome was the incidence of GDM. Three RCTs (n = 2333 participants) were included in the meta-analysis. 910 were randomized to the one step approach (75 g, 2 hrs), and 1423 to the two step approach. No significant difference in the incidence of GDM was found comparing the one step versus the two step approaches (8.4 versus 4.3%; relative risk (RR) 1.64, 95%CI 0.77-3.48). Women screened with the one step approach had a significantly lower risk of preterm birth (PTB) (3.7 versus 7.6%; RR 0.49, 95%CI 0.27-0.88), cesarean delivery (16.3 versus 22.0%; RR 0.74, 95%CI 0.56-0.99), macrosomia (2.9 versus 6.9%; RR 0.43, 95%CI 0.22-0.82), neonatal hypoglycemia (1.7 versus 4.5%; RR 0.38, 95%CI 0.16-0.90), and admission to neonatal intensive care unit (NICU) (4.4 versus 9.0%; RR 0.49, 95%CI 0.29-0.84), compared to those randomized to screening with the two step approach. The one and the two step approaches were not associated with a significant difference in the incidence of GDM. However, the one step approach was associated with better maternal and perinatal outcomes.

  14. Gadofosveset-enhanced MR angiography of the pedal arteries in patients with diabetes mellitus and comparison with selective intraarterial DSA

    International Nuclear Information System (INIS)

    Roehrl, Boris; Kunz, Rainer Peter; Oberholzer, Katja; Pitton, Michael Bernhard; Dueber, Christoph; Kreitner, Karl-Friedrich; Neufang, Achim

    2009-01-01

    To compare gadofosveset-enhanced magnetic resonance angiography (MRA) of the pedal vasculature with selective intraarterial DSA. Eighteen patients with PAOD and type II diabetes were prospectively examined at 1.5 T. For contrast enhancement, 0.03 mmol/kg body weight gadofosveset was used. MR imaging consisted of dynamic and of high-resolution steady-state imaging. Selective digital subtraction angiography (DSA) was performed within 5 days and served as standard of reference. Image analysis was done by two observers. There were no differences between MRA and DSA regarding overall image quality. First-pass MRA detected significantly more patent vessel segments than did DSA (P < 0.001, kappa = 0.46). Interobserver agreement of MRA was very good with respect to the detection of patent vessel segments and the assessment of hemodynamically relevant stenoses (kappa = 0.97 and 0.89, respectively). Steady-state imaging depicted significantly more patent metatarsal arteries than did dynamic imaging, and delineated inflammatory complications including osteomyelitis, soft-tissue abscesses, and fistulas related to the diabetic foot. Gadofosveset-enhanced MRA of the pedal vasculature proved to be superior to DSA. It offered a long imaging time window, and allowed for better depiction of the pedal outflow. Steady-state imaging delineated inflammatory complications associated with the diabetic foot. (orig.)

  15. Gadofosveset-enhanced MR angiography of the pedal arteries in patients with diabetes mellitus and comparison with selective intraarterial DSA

    Energy Technology Data Exchange (ETDEWEB)

    Roehrl, Boris; Kunz, Rainer Peter; Oberholzer, Katja; Pitton, Michael Bernhard; Dueber, Christoph; Kreitner, Karl-Friedrich [Johannes Gutenberg University Mainz, Department of Diagnostic and Interventional Radiology, Mainz (Germany); Neufang, Achim [Johannes Gutenberg University Mainz, Department of Cardiothoracic and Vascular Surgery, Mainz (Germany)

    2009-12-15

    To compare gadofosveset-enhanced magnetic resonance angiography (MRA) of the pedal vasculature with selective intraarterial DSA. Eighteen patients with PAOD and type II diabetes were prospectively examined at 1.5 T. For contrast enhancement, 0.03 mmol/kg body weight gadofosveset was used. MR imaging consisted of dynamic and of high-resolution steady-state imaging. Selective digital subtraction angiography (DSA) was performed within 5 days and served as standard of reference. Image analysis was done by two observers. There were no differences between MRA and DSA regarding overall image quality. First-pass MRA detected significantly more patent vessel segments than did DSA (P < 0.001, kappa = 0.46). Interobserver agreement of MRA was very good with respect to the detection of patent vessel segments and the assessment of hemodynamically relevant stenoses (kappa = 0.97 and 0.89, respectively). Steady-state imaging depicted significantly more patent metatarsal arteries than did dynamic imaging, and delineated inflammatory complications including osteomyelitis, soft-tissue abscesses, and fistulas related to the diabetic foot. Gadofosveset-enhanced MRA of the pedal vasculature proved to be superior to DSA. It offered a long imaging time window, and allowed for better depiction of the pedal outflow. Steady-state imaging delineated inflammatory complications associated with the diabetic foot. (orig.)

  16. Application of random coherence order selection in gradient-enhanced multidimensional NMR

    International Nuclear Information System (INIS)

    Bostock, Mark J.; Nietlispach, Daniel

    2016-01-01

    Development of multidimensional NMR is essential to many applications, for example in high resolution structural studies of biomolecules. Multidimensional techniques enable separation of NMR signals over several dimensions, improving signal resolution, whilst also allowing identification of new connectivities. However, these advantages come at a significant cost. The Fourier transform theorem requires acquisition of a grid of regularly spaced points to satisfy the Nyquist criterion, while frequency discrimination and acquisition of a pure phase spectrum require acquisition of both quadrature components for each time point in every indirect (non-acquisition) dimension, adding a factor of 2 N -1 to the number of free- induction decays which must be acquired, where N is the number of dimensions. Compressed sensing (CS) ℓ 1 -norm minimisation in combination with non-uniform sampling (NUS) has been shown to be extremely successful in overcoming the Nyquist criterion. Previously, maximum entropy reconstruction has also been used to overcome the limitation of frequency discrimination, processing data acquired with only one quadrature component at a given time interval, known as random phase detection (RPD), allowing a factor of two reduction in the number of points for each indirect dimension (Maciejewski et al. 2011 PNAS 108 16640). However, whilst this approach can be easily applied in situations where the quadrature components are acquired as amplitude modulated data, the same principle is not easily extended to phase modulated (P-/N-type) experiments where data is acquired in the form exp (iωt) or exp (-iωt), and which make up many of the multidimensional experiments used in modern NMR. Here we demonstrate a modification of the CS ℓ 1 -norm approach to allow random coherence order selection (RCS) for phase modulated experiments; we generalise the nomenclature for RCS and RPD as random quadrature detection (RQD). With this method, the power of RQD can be extended

  17. The Effect of Omega-3 on Circulating Adiponectin in Adults with Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Bahreini, Mehdi; Ramezani, Amir-Hossein; Shishehbor, Farideh; Mansoori, Anahita

    2018-01-04

    Whether consumption of omega-3 affects circulating adiponectin has not been established. The objective of this study was to evaluate the effect of omega-3 (food or supplement) on circulating adiponectin in patients with type 2 diabetes through a systematic review of meta-analyses of randomized controlled trials. PubMed, Scopus and Web of Science were searched for relevant studies through May 2016. Two researchers screened and abstracted the literature independently. Pooled estimates were obtained using the random-effects models. Overall, omega-3 increased adiponectin by 0.57 µg/mL (95% confidence interval [CI] 0.15 to 1.31; p=0.01, I-square=74.2% p for heterogeneity omega-3 for more than 8 weeks. This systematic review and meta-analysis of randomized, placebo-controlled clinical trials suggests that omega-3 in patients with type 2 diabetes increases circulating adiponectin. These findings support the potentially beneficial effects of dietary omega-3 in patients with type 2 diabetes on pathways related to adiponectin metabolism. Copyright © 2017 Diabetes Canada. Published by Elsevier Inc. All rights reserved.

  18. The Effectiveness of Pharmacist Interventions on Cardiovascular Risk in Adult Patients with Type 2 Diabetes: The Multicentre Randomized Controlled RxEACH Trial.

    Science.gov (United States)

    Al Hamarneh, Yazid N; Hemmelgarn, Brenda R; Hassan, Imran; Jones, Charlotte A; Tsuyuki, Ross T

    2017-12-01

    Cardiovascular disease (CVD) is the leading cause of death among patients with diabetes. Management and control of CV risk factors in those with diabetes are generally poor. Pharmacists are frontline primary healthcare providers who see patients with chronic diseases frequently. As such, they are in a prime position to systematically identify patients with diabetes, assess their CV risk and assist in their disease management and preventive measures. to evaluate the effect of pharmacist case finding and intervention program on estimated CV risk in patients with diabetes. Sub-group analysis of a randomized controlled trial (RxEACH). Patients were randomized to receive intervention or usual care for 3 months. Those who were randomized to the intervention group received a Medication Therapy Management consultation which included patient assessment, laboratory assessment, individualized CV risk assessment. Treatment regimen adjustment, as needed, in order to meet treatment targets. Estimated CV risk was reduced from 26.9 +/- 21% to 26.5 +/- 21.3% in the control group and from 25.8 +/- 19.4% to 20.1 +/- 17.2% in the intervention group over the 3-month follow up period (an absolute reduction of 5.38; 95% confidence interval (CI) 4.24 to 6.52; p <0.001). Community pharmacy-based case finding and intervention program reduced the risk for major CV events by 21% when compared to usual practice. This represents a promising approach to help tackle the major public health problem of diabetes in Canada. Copyright © 2017 Diabetes Canada. Published by Elsevier Inc. All rights reserved.

  19. Reducing and preventing internalizing and externalizing behavior problems in children with type 1 diabetes: a randomized controlled trial of the Triple P-Positive Parenting Program.

    Science.gov (United States)

    Westrupp, E M; Northam, E; Lee, K J; Scratch, S E; Cameron, F

    2015-11-01

    Children with type 1 diabetes are at increased risk of mental health problems, which in turn are associated with poor glycemic control, diabetes-related complications, and long-term psychiatric morbidity. We tested the efficacy of the Triple P-Positive Parenting Program in reducing or preventing mental health problems and improving glycemic control in children with type 1 diabetes in a randomized controlled trial. Participants were recruited from the Diabetes Clinic, Royal Children's Hospital, Melbourne, Australia, and randomized to Triple P or standard diabetes care. The primary outcome was child internalizing and externalizing behavior problems 3 and 12 months postrandomization. Secondary outcomes were glycemic control, parent mental health, parenting skills, and family functioning at 3 and 12 months, and glycemic control at 24 months. A total of 76 participants were randomized (38 to intervention and 38 to control), 60 completed 3-month, and 57 completed 12-month assessments. Benefits of Triple P were evident at 3 months for parent mental health, parenting skills, and family functioning (p externalizing behavior problems indicated greater improvements in child mental health, parent mental health, parenting skills, and diabetes family conflict (p parenting self-efficacy at 3 months. Improvements in parent mental health and parenting competency associated with Triple P were sustained to 12 months for children with pre-existing mental health problems. This study provides some support for the efficacy of Triple P in improving parent and family outcomes, and reducing child internalizing and externalizing behavior problems primarily in children who have pre-existing mental health problems. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  20. Connecting Smartphone and Wearable Fitness Tracker Data with a Nationally Used Electronic Health Record System for Diabetes Education to Facilitate Behavioral Goal Monitoring in Diabetes Care: Protocol for a Pragmatic Multi-Site Randomized Trial.

    Science.gov (United States)

    Wang, Jing; Coleman, Deidra Carroll; Kanter, Justin; Ummer, Brad; Siminerio, Linda

    2018-04-02

    Mobile and wearable technology have been shown to be effective in improving diabetes self-management; however, integrating data from these technologies into clinical diabetes care to facilitate behavioral goal monitoring has not been explored. The objective of this paper is to report on a study protocol for a pragmatic multi-site trial along with the intervention components, including the detailed connected health interface. This interface was developed to integrate patient self-monitoring data collected from a wearable fitness tracker and its companion smartphone app to an electronic health record system for diabetes self-management education and support (DSMES) to facilitate behavioral goal monitoring. A 3-month multi-site pragmatic clinical trial was conducted with eligible patients with diabetes mellitus from DSMES programs. The Chronicle Diabetes system is currently freely available to diabetes educators through American Diabetes Association-recognized DSMES programs to set patient nutrition and physical activity goals. To integrate the goal-setting and self-monitoring intervention into the DSMES process, a connected interface in the Chronicle Diabetes system was developed. With the connected interface, patient self-monitoring information collected from smartphones and wearable fitness trackers can facilitate educators' monitoring of patients' adherence to their goals. Feasibility outcomes of the 3-month trial included hemoglobin A 1c levels, weight, and the usability of the connected system. An interface designed to connect data from a wearable fitness tracker with a companion smartphone app for nutrition and physical activity self-monitoring into a diabetes education electronic health record system was successfully developed to enable diabetes educators to facilitate goal setting and monitoring. A total of 60 eligible patients with type 2 diabetes mellitus were randomized into either group 1) standard diabetes education or 2) standard education enhanced with

  1. Use of Medicare's Diabetes Self-Management Training Benefit

    Science.gov (United States)

    Strawbridge, Larisa M.; Lloyd, Jennifer T.; Meadow, Ann; Riley, Gerald F.; Howell, Benjamin L.

    2015-01-01

    Medicare began reimbursing for outpatient diabetes self-management training (DSMT) in 2000; however, little is known about program utilization. Individuals diagnosed with diabetes in 2010 were identified from a 20% random selection of the Medicare fee-for-service population (N = 110,064). Medicare administrative and claims files were used to…

  2. Prevalence of Anemia, Overweight/Obesity, and Undiagnosed Hypertension and Diabetes among Residents of Selected Communities in Ghana

    Directory of Open Access Journals (Sweden)

    Alex Kojo Anderson

    2017-01-01

    Full Text Available The increasing numbers of lifestyle related chronic diseases in developing countries call for awareness, early detection, and effective management. The objective of this paper is to report the prevalence of undiagnosed hypertension, diabetes, overweight/obesity, and anemia among residents of selected communities in Ghana. The data comes from a community screening conducted in Ghana as part of the University of Georgia Summer Service Learning Program. Descriptive statistics were used to summarize the data while chi-square and independent t-test compared groups. A total of 976 participants (37.9% males and 62.1% females, 18 years and older, were screened. Mean age was 46.25±17.14 years, BMI was 25.44±5.26 kgm−2, and hemoglobin was 12.04±2.22 g/dL. 3.1% and 12.6% reported existing diagnosis for diabetes and hypertension, respectively. Almost half (47.8% were overweight/obese; 27.0% were hypertensive while 34.0% had diabetes. Also, 28.8% males compared to 37.8% females had diabetes (P=0.015, while 28.2% males compared to 26.2% females were hypertensive (P=0.635. There were differences in BMI (P<0.0001, anemia (P=0.007, and undiagnosed diabetes (P<0.0001 and hypertension (P<0.0001 by community (Takoradi versus Cape Coast where the screening took place. Findings from the screening exercise call for improved public health education with a focus on lifestyle habits and health seeking behaviors among Ghanaians.

  3. Mobile Phone Support for Diabetes Self-Care Among Diverse Adults: Protocol for a Three-Arm Randomized Controlled Trial

    Science.gov (United States)

    Nelson, Lyndsay A; Wallston, Kenneth A; Kripalani, Sunil; Greevy Jr, Robert A; Elasy, Tom A; Bergner, Erin M; Gentry, Chad K

    2018-01-01

    Background Nonadherence to self-care is common among patients with type 2 diabetes (T2D) and often leads to severe complications. Moreover, patients with T2D who have low socioeconomic status and are racial/ethnic minorities disproportionately experience barriers to adherence and poor outcomes. Basic phone technology (text messages and phone calls) provides a practical medium for delivering content to address patients’ barriers to adherence; however, trials are needed to explore long-term and sustainable effects of mobile phone interventions among diverse patients. Objective The aim of this study is to evaluate the effects of mobile phone–based diabetes support interventions on self-care and hemoglobin A1c (HbA1c) among adults with T2D using a 3-arm, 15-month randomized controlled trial with a Type 1 hybrid effectiveness-implementation approach. The intervention arms are (1) Rapid Encouragement/Education And Communications for Health (REACH) and (2) REACH + Family-focused Add-on for Motivating Self-care (FAMS). Methods We recruited primary care patients with T2D (N=512) from Federally Qualified Health Centers and an academic medical center, prioritizing recruitment of publicly insured and minority patients from the latter. Eligible patients were prescribed daily diabetes medication and owned a cell phone with text messaging capability. We excluded patients whose most recent HbA1c result within 12 months was <6.8% to support detection of intervention effects on HbA1c. Participants were randomly assigned to REACH only, REACH + FAMS, or the control condition. REACH provides text messages tailored to address patient-specific barriers to medication adherence based on the Information-Motivation-Behavioral skills model, whereas FAMS provides monthly phone coaching with related text message content focused on family and friend barriers to diet and exercise adherence. We collect HbA1c and self-reported survey data at baseline and at 3, 6, and 12 months, and again at 15

  4. A randomized pilot trial of a moderate carbohydrate diet compared to a very low carbohydrate diet in overweight or obese individuals with type 2 diabetes mellitus or prediabetes

    OpenAIRE

    Saslow, LR; Kim, S; Daubenmier, JJ; Moskowitz, JT; Phinney, SD; Goldman, V; Murphy, EJ; Cox, RM; Moran, P; Hecht, FM

    2014-01-01

    We compared the effects of two diets on glycated hemoglobin (HbA1c) and other health-related outcomes in overweight or obese adults with type 2 diabetes or prediabetes (HbA1c>6%). We randomized participants to either a medium carbohydrate, low fat, calorie-restricted, carbohydrate counting diet (MCCR) consistent with guidelines from the American Diabetes Association (n = 18) or a very low carbohydrate, high fat, non calorie-restricted diet whose goal was to induce nutritional ketosis (LCK, n ...

  5. Random genetic drift, natural selection, and noise in human cranial evolution.

    Science.gov (United States)

    Roseman, Charles C

    2016-08-01

    This study assesses the extent to which relationships among groups complicate comparative studies of adaptation in recent human cranial variation and the extent to which departures from neutral additive models of evolution hinder the reconstruction of population relationships among groups using cranial morphology. Using a maximum likelihood evolutionary model fitting approach and a mixed population genomic and cranial data set, I evaluate the relative fits of several widely used models of human cranial evolution. Moreover, I compare the goodness of fit of models of cranial evolution constrained by genomic variation to test hypotheses about population specific departures from neutrality. Models from population genomics are much better fits to cranial variation than are traditional models from comparative human biology. There is not enough evolutionary information in the cranium to reconstruct much of recent human evolution but the influence of population history on cranial variation is strong enough to cause comparative studies of adaptation serious difficulties. Deviations from a model of random genetic drift along a tree-like population history show the importance of environmental effects, gene flow, and/or natural selection on human cranial variation. Moreover, there is a strong signal of the effect of natural selection or an environmental factor on a group of humans from Siberia. The evolution of the human cranium is complex and no one evolutionary process has prevailed at the expense of all others. A holistic unification of phenome, genome, and environmental context, gives us a strong point of purchase on these problems, which is unavailable to any one traditional approach alone. Am J Phys Anthropol 160:582-592, 2016. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  6. Effects of Urtica dioica supplementation on blood lipids, hepatic enzymes and nitric oxide levels in type 2 diabetic patients: A double blind, randomized clinical trial.

    Science.gov (United States)

    Amiri Behzadi, Alidad; Kalalian-Moghaddam, Hamid; Ahmadi, Amir Hossein

    2016-01-01

    Oxidative stress plays an important role in the development of diabetic complications including metabolic abnormality-induced diabetic micro-vascular and macro-vascular complications. Urtica dioica L. ( U. dioica ) has been traditionally used in Iranian medicine as an herbal remedy for hypoglycemic or due to its anti-inflammatory properties. The aim of the present study was to evaluate the effects of hydro-alcoholic extract of U. dioica on blood lipids, hepatic enzymes and nitric oxide levels in patients with type 2 diabetes mellitus. 50 women with type 2 diabetes participated in this study and were randomly divided into two groups namely, control and intervention groups. Control group received placebo and intervention group received hydro-alcoholic extract of U. dioica . Before and after 8 weeks of continuous treatment, some biochemical serum levels including FPG, TG, SGPT, SGOT, HDL, LDL, SOD and NO were measured. The results indicated that after 8 weeks, in the intervention group, FPG, TG, and SGPT levels significantly decreased and HDL, NO and SOD levels significantly increased as compared to the control group. Our results encourage the use of hydro-alcoholic extract of U. dioica as an antioxidant agent for additional therapy of diabetes as hydro-alcoholic extract of U. dioica may decrease risk factors of cardiovascular incidence and other complications in patients with diabetes mellitus.

  7. Effects of Urtica dioica supplementation on blood lipids, hepatic enzymes and nitric oxide levels in type 2 diabetic patients: A double blind, randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Alidad Amiri Behzadi

    2016-11-01

    Full Text Available Objective: Oxidative stress plays an important role in the development of diabetic complications including metabolic abnormality-induced diabetic micro-vascular and macro-vascular complications. Urtica dioica L. (U. dioica has been traditionally used in Iranian medicine as an herbal remedy for hypoglycemic or due to its anti-inflammatory properties. The aim of the present study was to evaluate the effects of hydro-alcoholic extract of U. dioica on blood lipids, hepatic enzymes and nitric oxide levels in patients with type 2 diabetes mellitus. Materials and Methods: 50 women with type 2 diabetes participated in this study and were randomly divided into two groups namely, control and intervention groups. Control group received placebo and intervention group received hydro-alcoholic extract of U. dioica. Before and after 8 weeks of continuous treatment, some biochemical serum levels including FPG, TG, SGPT, SGOT, HDL, LDL, SOD and NO were measured. Results: The results indicated that after 8 weeks, in the intervention group, FPG, TG, and SGPT levels significantly decreased and HDL, NO and SOD levels significantly increased as compared to the control group. Conclusion: Our results encourage the use of hydro-alcoholic extract of U. dioica as an antioxidant agent for additional therapy of diabetes as hydro-alcoholic extract of U. dioica may decrease risk factors of cardiovascular incidence and other complications in patients with diabetes mellitus.

  8. Prevention of contrast-induced nephropathy with single bolus erythropoietin in patients with diabetic kidney disease: A randomized controlled trial.

    Science.gov (United States)

    Shema-Didi, Lilach; Kristal, Batya; Eizenberg, Sarit; Marzuq, Nabil; Sussan, Majdy; Feldman-Idov, Yulie; Ofir, Pnina; Atar, Shaul

    2016-04-01

    Contrast-induced-nephropathy (CIN) is associated with poor outcomes, thus prevention of CIN may be of clinical value. Erythropoietin (EPO) has been shown to elicit tissue-protective effects in experimental models and in clinical studies of acute kidney injury. We therefore evaluated its effectiveness for prevention of CIN after coronary angiography (CA) ± percutaneous coronary intervention (PCI) in diabetic patients with chronic kidney disease. A prospective, randomized, controlled trial was carried out in 138 diabetic patients with eGFR <60 mL/min who underwent non-urgent CA ± PCI. Patients received normal saline and n-acetyl cysteine before CA, with or without 50,000 U of EPO administered 30 min prior to CA. CIN was defined as an increase in serum creatinine of at least 0.5 mg/dL during the first 2 days after exposure to contrast media. Primary outcome was the incidence of CIN. Secondary outcomes were the sensitivity and positive predictive value (PPV) of Cystatin C (CC) and Neutrophil-gelatinase-associated-lipocalin (NGAL) for diagnosis of CIN. The observed incidence of CIN was 8.7%, significantly lower than the expected for such high-risk population. The administration of EPO prior to CA did not reduce the incidence of CIN (9.7% vs. 7.6%, P = 0.65). CC and NGAL demonstrated a low sensitivity (16.6%) and low PPV (6.7 and 33.3%, respectively) for detecting CIN. The administration of EPO prior to CA did not reduce the incidence of CIN. Additional prospective research with a larger sample size and in other patient categories is essential to further define the potential protective effect of EPO on prevention of CIN. © 2015 Asian Pacific Society of Nephrology.

  9. Web-Based Cognitive Behavior Therapy for Depression in People With Diabetes Mellitus: A Randomized Controlled Trial.

    Science.gov (United States)

    Newby, Jill; Robins, Lisa; Wilhelm, Kay; Smith, Jessica; Fletcher, Therese; Gillis, Inika; Ma, Trevor; Finch, Adam; Campbell, Lesley; Andrews, Gavin

    2017-05-15

    Depression is twice as common in diabetes mellitus (DM) as the general population and is associated with adverse health outcomes, but access to evidence-based therapies such as cognitive behavioral therapy (CBT) is limited in routine diabetes care. Past research has shown that generic Internet-based cognitive behavioral therapy (iCBT) is an effective treatment for depression in the general population, but it has never been evaluated in people with comorbid depression and DM. The aim of our study was to examine the efficacy of a generic 6-lesson iCBT delivered over 10 weeks in people with major depressive disorder (MDD) and DM. Participants with comorbid MDD and DM (type 1 or 2) were recruited online and randomized to an iCBT program with therapist support provided by phone and email (n=42) or a treatment as usual (TAU, n=49) control group. Outcomes were assessed through Web-based self-report questionnaires and the trial was Web-based with no face-to-face components. Primary outcomes were self-reported depression (patient health questionnaire-9, PHQ-9), diabetes-related distress (problem areas in diabetes, PAID), and self-reported glycemic control (hemoglobin A1c, HbA1c). Secondary outcomes were general distress (Kessler 10-item psychological distress scale, K-10) and disability (short form 12-item, SF-12), generalized anxiety (generalized anxiety disorder 7-item, GAD-7), and somatization (PHQ-15). The iCBT group was assessed at 3 months. A total of 27 participants (66%; 27/41) completed the iCBT program. Analyses indicated between-group superiority of iCBT over TAU at posttreatment on PHQ-9 (g=0.78), PAID (g=0.80), K-10 (g=1.06), GAD-7 (g=0.72), and SF-12 mental well-being scores (g=0.66), but no significant differences in self-reported HbA1c levels (g=0.14), SF-12 physical well-being, or PHQ-15 scores (g=0.03-0.21). Gains were maintained at 3-month follow-up in the iCBT group, and the 87% (27/31) of iCBT participants who were interviewed no longer met criteria for

  10. Rationale and design of the Miami Healthy Heart Initiative: a randomized controlled study of a community health worker intervention among Latino patients with poorly controlled diabetes

    Directory of Open Access Journals (Sweden)

    Carrasquillo O

    2014-02-01

    Full Text Available Olveen Carrasquillo,1,2 Elizabeth Patberg,1 Yisel Alonzo,1 Hua Li,2 Sonjia Kenya1 1Department of Medicine, 2Public Health Sciences, University of Miami, Miller School of Medicine, Miami, FL, USA Background: Type 2 diabetes mellitus disproportionately affects the Latino community. Latinos with diabetes are also less likely to have adequate control of cardiovascular risk factors such as cholesterol and blood pressure. Community health workers (CHWs are increasingly being used to address various health disparity conditions, including diabetes. However, evidence of their effectiveness from randomized controlled trials is limited. Methods: The Miami Health Heart Initiative is a randomized controlled trial of 300 Latino patients with diabetes. Patients with hemoglobin A1c (HbA1c ≥8.0% were recruited from Miami-Dade's public hospital system. At baseline, all patients underwent phlebotomy, physical examination, and a structured 90-minute research interview. They were then randomized to either usual care or a CHW intervention called Cariño. For participants in the Cariño arm of the study, CHW services included assistance with nonmedical social services, health education, and patient navigation in which the CHWs serve as a bridge between patients and the health care system. These services were delivered through home visits, phone calls, and group visits. At 12 months, all subjects had a follow-up examination. The primary outcomes at 1 year are changes in systolic blood pressure, low-density lipoprotein, and HbA1c. Secondary outcomes include medication adherence, medication intensification, diabetes self-efficacy, physical activity, and self-reported fruit and vegetable intake. Discussion: The Miami Healthy Heart Initiative is one of the first rigorously conducted randomized controlled trials to provide evidence on the impact of CHWs on diabetes intermediate outcomes among Latinos. If the data support our primary hypotheses, the study would lend added

  11. Comparison of paroxetine and agomelatine in depressed type 2 diabetes mellitus patients: a double-blind, randomized, clinical trial

    Directory of Open Access Journals (Sweden)

    Kang RY

    2015-05-01

    Full Text Available Ruiying Kang,1 Yan He,1 Yuxiang Yan,1 Zhiwu Li,2 Yeqing Wu,3 Xiaojuan Guo,4 Zhigang Liang,5 Jun Jiang2 1Department of Epidemiology and Biostatics, School of Public Health, Capital Medical University, Beijing, People’s Republic of China; 2Fengtai Nanyuan Hospital of Beijing, Beijing, People’s Republic of China; 3Fengtai District Community Health Center, Beijing, People’s Republic of China; 4Department of Preventive Medicine, School of Environmental and Public Health, Wenzhou Medical University, Wenzhou, People’s Republic of China; 5Xuanwu Hospital, Capital Medical University, Beijing, People’s Republic of China Background: Comorbid depression/anxiety in type 2 diabetes mellitus (DM patients is highly prevalent, affecting both diabetes control and quality of life. However, the best treating method for depression/anxiety in type 2 DM patients is still unclear. This study was conducted to compare the efficacy of paroxetine and agomelatine on depression/anxiety and metabolic control of type 2 DM patients.Methods: A total of 116 depressed, type 2 DM patients were recruited for 12 weeks treatment. Patients were randomly assigned to receive either paroxetine or agomelatine. Hamilton Depression Rating Scale and Hamilton Anxiety Rating Scale were used to assess depression and anxiety, respectively. Hemoglobin A1c, fasting plasma glucose, and body mass index were assessed at baseline and at the end of the trial.Results: At the end of the trial, there were 34 (60.7% responders and 22 (39.3% remissions in paroxetine group; and 38 (63.3% responders and 26 (43.3% remissions in agomelatine group. Compared to paroxetine group, lower depression scores were observed in agomelatine group. Fasting plasma glucose and body mass index were not significantly different after 12 weeks treatment between the two groups, but agomelatine group had a significantly lower final hemoglobin A1c level compared to paroxetine group. The two antidepressants had comparable

  12. TECNOB: study design of a randomized controlled trial of a multidisciplinary telecare intervention for obese patients with type-2 diabetes

    Directory of Open Access Journals (Sweden)

    Tuzzi Cristina

    2010-04-01

    Full Text Available Abstract Background Obesity is one of the most important medical and public health problems of our time: it increases the risk of many health complications such as hypertension, coronary heart disease and type 2 diabetes, needs long-lasting treatment for effective results and involves high public and private costs. Therefore, it is imperative that enduring and low-cost clinical programs for obesity and related co-morbidities are developed and evaluated. Methods/Design TECNOB (TEChnology for OBesity is a comprehensive two-phase stepped down program enhanced by telemedicine for the long-term treatment of obese people with type 2 diabetes seeking intervention for weight loss. Its core features are the hospital-based intensive treatment (1-month, that consists of diet therapy, physical training and psychological counseling, and the continuity of care at home using new information and communication technologies (ICT such as internet and mobile phones. The effectiveness of the TECNOB program compared with usual care (hospital-based treatment only will be evaluated in a randomized controlled trial (RCT with a 12-month follow-up. The primary outcome is weight in kilograms. Secondary outcome measures are energy expenditure measured using an electronic armband, glycated hemoglobin, binge eating, self-efficacy in eating and weight control, body satisfaction, healthy habit formation, disordered eating-related behaviors and cognitions, psychopathological symptoms and weight-related quality of life. Furthermore, the study will explore what behavioral and psychological variables are predictive of treatment success among those we have considered. Discussion The TECNOB study aims to inform the evidence-based knowledge of how telemedicine may enhance the effectiveness of clinical interventions for weight loss and related type-2 diabetes, and which type of obese patients may benefit the most from such interventions. Broadly, the study aims also to have a effect on

  13. Multi-Label Learning via Random Label Selection for Protein Subcellular Multi-Locations Prediction.

    Science.gov (United States)

    Wang, Xiao; Li, Guo-Zheng

    2013-03-12

    Prediction of protein subcellular localization is an important but challenging problem, particularly when proteins may simultaneously exist at, or move between, two or more different subcellular location sites. Most of the existing protein subcellular localization methods are only used to deal with the single-location proteins. In the past few years, only a few methods have been proposed to tackle proteins with multiple locations. However, they only adopt a simple strategy, that is, transforming the multi-location proteins to multiple proteins with single location, which doesn't take correlations among different subcellular locations into account. In this paper, a novel method named RALS (multi-label learning via RAndom Label Selection), is proposed to learn from multi-location proteins in an effective and efficient way. Through five-fold cross validation test on a benchmark dataset, we demonstrate our proposed method with consideration of label correlations obviously outperforms the baseline BR method without consideration of label correlations, indicating correlations among different subcellular locations really exist and contribute to improvement of prediction performance. Experimental results on two benchmark datasets also show that our proposed methods achieve significantly higher performance than some other state-of-the-art methods in predicting subcellular multi-locations of proteins. The prediction web server is available at http://levis.tongji.edu.cn:8080/bioinfo/MLPred-Euk/ for the public usage.

  14. Cluster randomized controlled trial of a peer support program for people with diabetes: study protocol for the Australasian peers for progress study

    Directory of Open Access Journals (Sweden)

    Riddell Michaela A

    2012-10-01

    Full Text Available Abstract Background Well managed diabetes requires active self-management in order to ensure optimal glycaemic control and appropriate use of available clinical services and other supports. Peer supporters can assist people with their daily diabetes self-management activities, provide emotional and social support, assist and encourage clinical care and be available when needed. Methods A national database of Australians diagnosed with type 2 diabetes is being used to invite people in pre-determined locations to participate in community-based peer support groups. Peer supporters are self-identified from these communities. All consenting participants receive diabetes self-management education and education manual prior to randomization by community to a peer support intervention or usual care. This multi-faceted intervention comprises four interconnected components for delivering support to the participants. (1 Trained supporters lead 12 monthly group meetings. Participants are assisted to set goals to improve diabetes self-management, discuss with and encourage each other to strengthen linkages with local clinical services (including allied health services as well as provide social and emotional support. (2 Support through regular supporter-participant or participant-participant contact, between monthly sessions, is also promoted in order to maintain motivation and encourage self-improvement and confidence in diabetes self-management. (3 Participants receive a workbook containing diabetes information, resources and community support services, key diabetes management behaviors and monthly goal setting activity sheets. (4 Finally, a password protected website contains further resources for the participants. Supporters are mentored and assisted throughout the intervention by other supporters and the research team through attendance at a weekly teleconference. Data, including a self-administered lifestyle survey, anthropometric and biomedical

  15. Protocol for the CHORD project (community health outreach to reduce diabetes): a cluster-randomized community health worker trial to prevent diabetes.

    Science.gov (United States)

    Islam, Nadia; Gepts, Thomas; Lief, Isaac; Gore, Radhika; Levy, Natalie; Tanner, Michael; Fang, Yixin; Sherman, Scott E; Schwartz, Mark D

    2018-04-19

    Type 2 diabetes mellitus (DM) affects 9.4% of US adults and children, while another 33.9% of Americans are at risk of DM. Health care institutions face many barriers to systematically delivering the preventive care needed to decrease DM incidence. Community health workers (CHWs) may, as frontline public health workers bridging clinic and community, help overcome these challenges. This paper presents the protocol for a pragmatic, cluster-randomized trial integrating CHWs into two primary care clinics to support DM prevention for at-risk patients. The trial will randomize 15 care teams, stratified by practice site (Bellevue Hospital and Manhattan VA), totaling 56 primary care physicians. The study cohort will consist of ~ 2000 patients who are 18-75 years of age, actively enrolled in a primary care team, able to speak English or Spanish, and have at least one glycosylated hemoglobin (HbA1c) result in the prediabetic range (5.7-6.4%) since 2012. Those with a current DM diagnosis or DM medication prescription (other than metformin) are ineligible. The intervention consists of four core activities - setting health goals, health education, activation for doctor's appointments, and referrals to DM prevention programs - adjustable according to the patient's needs and readiness. The primary outcome is DM incidence. Secondary outcomes include weight loss, HbA1C, and self-reported health behaviors. Clinical variables and health behaviors will be obtained through electronic medical records and surveys, respectively. Implementation outcomes, namely implementation fidelity and physicians' perspectives about CHW integration into the clinic, will be assessed using interviews and CHW activity logs and analyzed for the influence of moderating organizational factors. This is the first rigorous, pragmatic trial to test the effectiveness of integrating CHWs into primary care for DM prevention reaching a population-based sample. Our study's limitations include language

  16. ForgIng New paths in DIabetes PrevenTion (FINDIT): Study Protocol for a Randomized Controlled Trial.

    Science.gov (United States)

    Kullgren, Jeffrey T; Youles, Bradley; Shetty, Shaina; Richardson, Caroline; Fagerlin, Angela; Heisler, Michele

    2017-04-08

    Prediabetes is an asymptomatic condition in which patients' blood glucose levels are higher than normal but do not meet diagnostic criteria for type 2 diabetes mellitus (T2DM). A key window of opportunity to increase engagement of patients with prediabetes in strategies to prevent T2DM is when they are screened for T2DM and found to have prediabetes, yet the effects of this screening and brief counseling are unknown. In this parallel-design randomized controlled trial we will recruit 315 non-diabetic patients from the Ann Arbor VA Medical Center (AAVA) who have one or major risk factors for T2DM and an upcoming primary care appointment at the AAVA, but have not had a hemoglobin A1c (HbA1c) test to screen for T2DM in the previous 12 months. After informed consent, participants will complete a baseline survey and be randomly assigned to, at the time of their next primary care appointment, one of two arms: (1) to have a hemoglobin A1c (HbA1c) test to screen for T2DM and receive brief, standardized counseling about these results or (2) to review a brochure about clinical preventive services. Participants will complete surveys 2 weeks, 3 months, and 12 months after their primary care appointment, and a weight measurement 12 months after their primary care appointment. The primary outcome is weight change after 12 months. The secondary outcomes are changes in perception of risk for T2DM; knowledge of T2DM prevention; self-efficacy and motivation to prevent T2DM; use of pharmacotherapy for T2DM prevention; physical activity; participation in weight management programs; and mental health. Quantitative analyses will compare outcomes among participants in the HbA1c test arm found to have prediabetes with participants in the brochure arm. Among participants in the HbA1c test arm found to have prediabetes we will conduct semi-structured interviews about their understanding of and reactions to receiving a prediabetes diagnosis. This trial will generate foundational data

  17. Impact of an acceptance facilitating intervention on diabetes patients' acceptance of Internet-based interventions for depression: a randomized controlled trial.

    Science.gov (United States)

    Baumeister, H; Nowoczin, L; Lin, J; Seifferth, H; Seufert, J; Laubner, K; Ebert, D D

    2014-07-01

    To (1) determine diabetes patients' acceptance of Internet-based interventions (IBIs) for depression, to (2) examine the effectiveness of an acceptance facilitating intervention (AFI) and to (3) explore subgroup specific effects. 141 diabetes patients from two inpatient rehabilitation units and one outpatient clinic in Germany were randomly allocated to an intervention (IG) and a no-intervention control group (CG). The IG received an AFI consisting of a personal information session before filling-out a questionnaire on patients' acceptance of IBIs, predictors of acceptance (performance expectancy, effort expectancy, social influence, facilitating conditions, and Internet anxiety) as well as sociodemographic, depression-related and diabetes-related variables. The CG filled out the questionnaire immediately. Patients' acceptance of IBIs was measured with a four-item scale (sum-score ranging from 4 to 20). The CG showed a low (50.7%) to medium (40.8%) acceptance with only 8.5% of all diabetes patients reporting a high acceptance of IBIs for depression. The AFI had no significant effect on acceptance (IG: M=10.55, SD=4.69, n=70; KG: M=9.65, SD=4.27, n=71; d=0.20 [95%-CI: -0.13;0.53]) and the predictors of acceptance. Yet, subgroup analyses yielded a trend for depressed, diabetes-related distressed, female and younger (Internet to profit from the AFI. Diabetes patients show a rather low acceptance toward IBIs for depression. Findings indicate that the AFI is likely to be effective in the subgroup of depressed, diabetes-related distressed, female or younger diabetes patients, but not in the whole target population. Hence, AFIs might need to be tailored to the specific needs of subpopulations. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  18. Increasing capacity to deliver diabetes self-management education: results of the DESMOND lay educator non-randomized controlled equivalence trial.

    Science.gov (United States)

    Carey, M E; Mandalia, P K; Daly, H; Gray, L J; Hale, R; Martin Stacey, L; Taub, N; Skinner, T C; Stone, M; Heller, S; Khunti, K; Davies, M J

    2014-11-01

    To develop and test a format of delivery of diabetes self-management education by paired professional and lay educators. We conducted an equivalence trial with non-randomized participant allocation to a Diabetes Education and Self Management for Ongoing and Newly Diagnosed Type 2 diabetes (DESMOND) course, delivered in the standard format by two trained healthcare professional educators (to the control group) or by one trained lay educator and one professional educator (to the intervention group). A total of 260 people with Type 2 diabetes diagnosed within the previous 12 months were referred for self-management education as part of routine care and attended either a control or intervention format DESMOND course. The primary outcome measure was change in illness coherence score (derived from the Diabetes Illness Perception Questionnaire-Revised) between baseline and 4 months after attending education sessions. Secondary outcome measures included change in HbA1c level. The trial was conducted in four primary care organizations across England and Scotland. The 95% CI for the between-group difference in positive change in coherence scores was within the pre-set limits of equivalence (difference = 0.22, 95% CI 1.07 to 1.52). Equivalent changes related to secondary outcome measures were also observed, including equivalent reductions in HbA1c levels. Diabetes education delivered jointly by a trained lay person and a healthcare professional educator with the same educator role can provide equivalent patient benefits. This could provide a method that increases capacity, maintains quality and is cost-effective, while increasing access to self-management education. © 2014 The Authors. Diabetic Medicine © 2014 Diabetes UK.

  19. An Innovative Multiphased Strategy to Recruit Underserved Adults into a Randomized Trial of a Community-Based Diabetes Risk Reduction Program

    Science.gov (United States)

    Santoyo-Olsson, Jasmine; Cabrera, Julissa; Freyre, Rachel; Grossman, Melanie; Alvarez, Natalie; Mathur, Deepika; Guerrero, Maria; Delgadillo, Adriana T.; Kanaya, Alka M.; Stewart, Anita L.

    2011-01-01

    Purpose: To conduct and evaluate a two-phased community-based approach to recruit lower socioeconomic status, minority, or Spanish-speaking adults at risk of developing diabetes to a randomized trial of a lifestyle intervention program delivered by a public health department. Design: Within geographic areas comprising our target population, 4 community organizations provided local space for conducting the study and program. Phase I—outreach in venues surrounding these organizations—included diabetes education, a short diabetes risk appraisal (DRA), and diabetes risk screening based on a fasting fingerstick glucose test. Phase II—trial recruitment—began concurrently for those found to be at risk of developing diabetes in Phase I by explaining the study, lifestyle program, and research process. Those interested and eligible enrolled in the 1-year study. Results: Over 2 years, approximately 5,110 individuals received diabetes education, 1,917 completed a DRA, and 1,164 were screened of which 641 (55%) had an elevated fingerstick result of ≥106 mg/dl. Of the study sampling frame—persons over age 25 at risk of developing diabetes (N = 544)—238 (43%) enrolled in the trial; of those who were study eligible (n = 427), 56% enrolled. In the final sample, mean age was 56 years (SD = 17), 78% were ethnic minorities, 32% were Spanish-speaking, and 15% had a high school education or less. Implications: Providing diabetes health education and screening prior to study recruitment may help overcome barriers to research participation in underserved communities, thus helping address difficulties recruiting minority and older populations into research, particularly research pertaining to chronic disease risk factors. PMID:21565823

  20. Virtually optimized insoles for offloading the diabetic foot: A randomized crossover study.

    Science.gov (United States)

    Telfer, S; Woodburn, J; Collier, A; Cavanagh, P R

    2017-07-26

    Integration of objective biomechanical measures of foot function into the design process for insoles has been shown to provide enhanced plantar tissue protection for individuals at-risk of plantar ulceration. The use of virtual simulations utilizing numerical modeling techniques offers a potential approach to further optimize these devices. In a patient population at-risk of foot ulceration, we aimed to compare the pressure offloading performance of insoles that were optimized via numerical simulation techniques against shape-based devices. Twenty participants with diabetes and at-risk feet were enrolled in this study. Three pairs of personalized insoles: one based on shape data and subsequently manufactured via direct milling; and two were based on a design derived from shape, pressure, and ultrasound data which underwent a finite element analysis-based virtual optimization procedure. For the latter set of insole designs, one pair was manufactured via direct milling, and a second pair was manufactured through 3D printing. The offloading performance of the insoles was analyzed for forefoot regions identified as having elevated plantar pressures. In 88% of the regions of interest, the use of virtually optimized insoles resulted in lower peak plantar pressures compared to the shape-based devices. Overall, the virtually optimized insoles significantly reduced peak pressures by a mean of 41.3kPa (p<0.001, 95% CI [31.1, 51.5]) for milled and 40.5kPa (p<0.001, 95% CI [26.4, 54.5]) for printed devices compared to shape-based insoles. The integration of virtual optimization into the insole design process resulted in improved offloading performance compared to standard, shape-based devices. ISRCTN19805071, www.ISRCTN.org. Copyright © 2017 Elsevier Ltd. All rights reserved.

  1. Efficacy of vildagliptin for prevention of postpartum diabetes in women with a recent history of insulin-requiring gestational diabetes: A phase II, randomized, double-blind, placebo-controlled study.

    Science.gov (United States)

    Hummel, Sandra; Beyerlein, Andreas; Pfirrmann, Markus; Hofelich, Anna; Much, Daniela; Hivner, Susanne; Bunk, Melanie; Herbst, Melanie; Peplow, Claudia; Walter, Markus; Kohn, Denise; Hummel, Nadine; Kratzsch, Jürgen; Hummel, Michael; Füchtenbusch, Martin; Hasford, Joerg; Ziegler, Anette-G

    2018-03-01

    Women with insulin-requiring gestational diabetes mellitus (GDM) are at high risk of developing diabetes within a few years postpartum. We implemented this phase II study to test the hypothesis that vildagliptin, a dipeptidyl peptidase-4 inhibitor, is superior to placebo in terms of reducing the risk of postpartum diabetes. Women with insulin-requiring GDM were randomized to either placebo or 50 mg vildagliptin twice daily for 24 months followed by a 12-month observation period (EudraCT: 2007-000634-39). Both groups received lifestyle counseling. The primary efficacy outcomes were the diagnosis of diabetes (American Diabetes Association (ADA) criteria) or impaired fasting glucose (IFG)/impaired glucose tolerance (IGT). Between 2008 and 2015, 113 patients (58 vildagliptin, 55 placebo) were randomized within 2.2-10.4 (median 8.6) months after delivery. At the interim analysis, nine diabetic events and 28 IFG/IGT events had occurred. Fifty-two women withdrew before completing the treatment phase. Because of the low diabetes rate, the study was terminated. Lifestyle adherence was similar in both groups. At 24 months, the cumulative probability of postpartum diabetes was 3% and 5% (hazard ratio: 1.03; 95% confidence interval: 0.15-7.36) and IFG/IGT was 43% and 22% (hazard ratio: 0.55; 95% confidence interval: 0.26-1.19) in the placebo and vildagliptin groups, respectively. Vildagliptin was well tolerated with no unexpected adverse events. The study did not show significant superiority of vildagliptin over placebo in terms of reducing the risk of postpartum diabetes. However, treatment was safe and suggested some improvements in glycemic control, insulin resistance, and β-cell function. The study identified critical issues in performing clinical trials in the early postpartum period in women with GDM hampering efficacy assessments. With this knowledge, we have set a basis for which properly powered trials could be performed in women with recent GDM. TRIAL REGISTRATION

  2. A Traditional Mouthwash (Punica granatum var pleniflora) for Controlling Gingivitis of Diabetic Patients: A Double-Blind Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Sedigh-Rahimabadi, Massih; Fani, Mohammadmehdi; Rostami-Chijan, Mahsa; Zarshenas, Mohammad M; Shams, Mesbah

    2017-01-01

    This study evaluates the safety and efficacy of Punica granatum var pleniflora mouthwash in treatment of diabetic gingivitis. In a double-blind randomized clinical trial 80 patients with diabetes mellitus and gingivitis were assigned to Golnaar and chlorhexidine 0.2% groups. After using mouthwashes for 2 weeks; participants underwent tooth scaling and the last visit was 2 weeks after scaling. The primary outcome measures were plaque, modified gingival and gingival bleeding indices, and pocket depth. Both interventions had significant improvement on all of the gingival and plaque indices (P < .001 for all indices). There were no significant differences between Golnaar and chlorhexidine in primary outcome measures except for modified gingival index for which Golnaar mouthwash had a superiority after 2 weeks when comparing with chlorhexidine (P = .039). Meanwhile, Golnaar mouthwash had no staining effect. Golnaar mouthwash is safe and effective in treatment of gingivitis in diabetic patients although further studies are recommended. © The Author(s) 2016.

  3. Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema: Two-Year Results from a Comparative Effectiveness Randomized Clinical Trial.

    Science.gov (United States)

    Wells, John A; Glassman, Adam R; Ayala, Allison R; Jampol, Lee M; Bressler, Neil M; Bressler, Susan B; Brucker, Alexander J; Ferris, Frederick L; Hampton, G Robert; Jhaveri, Chirag; Melia, Michele; Beck, Roy W

    2016-06-01

    To provide 2-year results comparing anti-vascular endothelial growth factor (VEGF) agents for center-involved diabetic macular edema (DME) using a standardized follow-up and retreatment regimen. Randomized clinical trial. Six hundred sixty participants with visual acuity (VA) impairment from DME. Randomization to 2.0-mg aflibercept, 1.25-mg repackaged (compounded) bevacizumab, or 0.3-mg ranibizumab intravitreous injections performed up to monthly using a protocol-specific follow-up and retreatment regimen. Focal/grid laser photocoagulation was added after 6 months if DME persisted. Visits occurred every 4 weeks during year 1 and were extended up to every 4 months thereafter when VA and macular thickness were stable. Change in VA, adverse events, and retreatment frequency. Median numbers of injections were 5, 6, and 6 in year 2 and 15, 16, and 15 over 2 years in the aflibercept, bevacizumab, and ranibizumab groups, respectively (global P = 0.08). Focal/grid laser photocoagulation was administered in 41%, 64%, and 52%, respectively (aflibercept vs. bevacizumab, P 0.10, for pairwise comparisons). Anti-Platelet Trialists' Collaboration (APTC) events occurred in 5% with aflibercept, 8% with bevacizumab, and 12% with ranibizumab (global P = 0.047; aflibercept vs. bevacizumab, P = 0.34; aflibercept vs. ranibizumab, P = 0.047; ranibizumab vs. bevacizumab, P = 0.20; global P = 0.09 adjusted for potential confounders). All 3 anti-VEGF groups showed VA improvement from baseline to 2 years with a decreased number of injections in year 2. Visual acuity outcomes were similar for eyes with better baseline VA. Among eyes with worse baseline VA, aflibercept had superior 2-year VA outcomes compared with bevacizumab, but superiority of aflibercept over ranibizumab, noted at 1 year, was no longer identified. Higher APTC event rates with ranibizumab over 2 years warrants continued evaluation in future trials. Copyright © 2016 American Academy of Ophthalmology. All rights

  4. Treatment of clozapine-associated obesity and diabetes with exenatide in adults with schizophrenia: A randomized controlled trial (CODEX).

    Science.gov (United States)

    Siskind, Dan J; Russell, Anthony W; Gamble, Clare; Winckel, Karl; Mayfield, Karla; Hollingworth, Sam; Hickman, Ingrid; Siskind, Victor; Kisely, Steve

    2018-04-01

    Clozapine causes obesity and type 2 diabetes (T2DM). Glucagon-like peptide-1 (GLP-1) receptor agonists (e.g. exenatide) can counter clozapine-associated GLP-1 dysregulation in animals, and may be beneficial in people on clozapine. This randomized, controlled, open-label, pilot trial evaluated weekly exenatide for weight loss among clozapine-treated obese adults with schizophrenia, with or without T2DM. A total of 28 outpatients were randomized to once-weekly extended-release subcutaneous exenatide or usual care for 24 weeks. The primary outcome was proportion of participants with >5% weight loss. All 28 participants completed the study; 3/14 in the exenatide group and 2/14 in the usual care group had T2DM. Six people on exenatide achieved >5% weight loss vs one receiving usual care (P = .029). Compared with usual care, participants on exenatide had greater mean weight loss (-5.29 vs -1.12 kg; P = .015) and body mass index reduction (-1.78 vs -0.39 kg/m 2 ; P = .019), and reduced fasting glucose (-0.34 vs 0.39 mmol/L; P = .036) and glycated haemoglobin levels (-0.21% vs 0.03%; P = .004). There were no significant differences in other metabolic syndrome components. Exenatide may be a promising therapeutic agent for glycaemic control and weight loss in clozapine-treated people with obesity, and could assist in reducing clozapine-associated cardio-metabolic morbidity and mortality. © 2017 John Wiley & Sons Ltd.

  5. Phyto-metals screening of selected anti-diabetic herbs and infused concoctions

    Directory of Open Access Journals (Sweden)

    Olanrewaju O. Olujimi

    2017-10-01

    Conclusions: The study thus shows that the herbs and concoctions are safe from the heavy metals considered. However, right dosage of the anti-diabetic concoctions should always be considered to prevent possible chronic side effects from bio-accumulation of heavy metals.

  6. Incentives in Diabetic Eye Assessment by Screening (IDEAS): study protocol of a three-arm randomized controlled trial using financial incentives to increase screening uptake in London.

    Science.gov (United States)

    Judah, Gaby; Vlaev, Ivo; Gunn, Laura; King, Dominic; King, Derek; Valabhji, Jonathan; Darzi, Ara; Bicknell, Colin

    2016-03-18

    Diabetes is an increasing public health problem in the UK and globally. Diabetic retinopathy is a microvascular complication of diabetes, and is one of the leading causes of blindness in the UK working age population. The diabetic eye screening programme in England aims to invite all people with diabetes aged 12 or over for retinal photography to screen for the presence of diabetic retinopathy. However, attendance rates are only 81 %, leaving many people at risk of preventable sight loss. This is a three arm randomized controlled trial to investigate the impact of different types of financial incentives (based on principles from behavioral economics) on increasing attendance at diabetic eye screening appointments in London. Eligible participants will be aged 16 or over, and are those who have been invited to screening appointments annually, but who have not attended, or telephoned to rearrange an appointment, within the last 24 months. Eligible participants will be randomized to one of three conditions: 1. Control condition (usual invitation letter) 2. Fixed incentive condition (usual invitation letter, including a voucher for £10 if they attend their appointment) 3. Probabilistic incentive condition (invitation letter, including a voucher for a 1 in 100 chance of winning £1000 if they attend their appointment). Participants will be sent invitation letters, and the primary outcome will be whether or not they attend their appointment. One thousand participants will be included in total, randomized with a ratio of 1.4:1:1. In order to test whether the incentive scheme has a differential impact on patients from different demographic or socio-economic groups, information will be recorded on age, gender, distance from screening center, socio-economic status and length of time since they were last screened. A cost-effectiveness analysis will also be performed. This study will be the first trial of financial incentives for improving uptake of diabetic eye screening. If

  7. Awareness of diabetic retinopathy among patients with type 2 diabetes mellitus in Jordan.

    Science.gov (United States)

    Bakkar, May M; Haddad, Mera F; Gammoh, Yazan S

    2017-01-01

    Increasing the level of awareness of diabetic retinopathy among individuals with type 2 diabetes mellitus is considered an important factor for early diagnosis and management of diabetic retinopathy. The aim of this study was to evaluate awareness of diabetic retinopathy among a sample of type 2 diabetes mellitus patients in Jordan. The study period was from August to December 2015. The sample was selected randomly from patients with type 2 diabetes mellitus from the general population in three main cities of Jordan (Amman, Irbid, and Zarqa). A questionnaire was distributed to 237 participants with diabetes to assess their awareness and knowledge of diabetes and diabetic retinopathy. The questionnaire included questions to assess awareness about diabetic retinopathy, sources of knowledge about the disease, and patients' knowledge and compliance with available treatments and routine eye examinations. Patients were also questioned about the barriers that may interfere with early eye examination. A total of 237 participants (107 [45.1%] females and 130 [54.9%] males) with type 2 diabetes were interviewed. Mean age±SD for the study population was 54.51±10.28 years. Of the study population, 88.2% were aware that diabetes can affect the eyes and 81% reported that diabetic retinopathy can lead to blindness. Higher level of patients' awareness of diabetic retinopathy was related to higher level of formal education ( p diabetic retinopathy as reported by 47.3% patients was general practitioners. Patients' compliance with diabetes management was relatively high; however, their compliance with routine retinal assessment was poor, with only a total of 29.5% of participants having had an eye examination in the previous year. Awareness of the nature and consequences of diabetic retinopathy among patients with diabetes in Jordan is relatively high. However, patients' motivation to undergo retinal assessment was poor in the sample, thus hindering early diagnosis and management.

  8. Differential privacy-based evaporative cooling feature selection and classification with relief-F and random forests.

    Science.gov (United States)

    Le, Trang T; Simmons, W Kyle; Misaki, Masaya; Bodurka, Jerzy; White, Bill C; Savitz, Jonathan; McKinney, Brett A

    2017-09-15

    Classification of individuals into disease or clinical categories from high-dimensional biological data with low prediction error is an important challenge of statistical learning in bioinformatics. Feature selection can improve classification accuracy but must be incorporated carefully into cross-validation to avoid overfitting. Recently, feature selection methods based on differential privacy, such as differentially private random forests and reusable holdout sets, have been proposed. However, for domains such as bioinformatics, where the number of features is much larger than the number of observations p≫n , these differential privacy methods are susceptible to overfitting. We introduce private Evaporative Cooling, a stochastic privacy-preserving machine learning algorithm that uses Relief-F for feature selection and random forest for privacy preserving classification that also prevents overfitting. We relate the privacy-preserving threshold mechanism to a thermodynamic Maxwell-Boltzmann distribution, where the temperature represents the privacy threshold. We use the thermal statistical physics concept of Evaporative Cooling of atomic gases to perform backward stepwise privacy-preserving feature selection. On simulated data with main effects and statistical interactions, we compare accuracies on holdout and validation sets for three privacy-preserving methods: the reusable holdout, reusable holdout with random forest, and private Evaporative Cooling, which uses Relief-F feature selection and random forest classification. In simulations where interactions exist between attributes, private Evaporative Cooling provides higher classification accuracy without overfitting based on an independent validation set. In simulations without interactions, thresholdout with random forest and private Evaporative Cooling give comparable accuracies. We also apply these privacy methods to human brain resting-state fMRI data from a study of major depressive disorder. Code

  9. Effect of tree nuts on glycemic control in diabetes: a systematic review and meta-analysis of randomized controlled dietary trials.

    Directory of Open Access Journals (Sweden)

    Effie Viguiliouk

    Full Text Available Tree nut consumption has been associated with reduced diabetes risk, however, results from randomized trials on glycemic control have been inconsistent.To provide better evidence for diabetes guidelines development, we conducted a systematic review and meta-analysis of randomized controlled trials to assess the effects of tree nuts on markers of glycemic control in individuals with diabetes.MEDLINE, EMBASE, CINAHL, and Cochrane databases through 6 April 2014.Randomized controlled trials ≥3 weeks conducted in individuals with diabetes that compare the effect of diets emphasizing tree nuts to isocaloric diets without tree nuts on HbA1c, fasting glucose, fasting insulin, and HOMA-IR.Two independent reviewer's extracted relevant data and assessed study quality and risk of bias. Data were pooled by the generic inverse variance method and expressed as mean differences (MD with 95% CI's. Heterogeneity was assessed (Cochran Q-statistic and quantified (I2.Twelve trials (n = 450 were included. Diets emphasizing tree nuts at a median dose of 56 g/d significantly lowered HbA1c (MD = -0.07% [95% CI:-0.10, -0.03%]; P = 0.0003 and fasting glucose (MD = -0.15 mmol/L [95% CI: -0.27, -0.02 mmol/L]; P = 0.03 compared with control diets. No significant treatment effects were observed for fasting insulin and HOMA-IR, however the direction of effect favoured tree nuts.Majority of trials were of short duration and poor quality.Pooled analyses show that tree nuts improve glycemic control in individuals with type 2 diabetes, supporting their inclusion in a healthy diet. Owing to the uncertainties in our analyses there is a need for longer, higher quality trials with a focus on using nuts to displace high-glycemic index carbohydrates.ClinicalTrials.gov NCT01630980.

  10. Effectiveness of technology-assisted case management in low income adults with type 2 diabetes (TACM-DM: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Strom Joni L

    2011-10-01

    Full Text Available Abstract Background An estimated 1 in 3 American adults will have diabetes by the year 2050. Nationally, South Carolina ranks 10th in cases of diagnosed diabetes compared to other states. In adults, type 2 diabetes (T2DM accounts for approximately 90-95% of all diagnosed cases of diabetes. Clinically, provider and health system factors account for Methods We describe a four-year prospective, randomized clinical trial, which will test the effectiveness of technology-assisted case management in low income rural adults with T2DM. Two-hundred (200 male and female participants, 18 years of age or older and with an HbA1c ≥ 8%, will be randomized into one of two groups: (1 an intervention arm employing the innovative FORA system coupled with nurse case management or (2 a usual care group. Participants will be followed for 6-months to ascertain the effect of the interventions on glycemic control. Our primary hypothesis is that among indigent, rural adult patients with T2DM treated in FQHC's, participants randomized to the technology-assisted case management intervention will have significantly greater reduction in HbA1c at 6 months of follow-up compared to usual care. Discussion Results from this study will provide important insight into the effectiveness of technology-assisted case management intervention (TACM for optimizing diabetes care in indigent, rural adult patients with T2DM treated in FQHC's. Trial Registration National Institutes of Health Clinical Trials Registry (http://ClinicalTrials.gov identifier# NCT01373489

  11. Mobile Phone Support for Diabetes Self-Care Among Diverse Adults: Protocol for a Three-Arm Randomized Controlled Trial.

    Science.gov (United States)

    Nelson, Lyndsay A; Wallston, Kenneth A; Kripalani, Sunil; Greevy, Robert A; Elasy, Tom A; Bergner, Erin M; Gentry, Chad K; Mayberry, Lindsay S

    2018-04-10

    Nonadherence to self-care is common among patients with type 2 diabetes (T2D) and often leads to severe complications. Moreover, patients with T2D who have low socioeconomic status and are racial/ethnic minorities disproportionately experience barriers to adherence and poor outcomes. Basic phone technology (text messages and phone calls) provides a practical medium for delivering content to address patients' barriers to adherence; however, trials are needed to explore long-term and sustainable effects of mobile phone interventions among diverse patients. The aim of this study is to evaluate the effects of mobile phone-based diabetes support interventions on self-care and hemoglobin A 1c (HbA 1c ) among adults with T2D using a 3-arm, 15-month randomized controlled trial with a Type 1 hybrid effectiveness-implementation approach. The intervention arms are (1) Rapid Encouragement/Education And Communications for Health (REACH) and (2) REACH + Family-focused Add-on for Motivating Self-care (FAMS). We recruited primary care patients with T2D (N=512) from Federally Qualified Health Centers and an academic medical center, prioritizing recruitment of publicly insured and minority patients from the latter. Eligible patients were prescribed daily diabetes medication and owned a cell phone with text messaging capability. We excluded patients whose most recent HbA 1c result within 12 months was phone coaching with related text message content focused on family and friend barriers to diet and exercise adherence. We collect HbA 1c and self-reported survey data at baseline and at 3, 6, and 12 months, and again at 15 months to assess sustained changes. We will use generalized estimating equation models to test the effects of REACH (either intervention arm) on HbA 1c relative to the control group, the potential additive effects of FAMS, and effects of either intervention on adherence to self-care behaviors and diabetes self-efficacy. The trial is ongoing; recruitment closed

  12. A Mobile App for the Self-Management of Type 1 Diabetes Among Adolescents: A Randomized Controlled Trial.

    Science.gov (United States)

    Goyal, Shivani; Nunn, Caitlin A; Rotondi, Michael; Couperthwaite, Amy B; Reiser, Sally; Simone, Angelo; Katzman, Debra K; Cafazzo, Joseph A; Palmert, Mark R

    2017-06-19

    While optimal blood glucose control is known to reduce the long-term complications associated with type 1 diabetes mellitus, adolescents often struggle to achieve their blood glucose targets. However, their strong propensity toward technology presents a unique opportunity for the delivery of novel self-management interventions. To support type 1 diabetes self-management in this population, we developed the diabetes self-management app bant, which included wireless blood glucose reading transfer, out-of-range blood glucose trend alerts, coaching around out-of-range trend causes and fixes, and a point-based incentive system. The primary objective was to evaluate bant 's effect on hemoglobin A 1c (HbA 1c ) through a randomized controlled trial (RCT). Secondary measures (eg, self-monitoring of blood glucose [SMBG]) were also collected to assess bant 's impact on the self-management behaviors of adolescents with type 1 diabetes. We enrolled 92 adolescents into a 12-month RCT, with 46 receiving usual care and 46 receiving usual care plus bant. Clinical outcome data were collected at quarterly research visits via validated tools, electronic chart review, glucometer downloads, and semistructured interviews. App satisfaction was assessed at 6 and 12 months, and at trial end, users ranked bant components based on perceived usefulness. Mobile analytics captured frequency of blood glucose uploads, which were used to categorize participants into high, moderate, low, or very low engagement levels. Linear mixed models showed no changes in primary and secondary clinical outcomes. However, exploratory regression analysis demonstrated a statistically significant association between increased SMBG and improved HbA 1c in the intervention group. For a subgroup of bant users taking SMBG ≥5 daily, there was a significant improvement in HbA 1c of 0.58% (P=.02), while the parallel subgroup in the control arm experienced no significant change in HbA 1c (decrease of 0.06%, P=.84). Although

  13. Comparison of clinical effectiveness of laser acupuncture and amitriptyline in diabetic peripheral neuropathy (DPN): a sham controlled randomized clinical trial

    Science.gov (United States)

    Hassan Khan, Imran; Anwar, Shahzad; Hanif, Asif; Ayub, Muhammad; Jamil Raja, Arsalan

    2014-02-01

    Background: Painful neuropathy is a very common complication in diabetic patients. Various treatment strategies like manual therapies, conservative management, drug therapy and exercise have been opted for this problem. Studies have shown clinical effectiveness of laser acupuncture as well. On the other hand, Amitryptaline is also a commonly used treatment for this disease. We aim to compare the efficacy of both treatments. Objective: To assess the effect of laser acupuncture in patients suffering from painful diabetic neuropathy and its comparison with standard of care. Patients and Method: This study was conducted in Diabetic and Endocrine Management Center (DEMC) Lahore General Hospital, Lahore, Pakistan. A randomized control trial (RCT) was opted and a total of 164 patients were chosen using Non-probability purposive sampling technique. Pain was graded by using a patient friendly Visual Analogue Score (VAS), scoring from 0 to 10. Treatment was done involving organized fortnightly follow ups. Data of all patients was recorded on Performa and was entered and analyzed for descriptive statistics in PASW 18 (IBM®. SPSS). Results: A total of 164 subjects were included in the study who were subdivided into three groups labeled as A, B and C for laser therapy treatment, amitryptaline treatment and controls respectively. The mean age of subjects was 51.54+/-10.46 in Group A, 49.38+/-10.56 in Group B and 51.70+/-11.43 in Group C. The difference of mean ages in all study groups was statistically insignificant (p-value= 0.469). The average pain score in patients who received laser therapy was 5.95+/-0.91 before treatment, whereas after treatment it was 4.31+/-0.98. The mean pain score in subjects having Amitryptaline before starting the treatment was 6.87+/-0.71 and after treatment, it was 6.23+/-0.98. The mean score for daily life activities in subjects who received laser therapy was 9.562.37 before treatment, while after treatment it was 7.56+/-1.54. The average score

  14. Short article: A randomized-controlled study of sitagliptin for treating diabetes mellitus complicated by nonalcoholic fatty liver disease.

    Science.gov (United States)

    Deng, Xiao-Long; Ma, Rui; Zhu, Hong-Xia; Zhu, Jun

    2017-03-01

    This study aimed to evaluate the efficacy and safety of sitagliptin for treating Chinese patients with type 2 diabetes mellitus (T2DM) with nonalcoholic fatty liver disease (NAFLD). In total, 72 Chinese T2DM patients with NAFLD were divided randomly into two groups of 36 patients each group. All 72 patients were assigned to receive either sitagliptin or diet and exercise for 52 weeks between January 2013 and December 2015. The outcomes' measurements included serum levels of hemoglobin A1c, fasting plasma glucose, aspartate aminotransferase, and alanine aminotransferase. Seventy patients completed the study. Sitagliptin showed greater efficacy than the diet and exercise in decreasing the hemoglobin A1c and fasting plasma glucose levels at weeks 13, 26, 39, and 52. In addition, no significant changes in the average aspartate aminotransferase and alanine aminotransferase levels were found during the 52-week follow-up in both the sitagliptin and the control groups. The results of this study indicate that sitagliptin is an effective and safe treatment for patients with T2DM and NAFLD.

  15. Flexible treatment of gestational diabetes modulated on ultrasound evaluation of intrauterine growth: a controlled randomized clinical trial.

    Science.gov (United States)

    Bonomo, M; Cetin, I; Pisoni, M P; Faden, D; Mion, E; Taricco, E; Nobile de Santis, M; Radaelli, T; Motta, G; Costa, M; Solerte, L; Morabito, A

    2004-06-01

    In order to prevent abnormalities of fetal growth still characterizing pregnancies complicated by Gestational Diabetes (GDM), in the present study we evaluated a therapeutic strategy for GDM based on ultrasound (US) measurement of fetal insulin-sensitive tissues. All GDM women diagnosed before 28th week immediately started diet and self-monitoring of blood glucose; after 2 weeks they were randomized to conventional (C) or modified (M) management. In C the glycemic target (GT) was fixed at 90 fasting/120 post-prandial mg/dl; in M GT varied, according to US measurement of the Abdominal Circumference (AC) centile performed every 2 weeks: 80/100 if AC > or =75th, 100/140 if AC or =75th c. Mean metabolic data were similar in the 2 groups, but in M a tightly-optimized subgroup, resulting from the lowering of GT due to AC > or =75th, coexisted with a less-controlled one, whose higher GT was justified by ACgrowth, with clear advantages on global pregnancy outcome.

  16. Habitual coffee consumption and risk of type 2 diabetes, ischemic heart disease, depression and Alzheimer's disease: a Mendelian randomization study.

    Science.gov (United States)

    Kwok, Man Ki; Leung, Gabriel M; Schooling, C Mary

    2016-11-15

    Observationally, coffee is inversely associated with type 2 diabetes mellitus (T2DM), depression and Alzheimer's disease, but not ischemic heart disease (IHD). Coffee features as possibly protective in the 2015 Dietary Guidelines for Americans. Short-term trials suggest coffee has neutral effect on most glycemic traits, but raises lipids and adiponectin. To clarify we compared T2DM, depression, Alzheimer's disease, and IHD and its risk factors by genetically predicted coffee consumption using two-sample Mendelian randomization applied to large extensively genotyped case-control and cross-sectional studies. Childhood cognition was used as a negative control outcome. Genetically predicted coffee consumption was not associated with T2DM (odds ratio (OR) 1.02, 95% confidence interval (CI) 0.76 to 1.36), depression (0.89, 95% CI 0.66 to 1.21), Alzheimer's disease (1.17, 95% CI 0.96 to 1.43), IHD (0.96, 95% CI 0.80 to 1.14), lipids, glycemic traits, adiposity or adiponectin. Coffee was unrelated to childhood cognition. Consistent with observational studies, coffee was unrelated to IHD, and, as expected, childhood cognition. However, contrary to observational findings, coffee may not have beneficial effects on T2DM, depression or Alzheimer's disease. These findings clarify the role of coffee with relevance to dietary guidelines and suggest interventions to prevent these complex chronic diseases should be sought elsewhere.

  17. Effect of baking process on postprandial metabolic consequences: randomized trials in normal and type 2 diabetic subjects.

    Science.gov (United States)

    Rizkalla, S W; Laromiguiere, M; Champ, M; Bruzzo, F; Boillot, J; Slama, G

    2007-02-01

    To determine the impact of the form, fibre content, baking and processing on the glycaemic, insulinaemic and lipidaemic responses of different French breads. First study: Nine healthy subjects were randomized to consume in a crossover design one of six kinds of French bread (each containing 50 g available carbohydrate): classic baguette, traditional baguette, loaf of wholemeal bread (WM-B), loaf of bread fermented with yeast or with leaven, a sandwich and a glucose challenge as reference. The glycaemic index (GI) values ranged from 57+/-9% (mean+/-s.e.m.), for the traditional baguette, to 85+/-27% for the WM-B. No significant difference was found among the different tested bread. The insulinaemic index (II), however, of the traditional baguette and of the bread fermented with leaven were lower than the other breads (analysis of variance: Pvarieties of French bread (the TB) have lower II, in healthy subjects, and lower GI, in type 2 diabetic subjects, than that of the other varieties. These results might be due to bread processing difference rather than fibre content. Supported by grants from the National French Milling Association.

  18. Long-term effects of the Mediterranean lifestyle program: a randomized clinical trial for postmenopausal women with type 2 diabetes

    Directory of Open Access Journals (Sweden)

    Ritzwoller Debra P

    2007-01-01

    Full Text Available Abstract Background Multiple-risk-factor interventions offer a promising means for addressing the complex interactions between lifestyle behaviors, psychosocial factors, and the social environment. This report examines the long-term effects of a multiple-risk-factor intervention. Methods Postmenopausal women (N = 279 with type 2 diabetes participated in the Mediterranean Lifestyle Program (MLP, a randomized, comprehensive lifestyle intervention study. The intervention targeted healthful eating, physical activity, stress management, smoking cessation, and social support. Outcomes included lifestyle behaviors (i.e., dietary intake, physical activity, stress management, smoking cessation, psychosocial variables (e.g., social support, problem solving, self-efficacy, depression, quality of life, and cost analyses at baseline, and 6, 12, and 24 months. Results MLP participants showed significant 12- and 24-month improvements in all targeted lifestyle behaviors with one exception (there were too few smokers to analyze tobacco use effects, and in psychosocial measures of use of supportive resources, problem solving, self-efficacy, and quality of life. Conclusion The MLP was more effective than usual care over 24 months in producing improvements on behavioral and psychosocial outcomes. Directions for future research include replication with other populations.

  19. Neonatal outcomes in women with gestational diabetes mellitus treated with metformin in compare with insulin: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Safura Ruholamin

    2014-01-01

    Full Text Available Background: The objective of this study was to compare neonatal outcomes in women with gestational diabetes mellitus (GDM treated with either metformin or insulin. Materials and Methods: A randomized clinical trial carried out on year 2011 on 109 women with GDM who did not adequately control by dietary measures. They received metformin 500 mg once or twice daily or insulin 0.2 IU/kg/day initially. The dose was titrated to achieve target blood glucose values. Neonatal outcomes such as hypoglycemia, birth weight, Apgar score, umbilical artery pH, and hyperbilirubinemia in the 50 women who remained exclusively on metformin were compared with 50 women who treated with insulin. Results: Two groups were similar in mean fasting blood sugar (P = 0.7 and postprandial measurements (P = 0.8 throughout GDM treatment. Pregnancy complications or preterm labor were not different significantly between two groups. Considering neonatal outcomes between insulin and metformin groups, such as hypoglycemia (2 [4%] and 0 [0%], respectively, birth weight (3342 ± 506 mg and 3176 ± 438 mg, respectively, 5 th min Apgar score <7 (no one in either group, umbilical artery pH <7.05 (no one in either group and hyperbilirubinemia (1 [2%] and 0 [0%], respectively, no significant statistical differences were seen. Conclusion: Based on these preliminary data, considering neonatal outcomes, metformin appears to be a safe as insulin in the treatment of GDM.

  20. Bayesian dose selection design for a binary outcome using restricted response adaptive randomization.

    Science.gov (United States)

    Meinzer, Caitlyn; Martin, Renee; Suarez, Jose I

    2017-09-08

    In phase II trials, the most efficacious dose is usually not known. Moreover, given limited resources, it is difficult to robustly identify a dose while also testing for a signal of efficacy that would support a phase III trial. Recent designs have sought to be more efficient by exploring multiple doses through the use of adaptive strategies. However, the added flexibility may potentially increase the risk of making incorrect assumptions and reduce the total amount of information available across the dose range as a function of imbalanced sample size. To balance these challenges, a novel placebo-controlled design is presented in which a restricted Bayesian response adaptive randomization (RAR) is used to allocate a majority of subjects to the optimal dose of active drug, defined as the dose with the lowest probability of poor outcome. However, the allocation between subjects who receive active drug or placebo is held constant to retain the maximum possible power for a hypothesis test of overall efficacy comparing the optimal dose to placebo. The design properties and optimization of the design are presented in the context of a phase II trial for subarachnoid hemorrhage. For a fixed total sample size, a trade-off exists between the ability to select the optimal dose and the probability of rejecting the null hypothesis. This relationship is modified by the allocation ratio between active and control subjects, the choice of RAR algorithm, and the number of subjects allocated to an initial fixed allocation period. While a responsive RAR algorithm improves the ability to select the correct dose, there is an increased risk of assigning more subjects to a worse arm as a function of ephemeral trends in the data. A subarachnoid treatment trial is used to illustrate how this design can be customized for specific objectives and available data. Bayesian adaptive designs are a flexible approach to addressing multiple questions surrounding the optimal dose for treatment efficacy

  1. Screening for HbA1c-defined prediabetes and diabetes in an at-risk greek population: performance comparison of random capillary glucose, the ADA diabetes risk test and skin fluorescence spectroscopy.

    Science.gov (United States)

    Tentolouris, Nicholas; Lathouris, Panagiotis; Lontou, Stavroula; Tzemos, Kostas; Maynard, John

    2013-04-01

    We examined the accuracy of random capillary glucose (RCG) and two noninvasive screening methods, the ADA diabetes risk test (DRT) and skin fluorescence spectroscopy (SFS) as measured by Scout DS for detecting HbA1c-defined dysglycemia or type 2 diabetes in an at-risk cohort. Subjects were recruited at two clinical sites for a single non-fasting visit. Each subject had measurements of height, weight and waist circumference. A diabetes score was calculated from skin fluorescence measured on the left forearm. A finger prick was done to measure RCG and HbA1c (A1C). Health questionnaires were completed for the DRT. Increasing dysglycemia was defined as A1C ≥ 5.7% (39 mmol/mol) or ≥ 6.0% (42 mmol/mol). Type 2 diabetes was defined as A1C ≥ 6.5% (47.5 mmol/mol). 398 of 409 subjects had complete data for analysis with means for age, body mass index, and waist of 52 years, 27 kg/m(2) and 90 cm. 51% were male. Prevalence of A1C ≥ 5.7%, ≥ 6.0% and ≥ 6.5% were 54%, 34% and 12%, respectively. Areas under the curve (AUC) for detection of increasing levels dysglycemia or diabetes for RCG were 63%, 66% and 72%, for the ADA DRT the AUCs were 75%, 76% and 81% and for SFS the AUCs were 82%, 84% and 90%, respectively. For each level of dysglycemia or diabetes, the SFS AUC was significantly higher than RCG or the ADA DRT. The noninvasive skin fluorescence spectroscopy measurement outperformed both RCG and the ADA DRT for detection of A1C-defined dysglycemia or diabetes in an at-risk cohort. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  2. Using ArcMap, Google Earth, and Global Positioning Systems to select and locate random households in rural Haiti.

    Science.gov (United States)

    Wampler, Peter J; Rediske, Richard R; Molla, Azizur R

    2013-01-18

    A remote sensing technique was developed which combines a Geographic Information System (GIS); Google Earth, and Microsoft Excel to identify home locations for a random sample of households in rural Haiti. The method was used to select homes for ethnographic and water quality research in a region of rural Haiti located within 9 km of a local hospital and source of health education in Deschapelles, Haiti. The technique does not require access to governmental records or ground based surveys to collect household location data and can be performed in a rapid, cost-effective manner. The random selection of households and the location of these households during field surveys were accomplished using GIS, Google Earth, Microsoft Excel, and handheld Garmin GPSmap 76CSx GPS units. Homes were identified and mapped in Google Earth, exported to ArcMap 10.0, and a random list of homes was generated using Microsoft Excel which was then loaded onto handheld GPS units for field location. The development and use of a remote sensing method was essential to the selection and location of random households. A total of 537 homes initially were mapped and a randomized subset of 96 was identified as potential survey locations. Over 96% of the homes mapped using Google Earth imagery were correctly identified as occupied dwellings. Only 3.6% of the occupants of mapped homes visited declined to be interviewed. 16.4% of the homes visited were not occupied at the time of the visit due to work away from the home or market days. A total of 55 households were located using this method during the 10 days of fieldwork in May and June of 2012. The method used to generate and field locate random homes for surveys and water sampling was an effective means of selecting random households in a rural environment lacking geolocation infrastructure. The success rate for locating households using a handheld GPS was excellent and only rarely was local knowledge required to identify and locate households. This

  3. Using ArcMap, Google Earth, and Global Positioning Systems to select and locate random households in rural Haiti

    Directory of Open Access Journals (Sweden)

    Wampler Peter J

    2013-01-01

    Full Text Available Abstract Background A remote sensing technique was developed which combines a Geographic Information System (GIS; Google Earth, and Microsoft Excel to identify home locations for a random sample of households in rural Haiti. The method was used to select homes for ethnographic and water quality research in a region of rural Haiti located within 9 km of a local hospital and source of health education in Deschapelles, Haiti. The technique does not require access to governmental records or ground based surveys to collect household location data and can be performed in a rapid, cost-effective manner. Methods The random selection of households and the location of these households during field surveys were accomplished using GIS, Google Earth, Microsoft Excel, and handheld Garmin GPSmap 76CSx GPS units. Homes were identified and mapped in Google Earth, exported to ArcMap 10.0, and a random list of homes was generated using Microsoft Excel which was then loaded onto handheld GPS units for field location. The development and use of a remote sensing method was essential to the selection and location of random households. Results A total of 537 homes initially were mapped and a randomized subset of 96 was identified as potential survey locations. Over 96% of the homes mapped using Google Earth imagery were correctly identified as occupied dwellings. Only 3.6% of the occupants of mapped homes visited declined to be interviewed. 16.4% of the homes visited were not occupied at the time of the visit due to work away from the home or market days. A total of 55 households were located using this method during the 10 days of fieldwork in May and June of 2012. Conclusions The method used to generate and field locate random homes for surveys and water sampling was an effective means of selecting random households in a rural environment lacking geolocation infrastructure. The success rate for locating households using a handheld GPS was excellent and only

  4. Glimepiride versus pioglitazone combination therapy in subjects with type 2 diabetes inadequately controlled on metformin monotherapy: results of a randomized clinical trial.

    Science.gov (United States)

    Umpierrez, Guillermo; Issa, Maher; Vlajnic, Aleksandra

    2006-04-01

    To compare the effect of add-on glimepiride or pioglitazone in subjects with type 2 diabetes inadequately controlled on metformin monotherapy. Multicenter, randomized, parallel-group, open-label, forcedtitration study involving 203 adults with poorly controlled type 2 diabetes (A1C 7.5-10%) on metformin monotherapy. Subjects were randomized to receive glimepiride or pioglitazone, titrated to the maximum dose for 26 weeks. Subjects were evaluated for A1C changes, fasting plasma glucose (FPG), insulin, C-peptide, and lipid levels. Safety outcomes and diabetes-related healthcare resource utilization were also evaluated. Both treatment groups achieved similar and significant mean decreases from baseline to endpoint (week 26) in A1C (p = 0.0001) and FPG (p use of fasting C-peptide concentration > or = 0.27 nmol/L in the inclusion criteria was a potential limitation as it may have included those patients with an improved probability for glimepiride or pioglitazone response. In addition, a larger patient population would have provided a greater degree of data applicability. In patients with type 2 diabetes inadequately controlled on metformin monotherapy, add-on glimepiride or pioglitazone results in similar overall improvements in glycemic control. Compared with pioglitazone, glimepiride is associated with faster glycemic control, lower total and LDL cholesterol levels and reduced short-term healthcare costs.

  5. Effect of probiotics on glucose metabolism in patients with type 2 diabetes mellitus: A meta-analysis of randomized controlled trials

    OpenAIRE

    Zhang, Qingqing; Wu, Yucheng; Fei, Xiaoqiang

    2016-01-01

    Objective: Our aim was to investigate the effects of probiotics on glucose metabolism in patients with type 2 diabetes mellitus using a meta-analysis of randomized, controlled trials. Materials and methods: Online databases Embase, Web of Science, and PubMed were searched until August 2014 to identify eligible articles. Finally, 7 trials were included. Results: Probiotic consumption significantly changed fasting plasma glucose (FPG) by −15.92 mg/dL (95% confidence interval [CI], −29.75 ...

  6. Aspirin for Primary Prevention of Cardiovascular Events: Meta-Analysis of Randomized Controlled Trials and Subgroup Analysis by Sex and Diabetes Status

    OpenAIRE

    Xie, Manling; Shan, Zhilei; Zhang, Yan; Chen, Sijing; Yang, Wei; Bao, Wei; Rong, Ying; Yu, Xuefeng; Hu, Frank B.; Liu, Liegang

    2014-01-01

    Objective: To evaluate the benefits and harms of aspirin for the primary prevention of CVD and determine whether the effects vary by sex and diabetes status. Methods: We searched Medline, Embase, and Cochrane databases for randomized controlled trials comparing the effects of aspirin with placebo or control in people with no pre-existing CVD. Two investigators independently extracted data and assessed the study quality. Analyses were performed using Stata version 12. Results: Fourteen trials ...

  7. Theory-based self-management educational interventions on patients with type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Zhao, Fang-Fang; Suhonen, Riitta; Koskinen, Sanna; Leino-Kilpi, Helena

    2017-04-01

    To synthesize the effects of theory-based self-management educational interventions on patients with type 2 diabetes (T2DM) in randomized controlled trials. Type 2 diabetes is a common chronic disease causing complications that put a heavy burden on society and reduce the quality of life of patients. Good self-management of diabetes can prevent complications and improve the quality of life of T2DM patients. Systematic review with meta-analysis of randomized controlled trials following Cochrane methods. A literature search was carried out in the MEDLINE, EMBASE, CINAHL, PSYCINFO, and Web of Science databases (1980-April 2015). The risk of bias of these eligible studies was assessed independently by two authors using the Cochrane Collaboration's tool. The Publication bias of the main outcomes was examined. Statistical heterogeneity and random-effects model were used for meta-analysis. Twenty studies with 5802 participants met the inclusion criteria. The interventions in the studies were based on one or more theories which mostly belong to mid-range theories. The pooled main outcomes by random-effects model showed significant improvements in HbA1c, self-efficacy, and diabetes knowledge, but not in BMI. As for quality of life, no conclusions can be drawn as the pooled outcome became the opposite with reduced heterogeneity after one study was excluded. No significant publication bias was found in the main outcomes. To get theory-based interventions to produce more effects, the role of patients should be more involved and stronger and the education team should be trained beyond the primary preparation for the self-management education program. © 2016 John Wiley & Sons Ltd.

  8. Effects of metformin on markers of oxidative stress and antioxidant reserve in patients with newly diagnosed type 2 diabetes: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Yu V Pankratova

    2012-09-01

    Full Text Available Реферат по статье: Effects of metformin on markers of oxidative stress and antioxidant reserve in patients with newly diagnosed type 2 diabetes: A randomized clinical trial Alireza Esteghamati, Delaram Eskandari, Hossein Mirmiranpour, Sina Noshad, Mostafa Mousavizadeh, Mehdi Hedayati, Manouchehr Nakhjavan//Clinical Nutrition xxx (2012 1-7 Tehran, Iran

  9. A randomized trial comparing structured and lifestyle goals in an internet-mediated walking program for people with type 2 diabetes

    OpenAIRE

    Richardson, Caroline R; Mehari, Kathleen S; McIntyre, Laura G; Janney, Adrienne W; Fortlage, Laurie A; Sen, Ananda; Strecher, Victor J; Piette, John D

    2007-01-01

    Abstract Background The majority of individuals with type 2 diabetes do not exercise regularly. Pedometer-based walking interventions can help; however, pedometer-based interventions targeting only total daily accumulated steps might not yield the same health benefits as physical activity programs specifying a minimum duration and intensity of physical activity bouts. Methods This pilot randomized trial compared two goal-setting strategies: 1) lifestyle goals targeting total daily accumulated...

  10. A randomized controlled study of finerenone vs. eplerenone in patients with worsening chronic heart failure and diabetes mellitus and/or chronic kidney disease

    DEFF Research Database (Denmark)

    Filippatos, Gerasimos; Anker, Stefan D; Böhm, Michael

    2016-01-01

    Aims To evaluate oral doses of the non-steroidal mineralocorticoid receptor antagonist finerenone given for 90 days in patients with worsening heart failure and reduced ejection fraction and chronic kidney disease and/or diabetes mellitus. Methods and results Miner Alocorticoid Receptor antagonist...... Tolerability Study-Heart Failure (ARTS-HF) was a randomized, double-blind, phase 2b multicentre study (ClinicalTrials.gov: NCT01807221). Of 1286 screened patients, 1066 were randomized. Patients received oral, once-daily finerenone (2.5, 5, 7.5, 10, or 15 mg, uptitrated to 5, 10, 15, 20, or 20 mg, respectively...

  11. The Efficacy and Safety of Chinese Herbal Medicine Jinlida as Add-On Medication in Type 2 Diabetes Patients Ineffectively Managed by Metformin Monotherapy: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial

    OpenAIRE

    Lian, Fengmei; Tian, Jiaxing; Chen, Xinyan; Li, Zhibin; Piao, Chunli; Guo, Junjie; Ma, Licheng; Zhao, Lijuan; Xia, Chengdong; Wang, Chong-Zhi; Yuan, Chun-Su; Tong, Xiaolin

    2015-01-01

    Background Metformin plays an important role in diabetes treatment. Studies have shown that the combined use of oral hypoglycemic medications is more effective than metformin monotherapy. In this double-blind, randomized, placebo-controlled, multicenter trial, we evaluated whether Jinlida, a Chinese herbal medicine, enhances the glycemic control of metformin in type 2 diabetes patients whose HbA1c was ineffectively controlled with metformin alone. Methods A total of 186 diabetes patients were...

  12. The Effect of Probiotic Yogurt on Blood Glucose and cardiovascular Biomarkers in Patients with Type II Diabetes: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Mahin Rezaei

    2017-01-01

    Full Text Available Background: Given the high prevalence of type II diabetes and its complications, the evidence regarding the beneficial effects of probiotic yogurt on some cardiovascular biomarkers in diabetic patients is worthy of investigation. Aim: To investigate the effect of probiotic yogurt on blood glucose level and cardiovascular biomarkers in patients with type II diabetes. Method:This randomized, clinical trial was conducted on 90 patients with type II diabetes who visited the 5 Azar diabetes clinic in Gorgan, Iran, in 2014. The intervention group consumed three 100 g packages of probiotic yogurt per day for four weeks, while the control group used an equal amount of plain yogurt. Dietary intake, as well as anthropometric and biochemical parameters were measured before and after the trial. To analyze the data, independent t-test, paired t-test, and analysis of covariance were performed, using SPSS version 18. Results: The mean ages of the intervention and control groups were 50.49±10.92 and 50.13±9.20 years, respectively. In the intervention group, paired t-test showed significant differences between mean levels of blood glucose, cholesterol, low-density lipoprotein (LDL, triglycerides, diastolic blood pressure, and glycated hemoglobin before and after four weeks of daily intake of probiotic yogurt (P0.05. At the end of trial, the independent t-test showed a significant difference between the two groups in terms of mean levels of blood glucose, LDL, triglycerides, blood pressure, and glycated hemoglobin (P

  13. Genetic Predisposition to Weight Loss and Regain With Lifestyle Intervention: Analyses From the Diabetes Prevention Program and the Look AHEAD Randomized Controlled Trials.

    Science.gov (United States)

    Papandonatos, George D; Pan, Qing; Pajewski, Nicholas M; Delahanty, Linda M; Peter, Inga; Erar, Bahar; Ahmad, Shafqat; Harden, Maegan; Chen, Ling; Fontanillas, Pierre; Wagenknecht, Lynne E; Kahn, Steven E; Wing, Rena R; Jablonski, Kathleen A; Huggins, Gordon S; Knowler, William C; Florez, Jose C; McCaffery, Jeanne M; Franks, Paul W

    2015-12-01

    Clinically relevant weight loss is achievable through lifestyle modification, but unintentional weight regain is common. We investigated whether recently discovered genetic variants affect weight loss and/or weight regain during behavioral intervention. Participants at high-risk of type 2 diabetes (Diabetes Prevention Program [DPP]; N = 917/907 intervention/comparison) or with type 2 diabetes (Look AHEAD [Action for Health in Diabetes]; N = 2,014/1,892 intervention/comparison) were from two parallel arm (lifestyle vs. comparison) randomized controlled trials. The associations of 91 established obesity-predisposing loci with weight loss across 4 years and with weight regain across years 2-4 after a minimum of 3% weight loss were tested. Each copy of the minor G allele of MTIF3 rs1885988 was consistently associated with greater weight loss following lifestyle intervention over 4 years across the DPP and Look AHEAD. No such effect was observed across comparison arms, leading to a nominally significant single nucleotide polymorphism×treatment interaction (P = 4.3 × 10(-3)). However, this effect was not significant at a study-wise significance level (Bonferroni threshold P lifestyle. © 2015 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

  14. A web-based support for pregnant women and new mothers with type 1 diabetes mellitus in Sweden (MODIAB-Web): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Adolfsson, Annsofie; Linden, Karolina; Sparud-Lundin, Carina; Larsson, Per-Göran; Berg, Marie

    2014-12-29

    Women with type 1 diabetes face particular demands in their lives in relation to childbearing. During pregnancy, in order to optimize the probability of giving birth to a healthy child, their blood glucose levels need to be as normal as possible. After childbirth, they experience a 'double stress': in addition to the ordinary challenges they face as new mothers, they also need to focus on getting their blood glucose levels normal. To improve self-management of diabetes and overall well-being in women with type 1 diabetes, a person-centered web-based support was designed to be tested in a randomized controlled trial (RCT) to be used during pregnancy and early motherhood. This protocol outlines the design of this RCT, which will evaluate the effectiveness of the specially designed web-based support for mothers with type 1 diabetes in Sweden. The study is designed as an RCT. The web support consists of three parts: 1) evidence-based information, 2) a self-care diary, and 3) communication with peers. The primary outcome is general well-being evaluated with the Well-Being Questionnaire short version (W-BQ12) and diabetes management evaluated with the Diabetes Empowerment Scale, short version (SWE-DES). Women attending six hospital-based antenatal care centers in Sweden are invited to participate. The inclusion period is November 2011 to late 2014. The allocation of participants to web support (intervention group) and to usual care (control group) is equal (1:1). In total, 68 participants in each group will be needed to reach a statistical power of 80% with significance level 0.05. The web support is expected to strengthen the women's personal capacity and autonomy during pregnancy, breastfeeding, and early motherhood, leading to optimal well-being and diabetes management. ClinicalTrials.gov: NCT01565824 (registration date March 27th 2012).

  15. Peculiarities of the statistics of spectrally selected fluorescence radiation in laser-pumped dye-doped random media

    Science.gov (United States)

    Yuvchenko, S. A.; Ushakova, E. V.; Pavlova, M. V.; Alonova, M. V.; Zimnyakov, D. A.

    2018-04-01

    We consider the practical realization of a new optical probe method of the random media which is defined as the reference-free path length interferometry with the intensity moments analysis. A peculiarity in the statistics of the spectrally selected fluorescence radiation in laser-pumped dye-doped random medium is discussed. Previously established correlations between the second- and the third-order moments of the intensity fluctuations in the random interference patterns, the coherence function of the probe radiation, and the path difference probability density for the interfering partial waves in the medium are confirmed. The correlations were verified using the statistical analysis of the spectrally selected fluorescence radiation emitted by a laser-pumped dye-doped random medium. Water solution of Rhodamine 6G was applied as the doping fluorescent agent for the ensembles of the densely packed silica grains, which were pumped by the 532 nm radiation of a solid state laser. The spectrum of the mean path length for a random medium was reconstructed.

  16. Analysis of Postural Control During Quiet Standing in a Population with Diabetic Peripheral Neuropathy Undergoing Moderate Intensity Aerobic Exercise Training: A Single Blind, Randomized Controlled Trial.

    Science.gov (United States)

    Dixit, Snehil; Maiya, Arun; Shastry, Barkur A; Guddattu, Vasudev

    2016-07-01

    The aim of this study was to investigate the effect of 8 wks of moderate-intensity aerobic exercise on postural control during quiet standing in type 2 diabetic peripheral neuropathy. Individuals were included in the study if they had type 2 diabetes with clinical neuropathy, defined by a minimum score of 7 on the Michigan Diabetic Neuropathy Score, following which the patients were randomly assigned to an 8-wk program by computer-generated random number tables to study or control group. Repeated-measures analysis of variance was used for data analysis (P < 0.05 was considered significant). After final randomization, there were 36 patients in the study group and 45 in the control group. On comparison of results for control and study groups using repeated-measures analysis of variance only in the eyes closed on foam condition was there was a significant difference between the two groups for sway velocity along the x-axis (df1, df2 = 1, 18, F = 3.86, P = 0.04) and mediolateral displacement (df1, df2 = 1, 18, F = 4.04, P = 0.03). Aerobic exercise training could exert a therapeutic effect on center of pressure movement only along the x-axis in the eyes closed condition on foam surface during quiet standing.

  17. HEART FAILURE AND DIABETES MELLITUS: SELECTED ISSUES OF ETIOLOGY AND PATHOGENESIS, PROGNOSIS AND TREATMENT

    Directory of Open Access Journals (Sweden)

    B. U. Mardanov

    2016-01-01

    Full Text Available This review is devoted to the study of issues relating to the features of associated course of chronic heart failure (CHF and diabetes mellitus (DM. The modern views on the epidemiology, pathogenesis of DM and CHF are systematized. The pathogenesis of diabetic cardiomyopathy is described in details. The results of the well-known studies that show the negative impact of DM on CHF prognosis are presented. The principles of CHF pathogenetic therapy in patients with DM including the role of neurohormonal modulators are analyzed. The results of multicenter studies in patients with CHF and concomitant DM type 2 show that almost all first-line drugs recommended for CHF treatment are effective in patients with DM.

  18. No selection, but higher satisfaction of people participating in the disease management programme diabetes type 2 in Germany.

    Science.gov (United States)

    Kellner, Christiane; Kuniss, Nadine; Kloos, Christof; Müller, Ulrich Alfons; Müller, Nicolle

    2018-04-01

    We analysed metabolic control, complications and satisfaction in people with and without DMP participation. We retrospectively analysed the German data of the GUIDANCE study. The general practices included (n = 38) were selected from the physicians' register of the Thuringian Association of Statutory Health Insurance Physicians. Half of the practices (n = 19) participated in the DMP "Diabetes mellitus type 2". Nine hundred and fifty-nine people were included in the analysis. Of these, 541 (56.4%) were enrolled in the DMP and 418 (43.6%) not. There was no difference between the two groups (DMP vs. no DMP) regarding age (67.8 vs. 67.6y), gender (female 50.6 vs. 52.2%), diabetes duration (9.8 vs. 9.5y), BMI (31.3 vs. 30.7 kg/m 2 ), HbA1c (7.2 vs. 7.2%), systolic blood pressure (139 vs. 140 mm Hg) or antihypertensive drug (89.5 vs. 88.8%). More DMP participants had regular screening of diabetic late complications: retinopathy 84.7 versus 69.9% (p < 0.001); polyneuropathy 93.0 versus 52.6% (p < 0.001). Chronic kidney disease was more frequent in DMP participants (15.0 vs. 9.3%, p = 0.005). Treatment satisfaction was higher in participants enrolled in the DMP (31.1 vs. 30.0; p = 0.002). DMP participants do not exhibit positive selection. Process quality and treatment satisfaction are higher in DMP participants.

  19. Beneficial effects of a Paleolithic diet on cardiovascular risk factors in type 2 diabetes: a randomized cross-over pilot study

    Directory of Open Access Journals (Sweden)

    Hansson Anita

    2009-07-01

    Full Text Available Abstract Background Our aim was to compare the effects of a Paleolithic ('Old Stone Age' diet and a diabetes diet as generally recommended on risk factors for cardiovascular disease in patients with type 2 diabetes not treated with insulin. Methods In a randomized cross-over study, 13 patients with type 2 diabetes, 3 women and 10 men, were instructed to eat a Paleolithic diet based on lean meat, fish, fruits, vegetables, root vegetables, eggs and nuts; and a Diabetes diet designed in accordance with dietary guidelines during two consecutive 3-month periods. Outcome variables included changes in weight, waist circumference, serum lipids, C-reactive protein, blood pressure, glycated haemoglobin (HbA1c, and areas under the curve for plasma glucose and plasma insulin in the 75 g oral glucose tolerance test. Dietary intake was evaluated by use of 4-day weighed food records. Results Study participants had on average a diabetes duration of 9 years, a mean HbA1c of 6,6% units by Mono-S standard and were usually treated with metformin alone (3 subjects or metformin in combination with a sulfonylurea (3 subjects or a thiazolidinedione (3 subjects. Mean average dose of metformin was 1031 mg per day. Compared to the diabetes diet, the Paleolithic diet resulted in lower mean values of HbA1c (-0.4% units, p = 0.01, triacylglycerol (-0.4 mmol/L, p = 0.003, diastolic blood pressure (-4 mmHg, p = 0.03, weight (-3 kg, p = 0.01, BMI (-1 kg/m2, p = 0.04 and waist circumference (-4 cm, p = 0.02, and higher mean values of high density lipoprotein cholesterol (+0.08 mmol/L, p = 0.03. The Paleolithic diet was mainly lower in cereals and dairy products, and higher in fruits, vegetables, meat and eggs, as compared with the Diabetes diet. Further, the Paleolithic diet was lower in total energy, energy density, carbohydrate, dietary glycemic load, saturated fatty acids and calcium, and higher in unsaturated fatty acids, dietary cholesterol and several vitamins. Dietary GI

  20. Eicosapentaenoic acid as an add-on to antidepressant medication for co-morbid major depression in patients with diabetes mellitus : A randomized, double-blind placebo-controlled study

    NARCIS (Netherlands)

    Bot, M.; Pouwer, F.; Assies, J.; Jansen, E. H. J. M.; Diamant, M.; Snoek, F. J.; Beekman, A. T. F.; de Jonge, P.

    2010-01-01

    Background: Depression is common in individuals with diabetes. The present study is the first randomized controlled trial to test the efficacy of omega-3 ethyl-eicosapentaenoic acid (E-EPA) as adjuvant to antidepressant medication in the treatment of depression in adults with diabetes mellitus.

  1. CLOCK gene variation is associated with incidence of type-2 diabetes and cardiovascular diseases in type-2 diabetic subjects: dietary modulation in the PREDIMED randomized trial

    Science.gov (United States)

    Background Circadian rhythms regulate key biological processes influencing metabolic pathways. Dysregulation is associated with type 2 diabetes (T2D) and cardiovascular diseases (CVD). Circadian rhythms are generated by a transcriptional autoregulatory feedback loop involving core clock genes. CLOCK...

  2. Pyoderma gangrenosum in association with microscopic colitis, idiopathic hypereosinophilic syndrome, selective IgE deficiency and diabetes mellitus.

    Science.gov (United States)

    Riyaz, N; Sasidharanpillai, S; Rahima, S; Bindu, V; Shaan, M; Raghavan, N T; Mohan, L; Janardhanan, A K

    2015-08-01

    Pyoderma gangrenosum (PG) is a neutrophilic dermatosis of unknown aetiology. We report a 27-year-old male patient with diabetes, who presented with a nonhealing ulcer on the left leg, pruritic hyperpigmented papules distributed over the trunk and limbs, and chronic diarrhoea. He had eosinophilia, low haemoglobin and serum IgE levels, and raised erythrocyte sedimentation rate. Histopathology of the leg ulcer was consistent with the diagnosis of PG, while the histology of the hyperpigmented papule revealed tissue eosinophilia. Subsequent evaluation was conclusive of the diagnosis of PG, idiopathic hypereosinophilic syndrome (IHES) and selective IgE deficiency. Dexamethasone pulse therapy achieved resolution of the ulcer and reduction in the eosinophilia. Further evaluation for the persistent diarrhoea led to a diagnosis of lymphocytic colitis (LC), which responded to budesonide. To our knowledge, the association of PG with IHES, selective IgE deficiency or LC has not been previously reported. © 2015 British Association of Dermatologists.

  3. Screening For Gestational Diabetes Mellitus Selectively in a University Maternity Hospital

    LENUS (Irish Health Repository)

    O’Malley, EG

    2018-06-01

    Gestational diabetes mellitus (GDM) is one of the commonest complications of pregnancy. The prevalence varies depending, for example, on the diagnostic criteria, the screening test used, laboratory standards and the population studied. However, the prevalence is increasing globally due to the increasing levels of maternal obesity. The detection of GDM is important because there are clinical consequences. The woman has an increased risk of pre-eclampsia and of developing Type 2 diabetes mellitus (T2DM) in later life. Up to 70% of those women with GDM develop T2DM by 28 years after the affected pregnancy2. In a pregnancy complicated by GDM there is an increased risk of fetal macrosomia and polyhydramnios due to fetal hyperglycaemia3. This is associated with an increased risk of shoulder dystocia and caesarean delivery4. Neonatal hypoglycaemia may develop due to increased insulin production secondary to intrauterine hyperglycaemia. The offspring also have an increased risk in their childhood and adult life for the development of diabetes, obesity and metabolic syndrome5.

  4. A very low-carbohydrate, low-saturated fat diet for type 2 diabetes management: a randomized trial.

    Science.gov (United States)

    Tay, Jeannie; Luscombe-Marsh, Natalie D; Thompson, Campbell H; Noakes, Manny; Buckley, Jon D; Wittert, Gary A; Yancy, William S; Brinkworth, Grant D

    2014-11-01

    To comprehensively compare the effects of a very low-carbohydrate, high-unsaturated/low-saturated fat diet (LC) with those of a high-unrefined carbohydrate, low-fat diet (HC) on glycemic control and cardiovascular disease (CVD) risk factors in type 2 diabetes (T2DM). Obese adults (n = 115, BMI 34.4 ± 4.2 kg/m(2), age 58 ± 7 years) with T2DM were randomized to a hypocaloric LC diet (14% carbohydrate [fat [fat]) or an energy-matched HC diet (53% carbohydrate, 17% protein, and 30% fat [fat]) combined with structured exercise for 24 weeks. The outcomes measured were as follows: glycosylated hemoglobin (HbA1c), glycemic variability (GV; assessed by 48-h continuous glucose monitoring), antiglycemic medication changes (antiglycemic medication effects score [MES]), and blood lipids and pressure. A total of 93 participants completed 24 weeks. Both groups achieved similar completion rates (LC 79%, HC 82%) and weight loss (LC -12.0 ± 6.3 kg, HC -11.5 ± 5.5 kg); P ≥ 0.50. Blood pressure (-9.8/-7.3 ± 11.6/6.8 mmHg), fasting blood glucose (-1.4 ± 2.3 mmol/L), and LDL cholesterol (-0.3 ± 0.6 mmol/L) decreased, with no diet effect (P ≥ 0.10). LC achieved greater reductions in triglycerides (-0.5 ± 0.5 vs. -0.1 ± 0.5 mmol/L), MES (-0.5 ± 0.5 vs. -0.2 ± 0.5), and GV indices; P ≤ 0.03. LC induced greater HbA1c reductions (-2.6 ± 1.0% [-28.4 ± 10.9 mmol/mol] vs. -1.9 ± 1.2% [-20.8 ± 13.1 mmol/mol]; P = 0.002) and HDL cholesterol (HDL-C) increases (0.2 ± 0.3 vs. 0.05 ± 0.2 mmol/L; P = 0.007) in participants with the respective baseline values HbA1c >7.8% (62 mmol/mol) and HDL-C low saturated fat may be an effective dietary approach for T2DM management if effects are sustained beyond 24 weeks. © 2014 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

  5. Efficacy and safety of hydroxychloroquine in the treatment of type 2 diabetes mellitus: a double blind, randomized comparison with pioglitazone.

    Science.gov (United States)

    Pareek, Anil; Chandurkar, Nitin; Thomas, Nihal; Viswanathan, Vijay; Deshpande, Alaka; Gupta, O P; Shah, Asha; Kakrani, Arjun; Bhandari, Sudhir; Thulasidharan, N K; Saboo, Banshi; Devaramani, Shashidhar; Vijaykumar, N B; Sharma, Shrikant; Agrawal, Navneet; Mahesh, M; Kothari, Kunal

    2014-07-01

    To compare efficacy and safety of hydroxychloroquine with pioglitazone in type 2 diabetes mellitus (T2DM). This double-blind study randomized 267 uncontrolled type 2 diabetes patients (HbA1c ≥7.5% and ≤11.5%), post 3 months' treatment with glimepiride/gliclazide and metformin, to additionally receive hydroxychloroquine 400 mg/day (n = 135) or pioglitazone 15 mg/day (n = 132) for 24 weeks. Efficacy was assessed by changes in HbA1c, fasting (FBG) and post-prandial (PPG) blood glucose at Week 12 and Week 24. At Week 12 and Week 24, HbA1c, FBG and PPG significantly reduced from baseline in both groups. Mean reduction in glycemic parameters at Week 12 (HbA1c: -0.56% vs -0.72%, p = 0.394; FBG: -0.99 mmol/L vs -1.05 mmol/L, p = 0.878; PPG: -1.93 mmol/L vs -1.52 mmol/L, p = 0.423) and Week 24 (HbA1c: -0.87% vs -0.90%, p = 0.909; FBG: -0.79 mmol/L vs -1.02 mmol/L, p = 0.648; PPG: -1.77 mmol/L vs -1.36 mmol/L, p = 0.415) was not significantly different between the hydroxychloroquine and pioglitazone groups. Change in total cholesterol (TC) and LDL-C was significant in favor of hydroxychloroquine (TC: -0.37 mmol/L vs 0.03 mmol/L, p = 0.002; LDL-C: -0.23 mmol/L vs 0.09 mmol/L, p = 0.003). Triglycerides significantly reduced in both groups at Week 24. Mean HDL-C remained unchanged. Study treatments were well tolerated. With favorable effects on glycemic parameters and lipids, hydroxychloroquine may emerge as well tolerated therapeutic option for T2DM. The sample size for this study was small. However, based on the encouraging results of this proof-of-concept study, longer duration studies in larger population can be conducted to further confirm these findings. TRIAL REGISTRATION DETAILS: Clinical Trial Registry-India URL: http://ctri.nic.in, Registration Number: CTRI/2009/091/001036.

  6. Fiber-rich diet with brown rice improves endothelial function in type 2 diabetes mellitus: A randomized controlled trial.

    Science.gov (United States)

    Kondo, Keiko; Morino, Katsutaro; Nishio, Yoshihiko; Ishikado, Atsushi; Arima, Hisatomi; Nakao, Keiko; Nakagawa, Fumiyuki; Nikami, Fumio; Sekine, Osamu; Nemoto, Ken-Ichi; Suwa, Makoto; Matsumoto, Motonobu; Miura, Katsuyuki; Makino, Taketoshi; Ugi, Satoshi; Maegawa, Hiroshi

    2017-01-01

    A fiber-rich diet has a cardioprotective effect, but the mechanism for this remains unclear. We hypothesized that a fiber-rich diet with brown rice improves endothelial function in patients with type 2 diabetes mellitus. Twenty-eight patients with type 2 diabetes mellitus at a single general hospital in Japan were randomly assigned to a brown rice (n = 14) or white rice (n = 14) diet and were followed for 8 weeks. The primary outcome was changes in endothelial function determined from flow debt repayment by reactive hyperemia using strain-gauge plethysmography in the fasting state. Secondary outcomes were changes in HbA1c, postprandial glucose excursions, and markers of oxidative stress and inflammation. The area under the curve for glucose after ingesting 250 kcal of assigned rice was compared between baseline (T0) and at the end of the intervention (T1) to estimate glucose excursions in each group. Improvement in endothelial function, assessed by fasting flow debt repayment (20.4% vs. -5.8%, p = 0.004), was significantly greater in the brown rice diet group than the white rice diet group, although the between-group difference in change of fiber intake was small (5.6 g/day vs. -1.2 g/day, pdiet group compared with the white rice diet group (0.01 μg/L vs. -0.04 μg/L, p = 0.063). The area under the curve for glucose was subtly but consistently lower in the brown rice diet group (T0: 21.4 mmol/L*h vs. 24.0 mmol/L*h, p = 0.043, T1: 20.4 mmol/L*h vs. 23.3 mmol/L*h, p = 0.046) without changes in HbA1c. Intervention with a fiber-rich diet with brown rice effectively improved endothelial function, without changes in HbA1c levels, possibly through reducing glucose excursions.

  7. Evaluation of batroxobin in preventing vascular restenosis in diabetic patients after infrapopliteal arterial angioplasty: a randomized comparative study

    International Nuclear Information System (INIS)

    Xue Bo; Zhang Peilei; Wang Jue; Li Minghua; Zhao Jungong; Zhu Yueqi; Tan Huaqiao; Wang Jianbo

    2011-01-01

    Objective: To evaluate batroxobin in preventing vascular restenosis in diabetic patients after infrapopliteal arterial angioplasty through comparing the clinical results of the combination use of batroxobin and aspirin with that of simple use of aspirin. Methods: After a successful angioplasty, fifty-two diabetic patients with symptomatic infrapopliteal obstructions were randomly divided into the study group (n=26) and the control group (n=26). Patients in both groups received 100 aspirin everyday, but the patients in study group additionally received 5 IU batroxobin intravenous drip every day for six times. At the end of the follow-up period lasting for 12 months, magnetic resonance angiography (MRA) or Doppler ultrasonic angiography was performed to check the vessels to see if there was any restenosis or reocclusion. The relief degree of clinical symptoms were observed, and both preoperative and postoperative ankle-brachial index (ABI) were regularly determined and compared. Kaplan-Meier curves were constructed to evaluate restenosis/reocclusion-free rate, limb salvage rate and amputation-free rate. Results: During the follow-up period the occurrence of restenosis/reocclusion in study group and control group was 22.0% and 34.5% respectively (P=0.0307). Statistically significant difference in ABI existed between two groups both after the procedure (P<0.05) and at 12 months after the treatment (P=0.0094). Clinical improvement and tissue healing in study group and control group were observed in 23 and 19 patients respectively (P=0.0544). Twelve months after angioplasty, Kaplan-Meier analysis showed that the restenosis/reocclusion-free rate, the limb salvage rate and the amputation-free rate for study group were 74.0%, 96.2% and 84.6% respectively, while they was 54.8%, 92.3% and 84.6% respectively for control group. Conclusion: The results of this study indicate that the use of the clinical therapeutic efficacy and markedly relieve the symptoms, although this

  8. A randomized cross-over trial of the postprandial effects of three different diets in patients with type 2 diabetes.

    Directory of Open Access Journals (Sweden)

    Hanna Fernemark

    Full Text Available In the clinic setting both fasting levels of glucose and the area under the curve (AUC of glucose, by determination of HbA1c levels, are used for risk assessments, in type 2 diabetes (NIDDM. However little is known about postprandial levels, and hence AUC, regarding other traditional risk factors such as insulin and blood-lipids and how this is affected by different diets.To study postprandial effects of three diets, during a single day, in NIDDM.A low-fat diet (45-56 energy-% from carbohydrates, and a low-carbohydrate diet (16-24 energy-% from carbohydrates was compared with a Mediterranean-style diet (black coffee for breakfast and the same total-caloric intake as the other two diets for lunch with red wine, 32-35 energy-% from carbohydrates in a randomized cross-over design. Total-caloric intake/test-day at the clinic from food was 1025-1080 kCal in men and 905-984 kCal in women. The test meals were consumed at a diabetes ward under supervision.Twenty-one participants were recruited and 19 completed the studies. The low-carbohydrate diet induced lower insulin and glucose excursions compared with the low-fat diet (p<0.0005 for both AUC. The insulin-response following the single Mediterranean-style lunch-meal was more pronounced than during the low-fat diet lunch (insulin increase-ratio of the low-fat diet: 4.35 ± 2.2, of Mediterranean-style diet: 8.12 ± 5.2, p = 0.001 while postprandial glucose levels were similar. The increase-ratio of insulin correlated with the elevation of the incretin glucose-dependent insulinotropic-polypeptide following the Mediterranean-style diet lunch (Spearman, r = 0.64, p = 0.003.The large Mediterranean-style lunch-meal induced similar postprandial glucose-elevations as the low-fat meal despite almost double amount of calories due to a pronounced insulin-increase. This suggests that accumulation of caloric intake from breakfast and lunch to a single large Mediterranean style lunch-meal in NIDDM might

  9. A Crossover Design for Comparative Efficacy: A 36-Week Randomized Trial of Bevacizumab and Ranibizumab for Diabetic Macular Edema.

    Science.gov (United States)

    Wiley, Henry E; Thompson, Darby J S; Bailey, Clare; Chew, Emily Y; Cukras, Catherine A; Jaffe, Glenn J; Lee, Richard W J; Loken, Erin K; Meyerle, Catherine B; Wong, Wai; Ferris, Frederick L

    2016-04-01

    To investigate the comparative efficacy of bevacizumab (Avastin) and ranibizumab (Lucentis; both Genentech, Inc, South San Francisco, CA) for diabetic macular edema (DME) using a crossover study design. Randomized, double-masked, 36-week, 3-period crossover clinical trial. Fifty-six subjects with DME involving the center of the macula in one or both eyes. Monthly intravitreous injections of bevacizumab (1.25 mg) or ranibizumab (0.3 mg). Comparison of mean changes in visual acuity and central retinal thickness, tested using a linear mixed-effects model. Based on the linear mixed-effects model, the 3-month estimated mean improvement in visual acuity was 5.3 letters for bevacizumab and 6.6 letters for ranibizumab (difference, 1.3 letters; P = 0.039). Estimated change in optical coherence tomography (OCT) central subfield mean thickness (CSMT) was -89 μm for bevacizumab and -137 μm for ranibizumab (difference, 48 μm; P < 0.001). Incorporating cumulative treatment benefit, the model yielded a predicted 36-week (9-month) average improvement in visual acuity of 7.1 letters (95% confidence interval [CI], 5.0-9.2) for bevacizumab and 8.4 letters (95% CI, 6.3-10.5) for ranibizumab, and a change in OCT CSMT of -128 μm (95% CI, -155 to -100) for bevacizumab and -176 μm (95% CI, -202 to -149) for ranibizumab. There was no significant treatment-by-period interaction (i.e., treatment difference was constant in all 3 periods), nor was there a significant differential carryover effect from one period to the next. This trial demonstrated a statistically significant but small relative clinical benefit of ranibizumab compared with bevacizumab for treatment of DME, using a markedly reduced sample size relative to a full comparative efficacy study. The effects on visual acuity and central retinal thickness for the 2 drugs are consistent with those reported at 1 year for the concurrent parallel-group trial by the Diabetic Retinopathy Clinical Research Network testing bevacizumab

  10. A Randomized Cross-Over Trial of the Postprandial Effects of Three Different Diets in Patients with Type 2 Diabetes

    Science.gov (United States)

    Bunjaku, Bekim; Rosenqvist, Ulf; Nystrom, Fredrik H.; Guldbrand, Hans

    2013-01-01

    Background In the clinic setting both fasting levels of glucose and the area under the curve (AUC) of glucose, by determination of HbA1c levels, are used for risk assessments, in type 2 diabetes (NIDDM). However little is known about postprandial levels, and hence AUC, regarding other traditional risk factors such as insulin and blood-lipids and how this is affected by different diets. Objective To study postprandial effects of three diets, during a single day, in NIDDM. Methods A low-fat diet (45–56 energy-% from carbohydrates), and a low-carbohydrate diet (16–24 energy-% from carbohydrates) was compared with a Mediterranean-style diet (black coffee for breakfast and the same total-caloric intake as the other two diets for lunch with red wine, 32–35 energy−% from carbohydrates) in a randomized cross-over design. Total-caloric intake/test-day at the clinic from food was 1025–1080 kCal in men and 905–984 kCal in women. The test meals were consumed at a diabetes ward under supervision. Results Twenty-one participants were recruited and 19 completed the studies. The low-carbohydrate diet induced lower insulin and glucose excursions compared with the low-fat diet (pdiet lunch (insulin increase-ratio of the low-fat diet: 4.35±2.2, of Mediterranean-style diet: 8.12±5.2, p = 0.001) while postprandial glucose levels were similar. The increase-ratio of insulin correlated with the elevation of the incretin glucose-dependent insulinotropic-polypeptide following the Mediterranean-style diet lunch (Spearman, r = 0.64, p = 0.003). Conclusions The large Mediterranean-style lunch-meal induced similar postprandial glucose-elevations as the low-fat meal despite almost double amount of calories due to a pronounced insulin-increase. This suggests that accumulation of caloric intake from breakfast and lunch to a single large Mediterranean style lunch-meal in NIDDM might be advantageous from a metabolic perspective. Trial Registration ClinicalTrials.gov NCT

  11. The effect of aggressive versus standard lipid lowering by atorvastatin on diabetic dyslipidemia - The DALI Study : a double-blind, randomized, placebo-controlled trial in patients with type 2 diabetes and diabetic dyslipidemia

    NARCIS (Netherlands)

    Berkplanken, [No Value; Hoogerbrugge, N; Jansen, H; Jansen, H; Princen, HMG; Huisman, MV; van de Ree, MA; Stolk, RP; van Venrooij, FV; Banga, JD; Dallinga-Thie, G

    OBJECTIVE - In patients with type 2 diabetes, intensive glucose regulation, although effective for microangiopathy, has not been shown to have unambiguous preventive effects on the occurrence of cardiovascular disease. Patients with diabetes show a characteristic dyslipidermia (high triglyceride

  12. Short- and Long-Term Effects of Wholegrain Oat Intake on Weight Management and Glucolipid Metabolism in Overweight Type-2 Diabetics: A Randomized Control Trial

    Directory of Open Access Journals (Sweden)

    Xue Li

    2016-09-01

    Full Text Available Glycemic control and weight reduction are primary goals for the management of overweight and obese type 2 diabetes mellitus (T2DM. Effective management cannot be achieved without an appropriate diet. Our study aimed to evaluate the short- and long-term effects of oat intake and develop a reasonable dietary plan for overweight T2DM patients. A randomized control trial, registered under ClinicalTrials.gov (Identification code: NCT01495052, was carried out among adult T2DM patients. A subgroup of 298 overweight subjects was selected and received a 30-day centralized intervention and 1-year free-living follow-up. Participants were randomly allocated to one of the following four groups. The usual care group (n = 60 received no intervention; the healthy diet group (n = 79 received a low-fat and high-fiber diet (“healthy diet”; the 50 g-oats group (n = 80 and 100 g-oats group (n = 79 received the “healthy diet” with the same amount of cereals replaced by 50 g and 100 g oats respectively. Anthropometric, blood glycemic and lipid variables were measured. For the 30-day intervention, significant differences in the changes of FPG (fasting plasma glucose, PPG (postprandial plasma glucose, HbA1c (glycosylated hemoglobin, HOMA-IR (homeostasis model assessment of insulin resistance, TC (total cholesterol, TG (total triglycerides, and LDL-c (low-density lipoprotein cholesterol were observed among the four groups. Compared to the healthy diet group, the 50 g-oats group had a bigger reduction in PPG (mean difference (MD: −1.04 mmol/L; 95% CI: −2.03, −0.05 and TC (MD: −0.24 mmol/L; 95% CI: −0.47, −0.01; the 100 g-oats group had a bigger reduction in PPG (MD: −1.48 mmol/L; 95% CI: −2.57, −0.39, HOMA-IR (MD: −1.77 mU·mol/L2; 95% CI: −3.49, −0.05, TC (MD: −0.33 mmol/L; 95% CI: −0.56, −0.10 and LDL-c (MD: −0.22 mmol/L; 95% CI: −0.41, −0.03. In the 1-year follow-up, greater effects in reducing weight (MD: −0.89 kg; 95% CI

  13. A randomized, double-blind, placebo-controlled, phase II clinical trial to investigate the efficacy and safety of oral DA-1229 in patients with type 2 diabetes mellitus who have inadequate glycaemic control with diet and exercise.

    Science.gov (United States)

    Jung, Chang Hee; Park, Cheol-Young; Ahn, Kyu-Joeng; Kim, Nan-Hee; Jang, Hak-Chul; Lee, Moon-Kyu; Park, Joong-Yeol; Chung, Choon-Hee; Min, Kyung-Wan; Sung, Yeon-Ah; Park, Jeong-Hyun; Kim, Sung Jin; Lee, Hyo Jung; Park, Sung-Woo

    2015-03-01

    DA-1229 is a novel, potent and selective dipeptidyl peptidase-4 (DPP-IV) inhibitor that is orally bioavailable. We aimed to evaluate the optimal dose, efficacy and safety of DA-1229, in Korean subjects with type 2 diabetes mellitus suboptimally controlled with diet and exercise. We enrolled 158 patients (mean age, 53 years and a mean BMI, 25.6 kg/m(2) ). The mean baseline fasting plasma glucose level, HbA1c and duration of diabetes were 8.28 mmol/L, 7.6% (60 mmol/mol) and 3.9 years, respectively. After 2 or 6 weeks of an exercise and diet program followed by 2 weeks of a placebo period, the subjects were randomized into one of four groups for a 12-week active treatment period: placebo, 2.5, 5 or 10 mg of DA-1229. All three doses of DA-1229 significantly reduced HbA1c from baseline compared to the placebo group (-0.09 in the placebo group vs. -0.56, -0.66 and -0.61% in 2.5, 5 and 10-mg groups, respectively) but without any significant differences between the doses. Insulin secretory function, as assessed by homeostasis model assessment β-cell, the insulinogenic index, 2-h oral glucose tolerance test (OGTT) C-peptide and post-OGTT C-peptide area under the curve (AUC)0-2h, significantly improved with DA-1229 treatment. The incidence of adverse events was similar between the treatment groups and DA-1229 did not affect body weight or induce hypoglycaemic events. DA-1229 monotherapy (5 mg for 12 weeks) improved HbA1c, fasting plasma glucose level, OGTT results and β-cell function. This drug was well tolerated in Korean subjects with type 2 diabetes mellitus. © 2014 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons, Ltd.

  14. Vildagliptin versus insulin in patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea: results from a randomized, 24 week study.

    Science.gov (United States)

    Forst, Thomas; Koch, Cornelia; Dworak, Markus

    2015-06-01

    There is limited evidence to guide the selection of second-line anti-hyperglycemic agents in patients with type 2 diabetes mellitus (T2DM) who are inadequately controlled with sulfonylurea monotherapy and are intolerant to metformin. We compared the efficacy and safety of vildagliptin 50 mg qd and Neutral Protamine Hagedorn (NPH) insulin qd in such patients. This was a 24 week, multicenter, randomized, open-label study. The co-primary endpoints were (i) proportion of patients achieving HbA1c vildagliptin (n = 83) and NPH insulin (n = 79). Similar proportion of patients achieved the composite endpoint in vildagliptin versus NPH insulin group (35.4% versus 34.2%; OR 0.985; 95% CI 0.507, 1.915; p = 0.96). After 24 weeks, 48.8% of patients in the vildagliptin group and 60.8% in the NPH insulin group achieved HbA1c vildagliptin group and 29.1% in the insulin group had at least one confirmed HE; while 11.0% in the vildagliptin group and 22.8% in the insulin group experienced weight gain. The rate of confirmed HEs was significantly lower in patients receiving vildagliptin versus NPH insulin (1.3 versus 5.1 events per year). The TSQM-9 score for 'convenience' at week 24 increased significantly more with vildagliptin than with NPH insulin. Addition of vildagliptin and NPH insulin resulted in a similar number of patients reaching HbA1c target without HEs or weight gain in T2DM patients inadequately controlled with sulfonylurea. The addition of vildagliptin to sulfonylurea could be considered as a treatment option prior to intensification with insulin, with the advantages of a lower HE rate and greater patient convenience. Study results are limited by a higher drop-out rate in the vildagliptin arm.

  15. Short-term and long-term effects of dipeptidyl peptidase-4 inhibitors in type 2 diabetes mellitus patients with renal impairment: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Li, Ruifei; Wang, Rui; Li, Haixia; Sun, Sihao; Zou, Meijuan; Cheng, Gang

    2016-09-01

    To assess the short-term and long-term effects of dipeptidyl peptidase-4 (DPP-4) inhibitors in type 2 diabetes mellitus patients with renal impairment, a meta-analysis of randomized clinical trials of DPP-4 inhibitor interventions in type 2 diabetes mellitus patients with renal impairment was performed. PubMed, Embase, Cochrane Library and ClinicalTrials.gov were searched through the end of March 2015. Randomized clinical trials were selected if (1) DPP-4 inhibitors were compared with a placebo or other active-comparators, (2) the treatment duration was ≥12 weeks and (3) data regarding changes in haemoglobin A1c (HbA1c ), changes in fasting plasma glucose or hypoglycaemia and other adverse events were reported. Of 790 studies, ten studies on eight randomized clinical trials were included. Compared with the control group, DPP-4 inhibitors were associated with a greater HbA1c reduction in both the short-term [mean differences (MD) = -0.45, 95% confidence intervals (-0.57, -0.33), p 1] and long-term [MD = -0.33, 95% confidence intervals (-0.63, -0.03), p = 0.03] treatments. However, the long-term greater reduction in HbA1c with DPP-4 inhibitor treatment was only significant when the control treatment comprised placebo plus stable background treatment, but not glipizide plus stable background treatment. DPP-4 inhibitors were associated with a greater fasting plasma glucose reduction [MD = -12.59, 95% confidence intervals (-22.01, -3.17), p = 0.009] over the short-term; however, this effect was not present over the long-term. Regarding the hypoglycaemia adverse events assessment, the long-term treatment data indicated there was no increased risk of hypoglycaemia compared with placebo or active-controlled anti-diabetic drugs. The present meta-analysis confirms that DPP-4 inhibitors are effective and equivalent to other agents in type 2 diabetes mellitus patients with renal impairment. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015

  16. The effect of vitamin C and/or E supplementations on type 2 diabetic adult males under metformin treatment: A single-blinded randomized controlled clinical trial.

    Science.gov (United States)

    El-Aal, Ali Abd; El-Ghffar, Eman A Abd; Ghali, Asmaa Abu; Zughbur, Mohammed R; Sirdah, Mahmoud M

    2018-03-16

    Recently, there has been an increasing interest in the influence of antioxidant vitamins on the efficacy of oral hypoglycemic therapy in type 2 diabetic patients (T2DM). This single-blinded randomized controlled clinical trial aimed to investigate the effect of vitamin C and/or E supplementation on the efficacy of oral hypoglycemic therapy in T2DM Palestinian male patients from the Gaza Strip. Forty T2DM male patients aged 40-60 years on metformin treatment were randomly divided into four groups, each group received an additional one of the following daily oral supplements for 90 days: placebo; vitamin C; vitamin E and vitamin C plus vitamin E. After overnight fasting, venous blood specimens were collected from all individuals into K3-EDTA tubes and serum tubes for measuring the biochemical and hematological parameters of the study at baseline and after 90 days of vitamins supplementation. The results revealed that vitamin C and/or E improve fasting blood sugar (FBS), HbA1c, lipid profile, insulin, homeostasis model assessment of insulin resistance (HOMA-IR), reduced glutathione (GSH); and Quantitative Insulin Sensitivity Check Index (QISCI) compared with diabetic patients group that received placebo. This study provided additional evidence on the beneficial effects of supplementing antioxidant vitamins in T2DM which could improve the clinical condition and attenuate or prevent diabetic pathogenesis and complications that, secondly to poor glycemic control, could attribute to the imbalance between the decline in the endogenous antioxidants and increasing production of the reactive oxygen species leading to the oxidant-mediated damage present in the diabetic context. Copyright © 2018 Diabetes India. Published by Elsevier Ltd. All rights reserved.

  17. The Effects of Consumption of Bread Fortified With Soy Bean Flour on Metabolic Profile in Type 2 Diabetic Women: A Cross-over Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Moghaddam, Asma Salari; Entezari, Mohammad Hassan; Iraj, Bijan; Askari, Gholam Reza; Maracy, Mohammad Reza

    2014-12-01

    Diabetes mellitus is one of the most common chronic diseases in the world and has become a major threat for global health. Recent studies reported that the soy has beneficial effects in diabetic mellitus patients. The aim of this study was to assess the effects of soybean flour fortified bread consumption on metabolic profile in type 2 diabetic women. This randomized, cross-over, controlled clinical trial was carried out in 30 type 2 diabetic women. At first, a 2-week run-in period was applied. Then, participants were randomly assigned to either intervention or control groups. Participants in the intervention group were asked to replace 120 g of soybean flour fortified bread with the same amount of their usual bread intake or other cereal products for 6 weeks. After a 4 weeks washout period, participants were crossed over for another 6 weeks. Mean (±standard deviation) age and body mass index of subjects was 45.7 ± 3.8 years and 29.5 ± 3.9 kg/m(2), respectively. The results of our study showed no significant effects of soybean flour fortified bread on metabolic profile. We found a reduction in serum triglycerides (change difference: -3.7, P = 0.82), serum low-density lipoprotein-cholesterol (change difference: -11.2, P = 0.50), insulin (change difference: -3.6, P = 0.7), and homeostatic model assessment of insulin resistance (change differences: -0.57, P = 0.45) after 6 weeks but these changes were not statistically significant. No significant effects of soybean flour fortified bread on serum concentrations of fasting blood sugar, glycated hemoglobin, high-density lipoproteins and total cholesterol levels were found. Six weeks consumption of soybean flour fortified bread among diabetic patients had no significant effects on metabolic profile.

  18. The effects of consumption of bread fortified with soy bean flour on metabolic profile in type 2 diabetic women: A cross-over randomized controlled clinical trial

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    Asma Salari Moghaddam

    2014-01-01

    Full Text Available Background: Diabetes mellitus is one of the most common chronic diseases in the world and has become a major threat for global health. Recent studies reported that the soy has beneficial effects in diabetic mellitus patients. The aim of this study was to assess the effects of soybean flour fortified bread consumption on metabolic profile in type 2 diabetic women. Methods: This randomized, cross-over, controlled clinical trial was carried out in 30 type 2 diabetic women. At first, a 2-week run-in period was applied. Then, participants were randomly assigned to either intervention or control groups. Participants in the intervention group were asked to replace 120 g of soybean flour fortified bread with the same amount of their usual bread intake or other cereal products for 6 weeks. After a 4 weeks washout period, participants were crossed over for another 6 weeks. Results: Mean (±standard deviation age and body mass index of subjects was 45.7 ± 3.8 years and 29.5 ± 3.9 kg/m 2 , respectively. The results of our study showed no significant effects of soybean flour fortified bread on metabolic profile. We found a reduction in serum triglycerides (change difference: -3.7, P = 0.82, serum low-density lipoprotein-cholesterol (change difference: -11.2, P = 0.50, insulin (change difference: -3.6, P = 0.7, and homeostatic model assessment of insulin resistance (change differences: -0.57, P = 0.45 after 6 weeks but these changes were not statistically significant. No significant effects of soybean flour fortified bread on serum concentrations of fasting blood sugar, glycated hemoglobin, high-density lipoproteins and total cholesterol levels were found. Conclusions: Six weeks consumption of soybean flour fortified bread among diabetic patients had no significant effects on metabolic profile.

  19. Multimedia education program and nutrition therapy improves HbA1c, weight, and lipid profile of patients with type 2 diabetes: a randomized clinical trial.

    Science.gov (United States)

    Velázquez-López, Lubia; Muñoz-Torres, Abril Violeta; Medina-Bravo, Patricia; Vilchis-Gil, Jenny; Klϋnder-Klϋnder, Miguel; Escobedo-de la Peña, Jorge

    2017-11-01

    To evaluate the effect of a multimedia education program and nutrition therapy on metabolic control in patients with type 2 diabetes. What is the effect of a multimedia education program and nutritional therapy on metabolic control in type 2 diabetes? A randomized clinical trial was conducted in 351 patients randomly assigned to either an experimental group receiving a multimedia diabetes education program (MDE) and nutrition therapy (NT) (NT + MDE: n = 173), or to a control group who received nutrition therapy only (NT: n = 178). At baseline, 7, 14, and 21 months, the glycated hemoglobin (HbA1c), glucose, cholesterol, triglycerides, LDL-cholesterol, and HDL-cholesterol were measured. Weight, body mass index (BMI), waist circumference (WC), fat percentage, fat and lean mass, systolic blood pressure (SBP), and diastolic (DBP) were also recorded. Glycated hemoglobin decreased in both groups, although the group with NT + MDE had a greater reduction, with a difference of -0.76% (95%CI -1.33 to -0.19) at 7 months and -0.73% (95%CI -1.37 to -0.09) at 21 months. Only in the NT + MDE did the glucose decrease at 7 (-41.2 mg/dL; 95%CI -52.0 to -30.5), 14 (-27.8 mg/dL; 95%CI -32.6 to -23.1), and 21 months (-36.6 mg/dL; 95%CI -46.6 to -26.6). Triglycerides and the atherogenic index decreased in both groups at 7 and 14 months; while only in the NT + MDE group did it decrease at 21 months. (p Nutrition therapy and a multimedia diabetes education program have a favorable impact on achieving metabolic control goals in type 2 diabetes.

  20. The Effect of Foot Exercises on Wound Healing in Type 2 Diabetic Patients With a Foot Ulcer: A Randomized Control Study.

    Science.gov (United States)

    Eraydin, Şahizer; Avşar, Gülçin

    The purpose of this study was to investigate the effect of foot exercises on wound healing in type 2 diabetic patients with a diabetic foot ulcer. Prospective, randomized controlled study. Sixty-five patients from an outpatient clinic with grade 1 or 2 ulcers (Wagner classification) who met study criteria agreed to participate; 60 patients completed the study and were included in the final analysis. Subjects were followed up between February 2014 and June 2015. Subjects were recruited by the researchers in the clinics where they received treatment. Subjects were randomly allocated to either the control or intervention group. Data were collected using investigator-developed forms: patient information form and the diabetic foot exercises log. Patients in the intervention group received standard wound care and performed daily foot exercises for 12 weeks; the control group received standard wound care but no exercises. The ulcers of the patients in both the intervention and control groups were examined and measured at the 4th, 8th, and 12th weeks. The groups were compared in terms of the ulcer size and depth. To analyze and compare the data, frequency distribution, mean (standard deviation), variance analysis, and the independent samples t test and the χ test were used. The mean ulcer areas were 12.63 (14.43), 6.91 (5.44), 4.30 (3.70), and 3.29 (3.80) cm (P diabetic foot ulcer sizes in the study intervention