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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. 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.

  3. Blocked randomization with randomly selected block sizes.

    Science.gov (United States)

    Efird, Jimmy

    2011-01-01

    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. Randomized selection on the GPU

    Energy Technology Data Exchange (ETDEWEB)

    Monroe, Laura Marie [Los Alamos National Laboratory; Wendelberger, Joanne R [Los Alamos National Laboratory; Michalak, Sarah E [Los Alamos National Laboratory

    2011-01-13

    We implement here a fast and memory-sparing probabilistic top N selection algorithm on the GPU. To our knowledge, this is the first direct selection in the literature for the GPU. The algorithm proceeds via a probabilistic-guess-and-chcck process searching for the Nth element. It always gives a correct result and always terminates. The use of randomization reduces the amount of data that needs heavy processing, and so reduces the average time required for the algorithm. Probabilistic Las Vegas algorithms of this kind are a form of stochastic optimization and can be well suited to more general parallel processors with limited amounts of fast memory.

  5. Random selection of Borel sets

    Directory of Open Access Journals (Sweden)

    Bernd Günther

    2010-10-01

    Full Text Available A theory of random Borel sets is presented, based on dyadic resolutions of compact metric spaces. The conditional expectation of the intersection of two independent random Borel sets is investigated. An example based on an embedding of Sierpinski’s universal curve into the space of Borel sets is given.

  6. Species selection and random drift in macroevolution.

    Science.gov (United States)

    Chevin, Luis-Miguel

    2016-03-01

    Species selection resulting from trait-dependent speciation and extinction is increasingly recognized as an important mechanism of phenotypic macroevolution. However, the recent bloom in statistical methods quantifying this process faces a scarcity of dynamical theory for their interpretation, notably regarding the relative contributions of deterministic versus stochastic evolutionary forces. I use simple diffusion approximations of birth-death processes to investigate how the expected and random components of macroevolutionary change depend on phenotype-dependent speciation and extinction rates, as can be estimated empirically. I show that the species selection coefficient for a binary trait, and selection differential for a quantitative trait, depend not only on differences in net diversification rates (speciation minus extinction), but also on differences in species turnover rates (speciation plus extinction), especially in small clades. The randomness in speciation and extinction events also produces a species-level equivalent to random genetic drift, which is stronger for higher turnover rates. I then show how microevolutionary processes including mutation, organismic selection, and random genetic drift cause state transitions at the species level, allowing comparison of evolutionary forces across levels. A key parameter that would be needed to apply this theory is the distribution and rate of origination of new optimum phenotypes along a phylogeny. © 2016 The Author(s). Evolution © 2016 The Society for the Study of Evolution.

  7. Improving randomness characterization through Bayesian model selection.

    Science.gov (United States)

    Díaz Hernández Rojas, Rafael; Solís, Aldo; Angulo Martínez, Alí M; U'Ren, Alfred B; Hirsch, Jorge G; Marsili, Matteo; Pérez Castillo, Isaac

    2017-06-08

    Random number generation plays an essential role in technology with important applications in areas ranging from cryptography to Monte Carlo methods, and other probabilistic algorithms. All such applications require high-quality sources of random numbers, yet effective methods for assessing whether a source produce truly random sequences are still missing. Current methods either do not rely on a formal description of randomness (NIST test suite) on the one hand, or are inapplicable in principle (the characterization derived from the Algorithmic Theory of Information), on the other, for they require testing all the possible computer programs that could produce the sequence to be analysed. Here we present a rigorous method that overcomes these problems based on Bayesian model selection. We derive analytic expressions for a model's likelihood which is then used to compute its posterior distribution. Our method proves to be more rigorous than NIST's suite and Borel-Normality criterion and its implementation is straightforward. We applied our method to an experimental device based on the process of spontaneous parametric downconversion to confirm it behaves as a genuine quantum random number generator. As our approach relies on Bayesian inference our scheme transcends individual sequence analysis, leading to a characterization of the source itself.

  8. 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.

  9. 32 CFR 1624.1 - Random selection procedures for induction.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 6 2010-07-01 2010-07-01 false Random selection procedures for induction. 1624... SYSTEM INDUCTIONS § 1624.1 Random selection procedures for induction. (a) The Director of Selective Service shall from time to time establish a random selection sequence for induction by a drawing to be...

  10. 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.

  11. A random plasma glucose method for screening for gestational diabetes.

    Directory of Open Access Journals (Sweden)

    Maheshwari J

    1989-01-01

    Full Text Available Low renal threshold for glucose during pregnancy renders glycosuria less specific for the diagnosis of gestational diabetes. Screening for gestational diabetes was done by utilising random plasma glucose (RPG. RPG was done at the first antenatal visit. In 12,623 patients who registered for antenatal care at the N.W.M. Hospital, 1371 patients had a RPG more than 100 mg%. An oral glucose tolerance test was advised in these patients. The pick-up rate of gestational diabetes correlated with RPG level. Thirty-six cases of gestational diabetes were picked up. The pick up rate is significantly higher as compared to that which would have been detected utilising conventional screening criteria.

  12. Evaluation of selective screening for diagnosis of gestational diabetes mellitus

    Directory of Open Access Journals (Sweden)

    Garshasbi A

    2009-07-01

    Full Text Available "n Normal 0 false false false EN-US X-NONE AR-SA MicrosoftInternetExplorer4 st1":*{behavior:url(#ieooui } /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-qformat:yes; mso-style-parent:""; mso-padding-alt:0cm 5.4pt 0cm 5.4pt; mso-para-margin:0cm; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:11.0pt; font-family:"Calibri","sans-serif"; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:"Times New Roman"; mso-fareast-theme-font:minor-fareast; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:Arial; mso-bidi-theme-font:minor-bidi;} Background: Gestational diabetes mellitus is diagnosed as carbohydrate in tolerance demonstrated for the first time in the course of pregnancy. The aim of this study was to evaluate the selective screening method for gestational diabetes mellitus (GDM based on: 1- recommendation of the fourth workshop- conference on GDM 2- evaluation of risk factors"n"n Methods: A case- control study was performed on 370 pregnancies inflicted by GDM in Hazrat Zaynab Hospital, Shahed University. The maternal and perinatal outcomes and prevalence of risk factors based on recommendation of the fourth workshop- conference on GDM in these women with GDM were compared with the same data and risk factors of randomly selected 600 pregnant women at the same time and in the same hospital, they all underwent universal testing for GDM, and their OGTT were normal. "n"n Results: The prevalence of all risk factors was significantly higher in the group with GDM, but 45 of these women (12% had no risk factors. 107 women (29% with GDM were at low risk and would remain undiagnosed if selective screening method was used. The main neonatal complications in the low- risk group did not differ from the complications in other

  13. In-Place Randomized Slope Selection

    DEFF Research Database (Denmark)

    Blunck, Henrik; Vahrenhold, Jan

    2006-01-01

    Slope selection is a well-known algorithmic tool used in the context of computing robust estimators for fitting a line to a collection P of n points in the plane. We demonstrate that it is possible to perform slope selection in expected O(nlogn) time using only constant extra space in addition to...

  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. Mendelian randomization studies of biomarkers and type 2 diabetes.

    Science.gov (United States)

    Abbasi, Ali

    2015-12-01

    Many biomarkers are associated with type 2 diabetes (T2D) risk in epidemiological observations. The aim of this study was to identify and summarize current evidence for causal effects of biomarkers on T2D. A systematic literature search in PubMed and EMBASE (until April 2015) was done to identify Mendelian randomization studies that examined potential causal effects of biomarkers on T2D. To replicate the findings of identified studies, data from two large-scale, genome-wide association studies (GWAS) were used: DIAbetes Genetics Replication And Meta-analysis (DIAGRAMv3) for T2D and the Meta-Analyses of Glucose and Insulin-related traits Consortium (MAGIC) for glycaemic traits. GWAS summary statistics were extracted for the same genetic variants (or proxy variants), which were used in the original Mendelian randomization studies. Of the 21 biomarkers (from 28 studies), ten have been reported to be causally associated with T2D in Mendelian randomization. Most biomarkers were investigated in a single cohort study or population. Of the ten biomarkers that were identified, nominally significant associations with T2D or glycaemic traits were reached for those genetic variants related to bilirubin, pro-B-type natriuretic peptide, delta-6 desaturase and dimethylglycine based on the summary data from DIAGRAMv3 or MAGIC. Several Mendelian randomization studies investigated the nature of associations of biomarkers with T2D. However, there were only a few biomarkers that may have causal effects on T2D. Further research is needed to broadly evaluate the causal effects of multiple biomarkers on T2D and glycaemic traits using data from large-scale cohorts or GWAS including many different genetic variants. © 2015 The authors.

  16. Sequential selection of random vectors under a sum constraint

    OpenAIRE

    Stanke, Mario

    2004-01-01

    We observe a sequence X1,X2,...,Xn of independent and identically distributed coordinatewise nonnegative d-dimensional random vectors. When a vector is observed it can either be selected or rejected but once made this decision is final. In each coordinate the sum of the selected vectors must not exceed a given constant. The problem is to find a selection policy that maximizes the expected number of selected vectors. For a general absolutely continuous distribution of t...

  17. Improving Diabetes Self-Management through Acceptance, Mindfulness, and Values: A Randomized Controlled Trial

    Science.gov (United States)

    Gregg, Jennifer A.; Callaghan, Glenn M.; Hayes, Steven C.; Glenn-Lawson, June L.

    2007-01-01

    Patients in a low-income community health center with Type 2 diabetes (N = 81) taking a one-day education workshop as part of their diabetes medical management were randomly assigned either to education alone or to a combination of education and acceptance and commitment therapy (ACT). Both groups were taught how to manage their diabetes, but…

  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. Application of random forests methods to diabetic retinopathy classification analyses.

    Directory of Open Access Journals (Sweden)

    Ramon Casanova

    Full Text Available BACKGROUND: Diabetic retinopathy (DR is one of the leading causes of blindness in the United States and world-wide. DR is a silent disease that may go unnoticed until it is too late for effective treatment. Therefore, early detection could improve the chances of therapeutic interventions that would alleviate its effects. METHODOLOGY: Graded fundus photography and systemic data from 3443 ACCORD-Eye Study participants were used to estimate Random Forest (RF and logistic regression classifiers. We studied the impact of sample size on classifier performance and the possibility of using RF generated class conditional probabilities as metrics describing DR risk. RF measures of variable importance are used to detect factors that affect classification performance. PRINCIPAL FINDINGS: Both types of data were informative when discriminating participants with or without DR. RF based models produced much higher classification accuracy than those based on logistic regression. Combining both types of data did not increase accuracy but did increase statistical discrimination of healthy participants who subsequently did or did not have DR events during four years of follow-up. RF variable importance criteria revealed that microaneurysms counts in both eyes seemed to play the most important role in discrimination among the graded fundus variables, while the number of medicines and diabetes duration were the most relevant among the systemic variables. CONCLUSIONS AND SIGNIFICANCE: We have introduced RF methods to DR classification analyses based on fundus photography data. In addition, we propose an approach to DR risk assessment based on metrics derived from graded fundus photography and systemic data. Our results suggest that RF methods could be a valuable tool to diagnose DR diagnosis and evaluate its progression.

  20. A comparative analysis of recruitment methods used in a randomized trial of diabetes education interventions.

    Science.gov (United States)

    Beaton, Sarah J; Sperl-Hillen, JoAnn M; Worley, Ann Von; Fernandes, Omar D; Baumer, Dorothy; Hanson, Ann M; Parker, Emily D; Busch, Maureen E; Davis, Herbert T; Spain, C Victor

    2010-11-01

    Recruitment methods heavily impact budget and outcomes in clinical trials. We conducted a post-hoc examination of the efficiency and cost of three different recruitment methods used in Journey for Control of Diabetes: the IDEA Study, a randomized controlled trial evaluating outcomes of group and individual diabetes education in New Mexico and Minnesota. Electronic databases were used to identify health plan members with diabetes and then one of the following three methods was used to recruit study participants: 1. Minnesota Method 1--Mail only (first half of recruitment period). Mailed invitations with return-response forms. 2. Minnesota Method 2--Mail and selective phone calls (second half of recruitment period). Mailed invitations with return-response forms and subsequent phone calls to nonresponders. 3. New Mexico Method 3--Mail and non-selective phone calls (full recruitment period): Mailed invitations with subsequent phone calls to all. The combined methods succeeded in meeting the recruitment goal of 623 subjects. There were 147 subjects recruited using Minnesota's Method 1, 190 using Minnesota's Method 2, and 286 using New Mexico's Method 3. Efficiency rates (percentage of invited patients who enrolled) were 4.2% for Method 1, 8.4% for Method 2, and 7.9% for Method 3. Calculated costs per enrolled subject were $71.58 (Method 1), $85.47 (Method 2), and $92.09 (Method 3). A mail-only method to assess study interest was relatively inexpensive but not efficient enough to sustain recruitment targets. Phone call follow-up after mailed invitations added to recruitment efficiency. Use of return-response forms with selective phone follow-up to non-responders was cost effective. Copyright © 2010 Elsevier Inc. All rights reserved.

  1. Fast, Randomized Join-Order Selection - Why Use Transformations?

    NARCIS (Netherlands)

    C.A. Galindo-Legaria; A.J. Pellenkoft (Jan); M.L. Kersten (Martin)

    1994-01-01

    textabstractWe study the effectiveness of probabilistic selection of join-query evaluation plans, without reliance on tree transformation rules. Instead, each candidate plan is chosen uniformly at random from the space of valid evaluation orders. This leads to a transformation-free strategy where a

  2. 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 ...

  3. 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.

  4. The validity of monitoring the control of diabetes with random blood ...

    African Journals Online (AJOL)

    2013-07-13

    Jul 13, 2013 ... Scientific Letter: The validity of monitoring the control of diabetes with random blood glucose testing. 579. Vol 55 No 6. SA Fam Pract 2013. Introduction. One of the important clinical decisions that must be made when caring for a person with diabetes is to determine if his or her blood glucose is well ...

  5. Starting insulin in type 2 diabetes : Continue oral hypoglycemic agents? A randomized trial in primary care

    NARCIS (Netherlands)

    Goudswaard, AN; Stolk, RP; Zuithoff, P; de Valk, HW; Rutten, GE

    Objective To evaluate the effects of insulin 30/70 twice daily or bedtime isophane (NPH) insulin plus continued sulfonylurea and metformin in patients with type 2 diabetes in primary care. Study Design Open-label, randomized trial. Population Persons younger than 76 years with type 2 diabetes whose

  6. Selecting a phoneme-to-grapheme mapping: Random or weighted selection?

    Directory of Open Access Journals (Sweden)

    Binna Lee

    2015-05-01

    Our findings demonstrate that random selection underestimates MOA’s PG correspondences whereas weighted selection predicts higher PG correspondences than he produces. To explain his intermediate spelling performance on PPEs, we will test additional approaches to weighing the relative probability of PG mappings, including using log frequencies, separating consonant and vowel status, and considering the number of grapheme options in each phoneme.

  7. Culturally appropriate health education for Type 2 diabetes in ethnic minority groups: an updated Cochrane Review of randomized controlled trials.

    Science.gov (United States)

    Creamer, J; Attridge, M; Ramsden, M; Cannings-John, R; Hawthorne, K

    2016-02-01

    To give an updated perspective of interventions from additional data collected since our first review, conducted in 2008. This updated Cochrane Review incorporates new information from recent randomized controlled trials on culturally appropriate diabetes health education interventions. An electronic literature search of six databases was repeated, with databases of ongoing trials checked and three journals hand-searched. Meta-analysis was carried out for sufficiently homogeneous outcomes, and common themes among trials were highlighted. A total of 22 new trials were added to the original 11. Meta-analysis of 28 trials containing suitable data showed significant improvements in glycaemic control (HbA1c ) and diabetes knowledge over a period of 24 months, after the delivery of culturally appropriate education to participants, compared with those receiving 'conventional' care. There were no consistent benefits over the control group in other selected outcome measures, and lack of data continued to make analysis of several outcome measures difficult. Research activity in this field has increased considerably over the past 6 years, with culturally appropriate diabetes education showing consistent benefits over conventional care in terms of glycaemic control and diabetes knowledge, sustained in the short- to mid-term. Further research is needed to determine the clinical significance of these improvements and their cost-effectiveness. © 2015 The Authors. Diabetic Medicine © 2015 Diabetes UK.

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

    Science.gov (United States)

    Houchmandzadeh, Bahram; Vallade, Marcel

    2012-05-10

    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. 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. 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.

  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. Occupational Therapy Intervention Improves Glycemic Control and Quality of Life Among Young Adults With Diabetes: the Resilient, Empowered, Active Living With Diabetes (REAL Diabetes) Randomized Controlled Trial.

    Science.gov (United States)

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

    2018-01-19

    To assess the efficacy of a manualized occupational therapy (OT) intervention (Resilient, Empowered, Active Living with Diabetes [REAL Diabetes]) to improve glycemic control and psychosocial well-being among ethnically diverse young adults with low socioeconomic status (SES) who have type 1 or type 2 diabetes. Eighty-one young adults (age 22.6 ± 3.5 years; hemoglobin A1c [HbA1c] = 10.8%/95 mmol/mol ± 1.9%/20.8 mmol/mol) were randomly assigned to the REAL Diabetes intervention group (IG) or an attention control group (CG) over 6 months. IG participants received biweekly sessions guided by a manual composed of seven content modules; CG participants received standardized educational materials and biweekly phone calls. Blinded assessors collected data at baseline and 6 months. The primary outcome was HbA1c; secondary outcomes included diabetes self-care, diabetes-related quality of life (QOL), diabetes distress, depressive symptoms, and life satisfaction. Change scores were analyzed using Wilcoxon rank sum tests. Intent-to-treat analyses showed that IG participants showed significant improvement in HbA1c (-0.57%/6.2 mmol/mol vs. +0.36%/3.9 mmol/mol, P = 0.01), diabetes-related QOL (+0.7 vs. +0.15, P = 0.04), and habit strength for checking blood glucose (+3.9 vs. +1.7, P = 0.05) as compared with CG participants. There was no statistically significant effect modification by sex, ethnicity, diabetes type, recruitment site, or SES. No study-related serious adverse events were reported. The REAL Diabetes intervention improved blood glucose control and diabetes-related QOL among a typically hard-to-reach population, thus providing evidence that a structured OT intervention may be beneficial in improving both clinical and psychosocial outcomes among individuals with diabetes. © 2018 by the American Diabetes Association.

  11. 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

  12. 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 ...

  13. Treatment of diffuse diabetic maculopathy with intravitreal triamcinolone and laser photocoagulation: randomized clinical trial with morphological and functional evaluation

    National Research Council Canada - National Science Library

    Gil, Alberto Luiz; Azevedo, Mirela Jobim de; Tomasetto, Giovani Generali; Muniz, Carlos Henrique Gervini; Lavinsky, Jacó

    2011-01-01

    .... The purpose of this double blind randomized clinical trial was to compare the treatment of diffuse diabetic macular edema with intravitreal triamcinolone or laser in type 2 diabetes mellitus patients...

  14. Consideration of chronic pain in trials to promote physical activity for diabetes: a systematic review of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    John J Riva

    Full Text Available Chronic pain has been estimated to affect 60% of patients with diabetes and is strongly associated with reduced activity tolerance. We systematically reviewed randomized controlled trials (RCTs that explored interventions to improve physical activity among patients with diabetes to establish whether co-morbid chronic pain was captured at baseline or explored as an effect modifier and if trials reported a component designed to target chronic pain.We searched CINAHL, Cochrane Central Registry of Controlled Trials, EMBASE, ERIC, MEDLINE, SPORTDiscus and PsycInfo from inception of each database to March 2012 for RCTs that enrolled patients with diabetes and randomly assigned them to an intervention designed to promote physical activity. Two reviewers independently selected trials and abstracted data. We identified 136 trials meeting our inclusion criteria, only one of which that reported capturing chronic pain measures at baseline. No trial reported on specific interventions to address chronic pain as a competing demand, or as an effect modifier.Only 1 trial identified that aimed to promote physical activity among patients with diabetes reported that co-morbid chronic pain was captured at baseline. No trials reported exploring chronic pain as an effect modifier or targeting it as part of its intervention.

  15. Selectively disrupted functional connectivity networks in type 2 diabetes mellitus

    Directory of Open Access Journals (Sweden)

    Yaojing eChen

    2015-12-01

    Full Text Available Background: The high prevalence of type 2 diabetes mellitus (T2DM in individuals over 65 years old and cognitive deficits caused by T2DM have attracted broad attention. The pathophysiological mechanism of T2DM induced cognitive impairments, however, remains poorly understood. Previous studies have suggested that the cognitive impairments can be attributed not merely to local functional and structural abnormalities but also to specific brain networks. Thus, we aimed to investigate the changes of global networks selectively affected by T2DM. Methods: A resting state functional network analysis was conducted to investigate the intrinsic functional connectivity in 37 patients with diabetes and 40 healthy controls which were recruited from local communities in Beijing, China. Results: We found that patients with T2DM exhibited cognitive function declines and functional connectivity disruptions within the default mode network, left frontal parietal network, and sensorimotor network. More importantly, the fasting glucose level was correlated with abnormal functional connectivity.Conclusions: These findings could help to understand the neural mechanisms of cognitive impairments in T2DM and provide potential neuroimaging biomarkers that may be used for early diagnosis and intervention in cognitive decline.

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

    OpenAIRE

    Tsang, Tracey; Orr, Rhonda; Lam, Paul; Elizabeth J Comino; Singh, Maria Fiatarone

    2007-01-01

    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 li...

  18. 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...

  19. Bromelain and cardiovascular risk factors in diabetes: An exploratory randomized, placebo controlled, double blind clinical trial.

    Science.gov (United States)

    Ley, Chit Moy; Ni, Qing; Liao, Xing; Gao, Huai-Lin; Robinson, Nicola

    2016-10-01

    To assess whether the dietary supplement (bromelain) has the potential to reduce plasma fibrinogen and other cardiovascular disease (CVD) risk factors in patients with diabetes. This randomized placebo controlled, double blind, parallel design, efficacy study was carried out in China and investigated the effect of 12 weeks of bromelain (1,050 mg/day) on plasma fibrinogen. This randomized controlled trial (RCT) recruited 68 Chinese diabetic patients [32 males and 36 females; Han origin, mean age of 61.26 years (standard deviation (SD), 12.62 years)] with at least one CVD risk factor. Patients were randomized into either bromelain or placebo group. While bromelain group received bromelain capsule, the placebo group received placebo capsule which consisted inert ingredient and has no treatment effect. Subjects were required to take 1,050 mg (3×350 mg) of either bromelain or starch-filled placebo capsules, two to be taken (2×350 mg) after breakfast and another (350 mg) after dinner, daily for 12 weeks. Plasma fibrinogen, CVD risk factors and anthropometric indicators were determined at baseline and at 12 weeks. The change in the fibrinogen level in the bromelain group at the end of the study showed a mean reduction of 0.13 g/L (standard deviation (SD) 0.86g/L) compared with the mean reduction of 0.36 g/L (SD 0.96 g/L) for the placebo group. However, there was no significant difference in the mean change in fibrinogen between the placebo and bromelain groups (mean difference=0.23g/L (SD 0.22 g/L), =0.291). Similarly, the difference in mean change in other CVD risk factors (blood lipids, blood pressure), blood glucose, C-reactive protein and anthropometric measures between the bromelain and placebo groups was also not statistically significant. Statistical differences in fibrinogen between bromelain and placebo groups before the trial despite randomization may have influenced the results of this study. This RCT failed to show a beneficial effect in reducing fibrinogen

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

    OpenAIRE

    Marcela Janka-Zires; Paloma Almeda-Valdes; Ana Cecilia Uribe-Wiechers; Sonia Citlali Juárez-Comboni; Joel López-Gutiérrez; Jarod Jazek Escobar-Jiménez; Francisco J Gómez-Pérez

    2016-01-01

    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 convent...

  1. Pharmaceutical care of elderly patients with poorly controlled type 2 diabetes mellitus: a randomized controlled trial.

    Science.gov (United States)

    Chen, Jyun-Hong; Ou, Huang-Tz; Lin, Tzu-Chieh; Lai, Edward Chia-Cheng; Kao, Yea-Huei Yang

    2016-02-01

    Care of the elderly with diabetes is more complicated than that for other age groups. The elderly and/or those with multiple comorbidities are often excluded from randomized controlled trials of treatments for diabetes. The heterogeneity of health status of the elderly also increases the difficulty in diabetes care; therefore, diabetes care for the elderly should be individualized. Motivated patients educated about diabetes benefit the most from collaborating with a multidisciplinary patient-care team. A pharmacist is an important team member by serving as an educator, coach, healthcare manager, and pharmaceutical care provider. To evaluate the effects of pharmaceutical care on glycemic control of ambulatory elderly patients with type 2 diabetes. A 421-bed district hospital in Nantou City, Taiwan. We conducted a randomized controlled clinical trial involving 100 patients with type 2 diabetes with poor glycemic control (HbA1c levels of ≥9.0 %) aged ≥65 years over 6 months. Participants were randomly assigned to a standard-care (control, n = 50) or pharmaceutical-care (intervention, n = 50) group. Pharmaceutical care was provided by a certified diabetes-educator pharmacist who identified and resolved drug-related problems and established a procedure for consultations pertaining to medication. The Mann–Whitney test was used to evaluate nonparametric quantitative data. Statistical significance was defined as P Medical expenses between groups did not significantly differ (−624.06 vs. −418.7, P = 0.767). There was no significant difference in hospitalization rates between groups. The pharmacist intervention program provided pharmaceutical services that improved long-term, safe control of blood sugar levels for ambulatory elderly patients with diabetes and did not increase medical expenses.

  2. Unbiased split variable selection for random survival forests using maximally selected rank statistics.

    Science.gov (United States)

    Wright, Marvin N; Dankowski, Theresa; Ziegler, Andreas

    2017-04-15

    The most popular approach for analyzing survival data is the Cox regression model. The Cox model may, however, be misspecified, and its proportionality assumption may not always be fulfilled. An alternative approach for survival prediction is random forests for survival outcomes. The standard split criterion for random survival forests is the log-rank test statistic, which favors splitting variables with many possible split points. Conditional inference forests avoid this split variable selection bias. However, linear rank statistics are utilized by default in conditional inference forests to select the optimal splitting variable, which cannot detect non-linear effects in the independent variables. An alternative is to use maximally selected rank statistics for the split point selection. As in conditional inference forests, splitting variables are compared on the p-value scale. However, instead of the conditional Monte-Carlo approach used in conditional inference forests, p-value approximations are employed. We describe several p-value approximations and the implementation of the proposed random forest approach. A simulation study demonstrates that unbiased split variable selection is possible. However, there is a trade-off between unbiased split variable selection and runtime. In benchmark studies of prediction performance on simulated and real datasets, the new method performs better than random survival forests if informative dichotomous variables are combined with uninformative variables with more categories and better than conditional inference forests if non-linear covariate effects are included. In a runtime comparison, the method proves to be computationally faster than both alternatives, if a simple p-value approximation is used. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  3. 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

  4. Mendelian randomization studies of biomarkers and type 2 diabetes

    NARCIS (Netherlands)

    Abbasi, Ali

    2015-01-01

    Many biomarkers are associated with type 2 diabetes (T2D) risk in epidemiological observations. The aim of this study was to identify and summarize current evidence for causal effects of biomarkers on T2D. A systematic literature search in PubMed and EMBASE (until April 2015) was done to identify

  5. 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.

  6. Effect of Oral Insulin on Prevention of Diabetes in Relatives of Patients With Type 1 Diabetes: A Randomized Clinical Trial.

    Science.gov (United States)

    Krischer, Jeffrey P; Schatz, Desmond A; Bundy, Brian; Skyler, Jay S; Greenbaum, Carla J

    2017-11-21

    Type 1 diabetes requires major lifestyle changes and carries increased morbidity and mortality. Prevention or delay of diabetes would have major clinical effect. To determine whether oral insulin delays onset of type 1 diabetes in autoantibody-positive relatives of patients with type 1 diabetes. Between March 2, 2007, and December 21, 2015, relatives with at least 2 autoantibodies, including insulin autoantibodies and normal glucose tolerance, were enrolled in Canada, the United States, Australia, New Zealand, the United Kingdom, Italy, Sweden, Finland, and Germany. The main study group (n = 389) had first-phase insulin release on an intravenous glucose tolerance test that was higher than the threshold. The 55 patients in the secondary stratum 1 had an identical antibody profile as the main study group except they had first-phase insulin release that was lower than the threshold. Secondary strata 2 (n = 114) and strata 3 (n = 3) had different autoantibody profiles and first-phase insulin release threshold combinations. Follow-up continued through December 31, 2016. Randomization to receive 7.5 mg/d of oral insulin (n = 283) or placebo (n = 277), including participants in the main study group who received oral insulin (n = 203) or placebo (n = 186). The primary outcome was time to diabetes in the main study group. Significance was based on a 1-sided threshold of .05, and 1-sided 95% CIs are reported. Of a total of 560 randomized participants (median enrollment age, 8.2 years; interquartile range [IQR], 5.7-12.1 years; 170 boys [60%]; 90.7% white non-Hispanic; 57.6% with a sibling with type 1 diabetes), 550 completed the trial including 389 participants (median age, 8.4 years; 245 boys [63%]), 382 (96%) in the main study group. During a median follow-up of 2.7 years (IQR, 1.5-4.6 years) in the main study group, diabetes was diagnosed in 58 participants (28.5%) in the oral insulin group and 62 (33%) in the placebo group. Time to diabetes

  7. 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

  8. 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.

  9. 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 (Ppsychomotricity a safe and efficacy therapy for pediatric selective mutism.

  10. 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.

  11. Beneficial effects of selected antioxdants in experimental diabetes ...

    African Journals Online (AJOL)

    The results of diabetic control rats showed that the concentrations of GSH-Px and GRT were increased as opposed to decreases in GSH levels suggesting that GSH regeneration by oxidized glutathione (GSSG) and the generation of NADP+ from NADPH is theoretically insufficient under diabetic conditions. This study ...

  12. 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.

  13. Differential effects of calcium channel blockers on size selectivity of proteinuria in diabetic glomerulopathy.

    Science.gov (United States)

    Smith, A C; Toto, R; Bakris, G L

    1998-09-01

    Calcium channel blockers (CCBs) are known to have differential effects on both changes in proteinuria as well as progression of diabetic nephropathy. No clinical study, however, has evaluated whether the differential antiproteinuric effects of CCBs may be explained by their effect on glomerular membrane permeability. We, therefore, tested the hypothesis that certain subclasses of CCBs reduce proteinuria by changing size selectivity of the glomerular membrane, hence changing its permeability. Twenty-one patients with type 2 diabetes and the presence of nephropathy with hypertension were randomized to receive either diltiazem CD or nifedipine GITS after baseline data for mean systolic and diastolic pressure, urinary protein excretion, glomerular filtration rate, renal plasma flow, neutral dextran and IgG clearances were obtained. Glomerular filtration rate, renal plasma flow, neutral dextran and IgG clearance were measured every three months, arterial pressure and heart rate every month. Patients were followed for 21 months. At 21 months, both patient groups had similar levels of blood pressure control, however, only the diltiazem group had a change in proteinuria (4+/-10%delta, nifedipine vs. -57+/-18%delta, diltiazem; P proteinuria do so, in part, by improving glomerular size permselectivity.

  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...

  15. The validity of monitoring the control of diabetes with random blood ...

    African Journals Online (AJOL)

    It is important to decide if a patient with diabetes has good glycaemic control in order to guide treatment and to offer behaviour change counselling. Currently, determining random blood glucose (RBG) is usually carried out in primary care in the public sector to make this decision. This study investigates the validity of these ...

  16. 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.

  17. A pragmatic cluster randomized clinical trial of diabetes prevention strategies for women with gestational diabetes: design and rationale of the Gestational Diabetes' Effects on Moms (GEM) study.

    Science.gov (United States)

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

    2014-01-15

    Women with gestational diabetes (GDM) are at high risk of developing diabetes later in life. After a GDM diagnosis, women receive prenatal care to control their blood glucose levels via diet, physical activity and medications. Continuing such lifestyle skills into early motherhood may reduce the risk of diabetes in this high risk population. In the Gestational Diabetes' Effects on Moms (GEM) study, we are evaluating the comparative effectiveness of diabetes prevention strategies for weight management designed for pregnant/postpartum women with GDM and delivered at the health system level. The GEM study is a pragmatic cluster randomized clinical trial of 44 medical facilities at Kaiser Permanente Northern California randomly assigned to either the intervention or usual care conditions, that includes 2,320 women with a GDM diagnosis between March 27, 2011 and March 30, 2012. A Diabetes Prevention Program-derived print/telephone lifestyle intervention of 13 telephonic sessions tailored to pregnant/postpartum women was developed. The effectiveness of this intervention added to usual care is to be compared to usual care practices alone, which includes two pages of printed lifestyle recommendations sent to postpartum women via mail. Primary outcomes include the proportion of women who reach a postpartum weight goal and total weight change. Secondary outcomes include postpartum glycemia, blood pressure, depression, percent of calories from fat, total caloric intake and physical activity levels. Data were collected through electronic medical records and surveys at baseline (soon after GDM diagnosis), 6 weeks (range 2 to 11 weeks), 6 months (range 12 to 34 weeks) and 12 months postpartum (range 35 to 64 weeks). There is a need for evidence regarding the effectiveness of lifestyle modification for the prevention of diabetes in women with GDM, as well as confirmation that a diabetes prevention program delivered at the health system level is able to successfully reach this

  18. 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.

  19. Natural selection? The evolution of diagnostic criteria for gestational diabetes.

    Science.gov (United States)

    Meek, Claire L

    2017-01-01

    Gestational diabetes is a common pregnancy disorder which is generally managed with diet, exercise, metformin or insulin treatment and which usually resolves after delivery of the infant. Identifying and treating gestational diabetes improves maternal and fetal outcomes and allows for health promotion to reduce the mother's risk of type 2 diabetes in later life. However, there remains considerable controversy about the optimal method of identification and diagnosis of women with gestational diabetes. The NICE-2015 diagnostic criteria (75 g oral glucose tolerance test (OGTT) 0 h ≥5.6 mmol/L; 2 h ≥7.8 mmol/L) are based upon cost-effectiveness estimates using observational data, while the WHO-2013 criteria (75 g OGTT 0 h ≥5.1 mmol/L; 1 h ≥10.0 mmol/L; 2 h ≥8.5 mmol/L) identify women and infants at risk of adverse outcomes according to prospective data. There is also considerable controversy about testing for gestational diabetes using universal or risk factor-based screening, and when and how testing should be performed. The aim of this review is to provide a summary of the clinical biochemistry aspects to these debates and to highlight the importance of appropriate identification of gestational diabetes and subsequent type 2 diabetes in this population.

  20. Selective endothelin A-receptor blockade attenuates coronary microvascular dysfunction after coronary stenting in patients with type 2 diabetes

    Directory of Open Access Journals (Sweden)

    Nikolaos Östlund Papadogeorgos

    2009-10-01

    Full Text Available Nikolaos Östlund Papadogeorgos, Mattias Bengtsson, Majid KalaniKarolinska Institute, Department of Clinical Sciences, Department of Cardiology, Danderyd Hospital, Stockholm, SwedenBackground: Endothelin-1 may be involved in the development of diabetic microangiopathy. We studied the effect of endothelin-1 blockade on myocardial microcirculation during coronary stenting.Patients and methods: Patients with type 2 diabetes and stable coronary artery disease undergoing elective percutaneous coronary intervention (PCI were randomized to bolus dose of 500 mg bosentan (n = 4, a dual endothelin receptor blocker, or intracoronary administration of 0.03 mmol BQ123 (n = 6, a selective endothelin A-receptor blocker, or placebo (n = 5, respectively. Coronary flow reserve (CFR was measured immediately post-PCI. CFR was also measured in five nondiabetic controls post-coronary stenting.Results: Patients in the placebo group had (P < 0.05 lower values of CFR (2.3 ± 1.2 as compared to those who received endothelin blockade (n = 10; 3.1 ± 0.7 and nondiabetic controls (4.9 ± 2.3. Patients who received BQ123 showed significantly higher CFR (3.3 ± 0.5; P < 0.05 as compared to those on placebo. Nondiabetic patients had significantly higher CFR as compared to patients with diabetes (4.9 ± 2.3 and 2.8 ± 1.0, respectively; P < 0.05. Conclusion: Coronary microvascular dysfunction is present during coronary stenting in patients with type 2 diabetes and may be reversed by selective endothelin A-receptor blockade. Targeting endothelin system may be of importance in protecting the myocardium against ischemic events during elective PCI in type 2 diabetic patients.Keywords: coronary flow reserve, diabetes, endothelin-1, coronary artery disease, coronary angioplasty

  1. The clinical and biomechanical effects of subthreshold random noise on the plantar surface of the foot in diabetic patients and elder people: A systematic review.

    Science.gov (United States)

    Bagherzadeh Cham, Masumeh; Mohseni-Bandpei, Mohammad Ali; Bahramizadeh, Mahmood; Kalbasi, Saeed; Biglarian, Akbar

    2016-12-01

    Central nervous system receives information from foot mechanoreceptors in order to control balance and perform movement tasks. Subthreshold random noise seems to improve sensitivity of the cutaneous mechanoreceptor. The purpose of this study was to systematically review published evidence conducted to evaluate the clinical and biomechanical effects of subthreshold random noise on the plantar surface of the foot in diabetic patients and elder people. Systematic review. A literature search was performed in PubMed, Scopus, ScienceDirect, Web of Knowledge, CINAHL, and EMBASE databases based on population, intervention, comparison, outcomes, and study method. Quality of studies was assessed using the methodological quality assessment tool, using Physiotherapy Evidence Database scale. In all, 11 studies were selected for final evaluation based on inclusion criteria. Five studies evaluated the effects of subthreshold random noise in diabetic patients and six in elder people. In seven studies, biomechanical (balance and gait parameters) effects and in four studies clinical (pressure and vibration sensations) effects of subthreshold random noise were investigated. All reviewed studies were scored fair (2) to good (9) quality in terms of methodological quality assessment using Physiotherapy Evidence Database scale. The results indicated that subthreshold random noise improves balance and sensation in diabetic patients and elder people. Also gait variables can be improved in elder people with subthreshold random noise. However, further well-designed studies are needed. The previous studies reported that subthreshold random noise may improve gait, balance, and sensation, but more studies are needed to evaluate the long-term effect of subthreshold random noise in shoe or insole for daily living tasks in diabetic patients and elder people. © The International Society for Prosthetics and Orthotics 2016.

  2. Assessment of barriers to improve diabetes management in older adults: a randomized controlled study.

    Science.gov (United States)

    Munshi, Medha N; Segal, Alissa R; Suhl, Emmy; Ryan, Courtney; Sternthal, Adrianne; Giusti, Judy; Lee, Yishan; Fitzgerald, Shane; Staum, Elizabeth; Bonsignor, Patricia; DesRochers, Laura; McCartney, Richard; Weinger, Katie

    2013-03-01

    To evaluate whether assessment of barriers to self-care and strategies to cope with these barriers in older adults with diabetes is superior to usual care with attention control. The American Diabetes Association guidelines recommend the assessment of age-specific barriers. However, the effect of such strategy on outcomes is unknown. We randomized 100 subjects aged ≥69 years with poorly controlled diabetes (A1C >8%) in two groups. A geriatric diabetes team assessed barriers and developed strategies to help patients cope with barriers for an intervention group. The control group received equal amounts of attention time. The active intervention was performed for the first 6 months, followed by a "no-contact" period. Outcome measures included A1C, Tinetti test, 6-min walk test (6MWT), self-care frequency, and diabetes-related distress. We assessed 100 patients (age 75 ± 5 years, duration 21 ± 13 years, 68% type 2 diabetes, 89% on insulin) over 12 months. After the active period, A1C decreased by -0.45% in the intervention group vs. -0.31% in the control group. At 12 months, A1C decreased further in the intervention group by -0.21% vs. 0% in control group (linear mixed-model, P Tinetti), and endurance (6MWT) compared with the control group. Diabetes-related distress improved in both groups. Only attention between clinic visits lowers diabetes-related distress in older adults. However, communication with an educator cognizant of patients' barriers improves glycemic control and self-care frequency, maintains functionality, and lowers distress in this population.

  3. 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

  4. Efficacy of short-term adjunctive subantimicrobial dose doxycycline in diabetic patients--randomized study.

    Science.gov (United States)

    Gilowski, L; Kondzielnik, P; Wiench, R; Płocica, I; Strojek, K; Krzemiński, T F

    2012-11-01

    To investigate the effectiveness of short-term adjunctive subantimicrobial dose doxycycline (SDD) treatment in patients with diabetes mellitus type 2 and chronic periodontitis (CP). Thirty-four patients with CP and type 2 diabetes mellitus were included in the placebo-controlled, double-blind study. After scaling and root planing (SRP), patients were randomly assigned to two groups, receiving either SDD or placebo bid for 3 months. The probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), approximal plaque index, glycated hemoglobin (HbA1c) level were recorded and gingival crevicular fluid (GCF) samples were collected at baseline and after 3-month therapy for the estimation of matrix metalloproteinase-8 levels. Clinical attachment level, PD, and BOP improved significantly in both groups after therapy (P diabetes and CP. © 2012 John Wiley & Sons A/S.

  5. 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...... and type 2 diabetes, respectively. Most were normotensive, and all had normoalbuminuria (median urinary albumin excretion rate, 5.0 microg/min). INTERVENTION: Candesartan, 16 mg/d increasing to 32 mg/d, versus placebo. Assignment was done centrally using an interactive voice-response system. Patients...... 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...

  6. 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

  7. Predictors of Diabetes Self-Management among Type 2 Diabetes Patients

    National Research Council Canada - National Science Library

    Gunggu, Azylina; Thon, Chang Ching; Whye Lian, Cheah

    2016-01-01

    .... Diabetes self-management (DSM) is found to be essential for optimal glycemic control. This cross-sectional study was conducted among samples from four randomly selected diabetes clinics in Sarawak, Malaysia...

  8. 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.

  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 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. Diabetes Nurse Case Management in a Canadian Tertiary Care Setting: Results of a Randomized Controlled Trial.

    Science.gov (United States)

    Li, Danni; Elliott, Tom; Klein, Gerri; Ur, Ehud; Tang, Tricia S

    2017-06-01

    To examine the effects of a 6-month nurse case manager (NCM) intervention compared to standard care (SC) on glycemic control and diabetes distress in a Canadian tertiary-care setting. We recruited 140 adults with type 2 diabetes and glycated hemoglobin (A1C) levels >8% (64 mmol/mol) from 2 tertiary care facilities and randomized them to: 1) a 6-month NCM intervention in addition to SC or 2) SC by the primary endocrinologists. Assessments were conducted at baseline and at 6 months. Primary outcomes included A1C levels and diabetes distress scores (DDS). Secondary outcomes included body mass index, blood pressure, diabetes-related behaviour measures, depressive symptoms, self-motivation and perception of support. At the 6-month follow up, the NCM group experienced larger reductions in A1C levels of -0.73% compared to the SC group (p=0.027; n=134). The NCM group also showed an additional reduction of -0.40 (26% reduction) in DDS compared to those in the SC group (p=0.001; n=134). The NCM group had lower blood pressure, ate more fruit and vegetables, exercised more, checked their feet more frequently, were more motivated, were less depressed and perceived more support. There were no changes and no group differences in terms of body mass index, medication compliance or frequency of testing. Compared to SC, NCM intervention was more effective in improving glycemic control and reducing diabetes distress. It is, therefore, a viable adjunct to standard diabetes care in the tertiary care setting, particularly for patients at high risk and with poor control. Copyright © 2017 Diabetes Canada. Published by Elsevier Inc. All rights reserved.

  12. Feasibility of closed-loop insulin delivery in type 2 diabetes: a randomized controlled study.

    Science.gov (United States)

    Kumareswaran, Kavita; Thabit, Hood; Leelarathna, Lalantha; Caldwell, Karen; Elleri, Daniela; Allen, Janet M; Nodale, Marianna; Wilinska, Malgorzata E; Evans, Mark L; Hovorka, Roman

    2014-01-01

    Closed-loop insulin delivery offers a promising treatment option, but to date, it has only been evaluated in type 1 diabetes. Our aim was to evaluate the feasibility of fully closed-loop subcutaneous insulin delivery in insulin-naïve patients with type 2 diabetes. Twelve subjects (seven males, age 57.2 years, BMI 30.5 kg/m2) with noninsulin-treated type 2 diabetes (HbA1c 8.4% [68 mmol/mol], diabetes duration 7.6 years) underwent two 24-h visits (closed-loop and control) in a randomized crossover design. During closed-loop visits, the subjects' routine diabetes therapy was replaced with model predictive control algorithm-driven subcutaneous insulin pump delivery based on real-time continuous glucose monitoring. Meals were unannounced, and no additional insulin was administered for carbohydrates consumed. During control visits, the usual diabetes regimen was continued (metformin 92%, sulfonylureas 58%, dipeptidyl peptidase-4 inhibitors 33%). On both visits, subjects consumed matched 50- to 80-g carbohydrate meals and optional 15-g carbohydrate snacks and remained largely sedentary. Plasma glucose measurements evaluated closed-loop performance. Compared with conventional therapy, 24 h of closed-loop insulin delivery increased overall the median time in target plasma glucose (3.9-8.0 mmol/L) from 24 to 40% (P = 0.016), despite sensor under-reading by a median of 1.2 mmol/L. The benefit of the closed-loop system was more prominent overnight, with greater time in target glucose (median 78 vs. 35%; P = 0.041) and less time in hyperglycemia (22 vs. 65%; P = 0.041). There was no hypoglycemia during either intervention. A closed-loop system without meal announcement and using subcutaneous insulin delivery in insulin-naïve patients with type 2 diabetes appears feasible and safe. Improvement in postprandial glucose control may require further optimization of system performance.

  13. The screening for diabetic nephropathy in diabetes clinic in ...

    African Journals Online (AJOL)

    Study Design: Prospective cross- sectional study. Populations: during the period from Jan-March 2008, 98 diabetic patients with type 1 or type 2 were randomly selected from patients attending the outpatient diabetes clinic in Omdurman Teaching Hospital. Methodology: ninety eight adult type1 and 2 diabetic patients were ...

  14. A randomized comparative effectiveness trial of using cable television to deliver diabetes prevention programming

    Science.gov (United States)

    Ackermann, Ronald T; Sandy, Lewis G; Beauregard, Tom; Coblitz, Mark; Norton, Kristi L; Vojta, Deneen

    2014-01-01

    Objective To evaluate the use and effectiveness of two “in-home” strategies for delivering diabetes prevention programming using cable television. Methods An individually randomized, two-arm intervention trial including adults with diabetes risk factors living in two US cities. Interventions involved a 16-session lifestyle intervention delivered via “video-on-demand” cable television, offered alone versus in combination with web-based lifestyle support tools. Repeated measures longitudinal linear regression with imputation of missing observations was used to compare changes in body weight. Results A total of 306 individuals were randomized and offered the interventions. After 5 months, 265 (87%) participants viewed at least 1, and 110 (36%) viewed ≥9 of the video episodes. A total of 262 (86%) participants completed a 5-month weight measurement. In intention-to-treat analysis with imputation of missing observations, mean weight loss at 5 months for both treatment groups combined was 3.3% (95% CI 0.7-5.0%), regardless of intervention participation (with no differences between randomized groups (P = 0.19)), and was 4.9% (95% CI 2.1-6.5%) for participants who viewed ≥9 episodes. Conclusions In-home delivery of evidence-based diabetes prevention programming in a reality television format, offered with or without online behavioral support tools, can achieve modest weight losses consistent with past implementation studies of face-to-face programs using similar content. PMID:24740868

  15. Event selection with a Random Forest in IceCube

    Energy Technology Data Exchange (ETDEWEB)

    Ruhe, Tim [TU, Dortmund (Germany); Collaboration: IceCube-Collaboration

    2011-07-01

    The Random Forest method is a multivariate algorithm that can be used for classification and regression respectively. The Random Forest implemented in the RapidMiner learning environment has been used for training and validation on data and Monte Carlo simulations of the IceCube neutrino telescope. Latest results are presented.

  16. Types of pediatric diabetes mellitus defined by anti-islet autoimmunity and random C-peptide at diagnosis

    Science.gov (United States)

    The objective of this study was to test the hypothesis that anti-islet autoantibody expression and random serum C-peptide obtained at diagnosis define phenotypes of pediatric diabetes with distinct clinical features. We analyzed 607 children aged diabetes after ex...

  17. 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...

  18. 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

  19. The excess mortality of patients with diabetes and concurrent psychiatric illness is markedly reduced by structured personal diabetes care. A 19-year follow up of the randomized controlled study Diabetes Care in General Practice (DCGP)

    DEFF Research Database (Denmark)

    Larsen, Julie Rask; Siersma, Volkert Dirk; Davidsen, Annette Sofie

    2016-01-01

    OBJECTIVE: To assess the effectiveness of an intervention in Type 2 diabetic patients with concurrent psychiatric illness (PI) and compare this with the effectiveness in patients without PI. METHOD: In the Diabetes Care in General Practice trial, 1381 patients newly diagnosed with Type 2 diabetes...... were randomized to 6 years of structured personal diabetes care or routine diabetes care (ClinicalTrials.gov NCT01074762). In this observational post-hoc analysis, the effectiveness of the intervention for diabetes in 179 patients with concurrent PI was analyzed. RESULTS: During the 19-year follow......-up period, patients with PI in the structured personal care group experienced a lower risk for all-cause mortality [105.3 vs. 140.4 events per 1000 patient-years; hazard ratio (HR): 0.63, P=0.023, multivariably adjusted], diabetes-related death (66.0 vs. 95.1; HR: 0.57, P=0.015), any diabetes...

  20. Effect of yoga and aerobics exercise on sleep quality in women with Type 2 diabetes: a randomized controlled trial.

    Science.gov (United States)

    Ebrahimi, Mohsen; Guilan-Nejad, Tayebe Nazari; Pordanjani, Abbas Foroughi

    2017-01-01

    The aim of this study was investigating the effect of 12 weeks of yoga and aerobic exercise (running on a treadmill) on the sleep quality in women with Type 2 diabetes. 39 diabetic women were selected from Semnan city with the mean age of 46.85±3.35 years, weight of 69.79±17.18 kg, height of 155.03±5.00, BMI of 29.64±5.00 kg/m2 who had a background of diabetes for 6.46±2.69 years. They were then randomly divided into yoga exercise (n=15), aerobic exercise (n=13), and control group (n=11). The exercise program was performed for 12 weeks, three sessions per each week. In order to measure the sleep quality, the Pittsburgh Sleep Quality Index (PSQI) was used. The data were analyzed by non-parametric wilcoxon and Kruskal-Wallis Test at significance level of psleep quality improved after six (p=0.001) and 12 (p=0.001) weeks of yoga exercise. Also, significant effect was observed after 6 weeks of aerobic exercise (p=0.039). However, the positive effect was diminished to under significant levels after 12 weeks of aerobic exercise (p=0.154). Kruskal-Wallis Test showed significant differences between yoga and aerobic groups after 12 weeks of exercise (p=0.002). No significant differences were observed in control groups in all situation. It can be concluded that yoga exercise is more effective in improving the sleep quality in comparison with the same course of aerobic exercise in women suffering from diabetes Type 2. Thus, yoga exercise can be suggested to these patients.

  1. Monitoring of psychological well-being in outpatients with diabetes: effects on mood, HbA(1c), and the patient's evaluation of the quality of diabetes care: a randomized controlled trial

    NARCIS (Netherlands)

    Pouwer, F.; Snoek, F. J.; van der Ploeg, H. M.; Adèr, H. J.; Heine, R. J.

    2001-01-01

    To investigate whether monitoring and discussing psychological well-being in outpatients with diabetes improves mood, glycemic control, and the patient's evaluation of the quality of diabetes care. This study was a randomized controlled trial of 461 outpatients with diabetes who were randomly

  2. Effect of 12 Weeks of Yoga Therapy on Quality of Life and Indian Diabetes Risk Score in Normotensive Indian Young Adult Prediabetics and Diabetics: Randomized Control Trial.

    Science.gov (United States)

    Keerthi, Gorantla Shravya; Pal, Pravati; Pal, Gopal Krushna; Sahoo, Jaya Prakash; Sridhar, Magadi Gopalakrishna; Balachander, Jayaraman

    2017-09-01

    India has become the epicentre for diabetes, a stress-related disorder affecting the working skills and day-to-day lifestyle management of younger population. Most of the studies have reported the effect of yoga on improving Quality of Life (QoL) in diabetic patients with other comorbidities. Till date, no randomized control trial reports are available to show the effect of yoga therapy on QoL and Indian Diabetes Risk Score (IDRS) in normotensive prediabetic and diabetic young individuals. To determine the effect of 12 weeks of yoga therapy on QoL and IDRS among normotensive prediabetic and diabetic young Indian adults. A randomized control trial was conducted in Endocrinology Outpatient Department (OPD). Normotensive participants (n=310) aged 18-45 years were divided into healthy controls (n=62), prediabetics (n=124) and diabetics (n=124). Study group subjects were randomly assigned to Group II (n=62, prediabetes-standard treatment), Group III (n=62, prediabetes-standard treatment + yoga therapy), Group IV (n=62, diabetes-standard treatment) and Group V (n=62, diabetes-standard treatment + yoga therapy). Flanagan QoL scale, IDRS questionnaire, Fasting Plasma Glucose (FPG) and insulin were assessed pre and post 12 weeks of intervention. Statistical analysis was done using Student's paired t-test and one-way ANOVA. Pre-post intervention analysis showed significant improvement in QoL scale with ppV respectively. There was significant reduction in IDRS in Group II (ppV respectively. Significant difference (p<0.001) in QoL scale and IDRS were found when study groups with standard treatment along with yoga therapy were compared to standard treatment alone. Yoga therapy along with standard treatment for 12 weeks improved QoL and attenuated the diabetes risk among Indian prediabetics and diabetics compared to standard treatment alone.

  3. 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

  4. Compound Danshen Dripping Pill for Treating Early Diabetic Retinopathy: A Randomized, Double-Dummy, Double-Blind Study

    Science.gov (United States)

    Luo, Dan; Qin, Yali; Yuan, Wei; Deng, Hui; Zhang, Youhua; Jin, Ming

    2015-01-01

    This randomized, double-dummy, double-blind study was to observe the therapeutic effects of compound Danshen dripping pill (CDDP) in treating early diabetic retinopathy (DR). All the 57 type 2 diabetes cases in nonproliferative diabetic retinopathy (NPDR) stage were divided into two groups randomly: 28 cases treated with CDDP as the treated group and 29 cases treated with calcium dobesilate as the control group. The best corrected visual acuity (BCVA) in the treated group was significantly improved after treatment when compared to that before treatment (P dobesilate for NPDR. In future DR treatments, CDDP may function as the auxiliary drug. PMID:26457110

  5. Study on MAX-MIN Ant System with Random Selection in Quadratic Assignment Problem

    Science.gov (United States)

    Iimura, Ichiro; Yoshida, Kenji; Ishibashi, Ken; Nakayama, Shigeru

    Ant Colony Optimization (ACO), which is a type of swarm intelligence inspired by ants' foraging behavior, has been studied extensively and its effectiveness has been shown by many researchers. The previous studies have reported that MAX-MIN Ant System (MMAS) is one of effective ACO algorithms. The MMAS maintains the balance of intensification and diversification concerning pheromone by limiting the quantity of pheromone to the range of minimum and maximum values. In this paper, we propose MAX-MIN Ant System with Random Selection (MMASRS) for improving the search performance even further. The MMASRS is a new ACO algorithm that is MMAS into which random selection was newly introduced. The random selection is one of the edgechoosing methods by agents (ants). In our experimental evaluation using ten quadratic assignment problems, we have proved that the proposed MMASRS with the random selection is superior to the conventional MMAS without the random selection in the viewpoint of the search performance.

  6. Selection of essential medicines for diabetes in low and middle income countries : a survey of 32 national essential medicines lists

    NARCIS (Netherlands)

    Taghipour Bazargani, Y.; de Boer, Anthonius; Leufkens, Hubert G M; Mantel-Teeuwisse, Aukje K

    2014-01-01

    AIM: Diabetes is a growing burden especially in low and middle income countries (LMICs). Inadequate access to diabetes care is of particular concern and selection of appropriate diabetes medicines on national essential medicines lists (NEMLs) is a first step in achieving adequate access. This

  7. Nurse care manager collaboration with community-based physicians providing diabetes care: a randomized controlled trial.

    Science.gov (United States)

    Hiss, Roland G; Armbruster, Betty A; Gillard, Mary Lou; McClure, Leslie A

    2007-01-01

    The purpose of this study was to demonstrate the potential value of close collaboration at the office level of a nurse care manager with community-based primary care physicians in the care of adult patients with type 2 diabetes, particularly those physicians not affiliated with an integrated care system that some managed care organizations provide. Patients with type 2 diabetes were recruited from the general population of a large metropolitan area. Each received a comprehensive evaluation of his or her diabetes with results reported to patients and their physicians (basic intervention). A random one-half of patients were additionally assigned to individual counseling, problem identification, care planning, and management recommendations by a nurse care manager (individualized intervention). The patients receiving only the basic intervention served as the control group to those receiving the individualized intervention. Re-evaluation of all patients at 6 months after their entry into the study determined the effectiveness of the nurse-directed individualized intervention using A1C, blood pressure, and cholesterol as outcome measures. Of 220 patients recruited, 197 had type 2 diabetes, randomly assigned only the basic intervention (102 patients) or individualized intervention (95 patients). Postintervention data were obtained on 164 patients (83%). Significant improvement occurred in mean systolic blood pressure and A1C of all patients in the individualized but not the basic intervention only group. Patients with a systolic blood pressure>or=130 mm Hg at baseline showed improvement if they had more than 2 contacts with the study nurse but not if they had less than 2 contacts. A nurse care manager collaborating at the office level with community-based primary care physicians can enhance the care provided to adult patients with type 2 diabetes. For those many physicians not affiliated with an integrated care system featured by some managed care organizations, this

  8. Zinc supplementation in pre-diabetes: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Ranasinghe, Priyanga; Jayawardena, Ranil; Pigera, A S A D; Katulanda, Prasad; Constantine, Godwin R; Galappaththy, Priyadarshani

    2013-02-19

    The number of people with diabetes is increasing worldwide, especially in developing South Asian countries. Therefore, preventing diabetes at the early stages has become an important issue. Recent clinical trials, systematic reviews, and meta-analysis have shown that zinc has beneficial effects on glycemic and metabolic control in those with diabetes. The present study is designed to evaluate the effects of zinc supplementation on glycemic control and other metabolic parameters in those with pre-diabetes. The study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for a period of 12 months at the Faculty of Medicine, University of Colombo, Sri Lanka. The study has been approved by the Ethics Review Committee of Faculty of Medicine, University of Colombo (EC/11/189). A total of 200 adults (age 18-60 years) with pre-diabetes will be recruited for the study. They will be stratified according to age, gender, and body mass index and randomly assigned into the test and placebo groups on a 1:1 ratio. The zinc capsules, each weighing 456 mg, will contain the following ingredients:zinc sulfate monohydrate 55.096 mg (elemental zinc 20 mg), lactose monohydrate 399.504 mg, and stearic acid 1.400 mg. The placebo capsule with the same weight will be comprised of lactose monohydrate 454.600 mg and stearic acid 1.400 mg. The subjects will receive either zinc 20 mg capsules or placebo daily for a period of 12 months. The study drugs will be double blinded to both investigators and subjects. The visits and the evaluations will be done as follows: screening (visit 0), 1 month (visit 1), 3 month (visit 2), 6 month (visit 3), and 12 month (visit 4). The following primary outcome measures will be evaluated:fasting plasma glucose (FPG), post oral glucose tolerance test (OGTT), serum insulin, HbA1c, total/low-density lipoprotein (LDL)/high-density lipoprotein (HDL) cholesterol, triglycerides, serum zinc, and appetite using a visual analog scale. Secondary

  9. 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

  10. Pharmacological treatment of the pathogenetic defects in type 2 diabetes: the randomized multicenter South Danish Diabetes Study.

    Science.gov (United States)

    Gram, Jeppe; Henriksen, Jan Erik; Grodum, Ellen; Juhl, Henning; Hansen, Tony Bill; Christiansen, Christian; Yderstræde, Knud; Gjessing, Hans; Hansen, Henrik M; Vestergaard, Vibe; Hangaard, Jørgen; Beck-Nielsen, Henning

    2011-01-01

    To determine the effect of treatment with insulin aspart compared with NPH insulin, together with metformin/placebo and rosiglitazone/placebo. The hypothesis was that combined correction of major pathogenetic defects in type 2 diabetes would result in optimal glycemic control. This study was a 2-year investigator-driven randomized partly placebo-controlled multicenter trial in 371 patients with type 2 diabetes on at least oral antiglycemic treatment. Patients were assigned to one of eight treatment groups in a factorial design with insulin aspart at mealtimes versus NPH insulin once daily at bedtime, metformin twice daily versus placebo, and rosiglitazone twice daily versus placebo. The main outcome measurement was change in A1C. A1C decreased more in patients treated with insulin aspart compared with NPH (-0.41 ± 0.10%, P weight (1.6 ± 0.6 kg, P weight and hypoglycemic episodes. However, insulin therapy has to be combined with treatment of both peripheral and liver insulin resistance to normalize blood glucose, and in this case, the insulin regimen is less important.

  11. 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.

  12. Predictive value of testing random urine sample to detect microalbuminuria in diabetic subjects during outpatient visit.

    Science.gov (United States)

    Bouhanick, B; Berrut, G; Chameau, A M; Hallar, M; Bled, F; Chevet, B; Vergely, J; Rohmer, V; Fressinaud, P; Marre, M

    1992-01-01

    The predictive value of random urine sample during outpatient visit to predict persistent microalbuminuria was studied in 76 Type 1, insulin-dependent diabetic subjects, 61 Type 2, non-insulin-dependent diabetic subjects, and 72 Type 2, insulin-treated diabetic subjects. Seventy-six patients attended outpatient clinic during morning, and 133 during afternoon. Microalbuminuria was suspected if Urinary Albumin Excretion (UAE) exceeded 20 mg/l. All patients were hospitalized within 6 months following outpatient visit, and persistent microalbuminuria was assessed then if UAE was between 30 and 300 mg/24 h on 2-3 occasions in 3 urines samples. Of these 209 subjects eighty-three were also screened with Microbumintest (Ames-Bayer), a semi-quantitative method. Among the 209 subjects, 71 were positive both for microalbuminuria during outpatient visit and a persistent microalbuminuria during hospitalization: sensitivity 91.0%, specificity 83.2%, concordance 86.1%, and positive predictive value 76.3% (chi-squared test: 191; p less than 10(-4)). Data were not different for subjects examined on morning, or on afternoon. Among the 83 subjects also screened with Microbumintest, 22 displayed both a positive reaction and a persistent microalbuminuria: sensitivity 76%, specificity 81%, concordance 80%, and positive predictive value 69% (chi-squared test: 126; p less than 10(-4)). Both types of screening appeared equally effective during outpatient visit. Hence, a persistent microalbuminuria can be predicted during an outpatient visit in a diabetic clinic.

  13. Cardiac-diabetes self-management program for Australians and Taiwanese: A randomized blocked design study.

    Science.gov (United States)

    Wu, Chiung-Jung Jo; Sung, Huei-Chuan; Chang, Anne M; Atherton, John; Kostner, Karam; McPhail, Steven M

    2017-09-01

    Cardiac disease and type 2 diabetes are prevalent diseases globally. Cardiac rehabilitation and diabetes self-management programs empower patients' self-management to improve their health outcomes. However, inappropriate delivery modes and continuing low participation rates indicate some programs are less than optimal. A previous study demonstrated the feasibility of incorporating telephone and text messages into a cardiac-diabetes self-management program in Australia; however, the program did not specifically address patients' cultural backgrounds. This current study used a randomized blocked design to evaluate short-term efficacy of the cardiac-diabetes self-management program incorporating telephone and text-messaging across different cultural contexts in Australia and Taiwan in comparison to usual care. No significant differences between groups were observed for outcomes of self-care behavior, self efficacy, knowledge and health-related quality of life, with patients in both groups demonstrating improvements. Patient-reported outcomes indicated some evidence of an interaction effect between country of origin and group allocation. Findings indicated an improved tendency of outcome measures between the baseline and follow-up assessments within usual care and intervention groups. Further research is required to clarify components of the program work for each cultural group. © 2017 John Wiley & Sons Australia, Ltd.

  14. Oral probiotics in the management of gingivitis in diabetic patients: a double blinded randomized controlled study.

    Science.gov (United States)

    Sabatini, S; Lauritano, D; Candotto, V; Silvestre, F J; Nardi, G M

    2017-01-01

    Diabetic patients are more prone to develop infections such as periodontal diseases. Bacteriotherapy with the concept of using good bacterial strains to replace the pathogenic ones emerged as a fascinating field due to the increasing incidence of antibiotic resistance. The aim of this study was to evaluate if a particular combination of probiotics (Lactobacillus Reuteri DSM 17938 and Lactobaciullus Reuteri ATCC PTA 5289) is useful in treating gingivitis in diabetic patients. Eighty adult patients with diagnosis of controlled diabetes type II and gingivitis were enrolled for this study and randomized in two groups. Only oral hygiene instructions were given. Bacteriotherapy (Lactobacillus Reuteri) was administered to test group. Outcome measures were presence of Plaque (P.I.) and Bleeding on Probing (B.O.P.). Data were collected at baseline and after 30 days. At 30 days, both groups showed a statistically significant clinical indexes reduction from baseline. More reduction was present in the test group for P.I. (14%±6) and for B.O.P. (18%±4) and was statistically significant (p less than 0.05). Within the limitations of this study, bacteriotherapy can be considered effective in reducing plaque and BOP in patients with controlled diabetes type II and gingivitis.

  15. Optimizing weight control in diabetes: antidiabetic drug selection

    Directory of Open Access Journals (Sweden)

    Kalra S

    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

  16. 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

  17. 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.

    [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...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......: Subjects with type 2 diabetes were randomized to a control (n = 8), CWT (n = 12), or IWT group (n = 12). Training groups were prescribed five sessions per week (60 min/session) and were controlled with an accelerometer and a heart-rate monitor. CWT performed all training at moderate intensity, whereas IWT...

  18. 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...

  19. Evaluation of the UCL diabetes self-management programme (UCL-DSMP): a randomized controlled trial.

    Science.gov (United States)

    Steed, Liz; Lankester, Jill; Barnard, Maria; Earle, Ken; Hurel, Stephen; Newman, Stanton

    2005-03-01

    Self-management has been described as the cornerstone of care for diabetes. Many self-management studies are limited by poor methodology and poor descriptions of the intervention. The current study developed a theoretically based self-management programme for patients with type 2 diabetes, which was evaluated via a randomized controlled trial. At immediate post-intervention and three-month follow-up the intervention group showed significant improvement relative to controls on self-management behaviours, quality of life and illness beliefs. A trend towards improved HbA1c was also observed. Documentation in a manual and development of a training programme for facilitators ensures the programme is replicable.

  20. Continuous glucose monitoring in people with diabetes: the randomized controlled Glucose Level Awareness in Diabetes Study (GLADIS).

    Science.gov (United States)

    New, J P; Ajjan, R; Pfeiffer, A F H; Freckmann, G

    2015-05-01

    To investigate the best glucose monitoring strategy for maintaining euglycaemia by comparing self-monitoring of blood glucose with continuous glucose monitoring, with or without an alarm function. A 100-day, randomized controlled study was conducted at four European centres, enrolling 160 patients with Type 1 or Type 2 diabetes, on multiple daily insulin injections or continuous subcutaneous insulin infusion. Participants were randomized to continuous glucose monitoring without alarms (n = 48), continuous glucose monitoring with alarms (n = 49) or self-monitoring of blood glucose (n = 48). Time spent outside the glucose target during days 80-100 was 9.9 h/day for the continuous glucose monitoring without alarms group, 9.7 h/day for the continuous glucose monitoring with alarms group and 10.6 h/day for the self-monitoring of blood glucose group (P = 0.18 and 0.08 compared with continuous glucose monitoring without and with alarms, respectively).The continuous glucose monitoring with alarms group spent less time in hypoglycaemia compared with the self-monitoring of blood glucose group (1.0 h/day and 1.6 h/day, respectively; 95% CI -1.2 to -0.1; P = 0.030). Among those treated with continuous subcutaneous insulin infusion, time spent outside the glucose target was significantly different when comparing continuous glucose monitoring without alarms and self-monitoring of blood glucose (-1.9 h/day; 95% CI -3.8 to 0.0; P = 0.0461) and when comparing continuous glucose monitoring with alarms and self-monitoring of blood glucose (-2.4 h/day; 95% CI -4.1 to -0.5; P = 0.0134). There was no difference in HbA1c reduction from baseline in the three groups; however, the proportion of participants with a reduction of ≥ 6 mmol/mol (≥ 0.5%) was higher in the continuous glucose monitoring without alarms (27%) and continuous glucose monitoring with alarms groups (25%) than in the self-monitoring of blood glucose group (10.6%). This study shows that the use

  1. Effect of Probiotic Fermented Milk (Kefir) on Glycemic Control and Lipid Profile In Type 2 Diabetic Patients: A Randomized Double-Blind Placebo-Controlled Clinical Trial

    OpenAIRE

    Alireza Ostadrahimi; Akbar Taghizadeh; Majid Mobasseri; Nazila Farrin; Laleh Payahoo; Zahra Beyramalipoor Gheshlaghi; Morteza Vahedjabbari

    2015-01-01

    Background: Diabetes is a global health problem in the world. Probiotic food has anti-diabetic property. The aim of this trial was to determine the effect of probiotic fermented milk (kefir) on glucose and lipid profile control in patients with type 2 diabetes mellitus. Methods: This randomized double-blind placebo-controlled clinical trial was conducted on 60 diabetic patients aged 35 to 65 years.Patients were randomly and equally (n=30) assigned to consume either probiotic fermented milk (k...

  2. Supported Telemonitoring and Glycemic Control in People with Type 2 Diabetes: The Telescot Diabetes Pragmatic Multicenter Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Sarah H Wild

    2016-07-01

    Full Text Available Self-monitoring of blood glucose among people with type 2 diabetes not treated with insulin does not appear to be effective in improving glycemic control. We investigated whether health professional review of telemetrically transmitted self-monitored glucose results in improved glycemic control in people with poorly controlled type 2 diabetes.We performed a randomized, parallel, investigator-blind controlled trial with centralized randomization in family practices in four regions of the United Kingdom among 321 people with type 2 diabetes and glycated hemoglobin (HbA1c >58 mmol/mol. The supported telemonitoring intervention involved self-measurement and transmission to a secure website of twice-weekly morning and evening glucose for review by family practice clinicians who were not blinded to allocation group. The control group received usual care, with at least annual review and more frequent reviews for people with poor glycemic or blood pressure control. HbA1c assessed at 9 mo was the primary outcome. Intention-to-treat analyses were performed. 160 people were randomized to the intervention group and 161 to the usual care group between June 6, 2011, and July 19, 2013. HbA1c data at follow-up were available for 146 people in the intervention group and 139 people in the control group. The mean (SD HbA1c at follow-up was 63.0 (15.5 mmol/mol in the intervention group and 67.8 (14.7 mmol/mol in the usual care group. For primary analysis, adjusted mean HbA1c was 5.60 mmol/mol / 0.51% lower (95% CI 2.38 to 8.81 mmol/mol/ 95% CI 0.22% to 0.81%, p = 0·0007. For secondary analyses, adjusted mean ambulatory systolic blood pressure was 3.06 mmHg lower (95% CI 0.56-5.56 mmHg, p = 0.017 and mean ambulatory diastolic blood pressure was 2.17 mmHg lower (95% CI 0.62-3.72, p = 0.006 among people in the intervention group when compared with usual care after adjustment for baseline differences and minimization strata. No significant differences were identified

  3. 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

  4. Microcurrent transcutaneous electric nerve stimulation in painful diabetic neuropathy: a randomized placebo-controlled study.

    Science.gov (United States)

    Gossrau, Gudrun; Wähner, Michael; Kuschke, Marion; Konrad, Birgit; Reichmann, Heinz; Wiedemann, Bärbel; Sabatowski, Rainer

    2011-06-01

    Diabetes is a common health care problem in western countries. Painful diabetic neuropathy (PDN) might be one of the consequences of long ongoing diabetes; it is estimated that approximately 20% of European diabetic patients suffer from PDN. Transcutaneous electrical nerve stimulation (TENS) is often used as additional pain treatment. However, recent studies show inconsistent results. We aimed to assess the effect of micro-TENS in reducing neuropathic pain in patients with PDN in a placebo-controlled, single-blinded, and randomized design. DESIGN/SETTING/PATIENTS/OUTCOME MEASURES: 22 diabetic patients have been treated with a micro-TENS therapy and 19 patients have been treated with a placebo therapy. Treatment duration was 4 weeks with three therapeutical settings per week. Standardized questionnaires (Pain Disability Index [PDI], neuropathic pain score [NPS], Center for Epidemiologic Studies Depression Scale [CES-D]) were used to assess pain intensity, pain disability, as well as quality of life at baseline at the end of the treatment period and 4 weeks after treatment termination. Patients with a minimum of 30% reduction in NPS were defined as therapy responders. After 4 weeks of treatment, 6/21 patients in the verum group vs 10/19 patients in the placebo group responded to therapy. The median PDI score after 4 weeks of treatment showed a reduction of 23% in the verum vs 25% in the placebo group. The differences did not reach statistical significance. The pain reduction with the applied transcutaneous electrotherapy regimen is not superior to a placebo treatment. Wiley Periodicals, Inc.

  5. The Selected Traditional Chinese Medicinal Formulas for Treating Diabetic Nephropathy: Perspective of Modern Science

    Directory of Open Access Journals (Sweden)

    Thing-Fong Tzeng

    2013-07-01

    Full Text Available With the increasing patients and limited therapeutic options, diabetic nephropathy (DN is a long-term complication of diabetic mellitus. The precise mechanism of DN is not yet fully understood and the effective blockade of the progression of nephropathy remains a therapeutic challenge. Application of traditional Chinese medicine (TCM for diabetes and its related complications has received increasing attention due to its wide availability, low side effects, and proven therapeutic mechanisms and benefits. In the current review, we mainly focus on the recent laboratory studies of the TCM formulas including Wu-Ling-San (Poria Five Powder; 五苓散 Wǔ Líng Sǎn, Danggui-Buxue-Tang (Tangkuei and Astragalus Decoction; 當歸補血湯 Dāng Guī Bǔ Xuè Tang, and Danggui-Shaoyao-San (Tangkuei and Paeonia Formula; 當歸芍藥散 Dāng Guī Sháo Yào Sǎn, conducted by the Committee on Chinese Medicine and Pharmacy at the Department of Health of Taiwan Government, in the amelioration of DN. These selected TCM formulas have anti-diabetic properties, with antihyperglycemic activity accompanied by amelioration of advanced glycation end product–mediated renal damage in streptozotocin-induced diabetic rats. However, the renoprotective effects of the selected TCM formulas did not correlate with suppressing renal renin–angiotensin system hyperactivity in diabetic rats. These TCM formulas also have the capacity to ameliorate the defective antioxidative defense system, leading to modulation of the oxidative stress, thereby resulting in downregulation of nuclear factor-κB as well as transforming growth factor-β1 and, consequently, attenuation of extracellular matrix components such as fibronectin or type IV collagen expression in diabetic renal cortex tissue. More detailed mechanistic researches and long-term clinical evaluations, as well as evaluation of safety of the selected TCM formulas are needed for their future applications in DN therapy.

  6. The Melbourne Diabetes Prevention Study (MDPS): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Davis-Lameloise, Nathalie; Hernan, Andrea; Janus, Edward D; Stewart, Elizabeth; Carter, Rob; Bennett, Catherine M; O'Reilly, Sharleen; Philpot, Benjamin; Vartiainen, Erkki; Dunbar, James A

    2013-01-31

    Worldwide, type 2 diabetes (T2DM) prevalence has more than doubled over two decades. In Australia, diabetes is the second highest contributor to the burden of disease. Lifestyle modification programs comprising diet changes, weight loss and moderate physical activity, have been proven to reduce the incidence of T2DM in high risk individuals.As part of the Council of Australia Governments, the State of Victoria committed to develop and support the diabetes prevention program 'Life! Taking action on diabetes' (Life!) which has direct lineage from effective clinical and implementation trials from Finland and Australia. The Melbourne Diabetes Prevention Study (MDPS) has been set up to evaluate the effectiveness and cost-effectiveness of a specific version of the Life! program. We intend to recruit 796 participants for this open randomized clinical trial; 398 will be allocated to the intervention arm and 398 to the usual care arm. Several methods of recruitment will be used in order to maximize the number of participants. Individuals aged 50 to 75 years will be screened with a risk tool (AUSDRISK) to detect those at high risk of developing T2DM. Those with existing diabetes will be excluded. Intervention participants will undergo anthropometric and laboratory tests, and comprehensive surveys at baseline, following the fourth group session (approximately three months after the commencement of the intervention) and 12 months after commencement of the intervention, while control participants will undergo testing at baseline and 12 months only.The intervention consists of an initial individual session followed by a series of five structured-group sessions. The first four group sessions will be carried out at two week intervals and the fifth session will occur eight months after the first group session. The intervention is based on the Health Action Process Approach (HAPA) model and sessions will empower and enable the participants to follow the five goals of the Life

  7. Paediatric obesity appears to lower the risk of diabetes if selection bias is ignored.

    Science.gov (United States)

    Stovitz, Steven D; Banack, Hailey R; Kaufman, Jay S

    2018-01-26

    Frustrated with the onslaught of articles reporting fascination with results that appear paradoxical but are merely due to selection bias, we studied the apparent effect of obesity on diabetes risk in youth who had a test for diabetes. We hypothesised that obese subjects would have lower rates of diabetes than non-obese subjects due to selection bias, and consequently, obesity would appear to lower the risk of diabetes. Retrospective cohort study of children (4-9 years), pre-teens (10-12 years) and teenagers (13-19 years). Participation was restricted to those who had a test of haemoglobin A1C along with measured height and weight. Body mass index percentile via the Centers for Disease Control and Prevention age and sex standards was calculated and categorised. The main outcome was A1C%, subsequently categorised at the level for diagnosis of diabetes mellitus (≥6.5%). The sample consisted of 134 (2%) underweight, 1718 (30%) healthy weight, 660 (12%) overweight and 3190 (56%) obese individuals. 16% (n=936) had an A1C≥6.5%. Overall, healthy weight children had 8.2 times the risk of A1C≥6.5% (95% CI 5.3 to 12.7) compared with those in the obese category. The relative risk was 13 in pre-teens (95% CI 8.5 to 20.0) and 3.9 in teenagers (95% CI 3.3 to 4.7). Healthy weight was associated with a 4-13 times higher relative risk of diabetes mellitus compared with being obese. While apparently shocking, the study's fatal flaw (selection bias) explains the 'paradoxical' finding. Ignoring selection bias can delay advances in medical science. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  8. Plants used to manage type II diabetes mellitus in selected districts ...

    African Journals Online (AJOL)

    Such information can lay a firm and clear foundation for scientific investigation of the purported therapeutic benefits of the said plants. The objective of this study was to collect names of medicinal plants used to manage diabetes mellitus type II in selected districts of central Uganda. Methods: In this ethnobotanical survey, ...

  9. In vivo selection of randomly mutated retroviral genomes

    NARCIS (Netherlands)

    Berkhout, B.; Klaver, B.

    1993-01-01

    Darwinian evolution, that is the outgrowth of the fittest variants in a population, usually applies to living organisms over long periods of time. Recently, in vitro selection/amplification techniques have been developed that allow for the rapid evolution of functionally active nucleic acids from a

  10. 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 gestation and were randomly allocated to the intervention group (n = 155) or the control group (n = 138). Each subject in the intervention group received individualized counseling on diet, physical activity, and weight control from trained study nurses, and had one group meeting with a dietitian. The control group received standard antenatal care. The diagnosis of GDM was based on a 75-g, 2-h oral glucose tolerance test at 24-28 weeks of gestation. A total of 269 women were included in the analyses. The incidence of GDM was 13.9% in the intervention group and 21.6% in the control group ([95% CI 0.40-0.98%]; P = 0.044, after adjustment for age, prepregnancy BMI, previous GDM status, and the number of weeks of gestation). Gestational weight gain was lower in the intervention group (-0.58 kg [95% CI -1.12 to -0.04 kg]; adjusted P = 0.037). Women in the intervention group increased their leisure time physical activity more and improved their dietary quality compared with women in the control group. A moderate individualized 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.

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

    Science.gov (United States)

    Janka-Zires, Marcela; Almeda-Valdes, Paloma; Uribe-Wiechers, Ana Cecilia; Juárez-Comboni, Sonia Citlali; López-Gutiérrez, Joel; Escobar-Jiménez, Jarod Jazek; Gómez-Pérez, Francisco J

    2016-01-01

    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.

  12. 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.

  13. 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.

  14. 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...

  15. Evaluation of the effects of a diabetes educational program: a randomized clinical trial.

    Science.gov (United States)

    Torres, Heloísa de Carvalho; Pace, Ana Emília; Chaves, Fernanda Figueredo; Velasquez-Melendez, Gustavo; Reis, Ilka Afonso

    2018-02-05

    Evaluate the effectiveness of a diabetes mellitus educational program in primary health care. This cluster randomized trial was conducted in a sample of 470 people with type 2 diabetes mellitus from eight health units, randomly assigned to two groups: intervention (n = 231) and control (n = 239). The intervention group participated in the educational program composed of three strategies: group education, home visit, and telephone intervention. Simultaneously, the control group was monitored individually. Group monitoring took place over nine months in the year 2012. Clinical evaluations were performed at the initial time (T0), three (T3), six (T6) and nine (T9) months after the beginning of the intervention. After nine months of follow-up, 341 users remained in the study, 171 in the control group and 170 in the intervention group. The average age of users was 60.6 years. In both groups, statistically significant differences were observed in mean HbA1c levels over the follow-up time (p educational program model developed was effective to improve the glycemic control of the intervention group participants.

  16. The Chronic CARe for diAbeTes study (CARAT: a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Birnbaum Beatrice

    2010-06-01

    Full Text Available Abstract Background Diabetes is a major challenge for the health care system and especially for the primary care provider. The Chronic Care Model represents an evidence-based framework for the care for chronically ill. An increasing number of studies showed that implementing elements of the Chronic Care Model improves patient relevant outcomes and process parameters. However, most of these findings have been performed in settings different from the Swiss health care system which is dominated by single handed practices. Methods/Design CARAT is a cluster randomized controlled trial with general practitioners as the unit of randomization (trial registration: ISRCTN05947538. The study challenges the hypothesis that implementing several elements of the Chronic Care Model via a specially trained practice nurse improves the HbA1c level of diabetes type II patients significantly after one year (primary outcome. Furthermore, we assume that the intervention increases the proportion of patients who achieve the recommended targets regarding blood pressure ( Discussion This study challenges the hypothesis that the Chronic Care Model can be easily implemented by a practice nurse focused approach. If our results will confirm this hypothesis the suggestion arises whether this approach should be implemented in other chronic diseases and multimorbid patients and how to redesign care in Switzerland.

  17. Use of protein: creatinine ratio in a random spot urine sample for predicting significant proteinuria in diabetes mellitus.

    Science.gov (United States)

    Yadav, B K; Adhikari, S; Gyawali, P; Shrestha, R; Poudel, B; Khanal, M

    2010-06-01

    Present study was undertaken during a period of 6 months (September 2008-February 2009) to see an correlation of 24 hours urine protein estimation with random spot protein-creatinine (P:C) ratio among a diabetic patients. The study comprised of 144 patients aged 30-70 years, recruited from Kantipur hospital, Kathmandu. The 24-hr urine sample was collected, followed by spot random urine sample. Both samples were analyzed for protein and creatinine excretion. An informed consent was taken from all participants. Sixteen inadequately collected urine samples as defined by (predicted creatinine--measured creatinine)/predicted creatinine > 0.2 were excluded from analysis. The Spearman's rank correlation between the spot urine P:C ratio and 24-hr total protein were performed by the Statistical Package for Social Service. At the P:C ratio cutoff of 0.15 and reference method (24-hr urine protein) cutoff of 150 mg/day, the correlation coefficient was found to be 0.892 (p urine collection but the cutoff should be carefully selected for different patients group under different laboratory procedures and settings.

  18. Topical Administration of a Connexin43-based peptide Augments Healing of Chronic Neuropathic Diabetic Foot Ulcers: A Multicenter, Randomized Trial

    OpenAIRE

    Grek, Christina L.; Prasad, G.M.; Viswanathan, Vijay; Armstrong, David G.; Gourdie, Robert G.; Ghatnekar, Gautam S.

    2015-01-01

    Nonhealing neuropathic foot ulcers remain a significant problem in individuals with diabetes. The gap-junctional protein connexin43 (Cx43) has roles in dermal wound healing and targeting Cx43 signaling accelerates wound reepithelialization. In a prospective, randomized, multi-center clinical trial we evaluated the efficacy and safety of a peptide mimetic of the C-terminus of Cx43, ACT1, in accelerating the healing of chronic diabetic foot ulcers (DFUs) when incorporated into standard of care ...

  19. Consideration Of Chronic Pain In Trials To Promote Physical Activity For Diabetes: A Systematic Review Of Randomized Controlled Trials

    OpenAIRE

    Riva, John J.; Wong, Jessica J.; Brunarski, David J.; Chan, Alice H. Y.; Lobo, Rebecca A.; Aptekman, Marina; Alabousi, Mostafa; Imam, Maha; Gupta, Anita; Busse, Jason W.

    2013-01-01

    Background Chronic pain has been estimated to affect 60% of patients with diabetes and is strongly associated with reduced activity tolerance. We systematically reviewed randomized controlled trials (RCTs) that explored interventions to improve physical activity among patients with diabetes to establish whether co-morbid chronic pain was captured at baseline or explored as an effect modifier and if trials reported a component designed to target chronic pain. Methodology/principal Findings We ...

  20. Helicobacter Pylori in periodontal pockets of chronic periodontitis patients with and without type II diabetes mellitus: a randomized controlled trial

    OpenAIRE

    Savita Sambashivaiah; Shivaprasad Bilichodmath; Nanjammanni Nanjaiah; Rithesh Kulal

    2011-01-01

    This randomized controlled study evaluated the association of Helicobacter pylori (H. pylori) with chronic periodontitis patients with and without type II Diabetes Mellitus. H. pylori is considered to be a pathogen responsible for gastritis, peptic ulcers and a risk factor for gastric cancer. The aim of the present study was to evaluate the association of H. pylori with chronic periodontitis patients with and without type II diabetes mellitus before and after treatment. The prevalence of H. p...

  1. The frequency of drugs in randomly selected drivers in Denmark

    DEFF Research Database (Denmark)

    Simonsen, Kirsten Wiese; Steentoft, Anni; Hels, Tove

    Introduction Driving under the influence of alcohol and drugs is a global problem. In Denmark as well as in other countries there is an increasing focus on impaired driving. Little is known about the occurrence of psychoactive drugs in the general traffic. Therefore the European commission...... initiated the DRUID project. This roadside study is the Danish part of the EU-project DRUID (Driving under the Influence of Drugs, Alcohol, and Medicines) and included three representative regions in Denmark. Methods Oral fluid samples (n = 3002) were collected randomly from drivers using a sampling scheme...... stratified by time, season, and road type. The oral fluid samples were screened for 29 illegal and legal psychoactive substances and metabolites as well as ethanol. Results Fourteen (0.5%) drivers were positive for ethanol (alone or in combination with drugs) at concentrations above 0.53 g/l, which...

  2. Sample Selection in Randomized Experiments: A New Method Using Propensity Score Stratified Sampling

    Science.gov (United States)

    Tipton, Elizabeth; Hedges, Larry; Vaden-Kiernan, Michael; Borman, Geoffrey; Sullivan, Kate; Caverly, Sarah

    2014-01-01

    Randomized experiments are often seen as the "gold standard" for causal research. Despite the fact that experiments use random assignment to treatment conditions, units are seldom selected into the experiment using probability sampling. Very little research on experimental design has focused on how to make generalizations to well-defined…

  3. Pseudo cluster randomization dealt with selection bias and contamination in clinical trials

    NARCIS (Netherlands)

    Teerenstra, S.; Melis, R.J.F.; Peer, P.G.M.; Borm, G.F.

    2006-01-01

    BACKGROUND AND OBJECTIVES: When contamination is present, randomization on a patient level leads to dilution of the treatment effect. The usual solution is to randomize on a cluster level, but at the cost of efficiency and more importantly, this may introduce selection bias. Furthermore, it may slow

  4. 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.

  5. Effects of Inulin on Lipid Profile, Inflammation and Blood Pressure in Women with Type 2 Diabetes: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Bahram Pourghassem Gargari

    2013-12-01

    Full Text Available Background & Objectives: Diabetes mellitus is a metabolic disease characterized by hyperglycemia together with biochemical alterations of lipid profile, insulin resistance and inflammation . Considering the high prevalence of hypertension, dyslipidemia and inflammation in type 2 diabetic patients, the aim of the present study was to investigate the effects of inulin on lipid profile, inflammation and blood pressure in women with type 2 diabetes.   Methods: In this controlled, randomized clinical trial, 49 women with type 2 diabetes (fiber intake 0.04 . Changes in diastolic blood pressures, LDL-c and HDL-c were not significant in inulin group compared with the maltodextrin group. A significant decrease in systolic, diastolic blood pressures, total cholesterol, triglyceride, LDL-c, hs-CRP and significant increase in HDL-c were observed in inulin group compared to baseline.   Conclusions: Inulin supplementation may improve lipid profile, hs-CRP and blood pressure in women with type 2 diabetes.

  6. 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.

  7. 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

  8. 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.

  9. Saxagliptin: A Selective DPP-4 Inhibitor for the Treatment of Type 2 Diabetes Mellitus

    Directory of Open Access Journals (Sweden)

    Jay Shubrook

    2011-01-01

    Full Text Available The prevalence of type 2 diabetes mellitus is high and growing rapidly. Suboptimal glycemic control provides opportunities for new treatment options to improve the morbidity and mortality of this progressive disease. Saxagliptin, a selective DPP-4 inhibitor, increases endogenous incretin levels and incretin acitivty. In controlled clinical trials saxagliptin reduces both fasting and postprandial glucose and works in monotherapy and in combination with metformin, TZDs and sulfonylureas. Saxagliptin has a very favourable side effect profile and may have other beneficial non-glycemic effects. The authors review the current available evidence for the safety, efficacy and saxagliptin's place in therapy for type 2 diabetes mellitus. As understanding of the incretin hormones (GLP-1, GIP expand we may see additional important non-glycemic effects that may affect the chronic management of type 2 diabetes mellitus.

  10. Effect of telemedicine on glycated hemoglobin in diabetes: a systematic review and meta-analysis of randomized trials.

    Science.gov (United States)

    Faruque, Labib Imran; Wiebe, Natasha; Ehteshami-Afshar, Arash; Liu, Yuanchen; Dianati-Maleki, Neda; Hemmelgarn, Brenda R; Manns, Braden J; Tonelli, Marcello

    2017-03-06

    Telemedicine, the use of telecommunications to deliver health services, expertise and information, is a promising but unproven tool for improving the quality of diabetes care. We summarized the effectiveness of different methods of telemedicine for the management of diabetes compared with usual care. We searched MEDLINE, Embase and the Cochrane Central Register of Controlled Trials databases (to November 2015) and reference lists of existing systematic reviews for randomized controlled trials (RCTs) comparing telemedicine with usual care for adults with diabetes. Two independent reviewers selected the studies and assessed risk of bias in the studies. The primary outcome was glycated hemoglobin (HbA1C) reported at 3 time points (≤ 3 mo, 4-12 mo and > 12 mo). Other outcomes were quality of life, mortality and episodes of hypoglycemia. Trials were pooled using randomeffects meta-analysis, and heterogeneity was quantified using the I2 statistic. From 3688 citations, we identified 111 eligible RCTs (n = 23 648). Telemedicine achieved significant but modest reductions in HbA1C in all 3 follow-up periods (difference in mean at ≤ 3 mo: -0.57%, 95% confidence interval [CI] -0.74% to -0.40% [39 trials]; at 4-12 mo: -0.28%, 95% CI -0.37% to -0.20% [87 trials]; and at > 12 mo: -0.26%, 95% CI -0.46% to -0.06% [5 trials]). Quantified heterogeneity (I2 statistic) was 75%, 69% and 58%, respectively. In meta-regression analyses, the effect of telemedicine on HbA1C appeared greatest in trials with higher HbA1C concentrations at baseline, in trials where providers used Web portals or text messaging to communicate with patients and in trials where telemedicine facilitated medication adjustment. Telemedicine had no convincing effect on quality of life, mortality or hypoglycemia. Compared with usual care, the addition of telemedicine, especially systems that allowed medication adjustments with or without text messaging or a Web portal, improved HbA1C but not other clinically

  11. A diabetes scorecard does not improve HbA(1c), blood pressure, lipids, aspirin usage, exercise and diabetes knowledge over 9 months: a randomized controlled trial.

    Science.gov (United States)

    Irwig, M S; Sood, P; Ni, D; Amass, T; Khurana, P S; Jayanthi, V V; Wang, L; Adler, S M

    2012-09-01

    To test (1) whether a diabetes scorecard can improve glycaemic control, blood pressure control, LDL cholesterol, aspirin usage and exercise; (2) if the scorecard will motivate and/or educate patients to improve their scores for subsequent visits; and (3) whether the scorecard will improve rates of clinical inertia. Five physicians enrolled 103 patients ≥ 40 years old with uncontrolled Type 2 diabetes [HbA(1c) ≥ 64 mmol/mol (8.0%)] to randomly receive either a diabetes scorecard or not during four clinical visits over a 9-month period. The population was predominantly urban with a disproportionately higher percentage of black people than the general population. Our scorecard assigned points to six clinical variables, with a perfect total score of 100 points corresponding to meeting all targets. The primary outcomes were total scores and HbA(1c) in the scorecard and control groups at 9 months. There were no significant differences between the control and scorecard groups at visits 1 and 4 in total score, HbA(1c) , blood pressure, LDL cholesterol, aspirin usage, exercise or knowledge about diabetic targets. By visit 4 both the control and scorecard groups had statistically significant improvements with their mean total score (9 and 7 points, respectively), HbA(1c) [-9 mmol/mol (-0.8%) and -15 mmol/mol (-1.4%), respectively] and aspirin usage (33% increase and 16% increase, respectively). Rates of clinical inertia were low throughout the study. A diabetes scorecard did not improve glycaemic control, blood pressure control, LDL cholesterol, aspirin usage, exercise or diabetic knowledge in an urban population with uncontrolled Type 2 diabetes. © 2012 The Authors. Diabetic Medicine © 2012 Diabetes UK.

  12. An evaluation of the DEXLIFE 'self-selected' lifestyle intervention aimed at improving insulin sensitivity in people at risk of developing type 2 diabetes

    DEFF Research Database (Denmark)

    O'Donoghue, Grainne M; Kennedy, Aileen; Andersen, Gregers Stig

    2015-01-01

    , blood pressure, physical activity levels, dietary intake and quality of life. DISCUSSION: "Self-selected" lifestyle intervention has not previously been evaluated in type 2 diabetes prevention and if shown to be successful could be implemented in practice immediately. TRIAL REGISTRATION: Current......). Randomization is stratified by age, sex and body mass index. The control arm receives general information on lifestyle and diabetes risk. The intervention group participate in a 12 week 'self-selected' supervised exercise training programme accompanied with dietary advice to improve food choices. Participants...... are given access to Dublin City University Sport (an on-campus gym) and asked to perform four exercise classes per week. Dublin City University Sport offers over 50 classes per week, many of which are medically supervised. If weight loss is indicated, reduction in total calorie intake by 600 kcal...

  13. RANDOM FORESTS-BASED FEATURE SELECTION FOR LAND-USE CLASSIFICATION USING LIDAR DATA AND ORTHOIMAGERY

    Directory of Open Access Journals (Sweden)

    H. Guan

    2012-07-01

    Full Text Available The development of lidar system, especially incorporated with high-resolution camera components, has shown great potential for urban classification. However, how to automatically select the best features for land-use classification is challenging. Random Forests, a newly developed machine learning algorithm, is receiving considerable attention in the field of image classification and pattern recognition. Especially, it can provide the measure of variable importance. Thus, in this study the performance of the Random Forests-based feature selection for urban areas was explored. First, we extract features from lidar data, including height-based, intensity-based GLCM measures; other spectral features can be obtained from imagery, such as Red, Blue and Green three bands, and GLCM-based measures. Finally, Random Forests is used to automatically select the optimal and uncorrelated features for landuse classification. 0.5-meter resolution lidar data and aerial imagery are used to assess the feature selection performance of Random Forests in the study area located in Mannheim, Germany. The results clearly demonstrate that the use of Random Forests-based feature selection can improve the classification performance by the selected features.

  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. Should Side Effects Influence the Selection of Antidiabetic Therapies in Type 2 Diabetes?

    Science.gov (United States)

    Grunberger, George

    2017-04-01

    There are currently over 40 different drugs in 12 distinct classes approved in the USA to treat patients with type 2 diabetes mellitus. This review summarizes our current knowledge about potential side effects of antidiabetic therapy and attempts to apply it to a clinical practice setting. Given the heterogeneity of both the patients and the disease, it is mathematically impossible to test every available drug combination in long-term outcome, prospective, randomized blinded fashion before a clinician decides which agent(s) to prescribe to a specific patient in a given situation. To complicate the clinician's dilemma, there is lack of available tests to predict an individual's response or propensity to side effects. Further, the data available are derived from small, short-term registration trials and typically focus on relative rather than absolute risks of any given drug and do not address the potential adverse outcomes if a patient's diabetes remains untreated. Clinicians have to personalize their choice of antidiabetic therapy based both on the specific characteristics of the patient in front of them (stage of diabetes and its complications, overall health status, socioeconomic situation, other medications present, desire to improve control of diabetes, etc.) and the current knowledge about the relative and absolute balance of benefits and risks of any individual medication in that specific patient. It has to be recognized that this requires constant re-evaluation as database of our experience with antidiabetic therapy expands.

  16. 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...

  17. A randomized trial of a 6-week course of celecoxib on proteinuria in diabetic kidney disease.

    Science.gov (United States)

    Sinsakul, Marvin; Sika, Mohammed; Rodby, Roger; Middleton, John; Shyr, Yu; Chen, Heidi; Han, Ernest; Lehrich, Ruediger; Clyne, Stephen; Schulman, Gerald; Harris, Raymond; Lewis, Julia

    2007-12-01

    Preclinical data suggest that cyclooxygenase 2 inhibitors decrease proteinuria and preserve glomerular structure in animal models of diabetic nephropathy. The objective of this study is to compare the efficacy and safety of celecoxib with placebo for decreasing proteinuria in patients with diabetic nephropathy. Placebo-controlled double-blinded crossover design. 24 patients with type 1 or 2 diabetes mellitus, proteinuria with protein of 500 mg/d or greater, and serum creatinine level of 3.0 mg/dL or less. Patients were randomly assigned to: (1) 6 weeks of celecoxib followed by a 3-week washout period, followed by 6 weeks of placebo followed by another 3-week washout; or (2) 6 weeks of placebo followed by a 3-week washout, followed by 6 weeks of celecoxib followed by another 3-week washout period. All patients were administered quinapril, 20 to 40 mg/d, or irbesartan, 150 to 300 mg/d. All patients were administered aspirin, 81 mg/d. Proteinuria was assessed by means of protein-creatinine ratio. Data were analyzed using the mixed-effect statistical model. There was no significant difference in urinary proteinuria after 6 weeks of treatment with placebo or celecoxib (proteinuria ratio, celecoxib versus placebo, 1.041; 95% confidence interval, 0.846 to 1.282). Celecoxib had no significant effect on potassium or estimated glomerular filtration rate. Frequencies of adverse events were similar between the placebo and celecoxib treatments. This pilot study was not designed to evaluate the safety or long-term clinical effects of celecoxib. Celecoxib, 200 mg/d, for 6 weeks did not alter proteinuria. Few adverse events were noted in this high-risk population.

  18. Home-based exercise for middle-aged Chinese at diabetic risk: a randomized controlled trial.

    Science.gov (United States)

    Wu, Ying-Tai; Hwang, Chueh-Lung; Chen, Chiao-Nan; Chuang, Lee-Ming

    2011-05-01

    To evaluate short- (3 months) and long-term (9 months) effects of home-based exercise on adiponectin, exercise behavior and metabolic risk factors in middle-aged adults at diabetic risk. One hundred and thirty-five middle-aged adults (38 men, 97 women) with at least one diabetic risk factor were randomly assigned to either a home-based exercise group (Ex-group) or a usual care group (C-group). Outcome measures included plasma adiponectin, exercise self-efficacy, physical activity, and metabolic risk factors, as follows: insulin levels, insulin resistance by homeostasis model assessment (HOMA-IR), physical fitness, and components of metabolic syndrome. This study was conducted in metropolitan Taipei from 2004 to 2005. The Ex-group had improvements in exercise self-efficacy (+2.5, p = 0.01), body mass index (BMI) (-0.6 kg/m2, p < 0.001) and flexibility (+2.4 cm, p < 0.001) at 3-month follow-up and maintained BMI and flexibility at 9-month follow-up. The Ex-group exhibited significantly increased physical activity while the C-group exhibited decreased physical activity at 9-month follow-up (p < 0.001). No intervention effect was found on adiponectin (p = 0.64) or other outcome measures over time. Home-based exercise did not improve adiponectin levels, but significantly improved exercise behavior, and certain metabolic risk factors, with the effects maintained for 9-months in subjects with type 2 diabetic risk. Copyright © 2011 Elsevier Inc. All rights reserved.

  19. Aerobic and combined exercise sessions reduce glucose variability in type 2 diabetes: crossover randomized trial.

    Directory of Open Access Journals (Sweden)

    Franciele R Figueira

    Full Text Available To evaluate the effects of aerobic (AER or aerobic plus resistance exercise (COMB sessions on glucose levels and glucose variability in patients with type 2 diabetes. Additionally, we assessed conventional and non-conventional methods to analyze glucose variability derived from multiple measurements performed with continuous glucose monitoring system (CGMS.Fourteen patients with type 2 diabetes (56±2 years wore a CGMS during 3 days. Participants randomly performed AER and COMB sessions, both in the morning (24 h after CGMS placement, and at least 7 days apart. Glucose variability was evaluated by glucose standard deviation, glucose variance, mean amplitude of glycemic excursions (MAGE, and glucose coefficient of variation (conventional methods as well as by spectral and symbolic analysis (non-conventional methods.Baseline fasting glycemia was 139±05 mg/dL and HbA1c 7.9±0.7%. Glucose levels decreased immediately after AER and COMB protocols by ∼16%, which was sustained for approximately 3 hours. Comparing the two exercise modalities, responses over a 24-h period after the sessions were similar for glucose levels, glucose variance and glucose coefficient of variation. In the symbolic analysis, increases in 0 V pattern (COMB, 67.0±7.1 vs. 76.0±6.3, P = 0.003 and decreases in 1 V pattern (COMB, 29.1±5.3 vs. 21.5±5.1, P = 0.004 were observed only after the COMB session.Both AER and COMB exercise modalities reduce glucose levels similarly for a short period of time. The use of non-conventional analysis indicates reduction of glucose variability after a single session of combined exercises.Aerobic training, aerobic-resistance training and glucose profile (CGMS in type 2 diabetes (CGMS exercise. ClinicalTrials.gov ID: NCT00887094.

  20. Effect of Tree Nuts on Glycemic Control in Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Dietary Trials

    OpenAIRE

    Effie Viguiliouk; Kendall, Cyril W. C.; Sonia Blanco Mejia; Cozma, Adrian I.; Vanessa Ha; Arash Mirrahimi; Viranda H Jayalath; Augustin, Livia S A; Laura Chiavaroli; Leiter, Lawrence A; de Souza, Russell J.; Jenkins, David J.A.; John L Sievenpiper

    2014-01-01

    Background Tree nut consumption has been associated with reduced diabetes risk, however, results from randomized trials on glycemic control have been inconsistent. Objective 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. Data Sources MEDLINE, EMBASE, CINAHL, and Cochrane databases through 6 April 201...

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

    Science.gov (United States)

    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 in the blood glucose level of the subjects.

  2. 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...

  3. 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.

  4. Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: 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; Phillips, Paddy A; Ackland, Michael; Skinner, Timothy; Oats, Jeremy; Carter, Rob; Best, James D; Dunbar, James A

    2013-10-17

    Gestational diabetes mellitus (GDM) is defined as glucose intolerance with its onset or first recognition during pregnancy. Post-GDM women have a life-time risk exceeding 70% of developing type 2 diabetes mellitus (T2DM). Lifestyle modifications reduce the incidence of T2DM by up to 58% for high-risk individuals. The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial aiming to assess the effectiveness of a structured diabetes prevention intervention for post-GDM women. This trial has an intervention group participating in a diabetes prevention program (DPP), and a control group receiving usual care from their general practitioners during the same time period. The 12-month intervention comprises an individual session followed by five group sessions at two-week intervals, and two follow-up telephone calls. A total of 574 women will be recruited, with 287 in each arm. The women will undergo blood tests, anthropometric measurements, and self-reported health status, diet, physical activity, quality of life, depression, risk perception and healthcare service usage, at baseline and 12 months. At completion, primary outcome (changes in diabetes risk) and secondary outcome (changes in psychosocial and quality of life measurements and in cardiovascular disease risk factors) will be assessed in both groups. This study aims to show whether MAGDA-DPP leads to a reduction in diabetes risk for post-GDM women. The characteristics that predict intervention completion and improvement in clinical and behavioral measures will be useful for further development of DPPs for this population. Australian New Zealand Clinical Trials Registry ANZCTRN 12610000338066.

  5. A Randomized Controlled Trial of an Internet-Based Mentoring Program for Type 1 Diabetes Patients with Inadequate Glycemic Control

    Directory of Open Access Journals (Sweden)

    Sunghwan Suh

    2014-04-01

    Full Text Available BackgroundTo determine whether an internet-based mentoring program can improve glycemic control in subjects with type 1 diabetes mellitus (T1DM.MethodsSubjects with T1DM on intensive insulin therapy and with hemoglobin A1c (HbA1c ≥8.0% were randomized to mentored (glucometer transmission with feedback from mentors or control (glucometer transmission without feedback groups and were examined for 12 weeks. Five mentors were interviewed and selected, of which two were T1DM patients themselves and three were parents with at least one child diagnosed with T1DM since more than 5 years ago.ResultsA total of 57 T1DM adult subjects with a mean duration after being diagnosed with diabetes of 7.4 years were recruited from Samsung Medical Center. Unfortunately, the mentored group failed to show significant improvements in HbA1c levels or other outcomes, including the quality of life, after completion of the study. However, the mentored group monitored their blood glucose (1.41 vs. 0.30 and logged into our website (http://ubisens.co.kr/ more frequently (20.59 times vs. 5.07 times than the control group.ConclusionA 12-week internet-based mentoring program for T1DM patients with inadequate glycemic control did not prove to be superior to the usual follow-up. However, the noted increase in the subjects' frequency of blood glucose monitoring may lead to clinical benefits.

  6. Single Nucleotide Polymorphism relevance learning with Random Forests for Type 2 diabetes risk prediction.

    Science.gov (United States)

    López, Beatriz; Torrent-Fontbona, Ferran; Viñas, Ramón; Fernández-Real, José Manuel

    2017-09-21

    The use of artificial intelligence techniques to find out which Single Nucleotide Polymorphisms (SNPs) promote the development of a disease is one of the features of medical research, as such techniques may potentially aid early diagnosis and help in the prescription of preventive measures. In particular, the aim is to help physicians to identify the relevant SNPs related to Type 2 diabetes, and to build a decision-support tool for risk prediction. We use the Random Forest (RF) technique in order to search for the most important attributes (SNPs) related to diabetes, giving a weight (degree of importance), ranging between 0 and 1, to each attribute. Support Vector Machines and Logistic Regression have also been used since they are two other machine learning techniques that are well-established in the health community. Their performance has been compared to that achieved by RF. Furthermore, the relevance of the attributes obtained through the use of RF has then been used to perform predictions with k-Nearest Neighbour method weighting attributes in the similarity measure according to the relevance of the attributes with RF. Testing is performed on a set of 677 subjects. RF is able to handle the complexity of features' interactions, overfitting, and unknown attribute values, providing the SNPs' relevance with an up to 0.89 area under the ROC curve in terms of risk prediction. RF outperforms all the other tested machine learning techniques in terms of prediction accuracy, and in terms of the stability of the estimated relevance of the attributes. The Random Forest is a useful method for learning predictive models and the relevance of SNPs without any underlying assumption. Copyright © 2017 Elsevier B.V. All rights reserved.

  7. Comparison of bedtime insulin regimens in patients with type 2 diabetes mellitus. A randomized, controlled trial.

    Science.gov (United States)

    Yki-Järvinen, H; Ryysy, L; Nikkilä, K; Tulokas, T; Vanamo, R; Heikkilä, M

    1999-03-02

    Compared with other insulin regimens, combination therapy with oral hypoglycemic agents and bedtime insulin produces similar improvement in glycemic control but induces less weight gain. To determine whether bedtime insulin regimens differ with respect to their effects on weight gain in patients with type 2 diabetes. Randomized, controlled trial. Four outpatient clinics at central hospitals. 96 patients (mean age, 58 +/- 1 years; mean body mass index, 29 +/- 1 kg/m2) whose type 2 diabetes was poorly controlled with sulfonylurea therapy (mean glycosylated hemoglobin value, 9.9% +/- 0.2%; mean fasting plasma glucose level, 11.9 +/- 0.3 mmol/L [214 +/- 5 mg/dL]). Random assignment to 1 year of treatment with bedtime intermediate-acting insulin plus glyburide (10.5 mg) and placebo, metformin (2 g) and placebo, glyburide and metformin, or a second injection of intermediate-acting insulin in the morning. Patients were taught to adjust the bedtime insulin dose on the basis of fasting glucose measurements. Body weight, biochemical and symptomatic hypoglycemias, and indices of glycemic control. At 1 year, body weight remained unchanged in patients receiving bedtime insulin plus metformin (mean change, 0.9 +/- 1.2 kg; P bedtime insulin plus glyburide, those receiving bedtime insulin plus both oral drugs, and those receiving bedtime and morning insulin, respectively. The greatest decrease in the glycosylated hemoglobin value was observed in the bedtime insulin and metformin group (from 9.7% +/- 0.4% to 7.2% +/- 0.2% [difference, -2.5 +/- 0.4 percentage points] at 1 year; P bedtime insulin plus metformin prevents weight gain. This regimen also seems superior to other bedtime insulin regimens with respect to improvement in glycemic control and frequency of hypoglycemia.

  8. Continued smoking abstinence in diabetic patients in primary care: a cluster randomized controlled multicenter study.

    Science.gov (United States)

    Pérez-Tortosa, Santiago; Roig, Lydia; Manresa, Josep M; Martin-Cantera, Carlos; Puigdomènech, Elisa; Roura, Pilar; Armengol, Angelina; Advani, Mamta

    2015-01-01

    To assess the effectiveness of an intensive smoking cessation intervention based on the transtheoretical model of change (TTM) in diabetic smokers attending primary care. A cluster randomized controlled clinical trial was designed in which the unit of randomization (intervention vs. usual care) was the primary care team. An intensive, individualized intervention using motivational interview and therapies and medications adapted to the patient's stage of change was delivered. The duration of the study was 1 year. A total of 722 people with diabetes who were smokers (345 in the intervention group and 377 in the control group) completed the study. After 1 year, continued abstinence was recorded in 90 (26.1%) patients in the intervention group and in 67 (17.8%) controls (p=0.007). In patients with smoking abstinence, there was a higher percentage in the precontemplation and contemplation stages at baseline in the intervention group than in controls (21.2% vs. 13.7%, p=0.024). When the precontemplation stage was taken as reference (OR=1.0), preparation/action stage at baseline showed a protective effect, decreasing 3.41 times odds of continuing smoking (OR=0.293 95% CI 0.179-0.479, psmoking (OR=0.518, 95% CI 0.318-0.845, p=0.008). An intensive intervention adapted to the individual stage of change delivered in primary care was feasible and effective, with a smoking cessation rate of 26.1% after 1 year. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  9. 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…

  10. Types of pediatric diabetes mellitus defined by anti-islet autoimmunity and random C-peptide at diagnosis.

    Science.gov (United States)

    Redondo, Maria J; Rodriguez, Luisa M; Escalante, Mirna; Smith, E O'Brian; Balasubramanyam, Ashok; Haymond, Morey W

    2013-08-01

    To test the hypothesis that anti-islet autoantibody expression and random serum C-peptide obtained at diagnosis define phenotypes of pediatric diabetes with distinct clinical features. We analyzed 607 children aged diabetes after exclusion of 13% of cases with secondary diabetes (e.g., cystic fibrosis related, steroid induced) and 7.3% of cases lacking measurement of C-peptide and/or autoantibodies. Autoantibody positivity (A+) was defined as ≥ 1 positive out of GAD65, insulin, and ICA512 antibodies. Preserved beta-cell function (β+) was defined as random serum C-peptide at diagnosis ≥ 0.6 ng/mL. Body mass index (BMI) was measured at median 1.2 months after diagnosis. Characteristics at diagnosis and 2 yr (range 18-30 months) after diagnosis were compared among groups. Autoantibody expression and C-peptide at diagnosis defined the following groups: A+β- (52.1% of the children), A+β+ (32.8%), A-β+ (12.5%), and A-β- (2.6%). These four groups differed in gender, race/ethnicity, and clinical characteristics at diagnosis [i.e., age, pubertal development, obesity/overweight, diabetic ketoacidosis, glycemia, and hemoglobin A1c (HbA1c)] and at 2 yr (i.e., clinical diagnosis, treatment, and HbA1c) (all p 2 ng/mL was associated with lower HbA1c at onset (p = 0.0001) and, in the A+β+ subgroup, with higher frequency of achieving HbA1c diabetes (maturity onset diabetes of the young, MODY) were A-β+ with C-peptide between 0.6 and 2 ng/mL. Anti-islet autoantibodies status and serum random C-peptide at diagnosis define four distinct phenotypes of pediatric diabetes with prognostic value. © 2013 John Wiley & Sons A/S.

  11. Biomechanical characteristics of bone in streptozotocin-induced diabetic rats: An in-vivo randomized controlled experimental study.

    Science.gov (United States)

    Korres, Nektarios; Tsiridis, Eleftherios; Pavlou, George; Mitsoudis, Athanasios; Perrea, Despina N; Zoumbos, Aristedes B

    2013-07-18

    To investigate the in vivo effects of type I diabetes on the mechanical strength of tibial bone in a rodent model. The biomechanical effect of diabetes on the structural integrity of the tibia in streptozotocin induced diabetic Wistar rats was analysed. Induction of diabetes was achieved by an intra-peritoneal injection and confirmed by measuring serial blood glucose levels (> 150 mg/dL). After 8 wk the tibiae were harvested and compared to a control group. Biomechanical analysis of harvested tibiae was performed using a three-point bending technique on a servo hydraulic MTS 858 MiniBionix frame. Maximum force applied to failure (N), stiffness (N × mm) and energy absorbed (N/mm) were recorded and plotted on load displacement curves. A displacement control loading mode of 1 mm/min was selected to simulate quasi-static loading conditions. Measurements from load-displacement curves were directly compared between groups. Fourteen streptozotocin induced diabetic Wistar rats were compared against nineteen non-diabetic controls. An average increase of 155.2 g in body weight was observed in the control group compared with only 5 g in the diabetic group during the experimental study period. Levels of blood glucose increased to 440.25 mg/dL in the diabetic group compared to 116.62 mg/dL in the control group.The biomechanical results demonstrate a highly significant reduction in the maximum load to failure from 69.5 N to 58 N in diabetic group compared to control (P = 0.011). Energy absorption to fracture was reduced from 28.2 N in the control group to 23.5 N in the diabetic group (P = 0.082). No significant differences were observed between the groups for bending stiffness. Streptozotocin-induced diabetes in rodents reduces the maximum force and energy absorption to failure of bone, suggesting a predisposition for fracture risk.

  12. A pragmatic cluster randomized clinical trial of diabetes prevention strategies for women with gestational diabetes: design and rationale of the Gestational Diabetes' Effects on Moms (GEM) study

    National Research Council Canada - National Science Library

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

    2014-01-01

    .... In the Gestational Diabetes' Effects on Moms (GEM) study, we are evaluating the comparative effectiveness of diabetes prevention strategies for weight management designed for pregnant/postpartum women with GDM and delivered at the health system level...

  13. Improving the adherence of type 2 diabetes mellitus patients with pharmacy care: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Antoine, Sunya-Lee; Pieper, Dawid; Mathes, Tim; Eikermann, Michaela

    2014-07-07

    Oral medication for patients with type 2 diabetes mellitus plays an important role in diabetes care and is associated with a high level self-care behavior and self-management. However, poor adherence to diabetes treatment is common which causes severe health complications and increased mortality. Barriers to adherence may consist of complex treatment regimens often along with long-term multi-therapies, side effects due to the medication as well as insufficient, incomprehensible or confusing information or instructions provided by the health care provider. Multidisciplinary approaches can support adherence success and can enable a more effective management of diabetes care. One approach in diabetes care can be the involvement of a pharmacist. The aim was to analyze the effectiveness of adherence-enhancing pharmacist interventions for oral medication in type 2 diabetes mellitus. A systematic review of randomized controlled trials. The study quality was assessed with the Cochrane risk of bias tool. Of 491 hits, six publications were included. Two studies mainly examining educational interventions showed a significant improvement in adherence. Moreover, the quality of the included studies was deficient. Although pharmacist interventions might potentially improve adherence to type 2 diabetes mellitus medication, high-quality studies are needed to assess effectiveness.

  14. Web-based depression treatment for type 1 and type 2 diabetic patients: a randomized, controlled trial.

    Science.gov (United States)

    van Bastelaar, Kim M P; Pouwer, François; Cuijpers, Pim; Riper, Heleen; Snoek, Frank J

    2011-02-01

    Comorbid depression is common in patients with type 1 and type 2 diabetes, adversely affecting quality of life, diabetes outcomes, and mortality. Depression can be effectively treated with cognitive behavior therapy (CBT). The Internet is a new and attractive method for delivering CBT intervention on a large scale at relatively low costs. This study evaluated the effectiveness of Web-based CBT for depression treatment in adults with type 1 or type 2 diabetes, with minimal guidance. A randomized controlled trial was conducted in the Netherlands in 255 adult diabetic patients with elevated depressive symptoms. Primary outcomes were depressive symptoms. Secondary outcomes were diabetes-specific emotional distress and glycemic control. Assessments were at baseline, after treatment, and at the 1-month follow-up. The Web-based CBT was effective in reducing depressive symptoms by intention-to-treat analyses (P = 0.04, d = 0.29; clinical improvement 41% vs. 24% P 0.05). Web-based CBT depression treatment is effective in reducing depressive symptoms in adults with type 1 and type 2 diabetes. In addition, the intervention reduces diabetes-specific emotional distress in depressed patients.

  15. 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

  16. JinQi-Jiangtang tablet, a Chinese patent medicine, for pre-diabetes: a randomized controlled trial.

    Science.gov (United States)

    Cao, Hongbo; Ren, Ming; Guo, Liping; Shang, Hongcai; Zhang, Junhua; Song, Yuzhen; Wang, Hui; Wang, Baohe; Li, Xiantao; Hu, Jing; Wang, Xuemei; Wang, Dehui; Chen, Jianzong; Li, Shuanglei; Chen, Liming

    2010-03-10

    Pre-diabetes is a growing health concern where a large percentage of these patients develop full type 2 diabetes. Effective interventions on pre-diabetes can prevent or delay the occurrence or development of diabetes. Pharmacodynamics and pre-clinical of JinQi-Jiangtang tablets (JQJT) suggest that it could be benefit for pre-diabetes. Randomized controlled trial (RCT) is implemented in this study. The study term is 24 months (12 months for intervention and 12 months for follow up). Participants are recruited from four cities of China: Beijing, Tianjin, Xi'an and Nanning. Four hundred participants are randomized to treatment group (JQJT tablets) and control group (Placebo); two hundred participants each. People being included in this study must have been diagnosed as pre-diabetes via western medicine criteria and traditional Chinese medicine (TCM) criteria. The end-point indexes include: incidence of diabetes mellitus and reversion rate. Primary outcome indexes include: oral glucose tolerance test; insulin releasing test; glycosylated hemoglobin (HA1c). Secondary outcome indexes include: score of the Short Form 36 Health Survey Questionnaire (SF-36); score of TCM symptoms; blood lipid test. Indexes of safety include: general medical examination; blood and urine regular test; electrocardiogram (ECG), liver function (ALT) and renal function (BUN, Creatinine) test; record of adverse event, such as headache, faint, etc. Qualitative control will be implemented and a number of standard operating processes (SOPs) will be formed throughout the study: laboratory quality control measures; compliance control for researchers and participants; researcher training before study; supervision; investigational drug management and others. The aim of this study is to evaluate the effectiveness and safety of JinQi JiangTang (JQJT) tablets for the treatment of patients with pre-diabetes. Chinese clinical trials register ChiCTR-TRC-00000401.

  17. 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 (HbA1c), 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), HbA1c (-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 of

  18. Nursing appointment and cardiometabolic control of diabetics: a randomized clinical trial.

    Science.gov (United States)

    Teston, Elen Ferraz; Arruda, Guilherme Oliveira de; Sales, Catarina Aparecida; Marcon, Sonia Silva

    2017-01-01

    to verify the effect of nursing appointment on cardiometabolic profile of people with Diabetes Mellitus type 2. randomized controlled trial, developed with 134 individuals chosen for two groups: intervention and control. The intervention consisted of three nursing appointments alternated bimonthly, with two phone calls, over five months. The control group received usual care offered by the Health Unit. Data were collected through semi-structured interviews before and after the intervention, in addition to conducting laboratory tests. after the intervention, a significant difference was shown in the amount of glycated hemoglobin (p = 0.006) and in the systolic blood pressure (p = 0.031), which were higher in the control group. besides being low-cost and easy to develop on the monitoring routine of people with diabetes, the intervention performed influenced positively the biochemical profile. verificar o efeito da consulta de enfermagem sobre o perfil cardiometabólico de pessoas com Diabetes Mellitus tipo 2. ensaio clínico controlado e randomizado, desenvolvido com 134 indivíduos sorteados para dois grupos: intervenção e controle. A intervenção consistiu em três consultas de enfermagem bimensais alternadas, com duas ligações telefônicas, ao longo de cinco meses. O grupo-controle recebeu os cuidados habituais oferecidos pela Unidade de Saúde. Os dados foram coletados mediante entrevistas semiestruturadas antes e após a intervenção, além da realização de exames laboratoriais. após a intervenção, foi evidenciada diferença significativa no valor da hemoglobina glicada (p=0,006) e da pressão arterial sistólica (p=0,031), que se mostraram mais elevadas no grupo-controle. a intervenção realizada, além de ser de baixo custo e de fácil desenvolvimento na rotina de acompanhamento da pessoa com diabetes, influenciou positivamente a melhora do perfil bioquímico.

  19. 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

  20. 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.

  1. SNP selection and classification of genome-wide SNP data using stratified sampling random forests.

    Science.gov (United States)

    Wu, Qingyao; Ye, Yunming; Liu, Yang; Ng, Michael K

    2012-09-01

    For high dimensional genome-wide association (GWA) case-control data of complex disease, there are usually a large portion of single-nucleotide polymorphisms (SNPs) that are irrelevant with the disease. A simple random sampling method in random forest using default mtry parameter to choose feature subspace, will select too many subspaces without informative SNPs. Exhaustive searching an optimal mtry is often required in order to include useful and relevant SNPs and get rid of vast of non-informative SNPs. However, it is too time-consuming and not favorable in GWA for high-dimensional data. The main aim of this paper is to propose a stratified sampling method for feature subspace selection to generate decision trees in a random forest for GWA high-dimensional data. Our idea is to design an equal-width discretization scheme for informativeness to divide SNPs into multiple groups. In feature subspace selection, we randomly select the same number of SNPs from each group and combine them to form a subspace to generate a decision tree. The advantage of this stratified sampling procedure can make sure each subspace contains enough useful SNPs, but can avoid a very high computational cost of exhaustive search of an optimal mtry, and maintain the randomness of a random forest. We employ two genome-wide SNP data sets (Parkinson case-control data comprised of 408 803 SNPs and Alzheimer case-control data comprised of 380 157 SNPs) to demonstrate that the proposed stratified sampling method is effective, and it can generate better random forest with higher accuracy and lower error bound than those by Breiman's random forest generation method. For Parkinson data, we also show some interesting genes identified by the method, which may be associated with neurological disorders for further biological investigations.

  2. An efficient method of wavelength interval selection based on random frog for multivariate spectral calibration

    Science.gov (United States)

    Yun, Yong-Huan; Li, Hong-Dong; Wood, Leslie R. E.; Fan, Wei; Wang, Jia-Jun; Cao, Dong-Sheng; Xu, Qing-Song; Liang, Yi-Zeng

    2013-07-01

    Wavelength selection is a critical step for producing better prediction performance when applied to spectral data. Considering the fact that the vibrational and rotational spectra have continuous features of spectral bands, we propose a novel method of wavelength interval selection based on random frog, called interval random frog (iRF). To obtain all the possible continuous intervals, spectra are first divided into intervals by moving window of a fix width over the whole spectra. These overlapping intervals are ranked applying random frog coupled with PLS and the optimal ones are chosen. This method has been applied to two near-infrared spectral datasets displaying higher efficiency in wavelength interval selection than others. The source code of iRF can be freely downloaded for academy research at the website: http://code.google.com/p/multivariate-calibration/downloads/list.

  3. Does the Diabetic Foot Have a Significant Impact on Selected Psychological or Social Characteristics of Patients with Diabetes Mellitus?

    Directory of Open Access Journals (Sweden)

    Vladimíra Fejfarová

    2014-01-01

    Full Text Available The aim of our case-control study was to compare selected psychological and social characteristics between diabetic patients with and without the DF (controls. Methods. 104 patients with and 48 without DF were included into our study. Both study groups were compared in terms of selected psychosocial characteristics. Results. Compared to controls, patients with DF had a significantly worse quality of life in the area of health and standard of living as shown by lower physical health domain (12.7±2.8 versus 14.7±2.5; P<0.001 and environment domain (14.1±2.2 versus 15±1.8; P<0.01 that negatively correlated with diabetes duration (r=-0.061; P=0.003. Patients with DF subjectively felt more depressed in contrast to controls (24.5 versus 7.3%; P<0.05; however, the depressive tuning was objectively proven in higher percentage in both study groups (83.2 versus 89.6; NS. We observed a significantly lower level of achieved education (P<0.01, more patients with disability pensions (P<0.01, and low self-support (P<0.001 in patients with the DF compared to controls. In the subgroup of patients with a previous major amputation and DF (n=6, there were significantly worse outcomes as in the environment domain (P<0.01, employment status, and stress readaptation (P<0.01 in contrast to the main study groups. Conclusions. Patients with DF had a predominantly worse standard of living. In contrast to our expectations, patients with DF appeared to have good stress tolerability and mental health (with the exception of patients with previous major amputation and did not reveal severe forms of depression or any associated consequences.

  4. Delay line length selection in generating fast random numbers with a chaotic laser.

    Science.gov (United States)

    Zhang, Jianzhong; Wang, Yuncai; Xue, Lugang; Hou, Jiayin; Zhang, Beibei; Wang, Anbang; Zhang, Mingjiang

    2012-04-10

    The chaotic light signals generated by an external cavity semiconductor laser have been experimentally demonstrated to extract fast random numbers. However, the photon round-trip time in the external cavity can cause the occurrence of the periodicity in random sequences. To overcome it, the exclusive-or operation on corresponding random bits in samples of the chaotic signal and its time-delay signal from a chaotic laser is required. In this scheme, the proper selection of delay length is a key issue. By doing a large number of experiments and theoretically analyzing the interplay between the Runs test and the threshold value of the autocorrelation function, we find when the corresponding delay time of autocorrelation trace with the correlation coefficient of less than 0.007 is considered as the delay time between the chaotic signal and its time-delay signal, streams of random numbers can be generated with verified randomness.

  5. 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.

  6. Diabetic Profile- Screening of HBA1C - A Random Community Assessment

    OpenAIRE

    Suchitra, M.R.; Jaiganesh, K; Parthasarathy, S.

    2013-01-01

    Background: Diabetes mellitus is becoming the commonest non–communicable disease in the world. Strict control of diabetes mellitus is associated with fewer incidences of complications. Screening for control of diabetes is a useful intervention, because diabetes is a highly morbid illness with a long asymptomatic phase. Glycosylated Haemoglob in (HbA1C) is the ideal parameter which can be used to assess the diabetic control, as this parameter is not alterable with single day manipulations.

  7. 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......-64 A) by size exclusion chromatography. IgG/IgG4 selectivity index was significantly decreased in patients with albuminuria (p albuminuria (D2) and was not accompanied by any changes in tubular function or glomerular...

  8. Impact of probiotics in women with gestational diabetes mellitus on metabolic health: a randomized controlled trial.

    Science.gov (United States)

    Lindsay, Karen L; Brennan, Lorraine; Kennelly, Maria A; Maguire, Orla C; Smith, Thomas; Curran, Sinead; Coffey, Mary; Foley, Michael E; Hatunic, Mensud; Shanahan, Fergus; McAuliffe, Fionnuala M

    2015-04-01

    Probiotics are live microorganisms that may confer health benefits on the host. Recent trials of probiotic use among healthy pregnant women demonstrate potential for improved glycemic control. The aim of this study was to investigate the effects of a probiotic capsule intervention on maternal metabolic parameters and pregnancy outcome among women with gestational diabetes. This double-blind placebo-controlled randomized trial recruited pregnant women with a new diagnosis of gestational diabetes or impaired glucose tolerance following a 3-hour 100-g glucose tolerance test. Women were randomized to a daily probiotic (Lactobacillus salivarius UCC118) or placebo capsule from diagnosis until delivery. Fasting blood samples were collected at baseline and 4-6 weeks after capsule commencement for analysis of glucose, insulin, c-peptide, and lipids. The primary outcome was difference in fasting glucose postintervention, first analyzed on an intention-to-treat basis and followed by per-protocol analysis that excluded women commenced on pharmacological therapy (insulin or metformin). Secondary outcomes were changes in insulin, c-peptide, homeostasis model assessment and lipids, requirement for pharmacological therapy, and neonatal anthropometry. Of 149 women recruited and randomized, there were no differences between the probiotic and placebo groups in postintervention fasting glucose (4.65 ± 0.49 vs 4.65 ± 0.53 mmol/L; P = 373), requirement for pharmacological therapy (17% vs 14%; P = .643), or birthweight (3.57 ± 0.64 vs 3.60 ± 0.57 kg; P = .845). Among 100 women managed with diet and exercise alone, fasting plasma glucose decreased significantly within both the probiotic (4.76 ± 0.45 to 4.57 ± 0.42 mmol/L; P probiotic vs the placebo group (+0.27 ± 0.48 vs +0.50 ± 0.52 mmol/L total cholesterol, P = .031; +0.08 ± 0.51 vs +0.31 ± 0.45 mmol/L LDL cholesterol, P = .011). No differences were noted between groups in other metabolic parameters or pregnancy

  9. 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.

  10. A Hybrid PSO-DEFS Based Feature Selection for the Identification of Diabetic Retinopathy.

    Science.gov (United States)

    Balakrishnan, Umarani; Venkatachalapathy, Krishnamurthi; Marimuthu, Girirajkumar S

    2015-01-01

    Diabetic Retinopathy (DR) is an eye disease, which may cause blindness by the upsurge of insulin in blood. The major cause of visual loss in diabetic patient is macular edema. To diagnose and follow up Diabetic Macular Edema (DME), a powerful Optical Coherence Tomography (OCT) technique is used for the clinical assessment. Many existing methods found out the DME affected patients by estimating the fovea thickness. These methods have the issues of lower accuracy and higher time complexity. In order to overwhelm the above limitations, a hybrid approaches based DR detection is introduced in the proposed work. At first, the input image is preprocessed using green channel extraction and median filter. Subsequently, the features are extracted by gradient-based features like Histogram of Oriented Gradient (HOG) with Complete Local Binary Pattern (CLBP). The texture features are concentrated with various rotations to calculate the edges. We present a hybrid feature selection that combines the Particle Swarm Optimization (PSO) and Differential Evolution Feature Selection (DEFS) for minimizing the time complexity. A binary Support Vector Machine (SVM) classifier categorizes the 13 normal and 75 abnormal images from 60 patients. Finally, the patients affected by DR are further classified by Multi-Layer Perceptron (MLP). The experimental results exhibit better performance of accuracy, sensitivity, and specificity than the existing methods.

  11. Autologous platelet-rich gel for treatment of diabetic chronic refractory cutaneous ulcers: A prospective, randomized clinical trial.

    Science.gov (United States)

    Li, Lan; Chen, Dawei; Wang, Chun; Yuan, Nanbing; Wang, Yan; He, Liping; Yang, Yanzhi; Chen, Lihong; Liu, Guanjian; Li, Xiujun; Ran, Xingwu

    2015-01-01

    The purpose of the study is to examine the safety and effectiveness of topical autologous platelet-rich gel (APG) application on facilitating the healing of diabetic chronic refractory cutaneous ulcers. The study was designed as a prospective, randomized controlled trial between January 1, 2007 and December 31, 2011. Eligible inpatients at the Diabetic Foot Care Center of West China Hospital, Sichuan University (China) were randomly prescribed with a 12-week standard treatment of ulcers (the control group) or standard treatment plus topical application APG (the APG group). The wound healing grades (primary endpoint), time to complete healing, and healing velocity within 12 weeks were monitored as short-term effectiveness measurements, while side effects were documented safety endpoints. The rates of survival and recurrence within the follow up were recorded as long-term effectiveness endpoints. Analysis on total diabetic ulcers (DUs) (n = 117) and subgroup analysis on diabetic foot ulcers (DFUs) (n = 103) were both conducted. Standard treatment plus APG treatment was statistically more effective than standard treatment (p topical APG application. The long-term survival and recurrence rates were comparative between groups (p > 0.05). This study shows that topical APG application plus standard treatment is safe and quite effective on diabetic chronic refractory cutaneous ulcers, compared with standard treatment. © 2015 by the Wound Healing Society.

  12. 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.

  13. Managing the space between visits: a randomized trial of disease management for diabetes in a community health center.

    Science.gov (United States)

    Anderson, Daren R; Christison-Lagay, Joan; Villagra, Victor; Liu, Haibei; Dziura, James

    2010-10-01

    Diabetes outcomes are worse for underserved patients from certain ethnic/racial minority populations. Telephonic disease management is a cost-effective strategy to deliver self-management services and possibly improve diabetes outcomes for such patients. We conducted a trial to test the effectiveness of a supplemental telephonic disease management program compared to usual care alone for patients with diabetes cared for in a community health center. Randomized controlled trial. All patients had type 2 diabetes, and the majority was Hispanic or African American. Most were urban-dwelling with low socioeconomic status, and nearly all had Medicaid or were uninsured. Clinical measures included glycemic control, blood pressure, lipid levels, and body mass index. Validated surveys were used to measure dietary habits and physical activity. A total of 146 patients were randomized to the intervention and 149 to the control group. Depressive symptoms were highly prevalent in both groups. Using an intention to treat analysis, there were no significant differences in the primary outcome (HbA1c) between the intervention and control groups at 12 months. There were also no significant differences for secondary clinical or behavioral outcome measures including BMI, systolic or diastolic blood pressure, LDL cholesterol, smoking, or intake of fruits and vegetables, or physical activity. A clinic-based telephonic disease management support for underserved patients with diabetes did not improve clinical or behavioral outcomes at 1 year as compared to patients receiving usual care alone.

  14. The impact of tailored text messages on health beliefs and medication adherence in adults with diabetes: A randomized pilot study.

    Science.gov (United States)

    Gatwood, Justin; Balkrishnan, Rajesh; Erickson, Steven R; An, Lawrence C; Piette, John D; Farris, Karen B

    2016-01-01

    Inadequate medication adherence reduces optimal health outcomes and can lead to increased costs, particularly in patients with diabetes. Efforts to improve adherence have resulted in limited effects; approaches leveraging mobile technology have emerged, but their focus has mainly been limited to simple reminder messages. The purpose of this pilot study was to test the effectiveness of tailored text messages focusing on improving medication adherence and health beliefs in adults with diabetes. Adults aged 21-64, with uncontrolled diabetes, and taking at least one anti-diabetic medication were recruited and randomized into 2 study arms: daily tailored text messaging for 90 days or standard care. Comparing baseline and endpoint survey responses, changes in theory-driven health beliefs and attitudes were assessed. The impact on medication adherence was evaluated using pharmacy claims by calculating the percent of days covered (PDC). A total of 75 subjects were consented, and 48 were randomized. Mean PDC at baseline were comparable between cohorts (84.4% and 87.1%, respectively). Declines in adherence were observed in both groups over time but no significant differences were observed between groups or from baseline to the end of the active study period. Unadjusted tests suggested that perceived benefits and competence might have improved in the intervention arm. Tailoring mobile phone text messages is a novel way to address medication nonadherence and health beliefs; further investigation to this combined technique is needed to better understand its impact on behavior change in adults with diabetes. Copyright © 2016 Elsevier Inc. All rights reserved.

  15. Effect of Brazilian green propolis in patients with type 2 diabetes: A double-blind randomized placebo-controlled study.

    Science.gov (United States)

    Fukuda, Takuya; Fukui, Michiaki; Tanaka, Muhei; Senmaru, Takafumi; Iwase, Hiroya; Yamazaki, Masahiro; Aoi, Wataru; Inui, Toshio; Nakamura, Naoto; Marunaka, Yoshinori

    2015-05-01

    Propolis contains a variety of chemical compounds, including polyphenols, flavonoids, phenolic aldehydes, amino acids and vitamins, and presents numerous biological and pharmacological properties. The aim of the present study was to evaluate the effect of propolis on blood examination data in patients with type 2 diabetes. In the double-blind, 8-week randomized controlled study, 80 patients with type 2 diabetes were enrolled. Patients were randomly assigned to receive Brazilian green propolis (226.8 mg/day for 8 weeks) (n=41) or the placebo (n=39). The primary endpoint was to detect changes in blood examination data associated with metabolic disorders in patients suffering from diabetes mellitus, including the homeostasis model assessment of insulin resistance (HOMA-IR), uric acid and estimated glomerular filtration rate (eGFR) from baseline to the end of this study. The value of HOMA-IR was not significantly changed by the 8-week administration of propolis or placebo from the baseline data. Values of blood uric acid and eGFR in patients taking the placebo became worse at 8 weeks compared to the baseline, whereas this did not occur in patients consuming Brazilian green propolis. However, HOMA-IR was not improved by propolis intake. A randomized, controlled 8-week trial suggests that Brazilian green propolis (226.8 mg/day) prevents patients with type 2 diabetes from developing worse blood uric acid and eGFR.

  16. Two-year Randomized Clinical Trial Of Self-etching Adhesives And Selective Enamel Etching

    OpenAIRE

    Pena, MR; Rodrigues CE; JA; Ely; Giannini, C.; Reis, M; AF

    2016-01-01

    Objective: 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. Methods: 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...

  17. 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 A1c (HbA1c). Patients (n = 456) on oral diabetes medications with HbA1c ≥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 HbA1c change over 12 months. DSME game patients had significantly greater HbA1c 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). HbA1c reductions were greater among patients with baseline HbA1c >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 HbA1c improvements. Among patients with poorly controlled diabetes, the DSME game reduced HbA1c 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.

  18. Lifestyle INtervention for Diabetes prevention After pregnancy (LINDA-Brasil): study protocol for a multicenter randomized controlled trial.

    Science.gov (United States)

    Schmidt, Maria Inês; Duncan, Bruce B; Castilhos, Cristina; Wendland, Eliana Márcia; Hallal, Pedro C; Schaan, Beatriz D'Agord; Drehmer, Michele; Costa E Forti, Adriana; Façanha, Cristina; Nunes, Maria Angélica

    2016-03-30

    Gestational diabetes mellitus (GDM), a hyperglycemic state detected during pregnancy, is an established risk factor for diabetes. However, treatment during pregnancy in and of itself is not able to eliminate this risk, and a considerable fraction of women with GDM will develop frank diabetes in the decade following pregnancy. Our aim is to conduct a multicenter randomized controlled trial to investigate the effectiveness of a lifestyle intervention program implemented after a pregnancy complicated by GDM in delaying or preventing the development of type 2 diabetes. Women aged 18 or older identified as having recent GDM are recruited and followed by telephone to assess eligibility for the trial. To be eligible, women must have used insulin during pregnancy or present intermediate hyperglycemia postpartum. Women are encouraged to enter the trial as early as 10 weeks, and are permitted to do so up to 2 years after a pregnancy with GDM. An estimated 740 women will be randomized to either conventional care or to coach-based interventions focused on breastfeeding, weight loss, healthy eating, and increased physical activity, and predominantly delivered by telephone. Women are followed annually to detect new onset diabetes, the primary outcome, and additional secondary outcomes which include reversion to normoglycemia, weight loss, physical activity and fitness, and insulin resistance. Though previous studies have demonstrated that type 2 diabetes can be delayed or prevented, no study has yet demonstrated the feasibility and effectiveness of similar interventions implemented in the postpartum period for women with recent GDM. If shown to be successful, this approach could become an important means of preventing diabetes in primary care settings. ClinicalTrials.gov Identifier: NCT02327286; Registered 23 December 2014.

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

    Directory of Open Access Journals (Sweden)

    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

  20. Integrating medical management with diabetes self-management training: a randomized control trial of the Diabetes Outpatient Intensive Treatment program

    National Research Council Canada - National Science Library

    Polonsky, William H; Earles, Jay; Smith, Susan; Pease, Donna J; Macmillan, Mary; Christensen, Reed; Taylor, Thomas; Dickert, Judy; Jackson, Richard A

    2003-01-01

    This study evaluated the Diabetes Outpatient Intensive Treatment (DOIT) program, a multiday group education and skills training experience combined with daily medical management, followed by case management over 6 months...

  1. 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.

  2. 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

    2018-01-06

    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

  3. 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 ( rs = -.47, p = .004) and waist circumference ( rs = -.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.

  4. Controlled-release oxycodone relieves neuropathic pain: a randomized controlled trial in painful diabetic neuropathy.

    Science.gov (United States)

    Watson, C Peter N; Moulin, Dwight; Watt-Watson, Judith; Gordon, Allan; Eisenhoffer, John

    2003-09-01

    Painful neuropathy is one of the most common long-term complications of diabetes mellitus and often proves difficult to relieve. Patients with diabetic neuropathy with moderate or greater pain for at least 3 months, were evaluated for efficacy, safety and health-related quality of life (QOL) while receiving controlled-release (CR) oxycodone (OxyContin) or active placebo. Patients underwent washout from all opioids 2-7 days before randomization to 10 mg CR oxycodone or active placebo (0.25 mg benztropine) q12h. The dose was increased, approximately weekly, to a maximum of 40 mg q12h CR oxycodone or 1 mg q12h benztropine, with crossover to the alternate treatment after a maximum of 4 weeks. Acetaminophen, 325-650 mg q4-6h prn was provided as rescue. Thirty-six patients were evaluable for efficacy (21 men, 15 women, mean age 63.0+/-9.4 years). CR oxycodone resulted in significantly lower (P=0.0001) mean daily pain (21.8+/-20.7 vs. 48.6+/-26.6 mm VAS), steady pain (23.5+/-23.0 vs. 47.6+/-30.7 mm VAS), brief pain (21.8+/-23.5 vs. 46.7+/-30.8 mm VAS), skin pain (14.3+/-20.4 vs. 43.2+/-31.3 mm VAS), and total pain and disability (16.8+/-15.6 vs. 25.2+/-16.7; P=0.004). Scores from 6 of the 8 SF-36 domains and both summary scales, Standardized Physical Component (P=0.0002) and Standardized Mental Component (P=0.0338) were significantly better during CR oxycodone treatment. The number needed to treat to obtain one patient with at least 50% pain relief is 2.6 and clinical effectiveness scores favoured treatment with CR oxycodone over placebo (P=0.0001). CR oxycodone is effective and safe for the management of painful diabetic neuropathy and improves QOL.

  5. Curcuminoids modify lipid profile in type 2 diabetes mellitus: A randomized controlled trial.

    Science.gov (United States)

    Panahi, Yunes; Khalili, Nahid; Sahebi, Ebrahim; Namazi, Soha; Reiner, Željko; Majeed, Muhammed; Sahebkar, Amirhossein

    2017-08-01

    Type 2 diabetes (T2D) is an established risk factor for cardiovascular disease (CVD) and is associated with disturbed metabolism of lipids and lipoproteins. Curcuminoids are natural products with anti-diabetic and lipid-modifying actions but their efficacy in improving dyslipidemia in diabetic individuals has not been sufficiently studied. To investigate the efficacy of supplementation with curcuminoids, plus piperine as an absorption enhancer, in improving serum lipids in patients with T2D. In this 12-week randomized double-blind placebo-controlled trial, subjects with T2D (n=118) were assigned to curcuminoids (1000mg/day plus piperine 10mg/day) or placebo plus standard of care for T2D. Serum concentrations of lipids including total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), lipoprotein(a) [Lp(a)], and non-HDL-C were determined at baseline and at the end of trial. Between-group comparison of change in the study parameters revealed significant reductions in serum levels of TC (-21.86±25.78 versus -17.06±41.51, respectively; p=0.023), non-HDL-C (-23.42±25.13 versus -16.84±41.42, respectively; p=0.014) and Lp(a) (-1.50±1.61 versus -0.34±1.73, respectively; p=0.001) and elevations in serum HDL-C levels (1.56±4.25 versus -0.22±4.62, respectively; p=0.048) in the curcuminoids group as compared with the placebo group (p0.05). Curcuminoids supplementation can reduce serum levels of atherogenic lipid indices including non-HDL-C and Lp(a). Therefore, curcuminoids supplementation could contribute to a reduced risk of cardiovascular events in dyslipidemic patients with T2D. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

    Science.gov (United States)

    Lindsay, Grace W; Rigotti, Mattia; Warden, Melissa R; Miller, Earl K; Fusi, Stefano

    2017-11-08

    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 ("mixed

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

    DEFF Research Database (Denmark)

    Heide, Janus; Zhang, Qi; Fitzek, Frank

    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...

  8. Diabetes

    OpenAIRE

    Smith, Paul

    2003-01-01

    Derbyshire general practitioner Stuart Bootle has had diabetes for 20 years. He speaks to Paul Smith, who has type 1 diabetes himself, about the trials and tribulations of being on the receiving end of NHS care

  9. Effect of Tree Nuts on Glycemic Control in Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Dietary Trials

    Science.gov (United States)

    Viguiliouk, Effie; Kendall, Cyril W. C.; Blanco Mejia, Sonia; Cozma, Adrian I.; Ha, Vanessa; Mirrahimi, Arash; Jayalath, Viranda H.; Augustin, Livia S. A.; Chiavaroli, Laura; Leiter, Lawrence A.; de Souza, Russell J.; Jenkins, David J. A.; Sievenpiper, John L.

    2014-01-01

    Background Tree nut consumption has been associated with reduced diabetes risk, however, results from randomized trials on glycemic control have been inconsistent. Objective 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. Data Sources MEDLINE, EMBASE, CINAHL, and Cochrane databases through 6 April 2014. Study Selection 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. Data Extraction and Synthesis 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). Results 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. Limitations Majority of trials were of short duration and poor quality. Conclusions 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. Trial Registration ClinicalTrials.gov NCT01630980 PMID:25076495

  10. The Impact of a Mobile Diabetes Health Intervention on Diabetes Distress and Depression Among Adults: Secondary Analysis of a Cluster Randomized Controlled Trial.

    Science.gov (United States)

    Quinn, Charlene C; Swasey, Krystal K; Crabbe, J Christopher F; Shardell, Michelle D; Terrin, Michael L; Barr, Erik A; Gruber-Baldini, Ann L

    2017-12-07

    Diabetes is a complex, demanding disease that requires the constant attention of patients. The burden of self-management, including different medication regimens, routine self-care activities, and provider visits, has an impact on patients' emotional well-being. Diabetes distress and depression are two important components of emotional well-being that may negatively affect diabetes outcomes. The aim was to determine the impact of the 1-year Mobile Diabetes Intervention Study cluster randomized clinical trial on emotional well-being measured by diabetes distress and depression among adults with type 2 diabetes (T2D). A total of 163 adults with not-well-managed T2D were enrolled from community primary care practices. Primary care practices were cluster randomized into either a usual care control group or intervention group. Intervention participants were given a mobile phone with coaching software including a Web portal to communicate with providers. A priori established secondary outcomes included distress measured by the Diabetes Distress Scale (DDS), with subscales measuring emotional burden, interpersonal distress, physician-related distress, and regimen-related distress, as well as depression measured by the Patient Health Questionnaire (PHQ-9). Linear mixed models were used to calculate the effect of the intervention on diabetes distress levels over time, both overall and separately by sex, and to determine if the intervention affected distress or depression. The impact of total DDS on changes in HbA1c was also studied. There were no significant treatment group effects for DDS total (baseline: P=.07; differences over time: P=.38) or for depression (P=.06 over time). Significant declines in total DDS were observed over the 12-month intervention period (P=.01). Regimen-related distress significantly decreased for all study participants (P<.001), but no significant change over time was observed for emotional burden (P=.83), interpersonal distress (P=.64), or

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

    Science.gov (United States)

    Censin, J C; Nowak, Christoph; Cooper, Nicholas; Bergsten, Peter; Todd, John A; Fall, Tove

    2017-08-01

    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 (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 link between childhood adiposity and T1D risk. Together with evidence from observational studies, our findings further emphasize the importance of measures to reduce the

  12. 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

  13. Type 2 Diabetes Biomarkers of Human Gut Microbiota Selected via Iterative Sure Independent Screening Method.

    Directory of Open Access Journals (Sweden)

    Lihua Cai

    Full Text Available Type 2 diabetes, which is a complex metabolic disease influenced by genetic and environment, has become a worldwide problem. Previous published results focused on genetic components through genome-wide association studies that just interpret this disease to some extent. Recently, two research groups published metagenome-wide association studies (MGWAS result that found meta-biomarkers related with type 2 diabetes. However, One key problem of analyzing genomic data is that how to deal with the ultra-high dimensionality of features. From a statistical viewpoint it is challenging to filter true factors in high dimensional data. Various methods and techniques have been proposed on this issue, which can only achieve limited prediction performance and poor interpretability. New statistical procedure with higher performance and clear interpretability is appealing in analyzing high dimensional data. To address this problem, we apply an excellent statistical variable selection procedure called iterative sure independence screening to gene profiles that obtained from metagenome sequencing, and 48/24 meta-markers were selected in Chinese/European cohorts as predictors with 0.97/0.99 accuracy in AUC (area under the curve, which showed a better performance than other model selection methods, respectively. These results demonstrate the power and utility of data mining technologies within the large-scale and ultra-high dimensional genomic-related dataset for diagnostic and predictive markers identifying.

  14. A cluster randomized controlled trial of the effectiveness and cost-effectiveness of Intermediate Care Clinics for Diabetes (ICCD: study protocol for a randomized controlled trial

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    Armstrong Natalie

    2012-09-01

    Full Text Available Abstract Background World-wide healthcare systems are faced with an epidemic of type 2 diabetes. In the United Kingdom, clinical care is primarily provided by general practitioners (GPs rather than hospital specialists. Intermediate care clinics for diabetes (ICCD potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors. This study aims to (1 compare patients with type 2 diabetes registered with practices that have access to an ICCD service with those that have access only to usual hospital care; (2 assess the cost-effectiveness of the intervention; and (3 explore the views and experiences of patients, health professionals and other stakeholders. Methods/Design This two-arm cluster randomized controlled trial (with integral economic evaluation and qualitative study is set in general practices in three UK Primary Care Trusts. Practices are randomized to one of two groups with patients referred to either an ICCD (intervention or to hospital care (control. Intervention group: GP practices in the intervention arm have the opportunity to refer patients to an ICCD - a multidisciplinary team led by a specialist nurse and a diabetologist. Patients are reviewed and managed in the ICCD for a short period with a goal of improving diabetes and cardiovascular risk factor control and are then referred back to practice. or Control group: Standard GP care, with referral to secondary care as required, but no access to ICCD. Participants are adults aged 18 years or older who have type 2 diabetes that is difficult for their GPs to control. The primary outcome is the proportion of participants reaching three risk factor targets: HbA1c (≤7.0%; blood pressure ( Discussion Forty-nine practices have been randomized, 1,997 patients have been recruited to the trial, and 20 patients have been recruited to the qualitative study. Results will be available late 2012

  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. 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.

  17. Effects of Group Training on Depression and Anxiety among Patients with Type I Diabetes: a Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Shanaz Rostami

    2016-05-01

    Full Text Available Background Depression and anxiety can have a significant impact on prognosis in diabetic patients. In this study we evaluate how the effect of group learning on anxiety and depression in adolescents with type 1 diabetes at clinics of Ahvaz Jundishapur University of Medical Science. Materials and Methods  This study was carried out via a pretest- posttest design on the adolescent 11-21 ages with type I diabetes. 74 patients were randomized in education group (n=37 either to the control group (n=37. Data collection tools included demographic and clinical status questionnaires, and the Beck anxiety and depression inventory. Group training intervention was done for intervention group and three months after study two groups filled questionnaires and inventories. Data analyzed using chi-square test and t-test using SPSS- 22 software. Results  Findings showed that there was a significant difference between patients mean of depression in intervention group before and after intervention (P

  18. Adjunctive Hyperbaric Oxygen Therapy for Healing of Chronic Diabetic Foot Ulcers: A Randomized Controlled Trial.

    Science.gov (United States)

    Chen, Chen-Yu; Wu, Re-Wen; Hsu, Mei-Chi; Hsieh, Ching-Jung; Chou, Man-Chun

    The purpose of this study was to compare the effect of standard wound care with adjunctive hyperbaric oxygen therapy (HBOT) to standard wound care alone on wound healing, markers of inflammation, glycemic control, amputation rate, survival rate of tissue, and health-related quality of life in patients with diabetic foot ulcers (DFUs). Prospective, randomized, open-label, controlled study. The sample comprised 38 patients with nonhealing DFUs who were deemed poor candidates for vascular surgery. Subjects were randomly allocated to an experimental group (standard care plus HBOT, n = 20) or a control group (standard care alone, n = 18). The study setting was a medical center in Kaohsiung City, Taiwan. Hyperbaric oxygen therapy was administered in a hyperbaric chamber under 2.5 absolute atmospheric pressure for 120 minutes; subjects were treated 5 days a week for 4 consecutive weeks. Both groups received standard wound care including debridement of necrotic tissue, topical therapy for Wagner grade 2 DFUs, dietary control and pharmacotherapy to maintain optimal blood glucose levels. Wound physiological indices were measured and blood tests (eg, markers of inflammation) were undertaken. Health-related quality of life was measured using the Medical Outcomes Study 36-Item Short Form. Complete DFU closure was achieved in 5 patients (25%) in the HBOT group (n = 20) versus 1 participant (5.5%) in the routine care group (n = 18) (P = .001). The amputation rate was 5% for the HBOT group and 11% for the routine care group (χ = 15.204, P = .010). The HBOT group showed statistically significant improvements in inflammation index, blood flow, and health-related quality of life from pretreatment to 2 weeks after the last therapy ended (P treatment (P < .05) but not in the routine care group. Adjunctive HBOT improved wound healing in persons with DFU. Therapy also reduced the risk of amputation of the affected limb. We assert that at least 20 HBOT sessions are required to be

  19. The effects of probiotic and synbiotic supplementation on metabolic syndrome indices in adults at risk of type 2 diabetes: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Kassaian, Nazila; Aminorroaya, Ashraf; Feizi, Awat; Jafari, Parvaneh; Amini, Masoud

    2017-03-29

    The incidence of type 2 diabetes, cardiovascular diseases, and obesity has been rising dramatically; however, their pathogenesis is particularly intriguing. Recently, dysbiosis of the intestinal microbiota has emerged as a new candidate that may be linked to metabolic diseases. We hypothesize that selective modulation of the intestinal microbiota by probiotic or synbiotic supplementation may improve metabolic dysfunction and prevent diabetes in prediabetics. In this study, a synthesis and study of synbiotics will be carried out for the first time in Iran. In a randomized triple-blind controlled clinical trial, 120 adults with impaired glucose tolerance based on the inclusion criteria will be selected by a simple random sampling method and will be randomly allocated to 6 months of 6 g/d probiotic, synbiotic or placebo. The fecal abundance of bacteria, blood pressure, height, weight, and waist and hip circumferences will be measured at baseline and following treatment. Also, plasma lipid profiles, HbA1C, fasting plasma glucose, and insulin levels, will be measured and insulin resistance (HOMA-IR) and beta-cell function (HOMA-B) will be calculated at baseline and will be repeated at months 3, 6, 12, and 18. The data will be compared within and between groups using statistical methods. The results of this trial could contribute to the evidence-based clinical guidelines that address gut microbiota manipulation to maximize health benefits in prevention and management of metabolic syndrome in prediabetes. Iranian Registry of Clinical Trials: IRCT201511032321N2 . Registered on 27 February 2016.

  20. 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.

  1. Structured lifestyle intervention based on a trans-cultural diabetes-specific nutrition algorithm (tDNA) in individuals with type 2 diabetes: a randomized controlled trial

    Science.gov (United States)

    Chee, Winnie S S; Gilcharan Singh, Harvinder Kaur; Hamdy, Osama; Mechanick, Jeffrey I; Lee, Verna K M; Barua, Ankur; Mohd Ali, Siti Zubaidah; Hussein, Zanariah

    2017-01-01

    Objective Trans-cultural diabetes nutrition algorithm (tDNA) was created by international task force and culturally customized for Malaysian population. This study was designed to evaluate its effectiveness versus usual diabetes care in primary care settings. Research design and methods We randomized 230 patients with overweight/obesity, type 2 diabetes, and glycated hemoglobin (A1c) 7%–11% to receive usual care (UC) or UC with tDNA for 6 months. The tDNA intervention consisted of structured low-calorie meal plan, diabetes-specific meal replacements, and increased physical activity. Participants were counseled either through motivational interviewing (tDNA-MI) or conventional counseling (tDNA-CC). The UC group received standard dietary and exercise advice through conventional counseling. All patients were followed for another 6 months after intervention. Results At 6 months, A1c decreased significantly in tDNA-MI (−1.1±0.1%, pdiabetes control and body weight in primary care setting. PMID:29435347

  2. 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.

  3. 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.

  4. The efficacy of myo-inositol supplementation to prevent gestational diabetes onset: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Zhang, Haifeng; Lv, You; Li, Zhuo; Sun, Lin; Guo, Weiying

    2018-02-06

    The efficacy of myo-inositol supplementation to prevent gestational diabetes onset remains controversial. We conducted a systematic review and meta-analysis to explore the influence of myo-inositol supplementation on the incidence of gestational diabetes. We search PubMed, Embase, Web of science, EBSCO, and Cochrane Library databases through November 2017 for randomized controlled trials (RCTs) assessing the effect of myo-inositol supplementation on gestational diabetes onset. This meta-analysis is performed using the random-effect model. Five randomized controlled trials (RCTs) are included in the meta-analysis. Compared with control group in pregnant women, myo-inositol supplementation is associated with significantly reduced incidence of gestational diabetes (risk ratio (RR) = 0.43; 95%CI = 0.21-0.89; p = .02), and preterm delivery (RR = 0.36; 95%CI = 0.17-0.73; p = .005), but has no substantial impact on 2-h glucose oral glucose tolerance test (OGTT) (mean difference (MD) = -6.90; 95%CI = -15.07 to 1.27; p = .10), gestational age at birth (MD = 0.74; 95%CI = -1.06 to 2.54; p = .42), birth weight (MD = -5.50; 95%CI = -116.99 to 105.99; p = .92), and macrosomia (RR = 0.65; 95%CI = 0.20-2.11; p = .47). Myo-inositol supplementation has some ability to reduce the incidence of gestational diabetes and preterm delivery in pregnant women.

  5. Classification of epileptic EEG signals based on simple random sampling and sequential feature selection.

    Science.gov (United States)

    Ghayab, Hadi Ratham Al; Li, Yan; Abdulla, Shahab; Diykh, Mohammed; Wan, Xiangkui

    2016-06-01

    Electroencephalogram (EEG) signals are used broadly in the medical fields. The main applications of EEG signals are the diagnosis and treatment of diseases such as epilepsy, Alzheimer, sleep problems and so on. This paper presents a new method which extracts and selects features from multi-channel EEG signals. This research focuses on three main points. Firstly, simple random sampling (SRS) technique is used to extract features from the time domain of EEG signals. Secondly, the sequential feature selection (SFS) algorithm is applied to select the key features and to reduce the dimensionality of the data. Finally, the selected features are forwarded to a least square support vector machine (LS_SVM) classifier to classify the EEG signals. The LS_SVM classifier classified the features which are extracted and selected from the SRS and the SFS. The experimental results show that the method achieves 99.90, 99.80 and 100 % for classification accuracy, sensitivity and specificity, respectively.

  6. 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.

  7. 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

  8. Plants used to manage type II diabetes mellitus in selected districts of central Uganda.

    Science.gov (United States)

    Ssenyange, Comfort Were; Namulindwa, Angella; Oyik, Bruno; Ssebuliba, Jude

    2015-06-01

    Chronic diseases such as diabetes mellitus are increasing in incidence in sub-Saharan Africa. African traditional medicine is part and parcel of the health care system in Uganda. Majority of the indigenous population will have visited a traditional health care practioner or self-administered herbal medicines before seeking conventional health care. However, documentation of the various medicinal plants is still lacking, necessitating a well-organized information search for such knowledge through research. Such information can lay a firm and clear foundation for scientific investigation of the purported therapeutic benefits of the said plants. The objective of this study was to collect names of medicinal plants used to manage diabetes mellitus type II in selected districts of central Uganda. In this ethnobotanical survey, names, of plants used to manage diabetes mellitus type II as well as the methods of preparation, routes of administration and the plant parts used in the districts of Mukono, Kampala, Wakiso and Masaka in the central region of Uganda were documented using a researcher administered questionnaire. Participants were recruited using a snow ball approach in which one individual directed us to another. Informant consensus was determined for each of the plants mentioned. A total of 18 names of medicinal plants were recorded of which Aloe vera var, Solanum indicum and Vernonia amygydalina were the most commonly mentioned plants and thus had the highest informant consensus. Leaves were the main parts that were used to prepare the herbal medicine while water as the solvent used in all the preparations. In all the cases, only the oral route was used for administration of the medicines. Documentation of medicinal plants used to manage diabetes can further improve on the formalization process of the Ugandan traditional medicine system as well as lay a basis for further scientific investigation with emphasis on the plants whose informant consensus is high.

  9. 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

    were randomized to IDet (n = 152) or NPH (n = 158) ≤12 months before pregnancy or at 8-12 gestational weeks. RESULTS: For IDet and NPH, there were 128 and 136 live births, 11 and 9 early fetal losses, and two and one perinatal deaths, respectively. Gestational age at delivery was greater for children......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...... tolerated as NPH as regards perinatal outcomes in pregnant women with type 1 diabetes and no safety issues were identified....

  10. 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 characteristics were not associated with A1c improvements. Participants whose peers had a more controlled self-regulation style were more likely to initiate insulin ( P characteristics that lead to improved outcomes. This could allow for better matching and more effective partnerships.

  11. 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.

  12. Long-term effects of the Mediterranean lifestyle program: a randomized clinical trial for postmenopausal women with type 2 diabetes

    OpenAIRE

    Toobert, Deborah J; Glasgow, Russell E; Strycker, Lisa A; Barrera, Manuel; Ritzwoller, Debra P; Weidner, Gerdi

    2007-01-01

    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 eat...

  13. Neointimal hyperplasia after sirolimus-eluting and paclitaxel-eluting stent implantation in diabetic patients: the Randomized Diabetes and Drug-Eluting Stent (DiabeDES) Intravascular Ultrasound Trial

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Maeng, Michael; Thayssen, Per

    2008-01-01

    -eluting (Cypher) or paclitaxel-eluting (Taxus) stents in diabetic patients. METHODS AND RESULTS: One hundred and thirty diabetic patients were randomized to Cypher or Taxus stent implantation. IVUS was performed at 8 month follow-up. NIH volume was significantly reduced in the Cypher group when compared...

  14. Personal name in Igbo Culture: A dataset on randomly selected personal names and their statistical analysis.

    Science.gov (United States)

    Okagbue, Hilary I; Opanuga, Abiodun A; Adamu, Muminu O; Ugwoke, Paulinus O; Obasi, Emmanuela C M; Eze, Grace A

    2017-12-01

    This data article contains the statistical analysis of Igbo personal names and a sample of randomly selected of such names. This was presented as the following: 1). A simple random sampling of some Igbo personal names and their respective gender associated with each name. 2). The distribution of the vowels, consonants and letters of alphabets of the personal names. 3). The distribution of name length. 4). The distribution of initial and terminal letters of Igbo personal names. The significance of the data was discussed.

  15. 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.

  16. A randomized clinical trial aimed at preventing poor psychosocial and glycemic outcomes in teens with type 1 diabetes (T1D)

    OpenAIRE

    Weissberg-Benchell, Jill; Rausch, Joseph; Iturralde, Esti; Jedraszko, Aneta; Hood, Korey

    2016-01-01

    Adolescents with type 1 diabetes have an increased risk for a variety of emotional and behavioral challenges as well as negative diabetes outcomes. This study was designed to compare the effectiveness of a depression-prevention, resilience promotion program with an advanced diabetes education program. Each program consisted of 9 group-based sessions. There were 264 adolescents enrolled in this multi-site randomized clinical trial. The primary outcomes were depressive symptoms and glycemic con...

  17. Low Glycemic Index Carbohydrates versus All Types of Carbohydrates for Treating Diabetes in Pregnancy: A Randomized Clinical Trial to Evaluate the Effect of Glycemic Control

    OpenAIRE

    Perichart-Perera, Otilia; Balas-Nakash, Margie; Rodríguez-Cano, Ameyalli; Legorreta-Legorreta, Jennifer; Parra-Covarrubias, Adalberto; Vadillo-Ortega, Felipe

    2012-01-01

    Background. Due to the higher prevalence of obesity and diabetes mellitus (DM), more pregnant women complicated with diabetes are in need of clinical care. Purpose. Compare the effect of including only low glycemic index (GI) carbohydrates (CHO) against all types of CHO on maternal glycemic control and on the maternal and newborn's nutritional status of women with type 2 DM and gestational diabetes mellitus (GDM). Methods. Women (n = 107, ≤29 weeks of gestation) were randomly assigned to one ...

  18. A Randomized Study on the Effect of Weight Loss on Obstructive Sleep Apnea Among Obese Patients With Type 2 Diabetes

    Science.gov (United States)

    Foster, Gary D.; Borradaile, Kelley E.; Sanders, Mark H.; Millman, Richard; Zammit, Gary; Newman, Anne B.; Wadden, Thomas A.; Kelley, David; Wing, Rena R.; Pi-Sunyer, F. Xavier; Reboussin, David; Kuna, Samuel T.

    2010-01-01

    Background The belief that weight loss improves obstructive sleep apnea (OSA) has limited empirical support. The purpose of this 4-center study was to assess the effects of weight loss on OSA over a 1-year period. Methods The study included 264 participants with type 2 diabetes and a mean (SD) age of 61.2 (6.5) years, weight of 102.4 (18.3) kg, body mass index (BMI) (calculated as weight in kilograms divided by height in meters squared) of 36.7 (5.7), and an apnea-hypopnea index (AHI) of 23.2 (16.5) events per hour. The participants were randomly assigned to either a behavioral weight loss program developed specifically for obese patients with type 2 diabetes (intensive lifestyle intervention [ILI]) or 3 group sessions related to effective diabetes management (diabetes support and education [DSE]). Results The ILI participants lost more weight at 1 year than did DSE participants (10.8 kg vs 0.6 kg; P weight loss were the strongest predictors of changes in AHI at 1 year (Pweight loss of 10 kg or more had the greatest reductions in AHI. Conclusions Physicians and their patients can expect that weight loss will result in significant and clinically relevant improvements in OSA among obese patients with type 2 diabetes. Trial Registration clinicaltrials.gov Identifier: NCT00194259 PMID:19786682

  19. Check it! A randomized pilot of a positive psychology intervention to improve adherence in adolescents with type 1 diabetes.

    Science.gov (United States)

    Jaser, Sarah S; Patel, Niral; Rothman, Russell L; Choi, Leena; Whittemore, Robin

    2014-01-01

    The purpose of the current study was to pilot-test a positive psychology intervention to improve adherence to diabetes management in adolescents with type 1 diabetes. A total of 39 adolescents (ages, 13-17 years) with type 1 diabetes and their caregivers were randomized to a positive psychology intervention (n = 20) or an attention control (education) intervention (n = 19). The intervention condition used positive psychology exercises (eg, gratitude, self-affirmation), small gifts, and parent affirmations to boost positive affect. Outcomes included frequency of blood glucose monitoring, quality of life, and glycemic control. No main effects for treatment were observed at the 6-month follow-up. However, there was a significant association between adolescents' levels of positive affect and measures of adherence, including self-report and meter downloads of glucose monitoring. The results from the current study support the assertion that positive affect in the context of diabetes education is an important factor to consider in adolescents with type 1 diabetes. © 2014 The Author(s).

  20. Random Capillary Blood Glucose Cut Points for Diabetes and Pre-Diabetes Derived From Community-Based Opportunistic Screening in India

    Science.gov (United States)

    Somannavar, Suresh; Ganesan, Anbazhagan; Deepa, Mohan; Datta, Manjula; Mohan, Viswanathan

    2009-01-01

    OBJECTIVE To determine random capillary blood glucose (RCBG) cut points that discriminate diabetic and pre-diabetic subjects from normal individuals. RESEARCH DESIGN AND METHODS RCBG was performed in 1,333 individuals randomly chosen from 63,305 individuals who had participated in an opportunistic screening program. An oral glucose tolerance test was also performed by venous plasma glucose on an autoanalyzer. RCBG cut points that discriminate diabetes, impaired glucose tolerance (IGT), and impaired fasting glucose (IFG) were determined using receiver operating characteristic curves. RESULTS Using 2-h plasma glucose ≥200 mg/dl (11.1 mmol/l) criterion, the RCBG cut point of 140 mg/dl (7.7 mmol/l) gave the highest sensitivity and specificity. For 2-h plasma glucose ≥200 mg/dl (11.1 mmol/l) and fasting plasma glucose (FPG) ≥126 mg/dl (7.0 mmol/l) criteria, either 2-h plasma glucose ≥200 mg/dl (11.1 mmol/l) or FPG ≥126 mg/dl (7.0 mmol/l) criterion, and the FPG ≥126 mg/dl (7.0 mmol/l) criterion, RCBG cut point was 143 mg/dl (7.9 mmol/l). RCBG cut points for IGT, IFG according to World Health Organization criterion, and IFG according to American Diabetes Association criterion were 119 mg/dl (6.6 mmol/l), 118 mg/dl (6.6 mmol/l), and 113 mg/dl (6.3 mmol/l), respectively. CONCLUSIONS Asian Indians with RCBG >110 mg/dl at screening can be recommended to undergo definitive testing. PMID:19073758

  1. 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.

  2. 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 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 John Wiley & Sons, Ltd.

  3. Diabetes Mellitus Is Associated With Decreased Limb Survival in Patients With Critical Limb Ischemia : Pooled Data From Two Randomized Controlled Trials

    NARCIS (Netherlands)

    Spreen, Marlon I; Gremmels, Hendrik; Teraa, Martin; Sprengers, Ralf W; Verhaar, Marianne C; Statius van Eps, Randolph G; de Vries, Jean-Paul P M; Mali, Willem P.Th.M.; van Overhagen, Hans

    2016-01-01

    OBJECTIVE: Although never assessed prospectively, diabetes mellitus (DM) is assumed to negatively affect the outcomes of critical limb ischemia (CLI). DM was highly prevalent in two recently conducted randomized controlled trials in CLI patients, the PADI (Percutaneous Transluminal Balloon

  4. Long-term effects of addition of mineralocorticoid receptor antagonist to angiotensin II receptor blocker in patients with diabetic nephropathy: a randomized clinical trial

    National Research Council Canada - National Science Library

    Esteghamati, Alireza; Noshad, Sina; Jarrah, Sorour; Mousavizadeh, Mostafa; Khoee, Seyed Hamid; Nakhjavani, Manouchehr

    2013-01-01

    .... In an open-label, parallel-group, single-center, randomized clinical trial (NCT01667614), 136 patients with diabetes and proteinuria, already treated with enalapril and losartan, were included...

  5. 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

    allocated to the Families and Adolescents Communication and Teamwork Study (FACTS) diabetes education programme; (six 90-min monthly sessions attended by parents and adolescents incorporating skills training and family teamwork) or conventional clinical care. Primary outcome was HbA 1c at 18months (12months...

  6. 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

  7. Impact of the "Diabetes Interactive Diary" telemedicine system on metabolic control, risk of hypoglycemia, and quality of life: a randomized clinical trial in type 1 diabetes.

    Science.gov (United States)

    Rossi, Maria Chiara; Nicolucci, Antonio; Lucisano, Giuseppe; Pellegrini, Fabio; Di Bartolo, Paolo; Miselli, Valerio; Anichini, Roberto; Vespasiani, Giacomo

    2013-08-01

    Telemedicine systems based on mobile phones represent new promising educational tools. The "Diabetes Interactive Diary" (DID) is a carbohydrate/bolus calculator promoting the patient-physician communication via short message service. This study aimed to compare the efficacy of the DID versus usual care on metabolic control, hypoglycemia, and quality of life. Patients with type 1 diabetes on a basal:bolus regimen with insulin glargine and insulin glulisine, not previously educated on carbohydrate (CHO) counting, were randomized to DID (Group A; n=63) or traditional education (Group B; n=64). Generalized hierarchical linear regression models for repeated measures were applied to compare changes between groups. Incidence of hypoglycemia was compared using Poisson regression models. Of 127 patients (age, 36.9±10.5 years; diabetes duration, 16.3±9.3 years), 15 (11.8%) dropped out. After 6 months, hemoglobin A1c (HbA1c) levels decreased by -0.49±0.11 in Group A and -0.48±0.11 in Group B (P=0.73). Group A showed a 86% lower risk of grade 2 hypoglycemia than Group B. Compared with usual care, DID improved the "perceived frequency of hyperglycemic episodes" scale of the Diabetes Treatment Satisfaction Questionnaire and the "social relations" and the "fear of hypoglycemia" dimensions of the Diabetes Specific Quality of Life Scale. Results obtained with DID markedly differ among patients and centers. DID is no more effective than traditional CHO counting education in reducing HbA1c levels. DID reduces the risk of moderate/severe hypoglycemia and improves quality of life. A better understanding of patients' and healthcare professionals' attitudes associated with an effective care supported by technology is essential to avoid waste of resources.

  8. 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

  9. 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.

    Science.gov (United States)

    Lee, Shaun W H; Ooi, Leanne; Lai, Yin K

    2017-01-01

    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 control and

  10. Crestal Bone Loss under Delayed Loading of Full Thickness Versus Flapless Surgically Placed Dental Implants in Controlled Type 2 Diabetic Patients: A Parallel Group Randomized Clinical Trial.

    Science.gov (United States)

    Yadav, Rohit; Agrawal, Kaushal Kishor; Rao, Jitendra; Anwar, Mohd; Alvi, Habib Ahmed; Singh, Kalpana; Himanshu, D

    2016-10-12

    To compare crestal bone loss around dental implants using a delayed loading protocol. Bone loss was compared in patients following conventional full thickness flap and flapless surgery in controlled type 2 diabetic patients. Eighty-eight type 2 diabetic patients satisfying predetermined inclusion and exclusion criteria were selected for this single center, parallel group study after obtaining institutional review board approval and informed consent. These patients were randomly divided into two groups. Group I consisted of patients undergoing full thickness flap surgery for implant placement, and group II consisted of patients undergoing flapless surgery for implant placement. The mean age, duration of diabetes, glycosylated hemoglobin levels, and male-to-female ratio in both groups were matched and compared statistically. Dental implants were placed followed by delayed loading (4 months) in both groups. Crestal bone loss was assessed with intraoral periapical radiographs with the help of computer software (DBSWIN viewer). Actual implant length acted as the radiographic index, and implant-abutment junctions were used as a reference point for all measurements. Mesial and distal bone levels at baseline, 6, and 12 months post implant placement of the two groups were determined. Mesial and distal crestal bone loss from baseline to 6 and 12 months were calculated and compared with Tukey test using SPSS v15.0 statistical analysis software. Tukey test revealed similar (not statistically different) mean mesial crestal bone loss between the two groups after 6 months (0.47 ± 0.08 mm vs. 0.36 ± 0.13 mm, p = 0.576) and after 12 months (1.56 ± 0.25 mm vs. 1.50 ± 0.22 mm, p = 0.891). The mean distal bone loss resulting between the two groups was not statistically different at 6 months (0.44 ± 0.08 mm vs. 0.35 ± 0.12 mm, p = 0.687) and at 12 months (1.57 ± 0.23 mm vs. 1.61 ± 0.22 mm, p = 0.947). The results of this clinical randomized control trial indicated that in

  11. 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.

  12. Prevalence of sexual disorders in a selection-free diabetic population (JEVIN).

    Science.gov (United States)

    Schiel, R; Müller, U A

    1999-05-01

    There is an extensive literature on sexual disorders among diabetic patients, but a shortage of studies on their prevalence in selection-free populations. In the present trial (JEVIN), 90% of all insulin-treated diabetic patients (IDDM/NIDDM, n = 127/117) aged 16-60 years and living in the city of Jena (100247 inhabitants) were studied. Each subject underwent a structured interview followed by a clinical and laboratory examination. The prevalence of sexual disorders was 32% in IDDM and 46% in NIDDM male patients. Patients with sexual disorders were older (IDDM 47.5 +/- 9.8 vs. 37.7 +/- 11.6, P = 0.0004; NIDDM 53.4 +/- 4.3 vs. 49.5 +/- 8.2 years, P = 0.04) and had longer diabetes duration (IDDM 23.1 +/- 13.8 vs. 13.5 +/- 11.1, P = 0.001; NIDDM 12.4 +/- 7.5 vs. 8.4 +/- 5.8 years, P = 0.03) than patients without sexual disorders. There were no significant differences (P diabetes long-term complications in men with versus men without sexual disorders (IDDM/NIDDM): retinopathy, 65/53% vs. 50/18% (P = 0.34/0.03); neuropathy, 58/48% vs. 9/34% (P = 0.001/0.47); nephropathy, 65/50% vs. 12/36% (P = 0.001/0.45). In addition, all the patients completed standardized questionnaires according to Bradley et al. and Lewis et al. to assess quality of life and treatment satisfaction, and one question concerning sexual disorders. The quality of life of IDDM patients with sexual disorders was lower than that of patients without sexual disorders (42.2 +/- 11.4 vs. 54.2 +/- 8.5, P = 0.0005), but there were no differences (P women, the prevalence of sexual disorders was 18/42% in IDDM and NIDDM. Comparing these data with the literature and with reports from healthy controls, mostly there is clearly an underestimation of the prevalence of sexual disorders in diabetic populations. Physicians must make more efforts to detect and treat sexual disorders, which may result in an improvement of patients' quality of life.

  13. 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

    -based peer support for people with type 2 diabetes in a community setting. Results from this trial will contribute evidence about the effectiveness of peer support in achieving effective self-management of diabetes. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ANZCTR); ACTRN...... 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......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...

  14. Zinc supplementation in pre-diabetes: study protocol for a randomized controlled trial

    OpenAIRE

    Ranasinghe, Priyanga; Jayawardena, Ranil; Pigera, ASAD; Katulanda, Prasad; Constantine, Godwin R; Galappaththy, Priyadarshani

    2013-01-01

    Background The number of people with diabetes is increasing worldwide, especially in developing South Asian countries. Therefore, preventing diabetes at the early stages has become an important issue. Recent clinical trials, systematic reviews, and meta-analysis have shown that zinc has beneficial effects on glycemic and metabolic control in those with diabetes. The present study is designed to evaluate the effects of zinc supplementation on glycemic control and other metabolic parameters in ...

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

    DEFF Research Database (Denmark)

    Hussain, Dil Muhammad Akbar

    2006-01-01

      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...

  16. Classification of epileptic EEG signals based on simple random sampling and sequential feature selection

    OpenAIRE

    Ghayab, Hadi Ratham Al; Li, Yan; Abdulla, Shahab; Diykh, Mohammed; Wan, Xiangkui

    2016-01-01

    Electroencephalogram (EEG) signals are used broadly in the medical fields. The main applications of EEG signals are the diagnosis and treatment of diseases such as epilepsy, Alzheimer, sleep problems and so on. This paper presents a new method which extracts and selects features from multi-channel EEG signals. This research focuses on three main points. Firstly, simple random sampling (SRS) technique is used to extract features from the time domain of EEG signals. Secondly, the sequential fea...

  17. 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

  18. Randomized Controlled Trial of Topical Insulin for Healing Corneal Epithelial Defects Induced During Vitreoretinal Surgery in Diabetics.

    Science.gov (United States)

    Fai, Seng; Ahem, Amin; Mustapha, Mushawiathi; Mohd Noh, Umi Kalthum; Bastion, Mae-Lynn Catherine

    2017-01-01

    To determine the effect of topical insulin of 3 concentrations [0.5, 1, and 2 units per drop 4 times per day (QID)] on postoperative corneal epithelial wound healing in diabetic patients. A double blind randomized controlled hospital-based study involving diabetic patients with postoperative corneal epithelial defect after vitreoretinal surgery. Diabetic patients were randomized to 3 different concentrations of topical insulin (DTI 0.5, DTI 1, and DTI 2) or placebo in the control group (DNS). Primary outcome measure was the rate of corneal epithelial wound healing (mm² per hour) over pre-set interval and time from baseline to minimum size of epithelial defect on fluorescein stained anterior segment digital camera photography. Secondary outcome measure was any adverse effect of topical insulin. Follow-up was 1 month. Thirty-two eyes of 32 patients undergoing intraoperative corneal debridement with resultant epithelial defect (8 eyes per group) were analyzed. DTI 0.5 was superior to other concentrations achieving 100% healing rate within 72 hours of treatment compared with 62.5% in DNS, 75% in DTI 1, and 62.5% in DTI 2. Statistically, DTI 0.5 achieved significant results (P = 0.036) compared with the diabetic control group (DNS) in terms of mean rate of corneal epithelial wound healing from maximum to minimum defect size. No adverse effect of topical insulin was reported. Topical insulin 0.5 units QID is most effective for healing corneal epithelial defect in diabetic patients after vitrectomy surgery compared with placebo and higher concentrations. Topical insulin is safe for human ocular usage. Copyright 2017 Asia-Pacific Academy of Ophthalmology.

  19. 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.

  20. 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.

  1. 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

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

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    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.

  3. 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

  4. 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.

  5. Statistical inference of selection and divergence from a time-dependent Poisson random field model.

    Directory of Open Access Journals (Sweden)

    Amei Amei

    Full Text Available We apply a recently developed time-dependent Poisson random field model to aligned DNA sequences from two related biological species to estimate selection coefficients and divergence time. We use Markov chain Monte Carlo methods to estimate species divergence time and selection coefficients for each locus. The model assumes that the selective effects of non-synonymous mutations are normally distributed across genetic loci but constant within loci, and synonymous mutations are selectively neutral. In contrast with previous models, we do not assume that the individual species are at population equilibrium after divergence. Using a data set of 91 genes in two Drosophila species, D. melanogaster and D. simulans, we estimate the species divergence time t(div = 2.16 N(e (or 1.68 million years, assuming the haploid effective population size N(e = 6.45 x 10(5 years and a mean selection coefficient per generation μ(γ = 1.98/N(e. Although the average selection coefficient is positive, the magnitude of the selection is quite small. Results from numerical simulations are also presented as an accuracy check for the time-dependent model.

  6. 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.

  7. Individual Mindfulness-Based Cognitive Therapy for People with Diabetes : a Pilot Randomized Controlled Trial

    NARCIS (Netherlands)

    Schroevers, Maya J.; Tovote, K. Annika; Keers, Joost C.; Links, Thera P.; Sanderman, Robbert; Fleer, Joke

    Diabetes mellitus is a highly prevalent chronic health condition that places patients at greater risk for psychological problems. Yet, there is still a lack of empirical evidence to support the use of psychological interventions in patients with diabetes. In this trial, we examined the feasibility

  8. 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

      Cardiovascular disease is the leading cause of death in patients with type 2 diabetes mellitus (T2DM). We suggested that plasma osteoprotegerin (OPG), a strong, independent predictor of cardiovascular disease, could discriminate between anti-diabetic treatments depending on their benefits...

  9. Individual Mindfulness-Based Cognitive Therapy for People with Diabetes: a Pilot Randomized Controlled Trial

    NARCIS (Netherlands)

    Schroevers, M.J.; Tovote, K. Annika; Keers, J.C.; Links, T.P.; Sanderman, Robbert; Fleer, J.

    2015-01-01

    Diabetes mellitus is a highly prevalent chronic health condition that places patients at greater risk for psychological problems. Yet, there is still a lack of empirical evidence to support the use of psychological interventions in patients with diabetes. In this trial, we examined the feasibility

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

    Science.gov (United States)

    Brown, Sharon A; García, Alexandra A; Orlander, Philip R; Hanis, Craig L

    2017-01-01

    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. 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. 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. 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.

  11. 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.

  12. A randomized trial of selenium supplementation and risk of type-2 diabetes, as assessed by plasma adiponectin.

    Directory of Open Access Journals (Sweden)

    Margaret P Rayman

    Full Text Available Evidence that selenium affects the risk of type-2 diabetes is conflicting, with observational studies and a few randomized trials showing both lower and higher risk linked to the level of selenium intake and status. We investigated the effect of selenium supplementation on the risk of type-2 diabetes in a population of relatively low selenium status as part of the UK PRECISE (PREvention of Cancer by Intervention with SElenium pilot study. Plasma adiponectin concentration, a recognised independent predictor of type-2 diabetes risk and known to be correlated with circulating selenoprotein P, was the biomarker chosen.In a randomized, double-blind, placebo-controlled trial, five hundred and one elderly volunteers were randomly assigned to a six-month intervention with 100, 200 or 300 µg selenium/d as high-selenium or placebo yeast. Adiponectin concentration was measured by ELISA at baseline and after six months of treatment in 473 participants with one or both plasma samples available.Mean (SD plasma selenium concentration was 88.5 ng/g (19.1 at baseline and increased significantly in the selenium-treatment groups. In baseline cross-sectional analyses, the fully adjusted geometric mean of plasma adiponectin was 14% lower (95% CI, 0-27% in the highest than in the lowest quartile of plasma selenium (P for linear trend = 0.04. In analyses across randomized groups, however, selenium supplementation had no effect on adiponectin levels after six months of treatment (P = 0.96.These findings are reassuring as they did not show a diabetogenic effect of a six-month supplementation with selenium in this sample of elderly individuals of relatively low selenium status.

  13. Effects of a Topical Saffron (Crocus sativus L) Gel on Erectile Dysfunction in Diabetics: A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Trial.

    Science.gov (United States)

    Mohammadzadeh-Moghadam, Hossein; Nazari, Seyed Mohammad; Shamsa, Ali; Kamalinejad, Mohammad; Esmaeeli, Habibollah; Asadpour, Amir Abbas; Khajavi, Abdoljavad

    2015-10-01

    Erectile dysfunction is a man's persistent or recurrent inability to achieve and maintain erection for a satisfactory sexual relationship. As diabetes is a major risk factor for erectile dysfunction, the prevalence of erectile dysfunction among diabetic men has been reported as 35% to 90%. This randomized, parallel-group, double-blind, placebo-controlled trial investigated the effects of a topical saffron (Crocus sativus L) gel on erectile dysfunction in diabetic men. Patients were randomly allocated to 2 equal groups (with 25 patients each). The intervention group was treated with topical saffron, and the control received a similar treatment with placebo. The 2 groups were assessed using the International Index of Erectile Function Questionnaire before the intervention and 1 month after the intervention. Compared to placebo, the prepared saffron gel could significantly improve erectile dysfunction in diabetic patients (P saffron can be considered as a treatment option for diabetic men with erectile dysfunction. © The Author(s) 2015.

  14. Compound Danshen Dripping Pill for Treating Early Diabetic Retinopathy: A Randomized, Double-Dummy, Double-Blind Study

    Directory of Open Access Journals (Sweden)

    Dan Luo

    2015-01-01

    Full Text Available This randomized, double-dummy, double-blind study was to observe the therapeutic effects of compound Danshen dripping pill (CDDP in treating early diabetic retinopathy (DR. All the 57 type 2 diabetes cases in nonproliferative diabetic retinopathy (NPDR stage were divided into two groups randomly: 28 cases treated with CDDP as the treated group and 29 cases treated with calcium dobesilate as the control group. The best corrected visual acuity (BCVA in the treated group was significantly improved after treatment when compared to that before treatment (P<0.05. Mean defect (MD of visual field, hemorrhage area of the fundus, microaneurysm number, fluorescent leakage area, and capillary nonperfusion area evaluated by visual field, fundus photography, and fundus fluorescein angiography in the treated group had the same results as BCVA. However, there was no statistical difference in each index between the two groups. No obvious adverse events with clinical significance occurred. Our present study showed that CDDP has a similar improvement and safety to calcium dobesilate for NPDR. In future DR treatments, CDDP may function as the auxiliary drug.

  15. Brief intervention to promote smoking cessation and improve glycemic control in smokers with type 2 diabetes: a randomized controlled trial

    Science.gov (United States)

    Li, William H. C.; Wang, M. P.; LAM, T. H.; Cheung, Yannes T. Y.; Cheung, Derek Y. T.; Suen, Y. N.; Ho, K. Y.; Tan, Kathryn C. B.; CHAN, Sophia S. C.

    2017-01-01

    The aim of the study was to examine the effects of a brief stage-matched smoking cessation intervention group compared with a control group (with usual care) in type 2 diabetes mellitus patients who smoked by randomized controlled trial. There were 557 patients, randomized either into the intervention group (n = 283) who received brief (20- minute) individualized face-to-face counseling by trained nurses and a diabetes mellitus-specific leaflet, or a control group (n = 274) who received standard care. Patient follow-ups were at 1 week, 1 month, 3 months, 6 months, and 12 months via telephone, and assessment of smoking status from 2012 to 2014. Patients smoked an average of 14 cigarettes per day for more than 37 years, and more than 70% were in the precontemplation stage of quitting. The primary outcome showed that both the intervention and control groups had similar 7-day point-prevalence smoking abstinence (9.2% vs. 13.9%; p = 0.08). The secondary outcome showed that HbA1c levels with 7.95% [63 mmol/mol] vs. 8.05% [64 mmol/mol], p = 0.49 at 12 months, respectively. There was no evidence for effectiveness in promoting the brief stage-matched smoking cessation or improving glycemic control in smokers with type 2 diabetes mellitus, particularly those in the pre-contemplation stage. PMID:28378764

  16. Psychosocial intervention for patients with type 2 diabetes mellitus and comorbid depression: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Xie, Jing; Deng, Wuquan

    2017-01-01

    The efficacy of psychosocial intervention has been proven in treatment of diabetic patients with depression in some studies. This meta-analysis was conducted to explore the efficacy as well as additional effects of this method during diabetic management in patients with type 2 diabetes mellitus (T2DM) and comorbid depression. Electronic databases were searched from March 2000 to March 2017 for randomized controlled trials (RCTs) studying the effects of psychosocial intervention on T2DM patients with depression. There was no language limitation. Outcome measurements were symptoms of depression and anxiety, as well as glycemic control. A random effects model was conducted. In total, 31 RCTs composed of 2,616 patients were eligible for this analysis. The psychosocial intervention was effective for depression symptoms with pooled standardized mean difference (SMD) of -1.50 (95% CI =-1.83, -1.18) and anxiety symptoms with SMD of -1.18 (95% CI =-1.50, -0.85). Meanwhile, the additional effects indicated a better improvement of glycemic control, including the fasting blood-glucose with SMD of -0.93 (95% CI =-1.15, -0.71), 2-hour postprandial plasma glucose with SMD of -0.84 (95% CI =-1.13, -0.56), and hemoglobin A1c with SMD of -0.81 (95% CI =-1.10, -0.53). These results demonstrate that the psychosocial intervention is very effective in treating T2DM patients with depression.

  17. 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.

  18. 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.

  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

    2015-01-01

    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/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 (Pmassage group showed better improvement in TUG than the control group (pmassage 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. PMID:25892354

  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. [Medical certification for diabetic drivers in the selected European Union member states].

    Science.gov (United States)

    Marcinkiewicz, Andrzej; Szosland, Dorota

    2007-01-01

    There is in Poland an urgent need to set criteria and recommendations for medical certification of individuals working or taking up the job involving public safety, in which diabetes could have a particularly important and dangerous impact. In Europe, many countries have restrictions for diabetic drivers. Diabetes is identified as one of the medical conditions that may impair driving ability and thus drivers with diabetes must meet certain medical standards. The European Union legislation states that diabetic patients taking insulin are excluded from driving trucks, heavy goods vehicles, and buses, except for small trucks in "very exceptional cases". This directive is interpreted differently throughout the European Union. Several aspects should be taken into account when evaluating the current status of the medical certification: e.g., duration of diabetes, type of diabetes treatment, diabetes stability, hypoglycemias in the past, and diabetes complications.

  2. Comparison of a mindful eating intervention to a diabetes self-management intervention among adults with type 2 diabetes: a randomized controlled trial.

    Science.gov (United States)

    Miller, Carla K; Kristeller, Jean L; Headings, Amy; Nagaraja, Haikady

    2014-04-01

    Mindful eating may be an effective intervention for increasing awareness of hunger and satiety cues, improving eating regulation and dietary patterns, reducing symptoms of depression and anxiety, and promoting weight loss. Diabetes self-management education (DSME), which addresses knowledge, self-efficacy, and outcome expectations for improving food choices, also may be an effective intervention for diabetes self-care. Yet few studies have compared the impact of mindful eating to a DSME-based treatment approach on patient outcomes. Adults 35 to 65 years old with type 2 diabetes for ≥1 year not requiring insulin therapy were recruited from the community and randomly assigned to treatment group. The impact of a group-based 3-month mindful eating intervention (MB-EAT-D; n = 27) to a group-based 3-month DSME "Smart Choices" (SC) intervention (n = 25) postintervention and at 3-month follow-up was evaluated. Repeated-measures ANOVA with contrast analysis compared change in outcomes across time. There was no significant difference between groups in weight change. Significant improvement in depressive symptoms, outcome expectations, nutrition and eating-related self-efficacy, and cognitive control and disinhibition of control regarding eating behaviors occurred for both groups (all p < .0125) at 3-month follow-up. The SC group had greater increase in nutrition knowledge and self-efficacy than the MB-EAT-D group (all p < .05) at 3-month follow-up. MB-EAT-D had significant increase in mindfulness, whereas the SC group had significant increase in fruit and vegetable consumption at study end (all p < .0125). Both SC and MB-EAT-D were effective treatments for diabetes self-management. The availability of mindful eating and DSME-based approaches offers patients greater choices in meeting their self-care needs.

  3. Pharmacological treatment of the pathogenetic defects in Type 2 Diabetes. The randomized multi-centre South Danish Diabetes study (SDDS)

    DEFF Research Database (Denmark)

    Gram, Jeppe; Henriksen, Jan Erik; Grodum, Ellen

    2011-01-01

    AbstractObjective: To determine the effect of treatment with insulin Aspart as compared to NPH insulin, together with metformin/placebo and rosiglitazone/placebo. The hypothesis was that combined correction of major pathogenetic defects in type 2 diabetes would result in optimal glycemic control....... NPH insulin once daily at bedtime, metformin twice daily vs. placebo, and rosiglitazone twice daily vs placebo. Main outcome measurement: change in HbA1c. Results: HbA1c decreased more in patients treated with insulin aspart compared to NPH (-0.41 ± 0.10%, p...

  4. Prevalence of selective immunoglobulin A deficiency in Greek children and adolescents with type 1 diabetes.

    Science.gov (United States)

    Giza, Styliani; Kotanidou, Eleni; Papadopoulou-Alataki, Efimia; Antoniou, Maria Christina; Maggana, Ioanna; Kyrgios, Ioannis; Galli-Tsinopoulou, Assimina

    2016-11-01

    The association of selective immunoglobulin A (IgA) deficiency with type 1 diabetes (T1D) remains unclear. This study was to evaluate serum IgA concentrations in Greek children and adolescents with T1D. In two hundred individuals with T1D, serum IgA concentrations were quantitatively determined using nephelometry. Immunoglobulin A deficiency was detected in 6 (3.0%) of 200 patients who were subjected to immunological evaluation. Recurrent infections were not recorded, but human papilloma virus infection was clinically suspected and confirmed by laboratory examination in a 5-year-old girl. In regard to coincidence of selective IgA deficiency with autoimmune diseases, celiac disease was detected in a girl and juvenile idiopathic arthritis in a boy. Serum IgA concentrations differed significantly when patients were grouped according to age at the beginning of the study (PIgG (PIgG (P=0.035) concentrations. There was no association or correlation of serum IgA concentrations with glycemic control. The prevalence of selective IgA deficiency in Greek children and adolescents with T1D is high (3.0%). The correlation of serum IgA concentrations with serum IgG, IgE and anti-gliadin antibody IgG concentrations needs further investigation.

  5. Effect of non-random mating on genomic and BLUP selection schemes

    Directory of Open Access Journals (Sweden)

    Nirea Kahsay G

    2012-04-01

    Full Text Available Abstract Background The risk of long-term unequal contribution of mating pairs to the gene pool is that deleterious recessive genes can be expressed. Such consequences could be alleviated by appropriately designing and optimizing breeding schemes i.e. by improving selection and mating procedures. Methods We studied the effect of mating designs, random, minimum coancestry and minimum covariance of ancestral contributions on rate of inbreeding and genetic gain for schemes with different information sources, i.e. sib test or own performance records, different genetic evaluation methods, i.e. BLUP or genomic selection, and different family structures, i.e. factorial or pair-wise. Results Results showed that substantial differences in rates of inbreeding due to mating design were present under schemes with a pair-wise family structure, for which minimum coancestry turned out to be more effective to generate lower rates of inbreeding. Specifically, substantial reductions in rates of inbreeding were observed in schemes using sib test records and BLUP evaluation. However, with a factorial family structure, differences in rates of inbreeding due mating designs were minor. Moreover, non-random mating had only a small effect in breeding schemes that used genomic evaluation, regardless of the information source. Conclusions It was concluded that minimum coancestry remains an efficient mating design when BLUP is used for genetic evaluation or when the size of the population is small, whereas the effect of non-random mating is smaller in schemes using genomic evaluation.

  6. 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 gestat......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....

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

    DEFF Research Database (Denmark)

    Lund, Søren Søgaard; Tarnow, Lise; Astrup, Anne Sofie

    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...

  8. Start improving the quality of care for people with type 2 diabetes through a general practice support program: a cluster randomized trial.

    NARCIS (Netherlands)

    Goderis, G.; Borgermans, L.D.A.; Grol, R.P.T.M.; Broeke, C. Van Den; Boland, B.; Verbeke, G.; Carbonez, A.; Mathieu, C.; Heyrman, J.

    2010-01-01

    AIMS: To evaluate the effectiveness of a two-arm quality improvement program (QIP) to support general practice with limited tradition in chronic care on type 2 diabetes patient outcomes. METHODS: During 18 months, we performed a cluster randomized trial with randomization of General Practices. The

  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. 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

  11. Impact of remote management of diabetes via computer: the 360 study--a proof-of-concept randomized trial.

    Science.gov (United States)

    Leichter, Steven B; Bowman, Kelly; Adkins, Royce A; Jelsovsky, Zhihong

    2013-05-01

    Previous studies have provided limited guidance regarding the clinical efficacy and cost-effectiveness of interventions using "telemedicine" models in the management of diabetes mellitus. We conducted a study to determine if routine clinical assessments of diabetes patients could be effectively conducted via computer and telephone interaction with patients and still provide clinical results similar to traditional office care. We enrolled 100 subjects with diabetes in this 12-month, randomized, controlled, non-inferiority study. Subjects were randomized (1:1 ratio) to a control group (CG) or study group (SG). Baseline characteristics were similar. CG subjects participated in quarterly office visits; SG subjects participated in two office visits (months 6 and 12) and two telemedicine interactions (months 3 and 9). Changes in clinical measurements (hemoglobin A1c [HbA1c], blood pressure, lipids, body mass index [BMI], and body weight) and clinician time requirements were assessed. Seventy subjects completed the study (CG, n=37; SG, n=33). No significant between-group differences in HbA1c, blood pressure, lipids, or BMI were seen at 12 months. SG subjects showed significantly greater reductions in mean (SD) body weight compared with CG subjects: -5.2 (1.6) pounds versus -0.7 (1.5) pounds, respectively (P=0.04). Clinician time requirements for SG subjects were reduced by >40%. Our study demonstrated that use of a telemedicine-based treatment protocol in diabetes patients is feasible and efficient and yields similar clinical outcomes compared with traditional, clinic-based protocols. Telemedicine applications of computer software can potentially expand access to care for patients and may reduce costs for patients, providers, and payers.

  12. 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.

  13. 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 (Mage=48.8±11.2; MBMI=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.

  14. 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

    Altered filtration of macromolecules due to decreased electrical charge of the glomerular basement membrane might be the initial step in the development of albuminuria in patients with Type 1 (insulin-dependent) diabetes mellitus. We therefore investigated the selectivity index, i.e. renal...... 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...... correlation (r = 0.53, 2 p less than 0.01) between haemoglobin A1c and selectivity index was demonstrated in these patients, indicating a change in charge-dependent renal filtration could possibly be attributed to non-enzymatic glycation of components in the glomerular basement membrane and tubuli. Diabetic...

  15. Can a low-glycemic index diet reduce the need for insulin in gestational diabetes mellitus? A randomized trial.

    Science.gov (United States)

    Moses, Robert G; Barker, Megan; Winter, Meagan; Petocz, Peter; Brand-Miller, Jennie C

    2009-06-01

    A low-glycemic index diet is effective as a treatment for individuals with diabetes and has been shown to improve pregnancy outcomes when used from the first trimester. A low-glycemic index diet is commonly advised as treatment for women with gestational diabetes mellitus (GDM). However, the efficacy of this advice and associated pregnancy outcomes have not been systematically examined. The purpose of this study was to determine whether prescribing a low-glycemic index diet for women with GDM could reduce the number of women requiring insulin without compromise of pregnancy outcomes. All women with GDM seen over a 12-month period were considered for inclusion in the study. Women (n = 63) were randomly assigned to receive either a low-glycemic index diet or a conventional high-fiber (and higher glycemic index) diet. Of the 31 women randomly assigned to a low-glycemic index diet, 9 (29%) required insulin. Of the women randomly assigned to a higher-glycemic index diet, a significantly higher proportion, 19 of 32 (59%), met the criteria to commence insulin treatment (P = 0.023). However, 9 of these 19 women were able to avoid insulin use by changing to a low-glycemic index diet. Key obstetric and fetal outcomes were not significantly different. Using a low-glycemic index diet for women with GDM effectively halved the number needing to use insulin, with no compromise of obstetric or fetal outcomes.

  16. Influence of ascorbic acid supplementation on type 2 diabetes mellitus in observational and randomized controlled trials; a systematic review with meta-analysis.

    Science.gov (United States)

    Tabatabaei-Malazy, Ozra; Nikfar, Shekoufeh; Larijani, Bagher; Abdollahi, Mohammad

    2014-01-01

    There are controversial data regarding the beneficial effects of ascorbic acid (AA) supplementation in type 2 diabetes mellitus (T2DM). In this systematic review, we aimed to criticize the current relevant data from both observational and randomized controlled trials (RCTs). All observational and RCTs conducted to assess anti-hyperglycemic effects of AA in diabetics, published before January 2013, were included. To obtain all related studies Google Scholar, PubMed, Scopus, IranMedex, and Magiran web databases were searched. Exclusion criteria were animal studies, and studies conducted in Type 1 DM, children or pregnant women. Main outcome measures were fasting blood sugar (FBS), and glycated hemoglobin (HbA1c). According to degree of heterogeneity, fixed or random effect models were employed. Meta-analyses were done using Stats Direct software, version 3.0.97. The quality of included articles and publication bias were also assessed. We selected 38 articles; 26 observational studies and 12 RCTs. Due to severe methodological heterogeneity in all observational studies and some of RCTs, we could pool data from only 5 RCTs in a meta-analysis. Single intake of AA versus placebo showed a significant effect on FBS; with the standardized mean difference (SMD): -20.59, 95% confidence intervals (95% CI): -40.77 to -0.4 (p= 0.04), but non-significant effect on HbA1c; SMD: -0.46, 95% CI: -1.75 to 0.84 (p= 0.4). Effect of other antioxidants with/without AA supplementation on FBSwere nonsignificant; SMD: -4.26 (p= 0.8), and SMD: -12.04 (p= 0.3), respectively. Also, their effect on HbA1c was non-significant; SMD: 0.53 (p= 0.11), and SMD: 0.28 (p= 0.34), respectively. Our study supports the positive effect of AA in reduction of FBS in diabetics, however, due to insufficient evidence ragarding long term safety of AA supplementation and limited number of RCTs, the long term use of this vitamin for its anti-diabetic properties cannot be strongly recommended.

  17. 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,...

  18. Emulsion PCR: a high efficient way of PCR amplification of random DNA libraries in aptamer selection.

    Directory of Open Access Journals (Sweden)

    Keke Shao

    Full Text Available Aptamers are short RNA or DNA oligonucleotides which can bind with different targets. Typically, they are selected from a large number of random DNA sequence libraries. The main strategy to obtain aptamers is systematic evolution of ligands by exponential enrichment (SELEX. Low efficiency is one of the limitations for conventional PCR amplification of random DNA sequence library in aptamer selection because of relative low products and high by-products formation efficiency. Here, we developed emulsion PCR for aptamer selection. With this method, the by-products formation decreased tremendously to an undetectable level, while the products formation increased significantly. Our results indicated that by-products in conventional PCR amplification were from primer-product and product-product hybridization. In emulsion PCR, we can completely avoid the product-product hybridization and avoid the most of primer-product hybridization if the conditions were optimized. In addition, it also showed that the molecule ratio of template to compartment was crucial to by-product formation efficiency in emulsion PCR amplification. Furthermore, the concentration of the Taq DNA polymerase in the emulsion PCR mixture had a significant impact on product formation efficiency. So, the results of our study indicated that emulsion PCR could improve the efficiency of SELEX.

  19. Community Health Workers Supporting Clinical Pharmacists in Diabetes Management: A Randomized Controlled Trial.

    Science.gov (United States)

    Sharp, Lisa K; Tilton, Jessica J; Touchette, Daniel R; Xia, Yinglin; Mihailescu, Daniel; Berbaum, Michael L; Gerber, Ben S

    2018-01-01

    To evaluate the effectiveness of clinical pharmacists and community health workers (CHWs) in improving glycemic control within a low-income ethnic minority population. In a two-arm 2-year crossover trial, 179 African-American and 65 Hispanic adult patients with uncontrolled diabetes mellitus (hemoglobin A 1c [HbA1C] of 8% or higher) were randomized to CHW support either during the first or second year of the study. All participants received clinical pharmacist support for both years of the study. The primary outcome was change in HbA1C over 1 and 2 years. Similar HbA1C declines were noted after receiving the 1 year of CHW support: -0.45% (95% confidence interval [CI] -0.96 to 0.05) with CHW versus -0.42% (95% CI -0.93 to 0.08) without CHW support. In addition, no differences were noted in change on secondary outcome measures including body mass index, systolic blood pressure, high-density lipoprotein and low-density lipoprotein cholesterol, quality of life, and perceived social support. A difference in diastolic blood pressure change was noted: 0.80 mm Hg (95% CI -1.92 to 3.53) with CHW versus -1.85 mm Hg (95% CI -4.74 to 1.03) without CHW support (p=0.0078). Patients receiving CHW support had more lipid-lowering medication intensifications (0.39 [95% CI 0.27-0.52]) compared with those without CHW support (0.26 [95% CI 0.14-0.38], p<0.0001). However, no significant differences in intensification of antihyperglycemic and antihypertensive medications were observed between patients receiving CHW support and those without CHW support. Patients with low health literacy completed significantly more encounters with the pharmacist and CHW than those with high health literacy, although outcomes were comparable. No significant differences were noted between a clinical pharmacist-CHW team and clinical pharmacist alone in improving glycemic control within a low-income ethnic minority population. © 2017 Pharmacotherapy Publications, Inc.

  20. Role of antioxidants in gestational diabetes mellitus and relation to fetal outcome: a randomized controlled trial.

    Science.gov (United States)

    Maged, Ahmed M; Torky, Haitham; Fouad, Mona A; GadAllah, Sherine H; Waked, Nevien M; Gayed, Ahmed S; Salem, Ashraf K

    2016-12-01

    To examine the effect of antioxidant administration on the oxidative parameters in both blood and placental tissue and its relation to fetal outcome in women with GDM. Two-hundred pregnant women with gestational diabetes mellitus (GDM) were randomized into 2 groups, Group1 received 1 gram L-ascorbic acid per day and Group2 received placebo. The use of antioxidants significantly lower the needed insulin dose for blood sugar control (25.6 ± 20.3 versus 40.5 ± 23.7, respectively). In placental tissue homogenates, glutathione (GSH) was 49.6 ± 5.9 versus 62.34 ± 4.99, malondialdahyde (MDA) was 165.7 ± 9.2 versus 264.15 ± 12, superoxide dismutase (SOD) was 0.3 ± 0.3 versus 0.054 ± 0.16 while catalase (CAT) was 14.06 ± 2.4 versus 15.52 ± 3.97 and glutathione peroxidase (GPx) was 14 ± 4.1 versus 26.3 ± 4.26 in antioxidant group compared to the control group (p antioxidant group compared to control group (p antioxidants and control groups (4 ± 0.7 versus 6.6 7 ±0.66 and1 8 8 ± 15.3 versus 98.5 ± 11.05, respectively) (p antioxidant group (56.7 ± 10.9 versus 39.7 ± 11.1 and 58.5 ± 10.8 versus 41.7 ± 13.1, respectively) (p antioxidant group (5 versus 11) (p antioxidants markedly reverses the oxidative stresses in women with GDM with marked improvement on neonatal outcome.

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

    National Research Council Canada - National Science Library

    Janka-Zires, Marcela; Almeda-Valdes, Paloma; Uribe-Wiechers, Ana Cecilia; Juárez-Comboni, Sonia Citlali; López-Gutiérrez, Joel; Escobar-Jiménez, Jarod Jazek; Gómez-Pérez, Francisco J

    2016-01-01

    .... 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...

  2. Randomized trial of metformin vs insulin in the management of gestational diabetes

    National Research Council Canada - National Science Library

    Spaulonci, Cristiane Pavão; Bernardes, Lisandra Stein; Trindade, Thatianne Coutheux; Zugaib, Marcelo; Francisco, Rossana Pulcineli Vieira

    2013-01-01

    To evaluate glycemic control in women receiving metformin or insulin for gestational diabetes, and to identify factors predicting the need for supplemental insulin in women initially treated with metformin...

  3. Community health workers improve diabetes care in remote Australian Indigenous communities: results of a pragmatic cluster randomized controlled trial.

    Science.gov (United States)

    McDermott, Robyn A; Schmidt, Barbara; Preece, Cilla; Owens, Vickie; Taylor, Sean; Li, Ming; Esterman, Adrian

    2015-02-19

    Health outcomes for Indigenous Australians with diabetes in remote areas remain poor, including high rates of avoidable complications which could be reduced with better primary level care. We aimed to evaluate the effectiveness of a community-based health-worker led case management approach to the care of Indigenous adults with poorly controlled type 2 diabetes in primary care services in remote northern Australia. Two hundred and thirteen adults with poorly controlled diabetes (HbA1c > 8.5%) and significant comorbidities in 12 remote communities were randomly assigned by service cluster to receive chronic care co-ordination from a community-based health worker supported by a clinical outreach team, or to a waitlist control group which received usual care. At baseline, mean age of participants was 47.9 years, 62.4% were female, half were Aboriginal and half identified as Torres Strait Islander, 67% had less than 12 years of education, 39% were smokers, median income was $18,200 and 47% were unemployed. Mean HbA1c was 10.7% (93 mmol/mol) and BMI 32.5. At follow-up after 18 months, HbA1c reduction was significantly greater in the intervention group (-1.0% vs -0.2%, SE (diff) = 0.2, p = 0.02). There were no significant differences between the groups for blood pressure, lipid profile, BMI or renal function. Intervention group participants were more likely to receive nutrition and dental services according to scheduled care plans. Smoking rates were unchanged. A culturally safe, community level health-worker led model of diabetes care for high risk patients can be effective in improving diabetes control in remote Indigenous Australian communities where there is poor access to mainstream services. This approach can be effective in other remote settings, but requires longer term evaluation to capture accrued benefits. ANZCTR 12610000812099, Registered 29 September 2010.

  4. Improvement of glucose and lipid profile status with Aloe vera in pre-diabetic subjects: a randomized controlled-trial.

    Science.gov (United States)

    Alinejad-Mofrad, Samaneh; Foadoddini, Mohsen; Saadatjoo, Seyed Alireza; Shayesteh, Majid

    2015-01-01

    Pre-diabetes is a disturbing trend in the population, who are at risk of developing type-two diabetes. The aim of this study was to determine the effects use of Aloe vera in different doses on glucose and lipid profile in pre-diabetic subjects. This study was a double blind randomized controlled trial (72 subjects) with pre-diabetes symptoms in 3 groups consumed capsules twice a day: Aloe vera 300 mg (AL300), 500 mg (AL500) and placebo (PL). Fasting blood glucose (FBS), HbA1C and lipid profile were evaluated in baseline, 4 or 8 weeks. On-way ANOVA, Friedman, Wilcoxon, Kruskal-Wallis , Mann-Whitney and Chi-square tests were used for within or between groups statistical analysis. FBS level in group AL300, showed significantly decreased in fourth week after the intervention, compared to PL in the same time (p = 0.001). Also, HbA1C level in this group at the eighth week after the intervention (p = 0.042), had a significant decrease. The levels of Total cholesterol and LDL-C, only in the group AL500 (p < 0.001 and p = 0.01), was significantly reduced, along with HDL-C level improvement just after eight weeks (p = 0.004). Triglyceride level showed a significant decrease (p < 0.045) just after four weeks use of AL500. The Use of Aloe vera extract in pre-diabetic patients, could revert impaired blood glucose within four weeks, but after eight weeks could alleviate their abnormal lipid profile.

  5. Appropriate Insulin Level in Selecting Fortified Diet-Fed, Streptozotocin-Treated Rat Model of Type 2 Diabetes for Anti-Diabetic Studies

    OpenAIRE

    Stanley Irobekhian Reuben Okoduwa; Umar, Ismaila A.; James, Dorcas B; Hajiya M. Inuwa

    2017-01-01

    Background Pathophysiological investigation of disease in a suitable animal model is a classical approach towards development of a credible therapeutic strategy. This study examined appropriate insulin level in selecting animal model for type 2 diabetes (T2D) studies. Method Albino Wistar rats (150-200g) were divided into two groups fed with commercially available normal-diet-feed (NDF) and water or fortified diet feed (FDF) (10g NDF per gram of margarine) with 20% fructose solution as drinki...

  6. Roux-en-Y gastric bypass vs intensive medical management for the control of type 2 diabetes, hypertension, and hyperlipidemia: the Diabetes Surgery Study randomized clinical trial.

    Science.gov (United States)

    Ikramuddin, Sayeed; Korner, Judith; Lee, Wei-Jei; Connett, John E; Inabnet, William B; Billington, Charles J; Thomas, Avis J; Leslie, Daniel B; Chong, Keong; Jeffery, Robert W; Ahmed, Leaque; Vella, Adrian; Chuang, Lee-Ming; Bessler, Marc; Sarr, Michael G; Swain, James M; Laqua, Patricia; Jensen, Michael D; Bantle, John P

    2013-06-05

    Controlling glycemia, blood pressure, and cholesterol is important for patients with diabetes. How best to achieve this goal is unknown. To compare Roux-en-Y gastric bypass with lifestyle and intensive medical management to achieve control of comorbid risk factors. A 12-month, 2-group unblinded randomized trial at 4 teaching hospitals in the United States and Taiwan involving 120 participants who had a hemoglobin A1c (HbA1c) level of 8.0% or higher, body mass index (BMI) between 30.0 and 39.9, C peptide level of more than 1.0 ng/mL, and type 2 diabetes for at least 6 months. The study began in April 2008. Lifestyle-intensive medical management intervention and Roux-en-Y gastric bypass surgery. Medications for hyperglycemia, hypertension, and dyslipidemia were prescribed according to protocol and surgical techniques that were standardized. Composite goal of HbA1c less than 7.0%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg. All 120 patients received the intensive lifestyle-medical management protocol and 60 were randomly assigned to undergo Roux-en-Y gastric bypass. After 12-months, 28 participants (49%; 95% CI, 36%-63%) in the gastric bypass group and 11 (19%; 95% CI, 10%-32%) in the lifestyle-medical management group achieved the primary end points (odds ratio [OR], 4.8; 95% CI, 1.9-11.7). Participants in the gastric bypass group required 3.0 fewer medications (mean, 1.7 vs 4.8; 95% CI for the difference, 2.3-3.6) and lost 26.1% vs 7.9% of their initial body weigh compared with the lifestyle-medical management group (difference, 17.5%; 95% CI, 14.2%-20.7%). Regression analyses indicated that achieving the composite end point was primarily attributable to weight loss. There were 22 serious adverse events in the gastric bypass group, including 1 cardiovascular event, and 15 in the lifestyle-medical management group. There were 4 perioperative complications and 6 late postoperative complications. The gastric

  7. The Vermont Diabetes Information System (VDIS): Study Design and Subject Recruitment for a Cluster Randomized Trial of a Decision Support System in a Regional Sample of Primary Care Practices

    Science.gov (United States)

    MacLean, Charles D.; Littenberg, Benjamin; Gagnon, Michael; Reardon, Mimi; Turner, Paul D.; Jordan, Cy

    2008-01-01

    Background Despite evidence that optimal care for diabetes can result in reduced complications and improved economic outcomes, such care is often not achieved. The Vermont Diabetes Information System (VDIS) is a registry-based decision support and reminder system based on the Chronic Care Model and targeted to primary care physicians and their patients with diabetes. Purpose To develop and evaluate a regional decision support system for patients with diabetes. Methods Randomized trial of an information system with clustering at the practice level. Ten percent random sub sample of patients selected for a home interview. Subject and setting includes 10 hospitals, 121 primary care providers, and 7,348 patients in 55 Vermont and New York primary care practices. Results We report on the study design and baseline characteristics of the population. Patients have a mean age of 63 years and a mean glycosolated hemoglobin A1C of 7.1%. Sixty percent of the population has excellent glycemic control (A1C<7%); 45% have excellent lipid control (serum LDL-cholesterol < 100mg/dl and serum triglycerides < 400mg/dl). Twenty-five percent have excellent blood pressure control (<130/80 mm Hg). These results compare favorably to recent national reports. However, only 8% are in optimal control for all three of hyperglycemia, lipids and blood pressure. Conclusions Our experience to date indicates that a low cost decision support and information system based on the chronic care model is feasible in primary care practices that lack sophisticated electronic information systems. VDIS is well accepted by patients, providers, and laboratory staff. If proven beneficial in a rigorous, randomized, controlled evaluation, the intervention could be widely disseminated to practices across America and the world with a substantial impact on the outcomes and costs of diabetes. It could also be adapted to other chronic conditions. We anticipate the results of the study will be available in 2006. PMID

  8. Telephone-Delivered Behavioral Skills Intervention for African American Adults with Type 2 Diabetes: A Randomized Controlled Trial.

    Science.gov (United States)

    Egede, Leonard E; Williams, Joni S; Voronca, Delia C; Gebregziabher, Mulugeta; Lynch, Cheryl P

    2017-07-01

    Diabetes disproportionately affects African Americans and is associated with poorer outcomes. Self-management is important for glycemic control; however, evidence in African Americans is limited. To assess the efficacy of a combined telephone-delivered education and behavioral skills intervention (TBSI) in reducing hemoglobin A1c (HbA1c) levels in African Americans with type 2 diabetes, using a factorial design. This is a four-year randomized clinical trial, using a 2 x 2 factorial design.: Participants: African American adults ≥18 years) with poorly controlled type 2 diabetes (HbA1c ≥9%) were randomly assigned to one of four groups: 1) knowledge only, 2) skills only, 3) combined knowledge and skills (TBSI), or 4) control group. All participants received 12 telephone-delivered 30-min intervention sessions specific to their assigned group. Participants were assessed at baseline and 3, 6, and 12 months. The primary outcome was HbA1c at 12 months post-randomization in the intent-to-treat (ITT) population. Two hundred fifty-five participants were randomly assigned to the four groups. Based on the ITT population after multiple imputation, the analysis of covariance with baseline HbA1c as the covariate showed that HbA1c at 12 months for the intervention groups did not differ significantly from that of the control group (knowledge: 0.49, p = 0.123; skills: 0.23, p = 0.456; combined: 0.48, p = 0.105). Absolute change from baseline at 12 months for all treatment arms was 0.6. Longitudinal mixed effects analysis showed that, on average, there was a significant decline in HbA1c over time for all treatment groups (-0.07, p different from that of the control group (knowledge: 0.06, p = 0.052; skills: 0.02, p = 0.448; combined: 0.05, p = 0.062). Results from per-protocol populations were similar. For African Americans with poorly controlled type 2 diabetes, combined education and skills training did not achieve greater reductions in glycemic

  9. Novel Zn2+-chelating peptides selected from a fimbria-displayed random peptide library

    DEFF Research Database (Denmark)

    Kjærgaard, Kristian; Schembri, Mark; Klemm, Per

    2001-01-01

    H adhesin. FimH is a component of the fimbrial organelle that can accommodate and display a diverse range of peptide sequences on the E. coli cell surface. In this study we have constructed a random peptide library in FimH. The library, consisting of similar to 40 million individual clones, was screened...... for peptide sequences that conferred on recombinant cells the ability to bind Zn2+. By serial selection, sequences that exhibited various degrees of binding affinity and specificity toward Zn2+ were enriched. None of the isolated sequences showed similarity to known Zn2+-binding proteins, indicating...

  10. 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

  11. 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.

  12. 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

  13. PReFerSim: fast simulation of demography and selection under the Poisson Random Field model.

    Science.gov (United States)

    Ortega-Del Vecchyo, Diego; Marsden, Clare D; Lohmueller, Kirk E

    2016-11-15

    The Poisson Random Field (PRF) model has become an important tool in population genetics to study weakly deleterious genetic variation under complicated demographic scenarios. Currently, there are no freely available software applications that allow simulation of genetic variation data under this model. Here we present PReFerSim, an ANSI C program that performs forward simulations under the PRF model. PReFerSim models changes in population size, arbitrary amounts of inbreeding, dominance and distributions of selective effects. Users can track summaries of genetic variation over time and output trajectories of selected alleles. PReFerSim is freely available at: https://github.com/LohmuellerLab/PReFerSim CONTACT: klohmueller@ucla.eduSupplementary information: Supplementary data are available at Bioinformatics online. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  14. Gender differences in the selection of an action plan for patients with type 2 diabetes mellitus.

    Science.gov (United States)

    Nuovo, Jim; Balsbaugh, Thomas; Levich, Bridget

    2009-09-01

    : To assess differences between women and men in developing an action plan for the management of their type 2 diabetes mellitus (DM). : We chose a convenience sample of the first 153 patients who participated in a four-part educational class focused on the management of type 2 DM. The classes are run by a certified diabetes educator and have a specific format. We use a decision wheel to assist in the development of a patient-generated action plan to address a specific health behavior change. For each patient we documented age, gender, and glycosylated hemoglobin (HbA1c) level. : There was a difference in choice of action plan based on gender (p = 0.014). For women the distribution of action plans was exercise 38%, nutrition 22%, medication 20%, no action plan 13%, and monitoring 7%. For men the distribution of action plans was exercise 26%, nutrition 26%, medication 6%, no action plan 26%, and monitoring 16%. Age did not affect the choice of an action plan (p = 0.964); however, patients with a lower HbA1c level chose exercise more frequently (p < 0.002). : The results of this study suggest there may be gender-based differences affecting the selection of an action plan for patients with type 2 DM. Further research is needed to determine the relative weight of other important factors on the decision for a particular action plan; e.g. sociodemographic factors, stage of readiness to change, and comorbid conditions.

  15. 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

  16. Ethnopharmacological versus random plant selection methods for the evaluation of the antimycobacterial activity

    Directory of Open Access Journals (Sweden)

    Danilo R. Oliveira

    2011-05-01

    Full Text Available The municipality of Oriximiná, Brazil, has 33 quilombola communities in remote areas, endowed with wide experience in the use of medicinal plants. An ethnobotanical survey was carried out in five of these communities. A free-listing method directed for the survey of species locally indicated against Tuberculosis and lung problems was also applied. Data were analyzed by quantitative techniques: saliency index and major use agreement. Thirty four informants related 254 ethnospecies. Among these, 43 were surveyed for possible antimycobacterial activity. As a result of those informations, ten species obtained from the ethnodirected approach (ETHNO and eighteen species obtained from the random approach (RANDOM were assayed against Mycobacterium tuberculosis by the microdilution method, using resazurin as an indicator of cell viability. The best results for antimycobacterial activity were obtained of some plants selected by the ethnopharmacological approach (50% ETHNO x 16,7% RANDOM. These results can be even more significant if we consider that the therapeutic success obtained among the quilombola practice is complex, being the use of some plants acting as fortifying agents, depurative, vomitory, purgative and bitter remedy, especially to infectious diseases, of great importance to the communities in the curing or recovering of health as a whole.

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

    Science.gov (United States)

    Kapwata, Thandi; Gebreslasie, Michael T

    2016-11-16

    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.

  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. Selecting the appropriate pacing mode for patients with sick sinus syndrome: evidence from randomized clinical trials.

    Science.gov (United States)

    Albertsen, A E; Nielsen, J C

    2003-12-01

    Several observational studies have indicated that selection of pacing mode may be important for the clinical outcome in patients with symptomatic bradycardia, affecting the development of atrial fibrillation (AF), thromboembolism, congestive heart failure, mortality and quality of life. In this paper we present and discuss the most recent data from six randomized trials on mode selection in patients with sick sinus syndrome (SSS). In pacing mode selection, VVI(R) pacing is the least attractive solution, increasing the incidence of AF and-as compared with AAI(R) pacing, also the incidence of heart failure, thromboembolism and death. VVI(R) pacing should not be used as the primary pacing mode in patients with SSS, who haven't chronic AF. AAIR pacing is superior to DDDR pacing, reducing AF and preserving left ventricular function. Single site right ventricular pacing-VVI(R) or DDD(R) mode-causes an abnormal ventricular activation and contraction (called ventricular desynchronization), which results in a reduced left ventricular function. Despite the risk of AV block, we consider AAIR pacing to be the optimal pacing mode for isolated SSS today and an algorithm to select patients for AAIR pacing is suggested. Trials on new pacemaker algorithms minimizing right ventricular pacing as well as trials testing alternative pacing sites and multisite pacing to reduce ventricular desynchronization can be expected within the next years.

  20. 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

  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. 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.

  3. Feature selection for outcome prediction in oesophageal cancer using genetic algorithm and random forest classifier.

    Science.gov (United States)

    Paul, Desbordes; Su, Ruan; Romain, Modzelewski; Sébastien, Vauclin; Pierre, Vera; Isabelle, Gardin

    2017-09-01

    The outcome prediction of patients can greatly help to personalize cancer treatment. A large amount of quantitative features (clinical exams, imaging, …) are potentially useful to assess the patient outcome. The challenge is to choose the most predictive subset of features. In this paper, we propose a new feature selection strategy called GARF (genetic algorithm based on random forest) extracted from positron emission tomography (PET) images and clinical data. The most relevant features, predictive of the therapeutic response or which are prognoses of the patient survival 3 years after the end of treatment, were selected using GARF on a cohort of 65 patients with a local advanced oesophageal cancer eligible for chemo-radiation therapy. The most relevant predictive results were obtained with a subset of 9 features leading to a random forest misclassification rate of 18±4% and an areas under the of receiver operating characteristic (ROC) curves (AUC) of 0.823±0.032. The most relevant prognostic results were obtained with 8 features leading to an error rate of 20±7% and an AUC of 0.750±0.108. Both predictive and prognostic results show better performances using GARF than using 4 other studied methods. Copyright © 2016 Elsevier Ltd. All rights reserved.

  4. 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.

  5. 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.

  6. A Pilot Randomized, Controlled Study of Nanocrystalline Silver, Manuka Honey, and Conventional Dressing in Healing Diabetic Foot Ulcer

    Directory of Open Access Journals (Sweden)

    Ka-Kit Tsang

    2017-01-01

    Full Text Available Nanocrystalline silver (nAg and Manuka honey (MH dressing have increasing popularity for treating diabetic foot ulcer (DFU. This study was an open-label randomized controlled trial with three parallel groups’ design in examining the preliminary effectiveness of nAg against MH and conventional dressing in healing DFU in terms of ulcer healing, ulcer infection, and inflammation. 31 participants (11 in the nAg group, 10 in the MH group, and 10 in the convention group diagnosed with type 2 diabetes were enrolled. Wound cleaning, debridement, and topical dressing application were performed according to the group allocation in each visit at weeks 1, 2, 3, 4, 6, 8, 10, and 12. The results found that the proportions of complete ulcer healing were 81.8%, 50%, and 40% in the nAg, MH, and conventional groups, respectively. The ulcer size reduction rate was potentially higher in the nAg group (97.45% than the MH group (86.21% and the conventional group (75.17%. In bacteriology, nAg showed a greater rate of microorganism reduction although it was not significant. To conclude, nAg alginate was potentially superior to MH and conventional dressing in healing diabetic foot ulcer in terms of ulcer size reduction rate.

  7. Addition of sulfonylurea to insulin treatment in poorly controlled type II diabetes. A double-blind, randomized clinical trial.

    Science.gov (United States)

    Schade, D S; Mitchell, W J; Griego, G

    1987-05-08

    This study examined the potential beneficial effects of the addition of a second-generation sulfonylurea to insulin therapy for poorly controlled type II diabetes. A randomized, double-blind, crossover experimental design was utilized in 16 type II diabetic patients for a period of eight months. Treatment with glyburide, 20 mg/d (plus insulin), compared with placebo (plus insulin) resulted in a significant reduction in mean basal glucose (232 +/- 12 vs 262 +/- 11 mg/dL [12.8 vs 14.4 mmol/L]) and hemoglobin A1C (10.2% +/- 0.5% vs 10.9% +/- 03%) concentrations. Concomitant with this change, basal C-peptide and free insulin values increased with glyburide therapy, but this pharmacological agent did not alter the ability of the patient's erythrocytes to bind insulin. We conclude that in type II diabetic subjects receiving more than 28 units of insulin per day, the addition of glyburide results in a marginal, but statistically significant improvement in basal glucose concentration, but not in glucose tolerance as assessed by integrated glucose concentration. Whether this small improvement in glycemia is worth the additional cost of sulfonylureas or the risk of drug side effects is not known.

  8. Soy-protein consumption and kidney-related biomarkers among type 2 diabetics: a crossover, randomized clinical trial.

    Science.gov (United States)

    Azadbakht, Leila; Esmaillzadeh, Ahmad

    2009-11-01

    Renal disease is a major problem among diabetic patients. The type of protein consumed may affect alterations in kidney-related biomarkers in these patients. This study sought to assess the effects of soy-protein consumption on renal-related markers among type 2 diabetic patients with nephropathy. A crossover, randomized clinical trial was conducted among 14 patients (10 men and 4 women). One diet contained 0.8 g/kg protein (70% animal and 30% vegetable proteins), and a similar diet contained the same amount of protein with 35% animal protein, 35% soy protein, and 30% other vegetable proteins. These two diets were prescribed in each phase of the trial for 7 weeks. There was a 4-week washout between the two phases of the study. Consumption of soy protein reduced urinary urea nitrogen (-0.9 +/- 0.8 vs. 0.2 +/- 0.6 mg/dL, respectively, SD; P anima-protein consumption. Soy-protein consumption reduces proteinuria in type 2 diabetes with nephropathy.

  9. Outcome of sirolimus-eluting versus zotarolimus-eluting coronary stent implantation in patients with and without diabetes mellitus (a SORT OUT III Substudy)

    DEFF Research Database (Denmark)

    Maeng, Michael; Jensen, Lisette O; Hansen, Hans-Henrik Tilsted

    2011-01-01

    -generation Cypher Select+ sirolimus-eluting stent (SES). We randomized 2,332 patients to treatment with ZESs (n = 1,162, n = 169 diabetics) or SESs (n = 1,170, n = 168 diabetics) and followed them for 18 months. Randomization was stratified by presence/absence of diabetes. The primary end point was major adverse...

  10. 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

  11. An evaluation of the DEXLIFE 'self-selected' lifestyle intervention aimed at improving insulin sensitivity in people at risk of developing type 2 diabetes

    DEFF Research Database (Denmark)

    O'Donoghue, Grainne M; Kennedy, Aileen; Andersen, Gregers Stig

    2015-01-01

    for success outside the controlled research environment, while at the same time promoting positive responses relating to adherence, competence and self-efficacy, essential attributes for long-term success. Through a two-group parallel-randomised controlled trial, this study aims to assess the clinical......). Randomization is stratified by age, sex and body mass index. The control arm receives general information on lifestyle and diabetes risk. The intervention group participate in a 12 week 'self-selected' supervised exercise training programme accompanied with dietary advice to improve food choices. Participants....../day is advised. Common to all food plans is 15 g/1000 kcal. Insulin sensitivity is the primary outcome measure. Secondary outcome measures include glucose function, fitness, body composition, anthropometrics, heart rate variability, lipid profiles...

  12. Does the "stages of change" construct predict cross-sectional and temporal variations in dietary behavior and selected indicators of diabetes risk among Norwegian-Pakistani women?

    Science.gov (United States)

    Råberg Kjøllesdal, M K; Holmboe-Ottesen, G; Wandel, M

    2013-02-01

    The aim of this study is to explore the association between motivational "stage" and intake of selected foods, and risk factors for diabetes; and what degree of attendance in an intervention that was necessary to show movements across the motivational "stages of change". Participants (n = 198, aged 25-62 years) were randomly assigned into intervention and control. Interviews with a structured questionnaire, anthropometric and biochemical assessments. Intake of several food items and blood parameters at baseline differed according to motivational stage. Those who participated in at least four group sessions in the intervention were more likely to show a positive move through the "stages of change". Those in low motivational stages at baseline had benefitted just as much from the intervention as those in higher stages. Intake of several food items corresponded to the motivational "stage". High attendance in the intervention was necessary for a positive move through "stages of change".

  13. Topical administration of a connexin43-based peptide augments healing of chronic neuropathic diabetic foot ulcers: A multicenter, randomized trial.

    Science.gov (United States)

    Grek, Christina L; Prasad, G M; Viswanathan, Vijay; Armstrong, David G; Gourdie, Robert G; Ghatnekar, Gautam S

    2015-01-01

    Nonhealing neuropathic foot ulcers remain a significant problem in individuals with diabetes. The gap-junctional protein connexin43 (Cx43) has roles in dermal wound healing and targeting Cx43 signalling accelerates wound reepithelialization. In a prospective, randomized, multicenter clinical trial we evaluated the efficacy and safety of a peptide mimetic of the C-terminus of Cx43, alpha connexin carboxy-terminal (ACT1), in accelerating the healing of chronic diabetic foot ulcers (DFUs) when incorporated into standard of care (SOC) protocols. Adults with DFUs of at least four weeks duration were randomized to receive SOC with or without topical application of ACT1. Primary outcome was mean percent ulcer reepithelialization and safety variables included incidence of treatment related adverse events (AEs) and detection of ACT1 immunogenicity. ACT1 treatment was associated with a significantly greater reduction in mean percent ulcer area from baseline to 12 weeks (72.1% vs. 57.1%; p = 0.03). Analysis of incidence and median time-to-complete-ulcer closure revealed that ACT1 treatment was associated with a greater percentage of participants that reached 100% ulcer reepitheliazation and a reduced median time-to-complete-ulcer closure. No AEs reported were treatment related, and ACT1 was not immunogenic. Treatment protocols that incorporate ACT1 may present a therapeutic strategy that safely augments the reepithelialization of chronic DFUs. © 2015 Authors. Wound Repair and Regeneration published by Wiley Periodicals, Inc. on behalf of The Wound Healing Society.

  14. A Randomized Controlled Trial Translating the Diabetes Prevention Program to a University Worksite, Ohio, 2012–2014

    Science.gov (United States)

    Weinhold, Kellie R.; Marrero, David G.; Nagaraja, Haikady N.; Focht, Brian C.; Gascon, Gregg M.

    2015-01-01

    Introduction Working adults spend much time at the workplace, an ideal setting for wellness programs targeting weight loss and disease prevention. Few randomized trials have evaluated the efficacy of worksite diabetes prevention programs.This study evaluated the efficacy of a worksite lifestyle intervention on metabolic and behavioral risk factors compared with usual care. Methods A pretest–posttest control group design with 3-month follow-up was used. Participants with prediabetes were recruited from a university worksite and randomized to receive a 16-week lifestyle intervention (n = 35) or usual care (n = 34). Participants were evaluated at baseline, postintervention, and 3-month follow-up. Dietary intake was measured by a food frequency questionnaire and level of physical activity by accelerometers. Repeated measures analysis of variance compared the change in outcomes between and within groups. Results Mean (standard error [SE]) weight loss was greater in the intervention (−5.5% [0.6%]) than in the control (−0.4% [0.5%]) group (P worksite intervention improved metabolic and behavioral risk factors among employees with prediabetes. The long-term impact on diabetes prevention and program sustainability warrant further investigation. PMID:26605710

  15. A Randomized Controlled Trial Translating the Diabetes Prevention Program to a University Worksite, Ohio, 2012-2014.

    Science.gov (United States)

    Weinhold, Kellie R; Miller, Carla K; Marrero, David G; Nagaraja, Haikady N; Focht, Brian C; Gascon, Gregg M

    2015-11-25

    Working adults spend much time at the workplace, an ideal setting for wellness programs targeting weight loss and disease prevention. Few randomized trials have evaluated the efficacy of worksite diabetes prevention programs. This study evaluated the efficacy of a worksite lifestyle intervention on metabolic and behavioral risk factors compared with usual care. A pretest-posttest control group design with 3-month follow-up was used. Participants with prediabetes were recruited from a university worksite and randomized to receive a 16-week lifestyle intervention (n = 35) or usual care (n = 34). Participants were evaluated at baseline, postintervention, and 3-month follow-up. Dietary intake was measured by a food frequency questionnaire and level of physical activity by accelerometers. Repeated measures analysis of variance compared the change in outcomes between and within groups. Mean (standard error [SE]) weight loss was greater in the intervention (-5.5% [0.6%]) than in the control (-0.4% [0.5%]) group (P worksite intervention improved metabolic and behavioral risk factors among employees with prediabetes. The long-term impact on diabetes prevention and program sustainability warrant further investigation.

  16. Using web-based familial risk information for diabetes prevention: a randomized controlled trial

    OpenAIRE

    Wijdenes, Miranda; Henneman, Lidewij; Qureshi, Nadeem; Kostense, Piet J; Cornel, Martina C.; Timmermans, Danielle RM

    2013-01-01

    Background It has been suggested that family history information may be effective in motivating people to adopt health promoting behaviour. The aim was to determine if diabetic familial risk information by using a web-based tool leads to improved self-reported risk-reducing behaviour among individuals with a diabetic family history, without causing false reassurance among those without a family history. Methods An online sample of 1,174 healthy adults aged 35?65 years with a BMI ? 25 was rand...

  17. Treatment of diffuse diabetic maculopathy with intravitreal triamcinolone and laser photocoagulation: randomized clinical trial with morphological and functional evaluation

    Directory of Open Access Journals (Sweden)

    Alberto Luiz Gil

    2011-10-01

    Full Text Available PURPOSE: Treatment of diffuse macular edema in diabetes mellitus is currently unsatisfactory. The purpose of this double blind randomized clinical trial was to compare the treatment of diffuse diabetic macular edema with intravitreal triamcinolone or laser in type 2 diabetes mellitus patients using a morphofunctional assessment. METHODS: Fourteen patients (21 eyes with clinically significant diffuse macular-edema, previously untreated and with a macular thickness >250 µm at optical coherence tomography were randomized for treatment with laser or intravitreal injection of triamcinolone acetate. Optical coherence tomography, biomicroscopy, fundoscopy, fluorescein angiography, tonometry, scotometry, visual and contrast acuities were performed at 0, 1, 3 and 6 months. RESULTS: At pre-treatment stage, Laser (n=9 and Triamcinolone (n=12 groups did not differ regarding retinal thickness, visual and contrast acuities. In Triamcinolone group macular thickness decreased after 1 month (424.1 ± 19.9 µm to 358.4 ± 18.2 µm; p=0.04 and started to return to the initial values in the 3rd month (p=0.02. No changes occurred in macular scotometry and visual and contrast acuities. No side effects were observed with both treatments. CONCLUSION: During the study macular thickness diminished in the triamcinolone group, especially in the first month of treatment. At 3 and 6 months there was no difference. Macular thickness did not change during the study in the laser group. In the study sample it was not possible to demonstrate differences relates to visual acuity and scotometry between the two groups. CLINICALTRIALS.GOV IDENTIFIER: NCT00668239

  18. Treatment of diffuse diabetic maculopathy with intravitreal triamcinolone and laser photocoagulation: randomized clinical trial with morphological and functional evaluation.

    Science.gov (United States)

    Gil, Alberto Luiz; Azevedo, Mirela Jobim de; Tomasetto, Giovani Generali; Muniz, Carlos Henrique Gervini; Lavinsky, Jacó

    2011-01-01

    Treatment of diffuse macular edema in diabetes mellitus is currently unsatisfactory. The purpose of this double blind randomized clinical trial was to compare the treatment of diffuse diabetic macular edema with intravitreal triamcinolone or laser in type 2 diabetes mellitus patients using a morphofunctional assessment. Fourteen patients (21 eyes) with clinically significant diffuse macular-edema, previously untreated and with a macular thickness >250 µm at optical coherence tomography were randomized for treatment with laser or intravitreal injection of triamcinolone acetate. Optical coherence tomography, biomicroscopy, fundoscopy, fluorescein angiography, tonometry, scotometry, visual and contrast acuities were performed at 0, 1, 3 and 6 months. At pre-treatment stage, Laser (n=9) and Triamcinolone (n=12) groups did not differ regarding retinal thickness, visual and contrast acuities. In Triamcinolone group macular thickness decreased after 1 month (424.1 ± 19.9 µm to 358.4 ± 18.2 µm; p=0.04) and started to return to the initial values in the 3(rd) month (p=0.02). No changes occurred in macular scotometry and visual and contrast acuities. No side effects were observed with both treatments. During the study macular thickness diminished in the triamcinolone group, especially in the first month of treatment. At 3 and 6 months there was no difference. Macular thickness did not change during the study in the laser group. In the study sample it was not possible to demonstrate differences relates to visual acuity and scotometry between the two groups. CLINICALTRIALS.GOV IDENTIFIER: NCT00668239.

  19. Challenging the One-Dose-Fits-All Model for Insulin in the Acute Treatment of Pediatric Diabetic Ketoacidosis. A Critical Appraisal of "Low-Dose Versus Standard-Dose Insulin in Pediatric Diabetic Ketoacidosis: A Randomized Clinical Trial" by Nallasamy et al (JAMA Pediatrics 2014; 168:999-1005).

    Science.gov (United States)

    Orwoll, Benjamin Edward

    2016-10-01

    To review the findings and discuss the implications of the use of low-dose insulin infusions in pediatric diabetic ketoacidosis compared with standard-dose insulin. A search of the electronic PubMed database was used to perform the clinical query as well as to search for additional relevant literature. The article by Nallasamy K et al "Low-Dose vs Standard-Dose Insulin in Pediatric Diabetic Ketoacidosis: A Randomized Clinical Trial. JAMA Pediatrics 2014; 17:e477-e480" was selected for critical appraisal and literature review. The authors performed a randomized controlled trial among 50 consecutive patients of 0-12 years old presenting to the emergency department in diabetic ketoacidosis. They found that low-dose (0.05 U/kg/hr) insulin infusion was noninferior to standard-dose (0.1 U/kg/hr) insulin in terms of resolution of hyperglycemia and acidosis with a trend toward lower rates of therapy-related complications in the low-dose group. Low-dose insulin infusion is noninferior to standard-dose insulin in the treatment of younger pediatric patients with diabetic ketoacidosis and may lead to fewer therapy-related complications.

  20. Comparison of Azelnidipine and Trichlormethiazide in Japanese Type 2 Diabetic Patients with Hypertension: The COAT Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Masahiro Takihata

    Full Text Available This study compared the efficacy and safety of azelnidipine with that of trichlormethiazide in Japanese type 2 diabetic patients with hypertension.In a multicenter, open-label trial, 240 patients with adequately controlled diabetes (HbA1c ≤ 7.0% under lifestyle modification and/or administration of hypoglycemic agents and inadequately controlled hypertension (systolic blood pressure [sBP] ≥ 130 mmHg or diastolic blood pressure [dBP] ≥ 80 mmHg who were being treated with olmesartan were enrolled. Participants were randomly assigned to an azelnidipine group or a trichlormethiazide group and were followed up for 48 weeks. Main outcome measure was the difference in the change in HbA1c levels from the baseline values at 48 weeks between these two groups.Of the 240 subjects that were enrolled, 209 subjects (azelnidipine group: 103 patients, trichlormethiazide group: 106 patients completed this trial. At 48 weeks, the following changes were observed in the azelnidipine and trichlormethiazide groups, respectively: HbA1c levels, 0.19 ± 0.52% and 0.19 ± 0.54%; sBP/dBP, -10.7 ± 9.6/-6.6 ± 6.6 mmHg and -7.1 ± 7.7/-3.3 ± 6.1 mmHg (P < 0.001 for both sBP and dBP. In both groups, dizziness (12 patients [11.7%] and 16 patients [15.1%] and edema (16 patients [15.5%] and 7 patients [6.6%], P = 0.047 were observed during the 48-week follow-up period.Azelnidipine was more effective for controlling blood pressure than trichlormethiazide in Japanese type 2 diabetes patients, whereas trichlormethiazide was more effective for reducing albuminuria than azelnidipine. Both of these agents, however, similarly exacerbated glycemic control in type 2 diabetic patients with hypertension.UMIN 000006081.

  1. 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 yogurt consumption may be used as an alternative prevention approach and treatment method to improve dyslipidemia in patients with type 2 diabetes.

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

    Directory of Open Access Journals (Sweden)

    Majid Mohamadshahi

    2014-01-01

    Full Text Available Background: 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. Materials and Methods: 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. Results: 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 < 0.05. Conclusion: It is suggested that probiotic yogurt consumption may be used as an alternative prevention approach and treatment method to improve dyslipidemia in patients with type 2 diabetes.

  3. 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.

  4. 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.

  5. 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.

  6. 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

    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......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...

  7. A randomized, controlled trial of a stress management intervention for Latinos with type 2 diabetes delivered by community health workers: Outcomes for psychological wellbeing, glycemic control, and cortisol.

    Science.gov (United States)

    Wagner, Julie Ann; Bermudez-Millan, Angela; Damio, Grace; Segura-Perez, Sofia; Chhabra, Jyoti; Vergara, Cunegundo; Feinn, Richard; Perez-Escamilla, Rafael

    2016-10-01

    To test the efficacy of a community health worker (CHW) delivered stress management (SM) intervention on psychosocial, glycemic, and cortisol outcomes among U.S. Latinos with type 2 diabetes. A randomized, controlled trial compared CHW-delivered diabetes education (DE; one group session) to DE plus CHW-delivered SM (DE+SM; 8 group sessions). Psychosocial variables and urinary cortisol were measured at baseline and posttreatment. HbA1c was measured at baseline, posttreatment, and 3-month follow-up. In intent to treat analysis, compared to DE (n=46), DE+SM (n=61) showed significantly improved symptoms of depression, anxiety, and self-reported health status. There were no significant group effects for HbA1c, diabetes distress, or urinary cortisol. However, there was a dose response effect for HbA1c and diabetes distress; increasing attendance at SM sessions was associated with greater improvements in HbA1c and diabetes distress. This is the first randomized, controlled trial demonstrating that CHWs can improve psychological symptoms and self-reported health among Latinos with type 2 diabetes. Efforts to increase intervention attendance may improve HbA1c and diabetes distress. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  8. Improved Glycemic Control With Intraperitoneal Versus Subcutaneous Insulin in Type 1 Diabetes A randomized controlled trial

    NARCIS (Netherlands)

    Logtenberg, Susan J.; Kleefstra, Nanne; Houweling, Sebastiaan T.; Groenier, Klaas H.; Gans, Reinold O.; van Ballegooie, Evert; Bilo, Henk J.

    OBJECTIVE - Continuous intraperitoneal insulin infusion (CIPII) with an implantable pump has been available for the past 25 years. CIPII, with its specific pharmacodynamic properties, may be a viable treatment alternative to improve glycemic control in patients with type I diabetes for whom other

  9. Using web-based familial risk information for diabetes prevention: a randomized controlled trial

    NARCIS (Netherlands)

    Pijl, M.; Henneman, L.; Qureshi, N.; Kostense, P.J.; Cornel, M.C.; Timmermans, D.R.M.

    2013-01-01

    Background: It has been suggested that family history information may be effective in motivating people to adopt health promoting behaviour. The aim was to determine if diabetic familial risk information by using a web-based tool leads to improved self-reported risk-reducing behaviour among

  10. A randomized general population study of the effects of repeated health checks on incident diabetes

    DEFF Research Database (Denmark)

    Skaaby, Tea; Jørgensen, Torben; Linneberg, Allan

    2018-01-01

    results, the participants were given individual information about the results, disease risk and lifestyle. Their general practitioner, too, was provided with written information on the test results. Both groups were followed in the Danish Civil Registration System, the Danish National Diabetes Register...

  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. Action for Health in Diabetes (Look AHEAD) trial: baseline evaluation of selected nutrients and food group intake.

    Science.gov (United States)

    Vitolins, Mara Z; Anderson, Andrea M; Delahanty, Linda; Raynor, Hollie; Miller, Gary D; Mobley, Connie; Reeves, Rebecca; Yamamoto, Monica; Champagne, Catherine; Wing, Rena R; Mayer-Davis, Elizabeth

    2009-08-01

    Little has been reported regarding food and nutrient intake in individuals diagnosed with type 2 diabetes, and most reports have been based on findings in select groups or individuals who self-reported having diabetes. To describe the baseline food and nutrient intake of the Look AHEAD (Action for Health in Diabetes) trial participants, compare participant intake to national guidelines, and describe demographic and health characteristics associated with food group consumption. The Look AHEAD trial is evaluating the effects of a lifestyle intervention (calorie control and increased physical activity for weight loss) compared with diabetes support and education on long-term cardiovascular and other health outcomes. Participants are 45 to 75 years old, overweight or obese (body mass index [BMI] > or = 25), and have type 2 diabetes. In this cross-sectional analysis, baseline food consumption was assessed by food frequency questionnaire from 2,757 participants between September 2000 and December 2003. Descriptive statistics were used to summarize intake by demographic characteristics. Kruskal-Wallis tests assessed univariate effects of characteristics on consumption. Multiple linear regression models assessed factors predictive of intake. Least square estimates were based on final models, and logistic regression determined factors predictive of recommended intake. Ninety-three percent of the participants exceeded the recommended percentage of calories from fat, 85% exceeded the saturated fat recommendation, and 92% consumed too much sodium. Also, fewer than half met the minimum recommended servings of fruit, vegetables, dairy, and grains. These participants with pre-existing diabetes did not meet recommended food and nutrition guidelines. These overweight adults diagnosed with diabetes are exceeding recommended intake of fat, saturated fats, and sodium, which may contribute to increasing their risk of cardiovascular disease and other chronic diseases.

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

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    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.

  14. Changing the Face of Diabetic Care with Haptoglobin Genotype Selection and Vitamin E

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    Nina S. Levy

    2011-04-01

    Full Text Available Research over the past 10 years in our laboratory has led to two major findings. The first is that haptoglobin (Hp genotype can predict the risk of developing vascular complications in individuals with diabetes mellitus (DM, and the second, more far-reaching discovery, is that vitamin E treatment can significantly reduce vascular complications in individuals with DM and the Hp 2-2 genotype. The former finding has been well documented in numerous studies which included over 50,000 patients of diverse geographical and ethnic backgrounds. The latter discovery is more recent and less well accepted by the medical community due to confounding reports over the past 30 years regarding the efficacy of vitamin E treatment for vascular disease. We propose that the benefit of vitamin E treatment was not obvious in earlier studies due to the absence of any genetic basis for patient selection. Our studies dividing DM individuals into vitamin E treatment subgroups based on Hp genotype show a clear benefit for individuals of the Hp 2-2 genotype, while patients carrying the other two Hp genotypes are not affected or may be adversely affected by receiving vitamin E. These findings may explain the overall lack of benefit seen in previous vitamin E studies and emphasize the importance of carefully selecting which patients should receive vitamin E therapy. The pharmacogenomic paradigm discussed in this review potentially could result in a dramatic improvement in the health of millions of individuals worldwide using a treatment that is both accessible and affordable to all.

  15. Does the Use of a Decision Aid Improve Decision Making in Prosthetic Heart Valve Selection? A Multicenter Randomized Trial

    NARCIS (Netherlands)

    Korteland, Nelleke M.; Ahmed, Yunus; Koolbergen, David R.; Brouwer, Marjan; de Heer, Frederiek; Kluin, Jolanda; Bruggemans, Eline F.; Klautz, Robert J. M.; Stiggelbout, Anne M.; Bucx, Jeroen J. J.; Roos-Hesselink, Jolien W.; Polak, Peter; Markou, Thanasie; van den Broek, Inge; Ligthart, Rene; Bogers, Ad J. J. C.; Takkenberg, Johanna J. M.

    2017-01-01

    A Dutch online patient decision aid to support prosthetic heart valve selection was recently developed. A multicenter randomized controlled trial was conducted to assess whether use of the patient decision aid results in optimization of shared decision making in prosthetic heart valve selection. In

  16. Development of Highly Sensitive and Selective Breathing Sensors Using Molecular Imprinted Filtering for Diabetic and Alcoholic Patients

    Science.gov (United States)

    Bhuiyan, Md. Saleh Akram

    Wellness sensor technology is an emerging diagnostic test research field, which mostly deal with the point of care of the patients in the recent days. Due to the lack of awareness from the patients, most diseases cannot be detected in due time. This led to worse conditions, such as diabetic and alcoholic syndrome. Therefore, many research groups have been working to develop portable sensor devices that can track serious diseases. These include diabetic and alcoholic biomarkers in breathing. These devices have very high selectivity and reliability. However, the major limitation of biomarkers is that it deals with the bio-molecular based sensing mechanism. Extensive challenges exist in the selectivity and reliability of breathing sensors. These require development of proper materials and effective detection methods. Thus, selection of proper materials, correct sensing parameters, effective device architecture and simple fabrication processing are substantially critical. The goal of this work is to develop graphene based breathing sensors with high selectivity and sensitivity using a novel molecular imprinted filtering technique. The sensors have various applications including Point of Care Testing (POCT) device for personalized home and clinical use in early detection of diabetic and alcoholic patients. Different fabrication procedures were used to optimize the sensor performance. The optimized results demonstrate that a proper biomarker molecule imprinting process could selectively detect diabetes and alcohol. The graphene layer was optimized by maintaining spray coating time, pattern and distance between the substrate and spray coater. Graphene adhesion to the substrate was also improved using polyvinyl pyrrolidone. The molecular imprinting filter made on top of the graphene layer improved the performance of acetone and ethanol molecule detection, indicated by the change of resistance in the graphene layer. The sensors showed poor performance for long-time exposure

  17. Effect of Sulodexide on Urinary Biomarkers of Kidney Injury in Normoalbuminuric Type 2 Diabetes: A Randomized Controlled Trial

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    Bancha Satirapoj

    2015-01-01

    Full Text Available Glycosaminoglycans or sulodexide has shown benefits in early experimental diabetic nephropathy (DN models, but its efficacy in patients with early stage of DN is unknown. Methods. Twenty patients were randomly assigned to the placebo group and another 20 patients were randomly assigned to receive sulodexide 100 mg/day for 14 weeks. Primary outcome was a change of urinary TGF-beta1, albuminuria, and glomerular filtration rate (GFR. All patients had stable metabolic profiles for at least 90 days before randomization. Results. Urinary TGF-beta1 increased significantly in the placebo group but did not change significantly in the sulodexide group. Additionally, the mean change of urine TGF-beta1 in the placebo group was significantly higher than that in the sulodexide group (8.44±9.21 versus 2.17±6.96 pg/mg Cr, P=0.02. Mean changes of urinary albumin were 15.05±30.09 μg/mg Cr (P=0.038 in the placebo group and 13.89±32.25 μg/mg Cr (P=0.069 in the sulodexide group. No consistent patterns of side effects were observed. Conclusion. In this 14-week trial, benefits of sulodexide in preventing the increase of urinary TGF-beta1 were observed in patients with normoalbuminuric type 2 diabetes. The study suggests that sulodexide treatment may provide additional renoprotection in early stage DN. This trial is registered with TCTR20140806001.

  18. Improvement in medication adherence and self-management of diabetes with a clinical pharmacy program: a randomized controlled trial in patients with type 2 diabetes undergoing insulin therapy at a teaching hospital

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    Catarina Gomes Cani

    2015-02-01

    Full Text Available OBJECTIVE: To evaluate the impact of a clinical pharmacy program on health outcomes in patients with type 2 diabetes undergoing insulin therapy at a teaching hospital in Brazil. METHOD: A randomized controlled trial with a 6-month follow-up period was performed in 70 adults, aged 45 years or older, with type 2 diabetes who were taking insulin and who had an HbA1c level ≥8%. Patients in the control group (CG (n = 36 received standard care, patients in the intervention group (IG (n = 34 received an individualized pharmacotherapeutic care plan and diabetes education. The primary outcome measure was change in HbA1c. Secondary outcomes included diabetes and medication knowledge, adherence to medication, insulin injection and home blood glucose monitoring techniques and diabetes-related quality of life. Outcomes were evaluated at baseline and 6 months using questionnaires. RESULTS: Diabetes knowledge, medication knowledge, adherence to medication and correct insulin injection and home blood glucose monitoring techniques significantly improved in the intervention group but remained unchanged in the control group. At the end of the study, mean HbA1c values in the control group remained unchanged but were significantly reduced in the intervention group. Diabetes-related quality of life significantly improved in the intervention group but worsened significantly in the control group. CONCLUSION: The program improved health outcomes and resulted in better glycemic control in patients with type 2 diabetes undergoing insulin therapy.

  19. Selective outcome reporting and sponsorship in randomized controlled trials in IVF and ICSI.

    Science.gov (United States)

    Braakhekke, M; Scholten, I; Mol, F; Limpens, J; Mol, B W; van der Veen, F

    2017-10-01

    Are randomized controlled trials (RCTs) on IVF and ICSI subject to selective outcome reporting and is this related to sponsorship? There are inconsistencies, independent from sponsorship, in the reporting of primary outcome measures in the majority of IVF and ICSI trials, indicating selective outcome reporting. RCTs are subject to bias at various levels. Of these biases, selective outcome reporting is particularly relevant to IVF and ICSI trials since there is a wide variety of outcome measures to choose from. An established cause of reporting bias is sponsorship. It is, at present, unknown whether RCTs in IVF/ICSI are subject to selective outcome reporting and whether this is related with sponsorship. We systematically searched RCTs on IVF and ICSI published between January 2009 and March 2016 in MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and the publisher subset of PubMed. We analysed 415 RCTs. Per included RCT, we extracted data on impact factor of the journal, sample size, power calculation, and trial registry and thereafter data on primary outcome measure, the direction of trial results and sponsorship. Of the 415 identified RCTs, 235 were excluded for our primary analysis, because the sponsorship was not reported. Of the 180 RCTs included in our analysis, 7 trials did not report on any primary outcome measure and 107 of the remaining 173 trials (62%) reported on surrogate primary outcome measures. Of the 114 registered trials, 21 trials (18%) provided primary outcomes in their manuscript that were different from those in the trial registry. This indicates selective outcome reporting. We found no association between selective outcome reporting and sponsorship. We ran additional analyses to include the trials that had not reported sponsorship and found no outcomes that differed from our primary analysis. Since the majority of the trials did not report on sponsorship, there is a risk on sampling bias. IVF and ICSI trials are subject, to

  20. Writing for Health: Rationale and Protocol for a Randomized Controlled Trial of Internet-Based Benefit-Finding Writing for Adults With Type 1 or Type 2 Diabetes.

    Science.gov (United States)

    Crawford, Joanna; Wilhelm, Kay; Robins, Lisa; Proudfoot, Judy

    2017-03-14

    Diabetes mellitus is Australia's fastest growing chronic disease, and has high comorbidity with depression. Both subthreshold depression and diabetes distress are common amongst people with type 1 or type 2 diabetes, and are associated with poorer diabetes self-care. A need exists for low-intensity self-help interventions for large numbers of people with diabetes and diabetes distress or subthreshold depression, as part of a stepped-care approach to meeting the psychological needs of people with diabetes. Benefit-finding writing is a very brief intervention that involves writing about any positive thoughts and feelings about a stressful experience, such as an illness. Benefit-finding writing has been associated with increases in positive affect and positive growth, and has demonstrated promising results in trials amongst other clinical populations. However, benefit-finding writing has not yet been examined in people with diabetes. The aim of this randomized controlled trial (RCT) is to evaluate the efficacy of an Internet-based benefit-finding writing (iBFW) intervention for adults with type 1 or type 2 diabetes (compared to a control writing condition) for reducing diabetes distress and increasing benefit-finding in diabetes, and also improving a range of secondary outcomes. A two-arm RCT will be conducted, using the online program Writing for Health. Adults with type 1 or type 2 diabetes living in Australia will be recruited using diabetes-related publications and websites, and through advertisements in diabetes services and general practitioners' offices. Potential participants will be referred to the study-specific website for participant information and screening. All data will be collected online. Participants will be randomized to either iBFW about diabetes, or a control writing condition of writing about use-of-time. Both conditions involve three daily sessions (once per day for three consecutive days) of 15-minute online writing exercises. Outcome measures

  1. 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

  2. Active classifier selection for RGB-D object categorization using a Markov random field ensemble method

    Science.gov (United States)

    Durner, Maximilian; Márton, Zoltán.; Hillenbrand, Ulrich; Ali, Haider; Kleinsteuber, Martin

    2017-03-01

    In this work, a new ensemble method for the task of category recognition in different environments is presented. The focus is on service robotic perception in an open environment, where the robot's task is to recognize previously unseen objects of predefined categories, based on training on a public dataset. We propose an ensemble learning approach to be able to flexibly combine complementary sources of information (different state-of-the-art descriptors computed on color and depth images), based on a Markov Random Field (MRF). By exploiting its specific characteristics, the MRF ensemble method can also be executed as a Dynamic Classifier Selection (DCS) system. In the experiments, the committee- and topology-dependent performance boost of our ensemble is shown. Despite reduced computational costs and using less information, our strategy performs on the same level as common ensemble approaches. Finally, the impact of large differences between datasets is analyzed.

  3. 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

  4. Clinical outcome of intracytoplasmic injection of spermatozoa morphologically selected under high magnification: a prospective randomized study.

    Science.gov (United States)

    Balaban, Basak; Yakin, Kayhan; Alatas, Cengiz; Oktem, Ozgur; Isiklar, Aycan; Urman, Bulent

    2011-05-01

    Recent evidence shows that the selection of spermatozoa based on the analysis of morphology under high magnification (×6000) may have a positive impact on embryo development in cases with severe male factor infertility and/or previous implantation failures. The objective of this prospective randomized study was to compare the clinical outcome of 87 intracytoplasmic morphologically selected sperm injection (IMSI) cycles with 81 conventional intracytoplasmic sperm injection (ICSI) cycles in an unselected infertile population. IMSI did not provide a significant improvement in the clinical outcome compared with ICSI although there were trends for higher implantation (28.9% versus 19.5%), clinical pregnancy (54.0% versus 44.4%) and live birth rates (43.7% versus 38.3%) in the IMSI group. However, severe male factor patients benefited from the IMSI procedure as shown by significantly higher implantation rates compared with their counterparts in the ICSI group (29.6% versus 15.2%, P=0.01). These results suggest that IMSI may improve IVF success rates in a selected group of patients with male factor infertility. New technological developments enable the real time examination of motile spermatozoa with an inverted light microscope equipped with high-power differential interference contrast optics, enhanced by digital imaging. High magnification (over ×6000) provides the identification of spermatozoa with a normal nucleus and nuclear content. Intracytoplasmic injection of spermatozoa selected according to fine nuclear morphology under high magnification may improve the clinical outcome in cases with severe male factor infertility. Copyright © 2010 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

  5. A Comparison of Dietary Habits between Recreational Runners and a Randomly Selected Adult Population in Slovenia.

    Science.gov (United States)

    Škof, Branko; Rotovnik Kozjek, Nada

    2015-09-01

    The aim of the study was to compare the dietary habits of recreational runners with those of a random sample of the general population. We also wanted to determine the influence of gender, age and sports performance of recreational runners on their basic diet and compliance with recommendations in sports nutrition. The study population consisted of 1,212 adult Slovenian recreational runners and 774 randomly selected residents of Slovenia between the ages of 18 and 65 years. The data on the dietary habits of our subjects was gathered by means of two questionnaires. The following parameters were evaluated: the type of diet, a food pattern, and the frequency of consumption of individual food groups, the use of dietary supplements, fluid intake, and alcohol consumption. Recreational runners had better compliance with recommendations for healthy nutrition than the general population. This pattern increased with the runner's age and performance level. Compared to male runners, female runners ate more regularly and had a more frequent consumption of food groups associated with a healthy diet (fruit, vegetables, whole grain foods, and low-fat dairy products). The consumption of simple sugars and use of nutritional supplements by well-trained runners was inadequate with values recommended for physically active individuals. Recreational runners are an exemplary population group that actively seeks to adopt a healthier lifestyle.

  6. Radiographic methods used before removal of mandibular third molars among randomly selected general dental clinics.

    Science.gov (United States)

    Matzen, Louise H; Petersen, Lars B; Wenzel, Ann

    2016-01-01

    To assess radiographic methods and diagnostically sufficient images used before removal of mandibular third molars among randomly selected general dental clinics. Furthermore, to assess factors predisposing for an additional radiographic examination. 2 observers visited 18 randomly selected clinics in Denmark and studied patient files, including radiographs of patients who had their mandibular third molar(s) removed. The radiographic unit and type of receptor were registered. A diagnostically sufficient image was defined as the whole tooth and mandibular canal were displayed in the radiograph (yes/no). Overprojection between the tooth and mandibular canal (yes/no) and patient-reported inferior alveolar nerve sensory disturbances (yes/no) were recorded. Regression analyses tested if overprojection between the third molar and the mandibular canal and an insufficient intraoral image predisposed for additional radiographic examination(s). 1500 mandibular third molars had been removed; 1090 had intraoral, 468 had panoramic and 67 had CBCT examination. 1000 teeth were removed after an intraoral examination alone, 433 after panoramic examination and 67 after CBCT examination. 90 teeth had an additional examination after intraoral. Overprojection between the tooth and mandibular canal was a significant factor (p < 0.001, odds ratio = 3.56) for an additional examination. 63.7% of the intraoral images were sufficient and 36.3% were insufficient, with no significant difference between images performed with phosphor plates and solid-state sensors (p = 0.6). An insufficient image predisposed for an additional examination (p = 0.008, odds ratio = 1.8) but was only performed in 11% of the cases. Most mandibular third molars were removed based on an intraoral examination although 36.3% were insufficient.

  7. [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.

  8. Evaluation of the telephone intervention in the promotion of diabetes self-care: a randomized clinical trial.

    Science.gov (United States)

    Fernandes, Bárbara Sgarbi Morgan; Reis, Ilka Afonso; Torres, Heloisa de Carvalho

    2016-08-29

    to evaluate the effectiveness of the telephone intervention for promoting self-care related to physical activity and following a diet plan in users with diabetes, compared to conventional monitoring of users over a six-month period. this was a randomized clinical trial, which included 210 users with diabetes, linked to eight Primary Health Units of Belo Horizonte, Minas Gerais. The experimental group (104 members) received six telephone interventions over the six-month monitoring; the control group (106 members) received conventional monitoring. To evaluate the self-care practices related to physical activity and following a healthy eating plan, in both groups, the self-care questionnaire was applied before the intervention and at three and six months after its start. the mean effect of self-care scores in the experimental group was 1.03 to 1.78 higher than the control group, with progressive and significant improvement (pautocuidado relacionado à atividade física e ao seguimento de um plano alimentar, em usuários com diabetes, quando comparada ao acompanhamento convencional dos usuários, durante o período de seis meses. trata-se de um ensaio clínico randomizado, no qual participaram 210 usuários com diabetes, vinculados a oito Unidades Básicas de Saúde de Belo Horizonte, Minas Gerais. O grupo-experimental (104 usuários) recebeu seis intervenções telefônicas em seis meses de acompanhamento; o grupo-controle (106 usuários) recebeu acompanhamento convencional. Para avaliar as práticas de autocuidado, relacionada à atividade física e ao seguimento do plano alimentar saudável, em ambos os grupos, aplicou-se o questionário de autocuidado antes das intervenções, três e seis meses após o seu início. o efeito médio dos escores de autocuidado no grupo-experimental a pontuação foi de 1,03 a 1,78 maior do que o grupo-controle, apresentando melhora progressiva e significativa (valor-pautocuidado em diabetes. O registro clínico obteve identificador

  9. Efficacy and safety of prolonged-release melatonin in insomnia patients with diabetes: a randomized, double-blind, crossover study

    Directory of Open Access Journals (Sweden)

    Garfinkel D

    2011-08-01

    Full Text Available Doron Garfinkel1, Mariana Zorin2, Julio Wainstein2, Zipora Matas3, Moshe Laudon4, Nava Zisapel4,51Geriatric Palliative Department, Shoham Geriatric Medical Center, Pardes Hana, Israel; 2Diabetes Unit, 3Biochemistry Laboratory, The E Wolfson Medical Center, Holon, Israel; 4Neurim Pharmaceuticals Ltd, 5Department of Neurobiology, Tel Aviv University, Tel Aviv, IsraelBackground: Diabetes is a major comorbidity in insomnia patients. The efficacy and safety of prolonged-release melatonin 2 mg in the treatment of glucose, lipid metabolism, and sleep was studied in 36 type 2 diabetic patients with insomnia (11 men, 25 women, age 46–77 years.Methods: In a randomized, double-blind, crossover study, the subjects were treated for 3 weeks (period 1 with prolonged-release melatonin or placebo, followed by a one-week washout period, and then crossed over for another 3 weeks (period 2 of treatment with the other preparation. All tablets were taken 2 hours before bedtime for a period of 3 weeks. In an extension period of 5 months, prolonged-release melatonin was given nightly to all patients in an open-label design. Sleep was objectively monitored in a subgroup of 22 patients using wrist actigraphy. Fasting glucose, fructosamine, insulin, C-peptide, triglycerides, total cholesterol, high-density and low-density lipoprotein cholesterol, and some antioxidants, as well as glycosylated hemoglobin (HbA1c levels were measured at baseline and at the end of the study. All concomitant medications were continued throughout the study.Results: No significant changes in serum glucose, fructosamine, insulin, C-peptide, antioxidant levels or blood chemistry were observed after 3 weeks of prolonged-release melatonin treatment. Sleep efficiency, wake time after sleep onset, and number of awakenings improved significantly with prolonged-release melatonin as compared with placebo. Following 5 months of prolonged-release melatonin treatment, mean HbA1c (±standard deviation was

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

    OpenAIRE

    Christensen, Allan S; Viggers, Lone; Hasselstr?m, Kjeld; Gregersen, S?ren

    2013-01-01

    Background 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. Th...

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

    OpenAIRE

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

  12. Effect of pharmacist-led patient education on glycemic control of type 2 diabetics: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Shadi Farsaei

    2011-01-01

    Conclusions: This study demonstrates an improvement in diabetes management of type 2 diabetics by involving a pharmacist in the multidisciplinary teams in the outpatient clinics. The results suggest the benefits of adding adherence education to the diabetic education programs.

  13. A pregnancy and postpartum lifestyle intervention in women with gestational diabetes mellitus reduces diabetes risk factors: a feasibility randomized control trial.

    Science.gov (United States)

    Ferrara, Assiamira; Hedderson, Monique M; Albright, Cheryl L; Ehrlich, Samantha F; Quesenberry, Charles P; Peng, Tiffany; Feng, Juanran; Ching, Jenny; Crites, Yvonne

    2011-07-01

    To pilot, among women with gestational diabetes mellitus (GDM), the feasibility of a prenatal/postpartum intervention to modify diet and physical activity similar to the Diabetes Prevention Program. The intervention was delivered by telephone, and support for breastfeeding was addressed. The goal was to help women return to their prepregnancy weight, if it was normal, or achieve a 5% reduction from prepregnancy weight if overweight. Eligible participants were identified shortly after a GDM diagnosis; 83.8% consented to be randomly assigned to intervention or usual medical care (96 and 101 women, respectively). The retention was 85.2% at 12 months postpartum. The proportion of women who reached the postpartum weight goal was higher, although not statistically significant, in the intervention condition than among usual care (37.5 vs. 21.4%, absolute difference 16.1%, P=0.07). The intervention was more effective among women who did not exceed the recommended gestational weight gain (difference in the proportion of women meeting the weight goals: 22.5%, P=0.04). The intervention condition decreased dietary fat intake more than the usual care (condition difference in the mean change in percent of calories from fat: -3.6%, P=0.002) and increased breastfeeding, although not significantly (condition difference in proportion: 15.0%, P=0.09). No differences in postpartum physical activity were observed between conditions. This study suggests that a lifestyle intervention that starts during pregnancy and continues postpartum is feasible and may prevent pregnancy weight retention and help overweight women lose weight. Strategies to help postpartum women overcome barriers to increasing physical activity are needed.

  14. Systemic Inflammatory Biomarkers and Their Association With Periodontal and Diabetes-Related Factors in the Diabetes and Periodontal Therapy Trial, A Randomized Controlled Trial.

    Science.gov (United States)

    Geisinger, Maria L; Michalowicz, Bryan S; Hou, Wei; Schoenfeld, Elinor; Gelato, Marie; Engebretson, Steven P; Reddy, Michael S; Hyman, Leslie

    2016-08-01

    The present study evaluates effects of non-surgical periodontal treatment on serum biomarkers in patients with type 2 diabetes mellitus (t2DM) and chronic periodontitis who participated in the Diabetes and Periodontal Therapy Trial (DPTT); and associations among diabetes markers, serum biomarkers, and periodontal measures in these patients. DPTT participants randomized to receive immediate or delayed non-surgical periodontal therapy were evaluated at baseline and 6 months. Serum samples from 475 participants with 6-month data were analyzed for the following biomarkers: 1) high sensitivity C-reactive protein; 2) E-selectin; 3) tumor necrosis factor (TNF)-α; 4) vascular cell adhesion molecule (VCAM); 5) interleukin (IL)-6; 6) IL-8; 7) intercellular adhesion molecule; and 8) IL-10. Changes in biomarker levels from baseline and correlations among biomarker levels and clinical findings were analyzed. No differences between treatment and control groups were observed for any biomarkers at baseline or 6 months (P >0.05 for all variables). VCAM levels increased by an average (standard deviation) of 17.9 (99.5); ng/mL (P = 0.006) and E-selectin decreased by 2.33 (16.08) ng/mL (P = 0.03) in the treatment group after 6 months. E-selectin levels were significantly correlated with DM-related variables (hemoglobin A1c [HbA1c] and fasting glucose) at baseline and with 6-month change in both groups; no significant correlations were found among periodontal clinical parameters and serum biomarkers or DM-related variables. Neither HbA1c or body mass index varied during the study period in either study group. Non-surgical periodontal therapy and periodontal disease severity were not associated with significant changes in serum biomarkers in DPTT participants during the 6-month follow-up. Correlations among changes in E-selectin, IL-6, and DM-related variables suggest that t2DM may be the primary driver of systemic inflammation in these patients.

  15. 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 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 , metabolic clearance rate of glucose; OPLS , orthogonal projections to

  16. Positive parenting program (triple P) for families of adolescents with type 1 diabetes: a randomized controlled trial of self-directed teen triple P.

    Science.gov (United States)

    Doherty, Francesca M; Calam, Rachel; Sanders, Matthew R

    2013-09-01

    Adolescents with type 1 diabetes (T1D) have shown improvements in glycemic control and family relations, via clinic-based family interventions. However, reach and clinician availability may be limited. We evaluated a self-directed intervention for this purpose. Recruitment for a randomized controlled trial (RCT) occurred through national advertising with diabetes charities and conducted with online data collection. Parents of 11-17-year-olds with diabetes were randomized to usual care (n = 37) or intervention (n = 42) using computerized block randomization. The 10-week intervention comprised the Self-directed Teen Triple P workbook (10 × 1 hr modules) plus chronic illness tip sheet. Primary outcomes of diabetes-related family conflict and parenting stress were assessed pre and post-intervention. Intention-to-treat analyses (n = 79) identified significantly improved diabetes-related conflict, but not parental stress, compared with usual care. The preliminary findings suggest that this could be a useful way to expand intervention reach for this population.

  17. Laser therapy for onychomycosis in patients with diabetes at risk for foot complications: study protocol for a randomized, double-blind, controlled trial (LASER-1).

    Science.gov (United States)

    Nijenhuis-Rosien, Leonie; Kleefstra, Nanne; Wolfhagen, Maurice J; Groenier, Klaas H; Bilo, Henk J G; Landman, Gijs W D

    2015-03-22

    In a sham-controlled double-blind trial, we aim to establish the efficacy and safety of the local application of laser therapy in patients with diabetes, onychomycosis and risk factors for diabetes-related foot complications. Onychomycosis leads to thickened and distorted nails, which in turn lead to increased local pressure. The combination of onychomycosis and neuropathy or peripheral arterial disease (PAD) increases the risk of developing diabetes-related foot complications. Usual care for high-risk patients with diabetes and onychomycosis is completely symptomatic with frequent shaving and clipping of the nails. No effective curative local therapies exist, and systemic agents are often withheld due to concerns for side effects and interactions. The primary aim is to evaluate the efficacy of four sessions of Nd:YAG 1064 nM laser application on the one-year clinical and microbiological cure rate in a randomized, double-blind, sham-controlled design with blinded outcome assessment. Mandatory inclusion criteria are diagnosis of diabetes, risk factors for developing foot ulcers defined as a modified Simm's classification score 1 or 2 and either neuropathy or PAD. A total of 64 patients are randomized to intervention or sham treatment performed by a podiatrist. This study will be the first double-blind study that investigates the effects of local laser therapy on onychomycosis, specifically performed in patients with diabetes with additional risk factors for foot complications. Clinical trials.gov as NCT01996995 , first received 22 November 2013.

  18. Kidney Function Improvement by Soy Milk Containing Lactobacillus plantarum A7 in Type 2 Diabetic Patients With Nephropathy: a Double-Blinded Randomized Controlled Trial.

    Science.gov (United States)

    Abbasi, Behnood; Ghiasvand, Reza; Mirlohi, Maryam

    2017-01-01

    Even with the ultimate medical management, more than one-third of diabetic patients develop diabetic nephropathy. To our knowledge, there is no study that has examined the effect of probiotic soy milk on kidney function in type 2 diabetic patients with nephropathy. This clinical trial aimed to assess the effects of consumption of probiotic soy milk, compared with conventional soy milk, on kidney-related indexes in patients with diabetic nephropathy. In a randomized double-blinded placebo-controlled trial, 44 patients were randomly assigned to receive 200 mL/d of either soy milk containing Lactobacillus plantarum A7 or conventional soy milk for 8 weeks. Primary endpoints included urinary albumin excretion, estimated glomerular filtration rate, interlukin-18, serum sialic acid, and serum creatinine. Fasting blood samples and morning fasting spot urine samples were collected at the beginning and after 8 weeks for evaluation of biochemical parameters. Forty patients completed the study. Administration of probiotic soymilk resulted in a significant reduction in albuminuria (P = .03), serum creatinine (P soy milk. Probiotic soymilk supplementation also led to a significant improvement in estimated glomerular filtration rate (15.9 ± 10.8 mL/min versus 3.2 ± 8.4 mL/min, P soy milk was safe and well-tolerated by patients with diabetic nephropathy for 8 weeks. Probiotic soy milk also improved indexes of kidney function in type 2 diabetic patients with nephropathy.

  19. 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.

  20. Soluble fibers from psyllium improve glycemic response and body weight among diabetes type 2 patients (randomized control trial).

    Science.gov (United States)

    Abutair, Ayman S; Naser, Ihab A; Hamed, Amin T

    2016-10-12

    Water-soluble dietary fibers intake may help control blood glucose and body weight. The objective of the study was to determine whether soluble fiber supplementation from psyllium improves glycemic control indicators and body weight in type 2 diabetic patients. Forty type 2 diabetes patients, non-smoker, aged >35 years were stratified to different strata according to sex, age, body mass index (BMI) and fasting blood sugar level (FBS) and randomly assigned into two groups; The intervention group which consists of 20 participants was on soluble fiber (10.5 g daily), and the control group which consist of 20 participants continued on their regular diet for eight weeks duration. After 8 weeks of intervention, soluble fiber supplementation showed significant reduction in the intervention group in BMI (p < 0.001) when compared with the control group. Moreover, water soluble fiber supplementation proven to improve FBS (163 to 119 mg/dl), HbA1c (8.5 to 7.5 %), insulin level (27.9 to 19.7 μIU/mL), C-peptide (5.8 to 3.8 ng/ml), HOMA.IR (11.3 to 5.8) and HOMA-β % (103 to 141 %). The reduction in glycemic response was enhanced by combining soluble fiber to the normal diet. Consumption of foods containing moderate amounts of these fibers may improve glucose metabolism and lipid profile in type 2 diabetes patients. Current Controlled Trials PHRC/HC/28/15 .

  1. The effect of topical sodium diclofenac on macular thickness in diabetic eyes after phacoemulsification: a randomized controlled trial.

    Science.gov (United States)

    Entezari, Morteza; Ramezani, Alireza; Nikkhah, Homayon; Yaseri, Mehdi

    2017-02-01

    To evaluate the efficacy of prophylactic administration of the topical diclofenac 0.1 % on macular thickness in diabetic patients following phacoemulsification and intraocular lens implantation surgery. In a Randomized double-masked clinical trial, 108 eyes of 108 diabetic patients underwent phacoemulsification and intraocular lens implantation surgery were enrolled. Fifty four eyes received the conventional postoperative care with steroid drop, whereas the other group (54 eyes) was given a preoperative diclofenac drop four times daily in addition to steroid drop and continued 6 weeks after surgery. All patients were evaluated by optical coherence tomography (OCT) preoperatively and days 1, 30, and 90. The outcome measures including best-corrected visual acuity and OCT findings were compared in and between both groups. Mean CMT changed from 239 ± 16 and 235 ± 17 at baseline to 249 ± 15 and 254 ± 28 at 3 months in the case and control groups, respectively(p = 0.003). Mean total volume of macula changed from 7.61 ± 0.22 and 7.56 ± 0.3 at baseline to 7.64 ± 0.22 and 7.65 ± 0.31 at 3 months in the case and control groups, respectively (p = 0.820). In comparison to the quadrants thicknesses and mean of them between groups did not reach the significant level. This study showed that there is a beneficial effect of topical diclofenac for prevention of macular thickness increasing following phacoemulsification in diabetic patients.

  2. Comparative effects of metformin and pioglitazone on YKL-40 in type 2 diabetes: a randomized clinical trial.

    Science.gov (United States)

    Esteghamati, A; Rezvani, S; Khajeh, E; Ebadi, M; Nakhjavani, M; Noshad, S

    2014-12-01

    Metformin and pioglitazone are believed to exert their long-term benefits by means of amelioration of chronic low-grade inflammation, a key event in development of diabetes and its long-term complications. The present trial was designed to investigate the comparative efficacy of the two anti-diabetes medications on serum concentrations of YKL-40, a novel marker of inflammation. In a parallel-group, open-label, randomized trial setting (ClinicalTrials.gov Identifier No. NCT01521624), 84 newly diagnosed, medication-naïve type 2 diabetes patients were assigned to metformin 1,000 mg daily (n = 42) or pioglitazone 30 mg daily (n = 42). Serum concentrations of YKL-40, along with highly sensitive C-reactive protein, indices of glycemic control and lipid profile were measured at baseline and after 3 months. In the analyzed sample (metformin = 40, pioglitazone = 42), both medications were equally effective with regard to control of hyperglycemia, and hsCRP reduction (p > 0.05). However, metformin caused a significant decline in weight (p = 0.005), BMI (p = 0.004), and total cholesterol levels (p = 0.028) of the patients. Metformin also significantly reduced YKL-40 concentrations after 3 months (1.90 ± 17 vs. 1.66 ± 0.15 µg/L, p = 0.019). The amount of change in the pioglitazone arm did not reach statistical significance (2.18 ± 0.14 vs. 2.25 ± 0.16 µg/L, p = 0.687). When compared, metformin was significantly more effective than pioglitazone with respect to YKL-40 reduction in both univariate (p = 0.020, effect size = 6.7%) and multivariate models (p = 0.047, effect size = 5.7%). Metformin is more effective in reduction of YKL-40 concentration in short term and the effect seems to be independent of degree of glycemic control, or hsCRP reduction.

  3. The Role of Obesity, Type 2 Diabetes, and Metabolic Factors in Pancreatic Cancer: A Mendelian Randomization Study.

    Science.gov (United States)

    Carreras-Torres, Robert; Johansson, Mattias; Gaborieau, Valerie; Haycock, Philip C; Wade, Kaitlin H; Relton, Caroline L; Martin, Richard M; Davey Smith, George; Brennan, Paul

    2017-09-01

    Risk factors for pancreatic cancer include a cluster of metabolic conditions such as obesity, hypertension, dyslipidemia, insulin resistance, and type 2 diabetes. Given that these risk factors are correlated, separating out causal from confounded effects is challenging. Mendelian randomization (MR), or the use of genetic instrumental variables, may facilitate the identification of the metabolic drivers of pancreatic cancer. We identified genetic instruments for obesity, body shape, dyslipidemia, insulin resistance, and type 2 diabetes in order to evaluate their causal role in pancreatic cancer etiology. These instruments were analyzed in relation to risk using a likelihood-based MR approach within a series of 7110 pancreatic cancer patients and 7264 control subjects using genome-wide data from the Pancreatic Cancer Cohort Consortium (PanScan) and the Pancreatic Cancer Case-Control Consortium (PanC4). Potential unknown pleiotropic effects were assessed using a weighted median approach and MR-Egger sensitivity analyses. Results indicated a robust causal association of increasing body mass index (BMI) with pancreatic cancer risk (odds ratio [OR] = 1.34, 95% confidence interval [CI] = 1.09 to 1.65, for each standard deviation increase in BMI [4.6 kg/m2]). There was also evidence that genetically increased fasting insulin levels were causally associated with an increased risk of pancreatic cancer (OR = 1.66, 95% CI = 1.05 to 2.63, per SD [44.4 pmol/L]). Notably, no evidence of a causal relationship was observed for type 2 diabetes, nor for dyslipidemia. Sensitivity analyses did not indicate that pleiotropy was an important source of bias. Our results suggest a causal role of BMI and fasting insulin in pancreatic cancer etiology.

  4. Picky Eaters Improved Diet Quality in a Randomized Behavioral Intervention Trial in Youth with Type 1 Diabetes.

    Science.gov (United States)

    Nansel, Tonja R; Lipsky, Leah M; Haynie, Denise L; Eisenberg, Miriam H; Dempster, Katie; Liu, Aiyi

    2018-02-01

    Children who are picky eaters typically demonstrate persistent food refusal and poor diet quality and may be resistant to intervention. This study tested whether pickiness moderated the effect of a nutrition intervention on diet quality in youth with type 1 diabetes, hypothesizing that the intervention effect would be smaller among picky relative to nonpicky eaters. The study was an 18-month randomized clinical trial. Youth age 8.0 to 16.9 years (n=136) with type 1 diabetes duration ≥1 year, receiving care at an outpatient diabetes center in Boston, MA, and a parent, participated from 2010 to 2013. The intervention integrated motivational interviewing, active learning, and applied problem solving to increase whole plant food intake. Whole plant food density (WPFD, cup/oz equivalents per 1,000 kcal target food groups), Healthy Eating Index-2005 (HEI2005, measures conformance to US dietary guidelines), and dietary variety were calculated from 3-day food records completed at six different times. Parents completed the pickiness subscale of the Child Feeding Questionnaire. Mean WPFD and HEI2005 were estimated using the population ratio method; standard errors were computed using jackknife variance-covariance estimation. Overall P value comparing groups across visits was derived using the χ2 test. Baseline diet quality was lower in picky than in nonpicky eaters. No intervention effect on pickiness or dietary variety was seen. In stratified analyses, the intervention effect on diet quality was significant for picky eaters only (WPFD P=0.0003; HEI2005 P=0.04). Among picky eaters, diet quality in the treatment group improved, whereas diet quality in the control group remained low. Diet quality of nonpicky eaters in the intervention group changed to a lesser degree. The intervention resulted in increased diet quality in picky eaters, whereas no intervention effect was seen in nonpicky eaters. Findings suggest that diet quality of picky eaters can be improved without

  5. Control group selection in critical care randomized controlled trials evaluating interventional strategies: An ethical assessment.

    Science.gov (United States)

    Silverman, Henry J; Miller, Franklin G

    2004-03-01

    Ethical concern has been raised with critical care randomized controlled trials in which the standard of care reflects a broad range of clinical practices. Commentators have argued that trials without an unrestricted control group, in which standard practices are implemented at the discretion of the attending physician, lack the ability to redefine the standard of care and might expose subjects to excessive harms due to an inability to stop early. To develop a framework for analyzing control group selection for critical care trials. Ethical analysis. A key ethical variable in trial design is the extent with which the control group adequately reflects standard care practices. Such a control group might incorporate either the "unrestricted" practices of physicians or a protocol that specifies and restricts the parameters of standard practices. Control group selection should be determined with respect to the following ethical objectives of trial design: 1) clinical value, 2) scientific validity, 3) efficiency and feasibility, and 4) protection of human subjects. Because these objectives may conflict, control group selection will involve trade-offs and compromises. Trials using a protocolized rather than an unrestricted standard care control group will likely have enhanced validity. However, if the protocolized control group lacks representativeness to standard care practices, then trials that use such groups will offer less clinical value and could provide less assurance of protecting subjects compared with trials that use unrestricted control groups. For trials evaluating contrasting strategies that do not adequately represent standard practices, use of a third group that is more representative of standard practices will enhance clinical value and increase the ability to stop early if needed to protect subjects. These advantages might come at the expense of efficiency and feasibility. Weighing and balancing the competing ethical objectives of trial design should be

  6. Evidence for a causal relationship between early exocrine pancreatic disease and cystic fibrosis-related diabetes: a Mendelian randomization study.

    Science.gov (United States)

    Soave, David; Miller, Melissa R; Keenan, Katherine; Li, Weili; Gong, Jiafen; Ip, Wan; Accurso, Frank; Sun, Lei; Rommens, Johanna M; Sontag, Marci; Durie, Peter R; Strug, Lisa J

    2014-06-01

    Circulating immunoreactive trypsinogen (IRT), a biomarker of exocrine pancreatic disease in cystic fibrosis (CF), is elevated in most CF newborns. In those with severe CF transmembrane conductance regulator (CFTR) genotypes, IRT declines rapidly in the first years of life, reflecting progressive pancreatic damage. Consistent with this progression, a less elevated newborn IRT measure would reflect more severe pancreatic disease, including compromised islet compartments, and potentially increased risk of CF-related diabetes (CFRD). We show in two independent CF populations that a lower newborn IRT estimate is associated with higher CFRD risk among individuals with severe CFTR genotypes, and we provide evidence to support a causal relationship. Increased loge(IRT) at birth was associated with decreased CFRD risk in Canadian and Colorado samples (hazard ratio 0.30 [95% CI 0.15-0.61] and 0.39 [0.18-0.81], respectively). Using Mendelian randomization with the SLC26A9 rs7512462 genotype as an instrumental variable since it is known to be associated with IRT birth levels in the CF population, we provide evidence to support a causal contribution of exocrine pancreatic status on CFRD risk. Our findings suggest CFRD risk could be predicted in early life and that maintained ductal fluid flow in the exocrine pancreas could delay the onset of CFRD. © 2014 by the American Diabetes Association.

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

    Science.gov (United States)

    Shah, Anuja P; Shen, Jenny I; Wang, Ying; Tong, Lili; Pak, Youngju; Andalibi, Ali; LaPage, Janine A; Adler, Sharon G

    2016-01-01

    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. 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 osteoprotegerin were measured in a subset. Primary outcome. Natural log of urine protein/creatinine (ln U P:Cr) ratio at Month 6 vs Baseline. 30 patients completed the study. The 15% decline in U P: Cr in 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. 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. Clinicaltrials.gov NCT01779089.

  8. Silymarin in Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Luminita Voroneanu

    2016-01-01

    Full Text Available Type 2 diabetes mellitus (T2DM is associated with increased risk of cardiovascular disease and nephropathy—now the leading cause of end-stage renal disease and dialysis in Europe and the United States. Inflammation and oxidative stress play a pivotal role in the development of diabetic complications. Silymarin, an herbal drug with antioxidant and anti-inflammatory properties, may improve glycemic control and prevent the progression of the complications. In a systematic review and meta-analysis including five randomized controlled trials and 270 patients, routine silymarin administration determines a significant reduction in fasting blood glucose levels (−26.86 mg/dL; 95% CI −35.42–18.30 and HbA1c levels (−1.07; 95% CI −1.73–0.40 and has no effect on lipid profile. Benefits for silymarin on proteinuria and CKD progressions are reported in only one small study and are uncertain. However, being aware of the low quality of the available evidence and elevated heterogeneity of these studies, no recommendation can be made and further studies are needed.

  9. Effect of Salvia miltiorrhiza hydrophilic extract on antioxidant enzymes in diabetic patients with chronic heart disease: a randomized controlled trial.

    Science.gov (United States)

    Qian, Qingwen; Qian, Shuhong; Fan, Ping; Huo, Dongxia; Wang, Shijin

    2012-01-01

    To investigate whether Salvia miltiorrhiza hydrophilic extract (SMHE) has the ability to ameliorate oxidative stress in diabetic patients with chronic heart disease (CHD), 62 patients with CHD were recruited. These patients were assigned randomly into two groups: (1) placebo group receiving hypoglycemic therapy; (2) treatment group receiving hypoglycemic therapy plus SMHE. The biological markers related to oxidative stress were measured to determine the effect of treatment. Thirty patients in the placebo group and 24 patients in the treatment group were followed to completion in this study. Overall, the malondialdehyde (MDA) level at day 30 in the treatment group was significantly lower than in the placebo group. However, no significant difference in the serum antioxidant enzymes activities was observed between the groups. At day 60, the serum glutathione (GSH) level, superoxide dismutase (SOD), Paraoxonase (PONase) and glutathione reductase (GSSG-R) activities increased markedly in the treatment group compared with the placebo group. There was no significant difference in the level of lipid profile between the two groups. This study indicated that SMHE clearly reduced oxidative stress in diabetic patients with CHD. Copyright © 2011 John Wiley & Sons, Ltd.

  10. 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

  11. 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.

  12. A pregnancy and postpartum lifestyle intervention in women with gestational diabetes mellitus reduces diabetes risk factors: a feasibility randomized control trial

    National Research Council Canada - National Science Library

    Ferrara, Assiamira; Hedderson, Monique M; Albright, Cheryl L; Ehrlich, Samantha F; Quesenberry, Jr, Charles P; Peng, Tiffany; Feng, Juanran; Ching, Jenny; Crites, Yvonne

    2011-01-01

    To pilot, among women with gestational diabetes mellitus (GDM), the feasibility of a prenatal/postpartum intervention to modify diet and physical activity similar to the Diabetes Prevention Program...

  13. Screening selected Vietnamese plants used to treat diabetes for PTP1B inhibitory activity

    DEFF Research Database (Denmark)

    Trinh, Thi Dieu Binh; Staerk, D; Jäger, A K

    2016-01-01

    Type-2 diabetes is affecting 246 million people worldwide [1]. Patients with type-2 diabetes suffer from complications such as high blood pressure, blindness, kidney failure, lower limb amputation, heart disease and stroke. In this study, 18 medicinal plants traditionally used in Vietnam...... for treatment of diabetes were investigated for inhibition of human recombinant protein-tyrosine phosphatase 1B enzyme (PTP1B) based on a recently developed microplate-based assay [2]. This enzyme is a key negative regulator of the insulin signaling pathway and is considered a promising potential therapeutic...

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

    Directory of Open Access Journals (Sweden)

    Anuja P Shah

    Full Text Available 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.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 <150/95 mm Hg; intolerant of/at maximum RAASi dose. Protocol. 3-wk screening; Baseline randomization; Urine and blood measures at months 1, 2, 4, and Month 6 study completion. Urine interleukin-6 (IL-6 and osteoprotegerin were measured in a subset. Primary outcome. Natural log of urine protein/creatinine (ln U P:Cr ratio at Month 6 vs Baseline.30 patients completed the study. The 15% decline in U P: Cr in 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.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.Clinicaltrials.gov NCT01779089.

  15. A RANDOMIZED CLINICAL TRIAL ON THE ANTI - INFLAMATORY EFFECT OF INTRACAMERAL LOW MOLECULAR WE HEPARIN (ENOXAPAIN IN DIABETIC CATARACT SURGERY

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    Shivanand

    2015-08-01

    Full Text Available AIM: To study the effect intracameral low molecular weight on postoperative inflammation after cataract surgery in diabetic patients. SETTING: Department of Ophtha lmology J. N. Medical College. Belgaum. DESIGN: Randomized control trial . MATERIAL AND METHODS: Forty patients with diabetes undergoing small incision cataract surgery with posterior chamber intraocular lens (IOL implantation were randomly assigned to two groups, group A and group B. All patients in g roup A received low molecular weight heparin (enoxaparin in the concentration of 40 IU in 500ml in the irrigating solution and patients in group B received irrigating solution without low molecular weight heparin. In all patients polymethyl methacrylate ( PMMA IOLs were implanted. The patients were examined postoperatively on day 1, day 7, day 30 and day 60 for anterior chamber cells and flare and iris pigments on cell by slit lamp biomicroscopy. RESULTS: A statistically significant reduction in postoperat ive cells, flare and intraocular lens surface pigments was noted in group with addition of low molecular weight heparin (enoxaparin at day 1(p0.001 and 1 week (p<0.001. At 4 weeks and 8 weeks no statistically significant reduction in post - operative cell s and flare was seen between the two groups but there was a significant reduction in the intraocular lens pigments in the group with addition of low molecular weight heparin (enoxaparin. CONCLUSION: Intraoperative use of low molecular weight heparin (enox aparin reduced disturbance in the blood - aq ueous barrier in the early post - operative period evidenced by lower postoperative anterior chamber cells and flare, and also reduced iris pigments on the intraocular lens. At 8 weeks cells and flare in both the gr oups did not show significant difference.

  16. Effect of testosterone treatment on glucose metabolism in men with type 2 diabetes: a randomized controlled trial.

    Science.gov (United States)

    Gianatti, Emily J; Dupuis, Philippe; Hoermann, Rudolf; Strauss, Boyd J; Wentworth, John M; Zajac, Jeffrey D; Grossmann, Mathis

    2014-08-01

    To determine whether testosterone therapy improves glucose metabolism in men with type 2 diabetes (T2D) and lowered testosterone. We conducted a randomized, double-blind, parallel, placebo-controlled trial in 88 men with T2D, aged 35-70 years with an HbA1c ≤8.5% (69 mmol/mol), and a total testosterone level, measured by immunoassay, of ≤12.0 nmol/L (346 ng/dL). Participants were randomly assigned to 40 weeks of intramuscular testosterone undecanoate (n = 45) or matching placebo (n = 43). All study subjects were included in the primary analysis. Seven men assigned to testosterone and six men receiving placebo did not complete the study. Main outcome measures were insulin resistance by homeostatic model assessment (HOMA-IR, primary outcome) and glycemic control by HbA1c (secondary outcome). Testosterone therapy did not improve insulin resistance (mean adjusted difference [MAD] for HOMA-IR compared with placebo -0.08 [95% CI -0.31 to 0.47; P = 0.23]) or glycemic control (MAD HbA1c 0.36% [0.0-0.7]; P = 0.05), despite a decrease in fat mass (MAD -2.38 kg [-3.10 to -1.66]; P Testosterone therapy reduced subcutaneous (MAD -320 cm(3) [-477 to -163]; P Testosterone therapy does not improve glucose metabolism or visceral adiposity in obese men with moderately controlled T2D and modest reductions in circulating testosterone levels typical for men with T2D. © 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.

  17. Probiotic Soy Milk Consumption and Renal Function Among Type 2 Diabetic Patients with Nephropathy: a Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Miraghajani, Maryam; Zaghian, Nafiseh; Dehkohneh, Abolfazl; Mirlohi, Maryam; Ghiasvand, Reza

    2017-09-08

    Diabetic nephropathy (DN) is one the most important complications of diabetes leading to end-stage renal disease. Dietary approaches have been considered to control of the kidney function deterioration among these patients. The aim of the present study was to determine the effects of fortified soy milk with Lactobacillus plantarum A7 on renal function biomarkers in type 2 DN patients. Forty-eight DN subjects were attended to this parallel randomized trial study. Participants were randomly assigned to consume a diet containing 200 mL/day probiotic soy milk in intervention group or soy milk in the control condition for 8 weeks. An inflammatory adipokine-Progranulin (PGRN), a cytokine receptor-soluble tumor necrosis factor receptor 1 (sTNFR1), and serum levels of Neutrophil gelatinase-associated lipocalin (NGAL) and cystatin C (Cys-C) as the new renal function biomarkers were measured after 8 weeks of intervention according to the standard protocol. Our analysis showed that consumption of probiotic soy milk resulted in a significant reduction in the Cys-C and PGRN levels compared with the soy milk (P = 0.01) in the final adjusted model. In addition, after adjustment for age, weight, and energy intake, a marginally significant in the NGAL level was seen between two groups (P = 0.05). However, there was no significant differences on the sTNFR1concenteration between two groups (P = 0.06). Overall, intake of probiotic soy milk may have a beneficial effect on the renal function in patients with DN.

  18. Effects of thiazolidinedione therapy on inflammatory markers of type 2 diabetes: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Chen, Rui; Yan, Jinchuan; Liu, Peijing; Wang, Zhongqun

    2015-01-01

    Inflammation is a common feature in patients with type 2 diabetes mellitus (T2DM). This meta-analysis aimed to assess the influence of thiazolidinedione (TZD) therapy on the circulating levels of inflammatory markers in patients with T2DM. We searched the databases Medline, Embase, ScienceDirect, Web of Science, SpringerLink, and the Cochrane Library for randomized controlled trials (RCTs) that examined the effects of thiazolidinedione vs. a placebo on patients with T2DM. The main outcomes were absolute changes in levels of circulating inflammatory markers. Twenty-seven RCTs were included and data were analyzed using a fixed-effect model or a random-effect model based on heterogeneity. Pooled results indicated that circulating levels of high-sensitivity C reactive protein (hsCRP; SMD = -0.65, 95% CI = -0.98 to -0.32, p 2, p 2.81, p 0.01), fibrinogen (SMD = -0.26, 95% CI = -0.41 to -0.11, p adhesion molecule (ICAM-1) were not significantly affected. Subgroup analyses of PAI-1, vWF% and fibrinogen in terms of trial drugs showed significant reductions for rosiglitazone (all p valusestreatment. Conversely, the E-selectin (p treatment reduced serum hsCRP and MCP-1 but had no marked effects on MMP-9, IL-6 and ICAM-1. Limited evidence suggested that TZD therapy had anti-inflammatory property that might contribute to its beneficial effect on inflammatory state in patients with type 2 diabetes.

  19. Controlling type 2 diabetes mellitus with herbal medicines: A triple-blind randomized clinical trial of efficacy and safety.

    Science.gov (United States)

    Mirfeizi, Mani; Mehdizadeh Tourzani, Zahra; Mirfeizi, Seyedeh Zahra; Asghari Jafarabadi, Mohammad; Rezvani, Hamid Reza; Afzali, Monireh

    2016-09-01

    The use of alternative medicines is common in patients with diabetes mellitus. The primary aim of the present study was to determine the effects of cinnamon and Caucasian whortleberry (Vaccinium arctostaphylos L.) on blood glucose control, lipid profile and body mass index (BMI) in patients with type 2 diabetes (T2DM). In all, 105 T2DM patients were recruited to the present randomized triple-blinded clinical trial. Patients were randomly divided into three groups and administered either placebo, cinnamon or whortleberry supplements (1 g/day) for 90 days. Fasting blood glucose (FBG), serum insulin, lipid profiles, and HbA1c were measured before and after the study. There were no significant differences in baseline characteristics among the three groups. After treatment, FBG, 2-h blood postprandial glucose and homeostasis model assessment of insulin resistance (HOMA-IR) scores were significantly reduced in patients in the whortleberry group, but not in the placebo group. After treatment, there was a significant difference in BMI between the cinnamon and control groups (P = 0.02). There were no significant differences in any variables between the cinnamon and whortleberry groups (P>0.05 for all). In addition, there was a significant decrease in all indices of glucose control in all the cinnamon and whortleberry groups (P cinnamon and whortleberry in addition to conventional medical treatment is recommended to adjust weight and blood glucose levels in patients with T2DM, respectively. © 2015 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and Wiley Publishing Asia Pty Ltd.

  20. Diabetes nurse case management and motivational interviewing for change (DYNAMIC): results of a 2-year randomized controlled pragmatic trial.

    Science.gov (United States)

    Gabbay, Robert A; Añel-Tiangco, Raquel M; Dellasega, Cheryl; Mauger, David T; Adelman, Alan; Van Horn, Deborah H A

    2013-09-01

    The aim of the present study was to determine whether the addition of nurse case managers (NCMs) trained in motivational interviewing (MI) to usual care would result in improved outcomes in high-risk type 2 diabetes patients. A 2-year randomized controlled pragmatic trial randomized 545 patients to usual care control (n=313) or those who received the intervention (n=232) with additional practice-embedded NCM care, including MI-guided behavior change counseling. The NCMs received intensive MI training with ongoing fidelity assessment. Systolic blood pressure (SBP) was better in the intervention than usual care group (131 ± 15 vs. 135 ± 18 mmHg, respectively; P<0.05). Improvements were seen in both the control and intervention groups in terms of HbA1c (from 9.1% to 8.0% and from 8.8% to 7.8%, respectively), low-density lipoprotein (LDL; from 127 to 100 mg/dL and from 128 to 102 mg/dL, respectively), and diastolic blood pressure (from 78 to 74 mmHg and from 80 to 74 mmHg, respectively). Depression symptom scores were better in the intervention group. The reduction in diabetes-related distress approached statistical significance. The NCMs and MI improved SBP and complications screening. The large decrease in HbA1C and LDL in the control group may have obscured any further intervention effect. Although nurses prompted providers for medication titration, strategies to reduce provider clinical inertia may also be needed. © 2013 Wiley Publishing Asia Pty Ltd and Ruijin Hospital, Shanghai Jiaotong University School of Medicine.

  1. Effects of pomegranate juice consumption on inflammatory markers in patients with type 2 diabetes: A randomized, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Golbon Sohrab

    2014-01-01

    Full Text Available Background: Diabetes causes the increased concentration of circulatory cytokines as a result of inflammation. Considering that pomegranate juice (PJ is known to have antioxidant and anti-inflammatory properties, the purpose of this study was to determine the effects of PJ consumption on markers of inflammation in patients with type 2 diabetes (T2D. Materials and Methods: In a randomized, double-blind clinical trial study, 50 patients with T2D (40-65 years old were randomly assigned to one of two groups. Participants in each group received either 250 mL/day PJ or a control beverage for 12 weeks. Biochemical markers including fasting plasma glucose (FPG, insulin and inflammatory markers were assayed on the baseline and follow-up blood samples. Results: In all, 44 patients in two groups were included in the analysis: PJ (n = 22 and placebo (n = 22. After 12 weeks of intervention, in the PJ group, there were 32% and 30% significant decreases in plasma C-reactive protein (hs-CRP and Interlukin-6, respectively (P < 0.05. The mean ± SD plasma interlukin-6 (7.1 ± 5.6 vs. 11.9 ± 14.4 mg/L and hs-CRP (1791 ± 1657 and 1953 ± 1561 ng/mL concentrations in the PJ group were significantly lower than the placebo group after intervention (P < 0.05. Conclusion: PJ consumption by patients with T2D does not affect FPG or the insulin resistance index (HOMA-IR, whereas it does reduce Interlukin-6 and hs-CRP concentrations in plasma. Therefore, PJ consumption may have an anti-inflammatory effect in patients with T2D.

  2. The effects of metformin on weight loss in women with gestational diabetes: a pilot randomized, placebo-controlled trial.

    Science.gov (United States)

    Refuerzo, Jerrie S; Viteri, Oscar A; Hutchinson, Maria; Pedroza, Claudia; Blackwell, Sean C; Tyson, Jon E; Ramin, Susan M

    2015-03-01

    We sought to compare weight loss in the first 6 weeks postpartum among women with gestational diabetes mellitus (GDM) treated with metformin or placebo, a promising therapy to reduce later risk of progression to diabetes mellitus. We conducted a pilot, randomized trial of metformin vs placebo in postpartum women with GDM. Women with pre-GDM, unable to tolerate metformin, resumed on insulin or oral hypoglycemic agent, delivered Women were randomized to either metformin 850 mg daily for 7 days, then metformin 850 mg twice a day for the next 5 weeks or placebo prescribed in a similar frequency. The subject, health care provider, and research staff were blinded to the treatment. The primary outcome was weight change from delivery to 6 weeks postpartum. Secondary outcomes included the percentage of women achieving their self-reported prepregnancy weight, reported medication adherence, adverse effects, and satisfaction. Differences in weight change between groups were determined by Wilcoxon rank sum test and in achieving prepregnancy weight by χ(2) test. Of 114 women randomized, 79 (69.3%) completed the 6 weeks; 36 (45.6%) were randomized to metformin and 43 (54.4%) to placebo. Metformin and placebo groups were similar in median weight loss (6.3 kg [range, -0.3 to 19.8] vs 6.5 kg [range, -0.3 to 12.1], P = .988) and percentage of women achieving reported prepregnancy weight (41.7 vs 37.2%, P = .69). Self-reported adherence in taking >50% of medication was 75% at 3 weeks and 97% at 6 weeks. Nausea, diarrhea, and hypoglycemia were reported in approximately 11-17% of women and 56-63% reported dissatisfaction with the medication. Women with GDM lost approximately 6 kg by 6 weeks' postpartum. This was similar in both groups and resulted in women achieving their prepregnancy weight. Although the reported adherence and satisfaction with the medication was high, adverse effects were reported with nearly 1 in 5 women including nausea, diarrhea, and hypoglycemia. Contrary to

  3. Effectiveness of Computer Automation for the Diagnosis and Management of Childhood Type 2 Diabetes: A Randomized Clinical Trial.

    Science.gov (United States)

    Hannon, Tamara S; Dugan, Tamara M; Saha, Chandan K; McKee, Steven J; Downs, Stephen M; Carroll, Aaron E

    2017-04-01

    Type 2 diabetes (T2D) is increasingly common in young individuals. Primary prevention and screening among children and adolescents who are at substantial risk for T2D are recommended, but implementation of T2D screening practices in the pediatric primary care setting is uncommon. To determine the feasibility and effectiveness of a computerized clinical decision support system to identify pediatric patients at high risk for T2D and to coordinate screening for and diagnosis of prediabetes and T2D. This cluster-randomized clinical trial included patients from 4 primary care pediatric clinics. Two clinics were randomized to the computerized clinical decision support intervention, aimed at physicians, and 2 were randomized to the control condition. Patients of interest included children, adolescents, and young adults 10 years or older. Data were collected from January 1, 2013, through December 1, 2016. Comparison of physician screening and follow-up practices after adding a T2D module to an existing computer decision support system. Electronic medical record (EMR) data from patients 10 years or older were reviewed to determine the rates at which pediatric patients were identified as having a body mass index (BMI) at or above the 85th percentile and 2 or more risk factors for T2D and underwent screening for T2D. Medical records were reviewed for 1369 eligible children (712 boys [52.0%] and 657 girls [48.0%]; median [interquartile range] age, 12.9 [11.2-15.3]), of whom 684 were randomized to the control group and 685 to the intervention group. Of these, 663 (48.4%) had a BMI at or above the 85th percentile. Five hundred sixty-five patients (41.3%) met T2D screening criteria, with no difference between control and intervention sites. The T2D module led to a significant increase in the percentage of patients undergoing screening for T2D (89 of 283 [31.4%] vs 26 of 282 [9.2%]; adjusted odds ratio, 4.6; 95% CI, 1.5-14.7) and a greater proportion attending a scheduled follow

  4. 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

  5. Design and methods for a randomized clinical trial of a diabetes self-management intervention for low-income Latinos: Latinos en Control.

    Science.gov (United States)

    Rosal, Milagros C; White, Mary Jo; Restrepo, Angela; Olendzki, Barbara; Scavron, Jeffrey; Sinagra, Elise; Ockene, Ira S; Thompson, Michael; Lemon, Stephenie C; Candib, Lucy M; Reed, George

    2009-12-09

    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. 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%. 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.

  6. 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 self-adjustment (t = 7.53, p self-monitoring (t = 6.42, p self-management (t = 10.82, p self-manage diabetes.

  7. Quality of life and sleep quality are similarly improved after aquatic or dry-land aerobic training in patients with type 2 diabetes: A randomized clinical trial.

    Science.gov (United States)

    S Delevatti, Rodrigo; Schuch, Felipe Barreto; Kanitz, Ana Carolina; Alberton, Cristine L; Marson, Elisa Corrêa; Lisboa, Salime Chedid; Pinho, Carolina Dertzbocher Feil; Bregagnol, Luciana Peruchena; Becker, Maríndia Teixeira; Kruel, Luiz Fernando M

    2017-09-06

    To compare the effects of two aerobic training models in water and on dry-land on quality of life, depressive symptoms and sleep quality in patients with type 2 diabetes. Randomized clinical trial. Thirty-five patients with type 2 diabetes were randomly assigned to aquatic aerobic training group (n=17) or dry-land aerobic training group (n=18). Exercise training length was of 12 weeks, performed in three weekly sessions (45min/session), with intensity progressing from 85% to 100% of heart rate of anaerobic threshold during interventions. All outcomes were evaluated at baseline and 12 weeks later. In per protocol analysis, physical and psychological domains of quality of life improved in both groups (pland environment on quality of life, depressive symptoms and sleep quality in patients with type 2 diabetes. Clinical trial reg. no. NCT01956357, clinicaltrials.gov. Copyright © 2017 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  8. Appropriate Insulin Level in Selecting Fortified Diet-Fed, Streptozotocin-Treated Rat Model of Type 2 Diabetes for Anti-Diabetic Studies.

    Science.gov (United States)

    Okoduwa, Stanley Irobekhian Reuben; Umar, Ismaila A; James, Dorcas B; Inuwa, Hajiya M

    2017-01-01

    Pathophysiological investigation of disease in a suitable animal model is a classical approach towards development of a credible therapeutic strategy. This study examined appropriate insulin level in selecting animal model for type 2 diabetes (T2D) studies. Albino Wistar rats (150-200g) were divided into two groups fed with commercially available normal-diet-feed (NDF) and water or fortified diet feed (FDF) (10g NDF per gram of margarine) with 20% fructose solution as drinking water. After 6 weeks of dietary regimen both groups were divided into 5 sub-groups and injected intraperitoneally with a graded dose of streptozotocin (STZ) (0, 25, 35, 45 & 55mg/kg bw.). The result showed that the FDF-fed rats increased significantly in body weight, basal serum insulin, total cholesterol, triglycerides and blood glucose levels as compared to NDF-fed rats. Ten days post STZ induction, the groups treated with STZ (45 & 55 mg/kg) developed frank hyperglycaemia with insulin, a severe deficiency typical of diabetes type 1. The NDF25 and NDF35 groups with 75.7% and 64.4% serum insulin respectively presented relative normoglycemia, whereas the FDF35 (85.8% serum insulin) were notably hyperglycaemia (>300 mg/dL) throughout the 6weeks post diabetes confirmation. These FDF35 rats were sensitive to glibenclamide, metformin and pioglitazone in lowering hyperglycaemia, hypertriglyceridemia and hypercholesterolemia. The hyperglycaemia stability of the FDF35 rats (85.5% insulin) together with their sensitivity to 3 different hypoglycaemic drugs strongly suggests their suitability as a non-genetic model of T2D. Hence the study shows that circulating serum insulin ≥ 85.8% with overt hyperglycaemia may be utilized as the benchmark in selecting rat models for T2D studies.

  9. Bone mineral density and risk of type 2 diabetes and coronary heart disease: A Mendelian randomization study.

    Science.gov (United States)

    Gan, Wei; Clarke, Robert J; Mahajan, Anubha; Kulohoma, Benard; Kitajima, Hidetoshi; Robertson, Neil R; Rayner, N William; Walters, Robin G; Holmes, Michael V; Chen, Zhengming; McCarthy, Mark I

    2017-01-01

    Background: Observational studies have demonstrated that increased bone mineral density is associated with a higher risk of type 2 diabetes (T2D), but the relationship with risk of coronary heart disease (CHD) is less clear. Moreover, substantial uncertainty remains about the causal relevance of increased bone mineral density for T2D and CHD, which can be assessed by Mendelian randomisation studies.  Methods: We identified 235 independent single nucleotide polymorphisms (SNPs) associated at pMendelian randomization approaches was used to investigate the causal relevance of eBMD for risk of T2D and CHD. In addition, we explored the relationship of eBMD, instrumented by the 235 SNPs, on 12 cardiovascular and metabolic risk factors. Finally, we conducted Mendelian randomization analysis in the reverse direction to investigate reverse causality. Results: Each one standard deviation increase in genetically instrumented eBMD (equivalent to 0.14 g/cm 2) was associated with an 8% higher risk of T2D (odds ratio [OR] 1.08; 95% confidence interval [CI]: 1.02 to 1.14; p=0.012) and 5% higher risk of CHD (OR 1.05; 95%CI: 1.00 to 1.10; p=0.034). Consistent results were obtained in sensitivity analyses using several different Mendelian randomization approaches. Equivalent increases in eBMD were also associated with lower plasma levels of HDL-cholesterol and increased insulin resistance. Mendelian randomization in the reverse direction using 94 T2D SNPs or 52 CHD SNPs showed no evidence of reverse causality with eBMD. Conclusions: These findings suggest a causal relationship between elevated bone mineral density with risks of both T2D and CHD.

  10. 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

  11. Results From a European Multicenter Randomized Trial of Physical Activity and/or Healthy Eating to Reduce the Risk of Gestational Diabetes Mellitus: The DALI Lifestyle Pilot

    NARCIS (Netherlands)

    Simmons, D.; Jelsma, J.G.M.; Galjaard, S.; Devlieger, R.; van Assche, A.; Jans, G.; Corcoy, R.; Adelantado, J.M.; Dunne, F.; Desoye, G.; Harreiter, J.; Kautzky-Willer, A.; Damm, P.; Mathiesen, E.R.; Jensen, D.M.; Andersen, L.L.; Lapolla, A.; Dalfra, M.; Bertolotto, A.; Wender-Ozegowska, E.; Zawiejska, A.; Hill, D.; Rebollo, P.; Snoek, F.J.; van Poppel, M.N.M.

    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 Pregnant

  12. Effect of surgical decompression of nerves in the lower extremity in patients with painful diabetic polyneuropathy on stability : A randomized controlled trial

    NARCIS (Netherlands)

    Macare van Maurik, JFM; Ter Horst, Britt; Van Hal, Mireille; Kon, Moshe; Peters, Edgar J G

    2015-01-01

    Objective: To investigate the effect of decompression of nerves in the lower extremity in patients with painful diabetic polyneuropathy on static balance using a sensitive pressure mat system. Design: Non-blinded randomized controlled trial. Setting: Single center study performed at the University

  13. Effectiveness of shared goal setting and decision making to achieve treatment targets in type 2 diabetes patients : A cluster-randomized trial (OPTIMAL)

    NARCIS (Netherlands)

    Den Ouden, Henk; Vos, Rimke C.; Rutten, Guy E.H.M.|info:eu-repo/dai/nl/074622781

    2017-01-01

    Objective: About 20% of patients with type 2 diabetes achieve all their treatment targets. Shared decision making (SDM) using a support aid based on the 5-years results of the ADDITION study on multifactorial treatment, could increase this proportion. Research design and methods: Cluster-randomized

  14. 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...

  15. 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.

  16. Short- and medium-term effects of light to moderate alcohol intake on glycaemic control in diabetes mellitus: a systematic review and meta-analysis of randomized trials.

    Science.gov (United States)

    Hirst, J A; Aronson, J K; Feakins, B G; Ma, C; Farmer, A J; Stevens, R J

    2017-05-01

    People with diabetes are told that drinking alcohol may increase their risk of hypoglycaemia. To report the effects of alcohol consumption on glycaemic control in people with diabetes mellitus. Medline, EMBASE and the Cochrane Library databases were searched in 2015 to identify randomized trials that compared alcohol consumption with no alcohol use, reporting glycaemic control in people with diabetes. Data on blood glucose, HbA1c and numbers of hypoglycaemic episodes were pooled using random effects meta-analysis. Pooled data from nine short-term studies showed no difference in blood glucose concentrations between those who drank alcohol in doses of 16-80 g (median 20 g, 2.5 units) compared with those who did not drink alcohol at 0.5, 2, 4 and 24 h after alcohol consumption. Pooled data from five medium-term studies showed that there was no difference in blood glucose or HbA1c concentrations at the end of the study between those who drank 11-18 g alcohol/day (median 13 g/day, 1.5 units/day) for 4-104 weeks and those who did not. We found no evidence of a difference in number of hypoglycaemic episodes or in withdrawal rates between randomized groups. Studies to date have not provided evidence that drinking light to moderate amounts of alcohol, with or without a meal, affects any measure of glycaemic control in people with Type 2 diabetes. These results suggest that current advice that people with diabetes do not need to refrain from drinking moderate quantities of alcohol does not need to be changed; risks to those with Type 1 diabetes remain uncertain. © 2016 Diabetes UK.

  17. 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.

  18. The adverse effect of selective cyclooxygenase-2 inhibitor on random skin flap survival in rats.

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    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.

  19. 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.

  20. Antibiotic Susceptibility Profiles of Bacteria from Diabetic Foot Infections in Selected Teaching Hospitals in Southwestern Nigeria

    OpenAIRE

    Bello, Olorunjuwon O; Oyekanmi, Edward O; Kelly, Babatunde A; Mebude, Olakunle O; Bello, Temitope K

    2018-01-01

    One of the serious complications associated with diabetes is foot ulcer and this condition affects the quality of life in patients in all classes, races and ages. Chronic wounds are prone to colonization by wide array of microorganisms which could be extremely hazardous to patients if effective and timely therapeutic intervention is not made. This study was conducted to determine the antibiotic susceptibility profiles of bacteria from diabetic foot infections in southwestern Nigeria. Samples ...

  1. Rapid selection of accessible and cleavable sites in RNA by Escherichia coli RNase P and random external guide sequences

    OpenAIRE

    Lundblad, Eirik W.; Xiao, Gaoping; Ko, Jae-hyeong; Altman, Sidney

    2008-01-01

    A method of inhibiting the expression of particular genes by using external guide sequences (EGSs) has been improved in its rapidity and specificity. Random EGSs that have 14-nt random sequences are used in the selection procedure for an EGS that attacks the mRNA for a gene in a particular location. A mixture of the random EGSs, the particular target RNA, and RNase P is used in the diagnostic procedure, which, after completion, is analyzed in a gel with suitable control lanes. Within a few ho...

  2. Prevention of gestational diabetes: design of a cluster-randomized controlled trial and one-year follow-up.

    Science.gov (United States)

    Luoto, Riitta M; Kinnunen, Tarja I; Aittasalo, Minna; Ojala, Katriina; Mansikkamäki, Kirsi; Toropainen, Erja; Kolu, Päivi; Vasankari, Tommi

    2010-08-03

    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. 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>or=25 kg/m2, history of earlier gestational glucose intolerance or macrosomic newborn (>4500 g), age>or=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-effectiveness evaluation will be based on quality-adjusted life years. This

  3. 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

  4. Diabetes Learning in Virtual Environments: Testing the Efficacy of Self-Management Training and Support in Virtual Environments (Randomized Controlled Trial Protocol).

    Science.gov (United States)

    Vorderstrasse, Allison A; Melkus, Gail D; Pan, Wei; Lewinski, Allison A; Johnson, Constance M

    2015-01-01

    Ongoing self-management improves outcomes for those with Type 2 diabetes (T2D); however, there are many barriers to patients receiving assistance in this from the healthcare system and peers. Findings from our pilot study showed that a virtual diabetes community on the Internet with real-time interaction among peers with T2D-and with healthcare professionals-is feasible and has the potential to influence clinical and psychosocial outcomes. The purpose of this article is to present the protocol for the Diabetes Learning in Virtual Environments (LIVE) trial. Diabetes LIVE is a two-group, randomized controlled trial to compare effects of a virtual environment and traditional Web site on diet and physical activity. Our secondary aims will determine the effects on metabolic outcomes; effects of level of engagement and social network formation in LIVE on behavioral outcomes; potential mediating effects of changes in self-efficacy; and diabetes knowledge, diabetes-related distress, and social support on behavior change and metabolic outcomes. We will enroll 300 subjects at two sites (Duke University/Raleigh-Durham, NC and New York University/New York, NY) who have T2D and do not have serious complications or comorbidities. Those randomly assigned to the intervention group have access to the LIVE site where they can find information, synchronous classes with diabetes educators, and peer support to enhance self-management. Those in the control group have access to the same informational and educational content in a traditional asynchronous Web format. Measures of self-management, clinical outcomes, and psychosocial outcomes are assessed at baseline and 3, 6, 12, and 18 months. Should LIVE prove effective in improved self-management of diabetes, similar interventions could be applied to other prevalent chronic diseases. Innovative programs such as LIVE have potential for improving healthcare access in an easily disseminated alternative model of care that potentially improves

  5. 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.

  6. Does early intensive multifactorial therapy reduce modelled cardiovascular risk in individuals with screen-detected diabetes? Results from the ADDITION-Europe cluster randomized trial.

    Science.gov (United States)

    Black, J A; Sharp, S J; Wareham, N J; Sandbaek, A; Rutten, G E H M; Lauritzen, T; Khunti, K; Davies, M J; Borch-Johnsen, K; Griffin, S J; Simmons, R K

    2014-06-01

    Little is known about the long-term effects of intensive multifactorial treatment early in the diabetes disease trajectory. In the absence of long-term data on hard outcomes, we described change in 10-year modelled cardiovascular risk in the 5 years following diagnosis, and quantified the impact of intensive treatment on 10-year modelled cardiovascular risk at 5 years. In a pragmatic, cluster-randomized, parallel-group trial in Denmark, the Netherlands and the UK, 3057 people with screen-detected Type 2 diabetes were randomized by general practice to receive (1) routine care of diabetes according to national guidelines (1379 patients) or (2) intensive multifactorial target-driven management (1678 patients). Ten-year modelled cardiovascular disease risk was calculated at baseline and 5 years using the UK Prospective Diabetes Study Risk Engine (version 3β). Among 2101 individuals with complete data at follow up (73.4%), 10-year modelled cardiovascular disease risk was 27.3% (sd 13.9) at baseline and 21.3% (sd 13.8) at 5-year follow-up (intensive treatment group difference -6.9, sd 9.0; routine care group difference -5.0, sd 12.2). Modelled 10-year cardiovascular disease risk was lower in the intensive treatment group compared with the routine care group at 5 years, after adjustment for baseline cardiovascular disease risk and clustering (-2.0; 95% CI -3.1 to -0.9). Despite increasing age and diabetes duration, there was a decline in modelled cardiovascular disease risk in the 5 years following diagnosis. Compared with routine care, 10-year modelled cardiovascular disease risk was lower in the intensive treatment group at 5 years. Our results suggest that patients benefit from intensive treatment early in the diabetes disease trajectory, where the rate of cardiovascular disease risk progression may be slowed. © 2014 The Authors. Diabetic Medicine © 2014 Diabetes UK.

  7. Randomized Trial of a Literacy-Sensitive, Culturally Tailored Diabetes Self-Management Intervention for Low-Income Latinos

    Science.gov (United States)

    Rosal, Milagros C.; Ockene, Ira S.; Restrepo, Angela; White, Mary Jo; Borg, Amy; Olendzki, Barbara; Scavron, Jeffrey; Candib, Lucy; Welch, Garry; Reed, George

    2011-01-01

    OBJECTIVE To test whether a theory-based, literacy, and culturally tailored self-management intervention, Latinos en Control, improves glycemic control among low-income Latinos with type 2 diabetes. RESEARCH DESIGN AND METHODS A total of 252 patients recruited from community health centers were randomized to the Latinos en Control intervention or to usual care. The primarily group-based intervention consisted of 12 weekly and 8 monthly sessions and targeted knowledge, attitudes, and self-management behaviors. The primary outcome was HbA1c. Secondary outcomes included diet, physical activity, blood glucose self-monitoring, diabetes knowledge and self-efficacy, and other physiological factors (e.g., lipids, blood pressure, and weight). Measures were collected at baseline and at 4- and 12-month follow-up. Change in outcomes over time between the groups and the association between HbA1c and possible mediators were estimated using mixed-effects models and an intention-to-treat approach. RESULTS A significant difference in HbA1c change between the groups was observed at 4 months (intervention −0.88 [−1.15 to −0.60] versus control −0.35 [−0.62 to 0.07], P < 0.01), although this difference decreased and lost statistical significance at 12 months (intervention −0.46 [−0.77 to −0.13] versus control −0.20 [−0.53 to 0.13], P = 0.293). The intervention resulted in significant change differences in diabetes knowledge at 12 months (P = 0.001), self-efficacy (P = 0.001), blood glucose self-monitoring (P = 0.02), and diet, including dietary quality (P = 0.01), kilocalories consumed (P < 0.001), percentage of fat (P = 0.003), and percentage of saturated fat (P = 0.04). These changes were in turn significantly associated with HbA1c change at 12 months. CONCLUSIONS Literacy-sensitive, culturally tailored interventions can improve diabetes control among low-income Latinos; however, strategies to sustain improvements are needed. PMID:21378213

  8. 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.

  9. Effectiveness of Green Tea in a Randomized Human Cohort: Relevance to Diabetes and Its Complications

    Science.gov (United States)

    Aruoma, Okezie I.; Gunness, Teeluck K.; Kowlessur, Sudhir; Dambala, Venkatesh; Murad, Fatima; Googoolye, Kreshna; Daus, Diana; Indelicato, Joseph; Rondeau, Philippe

    2013-01-01

    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 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. PMID:24102055

  10. 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 weight if BMI ≥25.0 kg/m(2); and pregravid to postpartum weight change. On average, over the 12-month postpartum period, women in the intervention had significantly higher odds of meeting weight goals than women in usual care (odds ratio [OR] 1.28 [95% CI 1.10, 1.47]). The proportion meeting weight goals was significantly higher in the intervention than usual care at 6 weeks (25.5 vs. 22.4%; OR 1.17 [1.01, 1.36]) and 6 months (30.6 vs. 23.9%; OR 1.45 [1.14, 1.83]). Condition differences were reduced at 12 months (33.0 vs. 28.0%; OR 1.25 [0.96, 1.62]). At 6 months, women in the intervention retained significantly less weight than women in usual care (mean 0.39 kg [SD 5.5] vs. 0.95 kg [5.5]; mean condition difference -0.64 kg [95% CI -1.13, -0.14]) and had greater increases in vigorous-intensity physical activity (mean condition difference 15.4 min/week [4.9, 25.8]). A DPP-derived lifestyle intervention modestly reduced postpartum weight retention and increased vigorous-intensity physical activity. © 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.

  11. Serum lipids and diabetic retinopathy

    Directory of Open Access Journals (Sweden)

    Shoja MR

    2007-05-01

    Full Text Available Background: Diabetes Mellitus is the most common endocrinologic disease in human and retinopathy is one of the most common complications. Etiology of this complication is yet unknown but one of the factors that can be effective on its production or progression is serum lipid. We aim to study the relationship between different degrees of diabetic retinopathy and serum lipids levels. Methods: An observational cross-sectional study designed to study over 37 patients with diabetes mellitus type one and 157 patients with diabetes mellitus type two. Former was selected as sensus and latter was selected randomly from diabetic patients attending the diabetes clinic in Yazd during 2002. Inclusion criteria was duration of diabetes at least seven years from diagnosis. Statistical analysis performed by SPSS package edition 11 and wit statistical tests as Chi square, Fisher Exact and ANOVA. Results: Among 194 cases, 74 cases were males and 120 females. 90 cases (46.4% have normal total serum cholesterol and 104 (53.6% hypercholestrolemia. In case of triglyceride 94 cases (48.4% have normal serum triglyceride and 100 (51.6% hypertriglyceridemia. Distribution of different degrees of diabetic retinopathy was statistically significant due to cholesterol and triglycerides (P-Value<0.05. In different groups of sex, diabetic retinopathy was more prevalent if there was hypertriglyceridemia or hypercholesterolemia. This was correct about different groups of age and type of diabetes. This means that in different groups of age and type of diabetes, diabetic retinopathy was more prevalent if there was hypertriglyceridemia or hypercholesterolemia. Conclusion: Prevalence of diabetic retinopathy is higher in cases with hypertriglyceridemia or hypercholesterolemia than cases with normal serum triglyceride or cholesterole.

  12. 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.)

  13. 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.

  14. Evaluation of antidiabetic potential of selected traditional Chinese medicines in STZ-induced diabetic mice.

    Science.gov (United States)

    He, Kai; Li, Xuegang; Chen, Xin; Ye, Xiaoli; Huang, Jing; Jin, Yanan; Li, Panpan; Deng, Yafei; Jin, Qing; Shi, Qing; Shu, Hejing

    2011-10-11

    Traditional Chinese medicine (TCM) has been used for treating complex chronic diseases owing to their fewer side-effects, better patient tolerance and relatively less cost. The present work was carried out to study the anti-diabetic efficacy and mechanisms of 34 TCMs. Streptozotocin (STZ)-diabetic mice were orally administrated with corresponding herbal solution once a day for 4 weeks. At the end of experiment, the level of plasma glucose, malondialdehyde (MDA), the activity of superoxide dismutase (SOD) and the serum aldose reductase (AR) were determined, the effects of TCM extract on α-glucosidase and angiotensin-converting enzyme (ACE) in vitro were also evaluated. 13 out of the 34 herbs showed a statistically significant plasma glucose lowering action compared with the diabetic control group. Biochemical analysis revealed that Atractylodes macrocephala, Codonopsis pilosula, Dioscorea opposite, Flos lonicerae and Pueraria lobata may retard the progression of diabetes via reduce the blood glucose level and prevent the increase of AR activity. Other tested herbs, such as Ramulus cinnamomi, Cinnamomum cassia, and Eucommia ulmoides, showed the antidiabetic ability by either prevent the decrease in SOD activity or suppress the increase of MDA. Zymologic assay reveals that Pueraria lobata and Anemarrhena asphodeloides showed the highest inhibition against α-glucosidase and ACE respectively. Interestingly, the post-treatment glucose levels and AR activity were positively correlated with kidney/body weight of 34 herbs treated diabetic mice (p = 0.02, 0.04 respectively). Several potential antidiabetic herbs derived from Chinese traditional pharmacopeia such as Dioscorea opposite, Pueraria lobata, Codonopsis pilosula and Ramulus cinnamomi, have been found to exert a beneficial action on diabetes and diabetic complications via multi-mechanisms. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  15. CURE-SMOTE algorithm and hybrid algorithm for feature selection and parameter optimization based on random forests.

    Science.gov (United States)

    Ma, Li; Fan, Suohai

    2017-03-14

    The random forests algorithm is a type of classifier with prominent universality, a wide application range, and robustness for avoiding overfitting. But there are still some drawbacks to random forests. Therefore, to improve the performance of random forests, this paper seeks to improve imbalanced data processing, feature selection and parameter optimization. We propose the CURE-SMOTE algorithm for the imbalanced data classification problem. Experiments on imbalanced UCI data reveal that the combination of Clustering Using Representatives (CURE) enhances the original synthetic minority oversampling technique (SMOTE) algorithms effectively compared with the classification results on the original data using random sampling, Borderline-SMOTE1, safe-level SMOTE, C-SMOTE, and k-means-SMOTE. Additionally, the hybrid RF (random forests) algorithm has been proposed for feature selection and parameter optimization, which uses the minimum out of bag (OOB) data error as its objective function. Simulation results on binary and higher-dimensional data indicate that the proposed hybrid RF algorithms, hybrid genetic-random forests algorithm, hybrid particle swarm-random forests algorithm and hybrid fish swarm-random forests algorithm can achieve the minimum OOB error and show the best generalization ability. The training set produced from the proposed CURE-SMOTE algorithm is closer to the original data distribution because it contains minimal noise. Thus, better classification results are produced from this feasible and effective algorithm. Moreover, the hybrid algorithm's F-value, G-mean, AUC and OOB scores demonstrate that they surpass the performance of the original RF algorithm. Hence, this hybrid algorithm provides a new way to perform feature selection and parameter optimization.

  16. 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.

  17. Noise-induced hearing loss in randomly selected New York dairy farmers.

    Science.gov (United States)

    May, J J; Marvel, M; Regan, M; Marvel, L H; Pratt, D S

    1990-01-01

    To understand better the effects of noise levels associated with dairy farming, we randomly selected 49 full-time dairy farmers from an established cohort. Medical and occupational histories were taken and standard audiometric testing was done. Forty-six males (94%) and three females (6%) with a mean age of 43.5 (+/- 13) years and an average of 29.4 (+/- 14) years in farming were tested. Pure Tone Average thresholds (PTA4) at 0.5, 1.0, 2.0, and 3.0 kHz plus High Frequency Average thresholds (HFA3) at 3.0, 4.0, and 6.0 kHz were calculated. Subjects with a loss of greater than or equal to 20 db in either ear were considered abnormal. Eighteen subjects (37%) had abnormal PTA4S and 32 (65%) abnormal HFA3S. The left ear was more severely affected in both groups (p less than or equal to .05, t-test). Significant associations were found between hearing loss and years worked (odds ratio 4.1, r = .53) and age (odds ratio 4.1, r = .59). No association could be found between hearing loss and measles; mumps; previous ear infections; or use of power tools, guns, motorcycles, snowmobiles, or stereo headphones. Our data suggest that among farmers, substantial hearing loss occurs especially in the high-frequency ranges. Presbycusis is an important confounding variable.

  18. Modeling Slotted Aloha as a Stochastic Game with Random Discrete Power Selection Algorithms

    Directory of Open Access Journals (Sweden)

    Rachid El-Azouzi

    2009-01-01

    Full Text Available We consider the uplink case of a cellular system where bufferless mobiles transmit over a common channel to a base station, using the slotted aloha medium access protocol. We study the performance of this system under several power differentiation schemes. Indeed, we consider a random set of selectable transmission powers and further study the impact of priorities given either to new arrival packets or to the backlogged ones. Later, we address a general capture model where a mobile transmits successfully a packet if its instantaneous SINR (signal to interferences plus noise ratio is lager than some fixed threshold. Under this capture model, we analyze both the cooperative team in which a common goal is jointly optimized as well as the noncooperative game problem where mobiles reach to optimize their own objectives. Furthermore, we derive the throughput and the expected delay and use them as the objectives to optimize and provide a stability analysis as alternative study. Exhaustive performance evaluations were carried out, we show that schemes with power differentiation improve significantly the individual as well as global performances, and could eliminate in some cases the bi-stable nature of slotted aloha.

  19. Discovery of JANUVIA (Sitagliptin), a selective dipeptidyl peptidase IV inhibitor for the treatment of type 2 diabetes.

    Science.gov (United States)

    Thornberry, Nancy A; Weber, Ann E

    2007-01-01

    The emergence of glucagon-like peptide 1 (GLP-1) as a well validated approach to the treatment of type 2 diabetes and preclinical validation of dipeptidyl peptidase IV (DPP-4) inhibition as an alternate, oral approach to GLP-1 therapy prompted the initiation of a DPP-4 inhibitor program at Merck in 1999. DPP-4 inhibitors threo- and allo-isoleucyl thiazolidide were in-licensed to jump start the program; however, development was discontinued due to profound toxicity in rat and dog safety studies. The observation that both compounds inhibit the related proline peptidases DPP8 and DPP9 led to the hypothesis that inhibition of DPP8 and/or DPP9 could evoke severe toxicities in preclinical species. Indeed, the observed toxicities were recapitulated with a selective dual DPP8/9 inhibitor but not with an inhibitor selective for DPP-4. Thus, medicinal chemistry efforts focused on identifying a highly selective DPP-4 inibitor for clinical development. Initial work in an alpha-amino acid series related to isoleucyl thiazolidide was discontinued due to lack of selectivity; however, SAR studies on two screening leads led to the identification of a highly selective beta-amino acid piperazine series. In an effort to stabilize the piperazine moiety, which was extensively metabolized in vivo, a series of bicyclic derivatives were prepared, culminating in the identification of a potent and selective triazolopiperazine series. Unlike their monocyclic counterparts, these analogs typically showed excellent pharmacokinetic properties in preclinical species. Optimization of this series led to the discovery of JANUVIA (sitagliptin), a highly selective DPP-4 inhibitor for the treatment of type 2 diabetes.

  20. 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.

  1. Diabetes self-management education after pre-selection of patients: design of a randomised controlled trial.

    Science.gov (United States)

    Vos, Rimke C; Eikelenboom, Nathalie W D; Klomp, Maarten; Stellato, Rebecca K; Rutten, Guy E H M

    2016-01-01

    Many self-management programs have been developed so far. Their effectiveness varies. The program 'Beyond Good Intentions' (BGI) is based on proactive coping and has proven to be (cost-) effective in achieving reductions in BMI and blood pressure in screen-detected type 2 diabetes patients up until nine months follow-up. However, its long-term effectiveness in people already known with diabetes is lacking. In addition, its (cost-) effectiveness might increase if people who are likely not to be benefit from the program are excluded in a valid way. Therefore it was aimed to investigate the long-term effects of the educational program BGI on cardiovascular risk, quality of life and diabetes self-management behaviour in a pre-selected group of patients known with type 2 diabetes up to 5 years. Randomised controlled trial with 2.5 year follow-up. Adults (≤75 years) with a type 2 diabetes duration between 3 months and 5 years will be included. With the use of a self-management screening tool (SeMaS) their potential barriers of self-management due to depression and/or anxiety will be determined. Based on the results of the SeMaS selection patients will be randomised (1:1) to the BGI-group (n = 53) or the control-group (n = 53). In addition to receiving usual care, patients in the BGI-group will follow the 12-week theory-based self-management program and a booster session a few months thereafter. The control-group will receive care as usual. The primary outcome is change in Body Mass Index after 2.5 years follow-up. Secondary outcomes are HbA1c, lipid profile and systolic blood pressure, (diabetes) quality of life, level of physical activity, dietary intake and medication adherence and proactive coping. Cost-effectiveness will be based on total use of health care resources during the entire study period. Difference between groups in change over time will be analysed according to intention-to-treat analysis. By differentiating between patients who will and those

  2. A randomized controlled trial using glycemic plus fetal ultrasound parameters versus glycemic parameters to determine insulin therapy in gestational diabetes with fasting hyperglycemia.

    Science.gov (United States)

    Kjos, S L; Schaefer-Graf, U; Sardesi, S; Peters, R K; Buley, A; Xiang, A H; Bryne, J D; Sutherland, C; Montoro, M N; Buchanan, T A

    2001-11-01

    To compare management based on maternal glycemic criteria with management based on relaxed glycemic criteria and fetal abdominal circumference (AC) measurements in order to select patients for insulin treatment of gestational diabetes mellitus (GDM) with fasting hyperglycemia. In a pilot study, 98 women with fasting plasma glucose (FPG) concentrations of 105-120 mg/dl were randomized. The standard group received insulin treatment. The experimental group received insulin if the AC, measured monthly, was > or =70th percentile and/or if any venous FPG measurement was >120 mg/dl. Power was projected to detect a 250-g difference in birth weights. Gestational ages, maternal glycemia, and AC percentiles were similar at randomization. After initiation of protocol, venous FPG (P = 0.003) and capillary blood glucose levels (P = 0.049) were significantly lower in the standard group. Birth weights (3,271 +/- 458 vs. 3,369 +/- 461 g), frequencies of birth weights >90th percentile (6.3 vs 8.3%), and neonatal morbidity (25 vs. 25%) did not differ significantly between the standard and experimental groups, respectively. The cesarean delivery rate was significantly lower (14.6 vs. 33.3%, P = 0.03) in the standard group; this difference was not explained by birth weights. In the experimental group, infants of women who did not receive insulin had lower birth weights than infants of mothers treated with insulin (3,180 +/- 425 vs. 3,482 +/- 451 g, P = 0.03). In women with GDM and fasting hyperglycemia, glucose plus fetal AC measurements identified pregnancies at low risk for macrosomia and resulted in the avoidance of insulin therapy in 38% of patients without increasing rates of neonatal morbidity.

  3. 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…

  4. Retinal Changes in Nigerian Diabetics and Mode of Treatment | Mba ...

    African Journals Online (AJOL)

    The retinae of 200 randomly selected diabetics attending the University of Nigeria Teaching Hospital, Enugu diabetes clinic between 1989 and 1991 were examined with a Keeler fundoscope in a dark room after maximal pupillary dilation. The findings were analyzed according to the mode of treatment viz insulin treated, ...

  5. Genetically predicted milk consumption and bone health, ischemic heart disease and type 2 diabetes: a Mendelian randomization study.

    Science.gov (United States)

    Yang, Q; Lin, S L; Au Yeung, S L; Kwok, M K; Xu, L; Leung, G M; Schooling, C M

    2017-08-01

    Milk provides protein and micronutrients, and is recommended by some dietary guidelines, particularly for bone health. Meta-analysis of small randomized controlled trials suggests that milk may increase bone mineral density, but they are very heterogeneous. No randomized controlled trial has assessed the effects of milk on major chronic diseases. Previous Mendelian randomization studies of milk did not consider bone health, found no effects on ischemic heart disease (IHD) or type 2 diabetes (T2D) but higher body mass index. Using larger genetic studies, we estimated the effects of milk on osteoporosis, IHD, T2D, adiposity, lipids and glycemic traits. Instrumental variable analysis based on a genetic variant endowing lactase persistence (rs4988235 (MCM6)) was used to obtain estimates for osteoporosis (GEFOS), IHD (CARDIoGRAMplusC4D), T2D (DIAGRAM), adiposity (GIANT), lipids (GLGC) and glycaemic traits (MAGIC). Eye color was a negative control for IHD, as it mirrors the distribution of lactase persistence and IHD in Western Europe. Genetically predicted adult milk consumption was not clearly associated with bone mineral density, IHD (odds ratio (OR): 1.03 per s.d., 95% confidence interval (CI): 0.95-1.12) and or T2D (OR: 0.92, 95% CI: 0.83-1.02) but was associated with higher log-transformed fasting insulin (0.05, 95% CI: 0.02-0.07) and body mass index (0.06, 95% CI: 0.03-0.09). Genetically predicted eye color was not associated with IHD. The lack of association of genetically predicted milk consumption with bone health, IHD or T2D suggests few beneficial effects but is more consistent with milk promoting adiposity.

  6. 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.

  7. Efficacy of supplementary vitamins C and E on anxiety, depression and stress in type 2 diabetic patients: a randomized, single-blind, placebo-controlled trial.

    Science.gov (United States)

    Mazloom, Zohreh; Ekramzadeh, Maryam; Hejazi, Najmeh

    2013-11-15

    Diabetes mellitus as one of the most prevalent endocrine disease is associated with high oxidative stress. Anxiety, stress and depression are common neuropsychiatric features in diabetic patients. Hyperglycemia leads to increased oxidative stress which in turn diminishes antioxidant defense system. On the other hand oxidative stress is the leading cause of depression and anxiety disorders. Thus, it seems that diabetes could accelerate the trend of psychiatric diseases. In this randomized single-blind study, evaluation of the effects of two antioxidants (vitamin C and vitamin E) was done on Stress, depression and anxiety levels in 45 diabetic patients for six weeks. The patients were randomly divided in three groups of vitamin E (400 IU day(-1)), vitamin C (1000 mg day(-1)) and placebo. DASS-21 (Depression Anxiety Stress Scales 21-item) questionnaire items were read to each patient and completed by the main investigator of this study before and after six weeks of supplementation. The scores of depression, anxiety and stress were evaluated separately based on the DASS questionnaire. The results showed a significant decrease in anxiety level (p = 0.005) in vitamin C group compared to other groups but there were no significant differences between groups in terms of changes in stress and depression scores. In conclusion, this study suggests that short-term supplementation of vitamin C is safe and beneficial for reducing anxiety levels in diabetic patients through alleviating oxidative damage.

  8. Comparison of the sirolimus-eluting versus paclitaxel-eluting coronary stent in patients with diabetes mellitus: the diabetes and drug-eluting stent (DiabeDES) randomized angiography trial

    DEFF Research Database (Denmark)

    Maeng, Michael; Jensen, Lisette Okkels; Galloe, Anders Michael

    2008-01-01

    The aim of the present study was to evaluate angiographic late luminal loss after the implantation of sirolimus-eluting Cypher stents and paclitaxel-eluting Taxus stents in patients with diabetes. The study was a Danish multicenter, open-label, randomized trial. One hundred fifty-three patients...... stent thrombosis, or target lesion revascularization) were observed in 17 patients (Cypher, n = 6; Taxus, n = 11; p = 0.19). In conclusion, angiographic in-stent late luminal loss is significantly reduced in patients with diabetes by use of the sirolimus-eluting Cypher stent compared with the paclitaxel...

  9. 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 < 0.05. The multivariate analysis indicated a reduction in the rate of glucose disorders with a BMI of less than 27 kg/m(2) (OR 0.28; 0.12-0.65; p < 0.003), low fat intake pattern (OR 0.30; 0.13-0.70; p < 0.005), low saturated fat pattern (OR 0.30; 0.13-0.69; p < 0.005) and healthy fat pattern (OR 0.34; 0.12-0.94; p < 0.04). 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.

  10. Long-term Effect of Losartan on Kidney Disease in American Indians With Type 2 Diabetes: A Follow-up Analysis of a Randomized Clinical Trial.

    Science.gov (United States)

    Tanamas, Stephanie K; Saulnier, Pierre-Jean; Fufaa, Gudeta D; Wheelock, Kevin M; Weil, E Jennifer; Hanson, Robert L; Knowler, William C; Bennett, Peter H; Nelson, Robert G

    2016-11-01

    To determine whether early administration of losartan slows progression of diabetic kidney disease over an extended period. We conducted a 6-year clinical trial in 169 American Indians with type 2 diabetes and urine albumin/creatinine ratio losartan and 85 to placebo. Primary outcome was a decline in glomerular filtration rate (GFR; iothalamate) to ≤60 mL/min or to half the baseline value in persons who entered with GFR losartan vs. placebo) of 0.50 (95% CI 0.12-1.99). Participants were then followed posttrial for up to 12 years, with treatment managed outside the study. The effect of losartan on the primary GFR outcome was then reanalyzed for the entire study period, including the clinical trial and posttrial follow-up. After completion of the clinical trial, treatment with renin-angiotensin system inhibitors was equivalent in both groups. During a median of 13.5 years following randomization, 29 participants originally assigned to losartan and 35 to placebo reached the primary GFR outcome with an HR of 0.72 (95% CI 0.44-1.18). Long-term risk of GFR decline was not significantly different between persons randomized to early treatment with losartan and those randomized to placebo. Accordingly, we found no evidence of an extended benefit of early losartan treatment on slowing GFR decline in persons with type 2 diabetes. © 2016 by the American Diabetes Association.

  11. Aspirin for primary prevention of cardiovascular and all-cause mortality events in diabetes: updated meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Kunutsor, S K; Seidu, S; Khunti, K

    2017-03-01

    To evaluate the benefits and harms of aspirin for the primary prevention of cardiovascular disease and all-cause mortality events in people with diabetes by conducting a systematic review and meta-analysis. Randomized controlled trials of aspirin compared with placebo (or no treatment) in people with diabetes with no history of cardiovascular disease were identified from MEDLINE, EMBASE, Web of Science, the Cochrane Library and a manual search of bibliographies to November 2015. Study-specific relative risks with 95% CIs were aggregated using random effects models. A total of 10 randomized trials were included in the review. There was a significant reduction in risk of major adverse cardiovascular events: relative risk of 0.90 (95% CI 0.81-0.99) in groups taking aspirin compared with placebo or no treatment. Limited subgroup analyses suggested that the effect of aspirin on major adverse cardiovascular events differed by baseline cardiovascular disease risk, medication compliance and sex (P for interaction for all > 0.05).There was no significant reduction in the risk of myocardial infarction, coronary heart disease, stroke, cardiovascular mortality or all-cause mortality. Aspirin significantly reduced the risk of myocardial infarction for a treatment duration of ≤ 5 years. There were differences in the effect of aspirin by dosage and treatment duration on overall stroke outcomes (P for interaction for all diabetes who are at increased cardiovascular disease risk. © 2016 Diabetes UK.

  12. 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 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.

  13. Role of selected Indian plants in management of type 2 diabetes: a review.

    Science.gov (United States)

    Saxena, Abha; Vikram, Naval Kishore

    2004-04-01

    Type 2 diabetes has become a global epidemic. Modern medicines, despite offering a variety of effective treatment options, can have several adverse effects. Ayurveda, a science that uses herbal medicines extensively, originated in India. Of considerable interest is the adoption of Ayurveda by the mainstream medical system in some European countries (e.g., Hungary), emphasizing this modality is increasing worldwide recognition. From ancient times, some of these herbal preparations have been used in the treatment of diabetes. This paper reviews the accumulated literature for 10 Indian herbs that have antidiabetic activity and that have been scientifically tested. Few of these herbs, such as Momordica charantia, Pterocarpus marsupium, and Trigonella foenum greacum, have been reported to be beneficial for treating type 2 diabetes. Mechanisms such as the stimulating or regenerating effect on beta cells or extrapancreatic effects are proposed for the hypoglycemic action of these herbs.

  14. The prevalence of symptoms associated with pulmonary tuberculosis in randomly selected children from a high burden community

    OpenAIRE

    Marais, B.; Obihara, C; Gie, R.; Schaaf, H; Hesseling, A.; Lombard, C.; Enarson, D; Bateman, E; Beyers, N

    2005-01-01

    Background: Diagnosis of childhood tuberculosis is problematic and symptom based diagnostic approaches are often promoted in high burden settings. This study aimed (i) to document the prevalence of symptoms associated with tuberculosis among randomly selected children living in a high burden community, and (ii) to compare the prevalence of these symptoms in children without tuberculosis to those in children with newly diagnosed tuberculosis.

  15. Effects of diabetes mellitus vs. in vitro hyperglycemia on select immune cell functions.

    Science.gov (United States)

    Daoud, A K; Tayyar, M A; Fouda, I M; Harfeil, N Abu

    2009-03-01

    Diabetes mellitus (DM), one of the commonest metabolic disorders, can impair the function of cells involved in cellular and/or humoral immunity. This study sought to define potential effects upon cell-mediated immune cells due to an acute hyperglycemic state (in vitro) for comparison against those that might be attributable to a diabetic phenotype itself. Peripheral blood mononuclear cells (PBMC) were isolated from ten diabetic patients (5 with Type I disease and 5 with Type II) and 10 healthy controls. The cells were then challenged with 1 of 3 different mitogens (concanavalin A, phytohemagglutinin, pokeweed mitogen) in the presence of differing glucose concentrations (0, 100, 200, 400, or 800 mg/dl), and proliferative responses assessed. Neutrophils (PMNC) from the blood samples, exposed to the same experimental conditions, were analyzed for respiratory burst activity using nitroblue tetrazolium. The results indicated that there was significant inhibition of the proliferative responses to mitogens among the stimulated PBMC and in respiratory burst activity among the PMNC obtained from the diabetic patients. However, these effects were not affected by either the added presence of increasing amounts of exogenous glucose, the type of diabetes the patients had, the length of time the patient had had the disease, or whether or not the patients had been receiving insulin treatments. In contrast, the PBMC from healthy individuals appeared to display dose-trend decreases in responsiveness to mitogens; interestingly, similar effects on their PMNC were not evident. It was thus concluded that in situ ongoing repeated hyperglycemic states caused changes in cells of the immune system that could have been caused by repeated "continuous" exposures to excess sugar. Further studies are needed to more clearly identify hyperglycemia (sugar)-sensitive targets on/in these cells that could contribute to the appearance of the diabetic immunodeficiency in these types of patients.

  16. Effect of lower targets for blood pressure and LDL cholesterol on atherosclerosis in diabetes: the SANDS randomized trial.

    Science.gov (United States)

    Howard, Barbara V; Roman, Mary J; Devereux, Richard B; Fleg, Jerome L; Galloway, James M; Henderson, Jeffrey A; Howard, Wm James; Lee, Elisa T; Mete, Mihriye; Poolaw, Bryce; Ratner, Robert E; Russell, Marie; Silverman, Angela; Stylianou, Mario; Umans, Jason G; Wang, Wenyu; Weir, Matthew R; Weissman, Neil J; Wilson, Charlton; Yeh, Fawn; Zhu, Jianhui

    2008-04-09

    Individuals with diabetes are at increased risk for cardiovascular disease (CVD), but more aggressive targets for risk factor control have not been tested. To compare progression of subclinical atherosclerosis in adults with type 2 diabetes treated to reach aggressive targets of low-density lipoprotein cholesterol (LDL-C) of 70 mg/dL or lower and systolic blood pressure (SBP) of 115 mm Hg or lower vs standard targets of LDL-C of 100 mg/dL or lower and SBP of 130 mm Hg or lower. A randomized, open-label, blinded-to-end point, 3-year trial from April 2003-July 2007 at 4 clinical centers in Oklahoma, Arizona, and South Dakota. Participants were 499 American Indian men and women aged 40 years or older with type 2 diabetes and no prior CVD events. Participants were randomized to aggressive (n=252) vs standard (n=247) treatment groups with stepped treatment algorithms defined for both. Primary end point was progression of atherosclerosis measured by common carotid artery intimal medial thickness (IMT). Secondary end points were other carotid and cardiac ultrasonographic measures and clinical events. Mean target LDL-C and SBP levels for both groups were reached and maintained. Mean (95% confidence interval) levels for LDL-C in the last 12 months were 72 (69-75) and 104 (101-106) mg/dL and SBP levels were 117 (115-118) and 129 (128-130) mm Hg in the aggressive vs standard groups, respectively. Compared with baseline, IMT regressed in the aggressive group and progressed in the standard group (-0.012 mm vs 0.038 mm; P < .001); carotid arterial cross-sectional area also regressed (-0.02 mm(2) vs 1.05 mm(2); P < .001); and there was greater decrease in left ventricular mass index (-2.4 g/m(2.7) vs -1.2 g/m(2.7); P = .03) in the aggressive group. Rates of adverse events (38.5% and 26.7%; P = .005) and serious adverse events (n = 4 vs 1; P = .18) related to blood pressure medications were higher in the aggressive group. Clinical CVD events (1.6/100 and 1.5/100 person-years; P

  17. Telemonitoring and Protocolized Case Management for Hypertensive Community-Dwelling Seniors With Diabetes: Protocol of the TECHNOMED Randomized Controlled Trial.

    Science.gov (United States)

    Padwal, Raj; McAlister, Finlay Aleck; Wood, Peter William; Boulanger, Pierre; Fradette, Miriam; Klarenbach, Scott; Edwards, Alun L; Holroyd-Leduc, Jayna M; Alagiakrishnan, Kannayiram; Rabi, Doreen; Majumdar, Sumit Ranjan

    2016-06-24

    Diabetes and hypertension are devastating, deadly, and costly conditions that are very common in seniors. Controlling hypertension in seniors with diabetes dramatically reduces hypertension-related complications. However, blood pressure (BP) must be lowered carefully because seniors are also susceptible to low BP and attendant harms. Achieving "optimal BP control" (ie, avoiding both undertreatment and overtreatment) is the ultimate therapeutic goal in such patients. Regular BP monitoring is required to achieve this goal. BP monitoring at home is cheap, convenient, widely used, and guideline endorsed. However, major barriers prevent proper use. These may be overcome through use of BP telemonitoring-the secure teletransmission of BP readings to a health portal, where BP data are summarized for provider and patient use, with or without protocolized case management. To examine the incremental effectiveness, safety, cost-effectiveness, usability, and acceptability of home BP telemonitoring, used with or without protocolized case management, compared with "enhanced usual care" in community-dwelling seniors with diabetes and hypertension. A 300-patient, 3-arm, pragmatic randomized controlled trial with blinded outcome ascertainment will be performed in seniors with diabetes and hypertension living independently in seniors' residences in greater Edmonton. Consenting patients will be randomized to usual care, home BP telemonitoring alone, or home BP telemonitoring plus protocolized pharmacist case management. Usual care subjects will receive a home BP monitor but neither they nor their providers will have access to teletransmitted data. In both telemonitored arms, providers will receive telemonitored BP data summaries. In the case management arm, pharmacist case managers will be responsible for reviewing teletransmitted data and initiating guideline-concordant and protocolized changes in BP management. Outcomes will be ascertained at 6 and 12 months. Within-study-arm change

  18. Rapid selection of accessible and cleavable sites in RNA by Escherichia coli RNase P and random external guide sequences.

    Science.gov (United States)

    Lundblad, Eirik W; Xiao, Gaoping; Ko, Jae-Hyeong; Altman, Sidney

    2008-02-19

    A method of inhibiting the expression of particular genes by using external guide sequences (EGSs) has been improved in its rapidity and specificity. Random EGSs that have 14-nt random sequences are used in the selection procedure for an EGS that attacks the mRNA for a gene in a particular location. A mixture of the random EGSs, the particular target RNA, and RNase P is used in the diagnostic procedure, which, after completion, is analyzed in a gel with suitable control lanes. Within a few hours, the procedure is complete. The action of EGSs designed by an older method is compared with EGSs designed by the random EGS method on mRNAs from two bacterial pathogens.

  19. Capparis spinosa L. (Caper) fruit extract in treatment of type 2 diabetic patients: a randomized double-blind placebo-controlled clinical trial.

    Science.gov (United States)

    Huseini, Hassan Fallah; Hasani-Rnjbar, Shirin; Nayebi, Neda; Heshmat, Ramin; Sigaroodi, Farahnaz Khaliqi; Ahvazi, Maryam; Alaei, Behroz Abbasi; Kianbakht, Saeed

    2013-10-01

    Capparis spinosa L. (Caper) fruit is traditionally used as an anti-hyperglycemic food by Iranian diabetic patients. But yet, no controlled human study has determined its efficacy in treatment of hyperglycemia in type 2 diabetic patients. The present study was undertaken to explore the possible anti-hyperglycemic effects of the caper fruit extract in type 2 diabetic patients. A randomized clinical trial was conducted in 54 type 2 diabetic patients. Two groups 28 and 26 patients on standard anti-diabetic therapy, received 400mg caper fruit extract and placebo capsules three times a day respectively for two months. The patients fasting blood glucose, glycosylated hemoglobin, lipids levels, liver and renal function tests were determined at baseline and endpoint. Results showed significant decrease in fasting blood glucose levels (p=0.037) and glycosylated hemoglobin (p=0.043) in caper treated patients compared to control group at the end of the study. Triglyceride level also decreased significantly (p=0.29) in caper treated group at the end of the study compared to baseline. No liver, kidney and other side effects were observed in these two groups. Caper fruit extract may be a safe anti-hyperglycemic and anti-hypertriglyceridemic agent for type 2 diabetic patients. Copyright © 2013 Elsevier Ltd. All rights reserved.

  20. 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

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    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.

  1. 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.

  2. 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

    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. PMID:28078249

  3. Chinese herbal medicine for diabetic peripheral neuropathy: an updated meta-analysis of 10 high-quality randomized controlled studies.

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    Chi-zi Hao

    Full Text Available BACKGROUND: Diabetic peripheral neuropathy (DPN is very common in people with diabetes. Chinese herbal medicine (CHM therapy has been developed for DPN empirically over the years. The aim of this systematic review and meta-analysis was to assess the efficacy and safety of CHMs for patients suffering from DPN. METHODS: We performed a meta-analysis of randomized-controlled clinical trials (RCTs evaluating the efficacy and safety of CHM on DPN. Six databases were searched up to November 2012. The primary outcome measures were the absolute values or changing of motor or sensory nerve conduction velocity (NCV, and the secondary outcome measurements were clinical symptoms improvements and adverse events. The methodological quality was assessed by Jadad scale and the twelve criteria recommended by the Cochrane Back Review Group. RESULTS: One hundred and sixty-three studies claimed RCTs. Ten studies with 653 individuals were further identified based on the Jadad score ≥ 3. These 10 studies were all of high methodological quality with a low risk of bias. Meta-analysis showed the effects of NCV favoring CHMs when compared with western conventional medicines (WCM (P<0.05 or P<0.01. There is a significant difference in the total efficacy rate between the two groups (P<0.001. Adverse effects were reported in all of the ten included studies, and well tolerated in all patients with DPN. CONCLUSION: Despite of the apparently positive findings and low risk of bias, it is premature to conclude the efficacy of CHMs for the treatment of DPN because of the high clinical heterogeneity and small sample sizes of the included studies. However, CHM therapy was safe for DPN. Further standardized preparation, large sample-size and rigorously designed RCTs are required.

  4. Assessment of Knowledge of Diabetes Mellitus in the Urban Areas of Klang District, Malaysia

    OpenAIRE

    Sasikala Chinnappan; Palanisamy Sivanandy; Rajenthina Sagaran; Nagashekhara Molugulu

    2017-01-01

    Diabetes is the most common cause of non-traumatic lower limb amputations and cardiovascular diseases. However, only a negligible percentage of the patients and subjects knew that the feet are affected in diabetes and diabetes affects the heart. Hence, a cross-sectional study was carried out to evaluate the knowledge of diabetes mellitus among the public of different age group, gender, ethnicity, and education level. A sample of 400 participants was randomly selected and data was collected us...

  5. 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

  6. 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

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    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

  7. 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

  8. 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

  9. Comparison of paroxetine and agomelatine in depressed type 2 diabetes mellitus patients: a double-blind, randomized, clinical trial

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    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

  10. Cluster randomized controlled trial of a peer support program for people with diabetes: study protocol for the Australasian peers for progress study

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    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

  11. 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 allocatio