0
selected
-
1.
Probiotic and synbiotic supplementation could improve metabolic syndrome in prediabetic adults: A randomized controlled trial.
Kassaian, N, Feizi, A, Aminorroaya, A, Amini, M
Diabetes & metabolic syndrome. 2019;(5):2991-2996
Abstract
AIMS: Modulation of the gastrointestinal microbiome is suggested to contribute to the progression of metabolic syndrome associated diseases. This study was designed to assess the effects of probiotics and synbiotics on metabolic syndrome in individuals with prediabetes. METHODS 120 adults with prediabetes were enrolled in a double-blind, placebo-controlled randomized parallel-group clinical trial. Participants were randomized to a multi-species probiotic or inulin-based synbiotic or placebo. Blood samples and anthropometric measures were collected at baseline, 12 and 24 weeks after treatment. The primary outcome measures were the changes between groups in metabolic syndrome and its components' prevalence. RESULTS A significant trend for a reduction in the prevalence of hyperglycemia in probiotic and synbiotic groups (p = 0.01 and 0.005 respectively), and hypertension in probiotic group (p = 0.04) was found. The decreases in metabolic syndrome prevalence were significant after taking probiotic and synbiotic supplementation as compared with placebo (p = 0.02). Also, the prevalence of low HDL-cholesterol level was decreased during the study in the probiotic group compared with placebo (p = 0.02). CONCLUSIONS The potential benefits of using probiotic and synbiotic for metabolic syndrome management in prediabetes have been supported by the results in the current study which might provide an important strategy to combat metabolic syndrome-associated diseases.
-
2.
Prevention of Metabolic Syndrome by Telephone-Delivered Lifestyle Intervention in a Real-World Setting: Sub-Analysis of a Cluster-Randomized Trial.
Sakane, N, Kotani, K, Suganuma, A, Takahashi, K, Sato, J, Suzuki, S, Izumi, K, Kato, M, Noda, M, Nirengi, S, et al
Metabolic syndrome and related disorders. 2019;(7):355-361
Abstract
Background: Evidence of the long-term benefits of telephone-delivered lifestyle interventions is limited. This study investigated the ability of telephone-delivered lifestyle intervention to reduce the incidence of metabolic syndrome (MetS) in subjects diagnosed with impaired fasting glucose (IFG) during health checkups. Methods: Our subjects were participants in the Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1), a prospective, cluster-randomized controlled trial designed to investigate whether goal-focused lifestyle coaching over the telephone can effectively reduce the incidence of type 2 diabetes development in high-risk individuals in a primary health care setting. We extracted 753 and 844 J-DOIT1 participants from the intervention and controls arms, respectively, who had IFG but did not meet the MetS criteria at baseline. The intervention arm received goal-focused lifestyle support delivered by health care providers via telephone over a 1-year period. The endpoint was the development of incident MetS, defined based on the Adult Treatment Panel III criteria modified for Japan. Results: During the median follow-up period of 4.9 years, 8.0% of the intervention arm and 12.0% of the control arm developed MetS. Overall, the hazard ratio (HR) for the development of MetS was 0.75 [95% confidence interval (CI), 0.52-1.09; P = 0.14] in the intervention arm. However, the HR in overweight or obese [body mass index (BMI) ≥23 kg/m2] individuals was significantly reduced to 0.63 (95% CI, 0.41-0.95; P = 0.029), but not in lean (BMI <23 kg/m2) individuals. Conclusion: Telephone-delivered lifestyle intervention effectively reduced the incidence of MetS in overweight and obese subjects in a real-world setting. Clinical trial registration number: UMIN000000662 (registered March 30, 2007; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000000798).
-
3.
Evaluation of a culturally-adapted lifestyle intervention to treat elevated cardiometabolic risk of Latino adults in primary care (Vida Sana): A randomized controlled trial.
Rosas, LG, Lv, N, Xiao, L, Lewis, MA, Zavella, P, Kramer, MK, Luna, V, Ma, J
Contemporary clinical trials. 2016;:30-40
-
-
Free full text
-
Abstract
UNLABELLED Latinos bear a disproportionate burden of the dual pandemic of obesity and diabetes. However, successful interventions addressing this disparity through primary care are lacking. To address this gap, the 5-year Vida Sana (Healthy Life) study tests a culturally adapted and technology-enhanced group-based Diabetes Prevention Program intervention in a randomized controlled trial with overweight/obese Latino adults who have metabolic syndrome and/or pre-diabetes. Eligible, consenting patients (n=186) from a large community-based multispecialty group practice in Northern California will be randomly assigned to receive the culturally-adapted intervention or usual care. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework guided the planned evaluations. The primary aim is to determine the effectiveness of the intervention (the "E" in RE-AIM). We hypothesize that the intervention will lead to a greater mean reduction in weight at 24months (primary endpoint) vs. usual care. Secondary outcomes will include measures of cardiometabolic risk factors (e.g., blood pressure), psychosocial well-being (e.g., health-related quality of life), and behavior change (e.g., physical activity). The secondary aim is to evaluate the other RE-AIM dimensions using mixed methods: reach (e.g., participation rate of the target population), adoption (e.g., participating clinic and provider characteristics), implementation (e.g., intervention fidelity), and maintenance (e.g., sustainability in the practice setting). These findings have real word applicability with value to clinicians, patients, and other decision makers considering effective diabetes prevention programs for primary care that would support the millions of Latino adults who experience a disproportionate burden of diabetes. TRIAL REGISTRATION NCT02459691.
-
4.
Recruitment for a Diabetes Prevention Program translation effort in a worksite setting.
Taradash, J, Kramer, M, Molenaar, D, Arena, V, Vanderwood, K, Kriska, AM
Contemporary clinical trials. 2015;:204-10
-
-
Free full text
-
Abstract
BACKGROUND The success of the Diabetes Prevention Program (DPP) lifestyle intervention has led to community-based translation efforts in a variety of settings. One community setting which holds promise for the delivery of prevention intervention is the worksite; however, information regarding recruitment in this setting is limited. The current effort describes the initial processes surrounding provision of an adapted DPP lifestyle intervention at a corporate worksite. METHODS Investigators and key management at the worksite collaborated to develop and implement a recruitment plan for the intervention focusing on 1) in-person onsite activities and 2) implementation of a variety of media recruitment tools and methods. RESULTS Adult, non-diabetic overweight/obese employees and family members with pre-diabetes and/or the metabolic syndrome were eligible for the study. Telephone pre-screening was completed for 176 individuals resulting in 171 eligible for onsite screening. Of that number, 160 completed onsite screening, 107 met eligibility criteria, and 89 enrolled in the study. Support from worksite leadership, an invested worksite planning team and a solid recruitment plan consisting of multiple strategies were identified as crucial elements of this effective workplace recruitment effort. CONCLUSION A worksite team successfully developed and implemented a recruitment plan using existing mechanisms appropriate to that worksite in order to identify and enroll eligible individuals. The results of this effort indicate that employee recruitment in a worksite setting is feasible as the first step in offering onsite behavioral lifestyle intervention programs as part of a widespread dissemination plan to prevent diabetes and lower risk for cardiovascular disease.
-
5.
Effect of long term vitamin D supplementation on biomarkers of inflammation in Latino and African-American subjects with pre-diabetes and hypovitaminosis D.
Sinha-Hikim, I, Duran, P, Shen, R, Lee, M, Friedman, TC, Davidson, MB
Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme. 2015;(4):280-3
-
-
Free full text
-
Abstract
Low vitamin D levels are associated with minority subjects, the metabolic syndrome, and inflammation. The effect of vitamin D supplementation on markers of inflammation has not been well studied. The aim of the study was to evaluate the effects of high doses of vitamin D supplementation for 1 year on serum biomarkers of inflammation in Latino and African-American subjects with pre-diabetes and hypovitaminosis D. Latino (n=69) and African-American (n=11) subjects who had both pre-diabetes and hypovitaminosis D with a mean age of 52.0 years, a BMI of 32.7 kg/m(2), and 70% of whom were females, were randomized to receive weekly doses (mean±SD) of vitamin D (85 300 IU±16 000) or placebo oil for 1 year. Serum levels of interleukin-6, tumor necrosis factor, highly sensitive C-reactive protein), plasminogen activator inhibitor 1, and insulin-like growth factor-1 were measured at baseline, 6, and 12 months. Serum 25-OH vitamin D levels of 22 ng/ml at baseline quickly rose to nearly 70 ng/ml in subjects receiving vitamin D and did not change in the placebo group. Two-way repeated measures ANOVA showed no differences between the 2 groups in any of the 5 selected parameters. High dose vitamin D supplementation for 1 year in minority subjects with pre-diabetes and hypovitaminosis D failed to affect serum biomarkers of inflammation.Clinical trial reg. no.: NCT00876928, clinicaltrials.gov.
-
6.
Evaluation of lifestyle interventions to treat elevated cardiometabolic risk in primary care (E-LITE): a randomized controlled trial.
Ma, J, King, AC, Wilson, SR, Xiao, L, Stafford, RS
BMC family practice. 2009;:71
Abstract
BACKGROUND Efficacy research has shown that intensive individual lifestyle intervention lowers the risk for developing type 2 diabetes mellitus and the metabolic syndrome. Translational research is needed to test real-world models of lifestyle interventions in primary care settings. DESIGN E-LITE is a three-arm randomized controlled clinical trial aimed at testing the feasibility and potential effectiveness of two lifestyle interventions: information technology-assisted self-management, either alone or in combination with care management by a dietitian and exercise counselor, in comparison to usual care. Overweight or obese adults with pre-diabetes and/or metabolic syndrome (n = 240) recruited from a community-based primary care clinic are randomly assigned to one of three treatment conditions. Treatment will last 15 months and involves a three-month intensive treatment phase followed by a 12-month maintenance phase. Follow-up assessment occurs at three, six, and 15 months. The primary outcome is change in body mass index. The target sample size will provide 80% power for detecting a net difference of half a standard deviation in body mass index at 15 months between either of the self-management or care management interventions and usual care at a two-sided alpha level of 0.05, assuming up to a 20% rate of loss to 15-month follow-up. Secondary outcomes include glycemic control, additional cardiovascular risk factors, and health-related quality of life. Potential mediators (e.g., treatment adherence, caloric intake, physical activity level) and moderators (e.g., age, gender, race/ethnicity, baseline mental status) of the intervention's effect on weight change also will be examined. DISCUSSION This study will provide objective evidence on the extent of reductions in body mass index and related cardiometabolic risk factors from two lifestyle intervention programs of varying intensity that could be implemented as part of routine health care.
-
7.
Retinopathy in subjects with impaired fasting glucose: the NANSY-Eye baseline report.
Tyrberg, M, Melander, A, Lövestam-Adrian, M, Lindblad, U
Diabetes, obesity & metabolism. 2008;(8):646-51
Abstract
AIMS: Network for Pharmacoepidemiology (NEPI) Antidiabetes Study-Eye is a randomized placebo-controlled Swedish trial investigating if treatment with sulphonylurea, in addition to dietary regulation and increased exercise, delays the development of retinopathy in subjects with impaired fasting glucose (IFG). METHODS Subjects were surveyed in primary care with repeated fasting blood glucose measurements. Those with a mean of two consecutive values >or=5.6 and <6.1 mmol/l were invited to participate. Baseline physical examination included blood pressure and body mass index (BMI). Fundus photos were taken in two fields using 35-mm diafilm. The alternative classification of the Wisconsin Epidemiologic Study of Diabetic Retinopathy was used to classify the retinopathy level. RESULTS At baseline, 90 men and 64 women with IFG were photographed. Of these, 16 subjects (10%) had mild or very mild retinopathy. There was no difference in occurrence of retinopathy between subjects with known diagnosis of hypertension or not. However, subjects with retinopathy had significantly higher systolic (154 vs. 141 mmHg, p = 0.013) and diastolic (86 vs. 81 mmHg, p = 0.008) blood pressure levels independent of differences in age, sex and known hypertension. There was a corresponding difference in BMI, being greater in subjects with than in those without retinopathy (32.4 vs. 29.2 kg/m(2), p = 0.013). There were no associations between levels of fasting blood glucose or haemoglobin A1c, on the one hand, and retinopathy, on the other. CONCLUSION Retinopathy may be present even before type 2 diabetes is manifest. It is associated with higher blood pressure levels and higher BMI values, that is, with predominant features of the metabolic syndrome.