Resveratrol Supplementation for Improved Insulin Sensitivity in Type 2 Diabetes
This study aims to evaluate if Resveratrol supplementation can improve overall insulin sensitivity, specifically in your muscles and liver, if you have Type 2 Diabetes.
placebo
+ resveratrol
Diabetes Mellitus+3
+ Diabetes Mellitus, Type 2
+ Endocrine System Diseases
Treatment Study
Summary
Study start date: May 1, 2012
Actual date on which the first participant was enrolled.The main objective of the study is to investigate if resveratrol supplementation can improve overall and muscle-specific insulin sensitivity in type 2 diabetic patients. As a secondary objective the investigators want to investigate whether the improved insulin sensitivity can be attributed to improved muscle mitochondrial oxidative capacity and a reduced intrahepatic and cardiac lipid content.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.24 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.From 40 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Male sex * Age: 40-70 years * Body fat percentage \> 25, BMI 27-35 kg/m2 * Diagnosed with type 2 diabetes at least one year before the start of the study * Well-controlled type 2 diabetics: HBA1C \< 8.0% * Oral glucose lowering medication (metformin only or in combination with sulfonylurea agents) * Sedentary * Not more than 2 hours of sports a week * No active job that requires strenuous physical activity * Stable dietary habits * Willingness to abstain from resveratrol-containing food products Exclusion Criteria: * Unstable body weight (weight gain or loss \> 3kg in the last three months) * Total body fat percentage \< 25% * Hemoglobin \< 7.8 mmol/l * Use of anticoagulants * Engagement in programmed exercise \> 2 hours total per week * Impaired kidney and/or hepatic function Creatinine 50-100 umol/L Liver enzymes, within 2 times of normal range of laboratory standard (ASAT \< 60 U/L, ALAT \< 70 U/L, Billi \<40 umol/L, gamma-GT \< 80 U/L) * No diabetes related co-morbidities like cardiovascular diseases, diabetic foot, polyneuropathy, retinopathy * Insulin dependent Diabetic subjects * Any medical condition except type 2 diabetes mellitus requiring treatment and/or medication use except metformin only or in combination with sulfonylurea agents * Intake of dietary supplements except multivitamins and minerals * Current alcohol consumption \> 20 grams/day * Subjects who don't want to be informed about unexpected medical findings during the screening /study, or do not wish that their physician is informed, cannot participate in the study. * Participation in another biomedical study within 1 month before the first screening visit * Any contraindication to MRI scanning. These contra-indications include patients with following devices: * Central nervous system aneurysm clip * Implanted neural stimulator * Implanted cardiac pacemaker of defibrillator * Cochlear implant * Insulin pump * Or metal containing corpora aliena in the eye or brains
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Maastricht University Medical Center
Maastricht, NetherlandsOpen Maastricht University Medical Center in Google Maps