Overview

This trial is active, not recruiting.

Condition type 2 diabetes
Treatments placebo, resveratrol
Sponsor Maastricht University Medical Center
Collaborator DSM Nutritional Products, Inc.
Start date May 2012
End date September 2014
Trial size 24 participants
Trial identifier NCT01638780, 11-3-092

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
A placebo will be given for 30 days, twice daily. One pill will be provided with lunch and the other pill will be provided with dinner.
placebo
A placebo will given for 30 days, twice daily. One pill will be provided with lunch, and the other pill will be provided with dinner.
(Active Comparator)
resveratrol will be given for 30 days, twice daily. One pill, which contains 75 mg of resveratrol, will be provided with lunch, and the other pill of 75 mg will be provided with dinner. So in total 150 mg/day of resveratrol will be given.
resveratrol resVida (99% pure trans-resveratrol) provided by DSM Nutritional Products, Ltd.
resveratrol will be given for 30 days, twice daily. One pill, which contains 75 mg of resveratrol, will be provided with lunch, and the other pill, also containing 75 mg will be given with dinner. So in total a dose of 150 mg/day will be given.

Primary Outcomes

Measure
insulin sensitivity (overall, muscle- and liver specific)
time frame: 30 days after supplementation

Secondary Outcomes

Measure
muscle mitochondrial oxidative capacity
time frame: 30 days after supplementation
intramyocellular lipid content
time frame: 30 days after supplementation
intrahepatic lipid content
time frame: 30 days after supplementation
intracardiac lipid content
time frame: 30 days after supplementation
heart function
time frame: 30 days after supplementation

Eligibility Criteria

Male participants from 40 years up to 70 years old.

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

Additional Information

Official title Effect of Resveratrol on Insulin Sensitivity and Metabolic Profile in Type 2 Diabetics
Principal investigator Silvie Timmers, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Maastricht University Medical Center.