Resveratrol and Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Resveratrol on Insulin Sensitivity and Metabolic Profile in Type 2 Diabetics

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: placebo
* Dietary Supplement: resveratrol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>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. | Dietary Supplement: placebo<br>* 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.<br>|
| Active Comparator: resveratrol<br>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. | Dietary Supplement: resveratrol<br>* 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.<br>* Other names: resVida (99% pure trans-resveratrol) provided by DSM Nutritional Products, Ltd.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin sensitivity (overall, muscle- and liver specific) |  | 30 days after supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle mitochondrial oxidative capacity |  | 30 days after supplementation | 
| intramyocellular lipid content |  | 30 days after supplementation | 
| intrahepatic lipid content |  | 30 days after supplementation | 
| intracardiac lipid content |  | 30 days after supplementation | 
| heart function |  | 30 days after supplementation |