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Resveratrol and Type 2 Diabetes

Not Applicable
Conditions
Type 2 Diabetes
Interventions
Dietary Supplement: placebo
Dietary Supplement: resveratrol
Registration Number
NCT01638780
Lead Sponsor
Maastricht University Medical Center
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
Male
Target Recruitment
24
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 & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
placeboplaceboA 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.
resveratrolresveratrolresveratrol 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.
Primary Outcome Measures
NameTimeMethod
insulin sensitivity (overall, muscle- and liver specific)30 days after supplementation
Secondary Outcome Measures
NameTimeMethod
muscle mitochondrial oxidative capacity30 days after supplementation
intramyocellular lipid content30 days after supplementation
intracardiac lipid content30 days after supplementation
heart function30 days after supplementation
intrahepatic lipid content30 days after supplementation

Trial Locations

Locations (1)

Maastricht University Medical Center

🇳🇱

Maastricht, Limburg, Netherlands

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