Resveratrol and First-degree Relatives of Type 2 Diabetic Patients

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Pre-diabetes

Treatments: Dietary Supplement: placebo; Dietary Supplement: resveratrol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02129595

13-3-058

Details and patient eligibility

About

The main objective of the study is to investigate if resveratrol supplementation can improve overall and muscle-specific insulin sensitivity in first-degree relatives of 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. Furthermore, in a subset of the participants the investigators want to investigate the effect of resveratrol on glucose uptake in brown adipose tissue.

Enrollment: 15 patients

Sex: Male

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male sex
• Age: 40-70 years
• BMI 27-35 kg/m2
• Has first-degree relative(s) diagnosed with type 2 diabetes
• Sedentary
• Not more than 2 hours of sports a week
• No active job that requires strenuous physical activity
• Stable dietary habits: no weight gain or loss > 5kg in the last three months
• Insulin resistant: glucose clearance rate below < 350 ml/kg/min, as determined using OGIS120
• Willingness to abstain from resveratrol-containing food products
• Subjects will only be included when the dependent medical doctor of this study approves participation after evaluating data obtained during screening

Exclusion criteria

• Use of anticoagulants

• Uncontrolled hypertension

• Haemoglobin <7.8 mmol/l

• In case of an abnormal ECG in rest: this will be discussed with the responsible medical doctor

• HBA1C > 6.5%

• Diagnosed with type 2 diabetes

• Medication use known to interfere with glucose homeostasis/metabolism

• 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.

• Subjects who intend to donate blood during the intervention or subjects who have donated blood less than three months before the start of the intervention.

• Participation in another biomedical study within 1 month before the first screening visit

• Any condition, disease or abnormal laboratory test result that, in the opinion of the Investigator, would interfere with the study outcome, affect trial participation or put the subject at undue risk

• Any contra-indication 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
  • Metal containing corpora aliena in the eye or brains

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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15 participants in 2 patient groups, including a placebo group

resveratrol

Active Comparator group

Description:

resveratrol will be given for 30 or 34 days (if included in brown adipose tissue measurement), 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.

Treatment:

Dietary Supplement: resveratrol

placebo

Placebo Comparator group

Description:

A placebo will be given for 30 or 34 days (if included in brown adipose tissue measurement), twice daily. One pill will be provided with lunch and the other pill will be provided with dinner.

Treatment:

Dietary Supplement: placebo