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Completed

NCT Number: NCT02129595

Resveratrol and First-degree Relatives of Type 2 Diabetic Patients

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.

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Key information

Age range

40 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Centre

Maastricht, Limburg, 6200 MD, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

A placebo will given for 30 days 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.

Resveratrol

Dietary Supplement

resveratrol will be given for 30 days 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, also containing 75 mg will be given with dinner. So in total a dose of 150 mg/day will be given.

Other names: resVida (99% pure trans-resveratrol)

Primary outcomes

  1. insulin sensitivity: overall, muscle- and liver specific

    Time frame: 30 days after supplementation

    Hyperinsulinemic euglycemic clamp combined with indirect calorimetry: Glucose infusion rate (GIR), rate of appearance and disappearance of glucose (Ra, Rd), endogenous glucose production (EGP), oxidative and non-oxidative glucose disposal, carbohydrate and lipid oxidation, energy expenditure.

Secondary outcomes

  1. muscle mitochondrial oxidative capacity (in vivo and ex vivo)

    Time frame: 30 days after supplementation

    In vivo: Phosphocreatine levels will be measured by P-MRS (before, during, and after exercise) as a marker for in vivo mitochondrial function in the vastus lateralis muscle.

    Ex vivo mitochondrial function in skeletal muscle will be measured by oxygen consumption in muscle fibres (muscle biopsy) on lipid-derived and carbohydrate-derived substrates.

  2. intramyocellular lipid content

    Time frame: 30 days after supplementation

    Skeletal muscle lipid accumulation measured by immunohistochemistry in muscle biopsy from vastus lateralis muscle

  3. intrahepatic lipid content

    Time frame: 30 days after supplementation

    Intrahepatic lipid content measured with H-MRS

  4. intracardiac lipid content

    Time frame: 30 days after supplementation

    Intracardiac lipid content measured with H-MRS

  5. heart function

    Time frame: 30 days after supplementation

    Cardiac function: diastolic and systolic heart function will be measured with ultrasound

  6. brown adipose tissue activity

    Time frame: 34 days after supplementation

    subjects will be exposed to an individualized cooling protocol, after which an 18F-FDG PET/CT scan is made

Other outcomes

  1. Maximal aerobic capacity (VO2max)

    Time frame: 27 days after supplementation

  2. Blood pressure

    Time frame: 30 days after supplementation

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Diabetes Fonds
  • dsm-firmenich Switzerland AG

Registry information

Official study title

Effects of Resveratrol on Insulin Sensitivity, Brown Adipose Tissue and Metabolic Profile in First-degree Relatives of Type 2 Diabetic Patients

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 2, 2014
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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