Resveratrol and First-degree Relatives of Type 2 Diabetic Patients

August 7, 2017 updated by: Maastricht University Medical Center

Effects of Resveratrol on Insulin Sensitivity, Brown Adipose Tissue and Metabolic Profile in 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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Limburg
      • Maastricht, Limburg, Netherlands, 6200 MD
        • Maastricht University Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: resveratrol
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.
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)
PLACEBO_COMPARATOR: placebo
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days after supplementation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

30 days after supplementation
intramyocellular lipid content
Time Frame: 30 days after supplementation
Skeletal muscle lipid accumulation measured by immunohistochemistry in muscle biopsy from vastus lateralis muscle
30 days after supplementation
intrahepatic lipid content
Time Frame: 30 days after supplementation
Intrahepatic lipid content measured with H-MRS
30 days after supplementation
intracardiac lipid content
Time Frame: 30 days after supplementation
Intracardiac lipid content measured with H-MRS
30 days after supplementation
heart function
Time Frame: 30 days after supplementation
Cardiac function: diastolic and systolic heart function will be measured with ultrasound
30 days after supplementation
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
34 days after supplementation

Other Outcome Measures

Outcome Measure
Time Frame
Maximal aerobic capacity (VO2max)
Time Frame: 27 days after supplementation
27 days after supplementation
Blood pressure
Time Frame: 30 days after supplementation
30 days after supplementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ACTUAL)

April 1, 2017

Study Completion (ACTUAL)

July 31, 2017

Study Registration Dates

First Submitted

April 24, 2014

First Submitted That Met QC Criteria

May 1, 2014

First Posted (ESTIMATE)

May 2, 2014

Study Record Updates

Last Update Posted (ACTUAL)

August 8, 2017

Last Update Submitted That Met QC Criteria

August 7, 2017

Last Verified

August 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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