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Resveratrol and First-degree Relatives of Type 2 Diabetic Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02129595
First Posted: May 2, 2014
Last Update Posted: August 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
DSM Nutritional Products, Inc.
Diabetes Fonds
Information provided by (Responsible Party):
Maastricht University Medical Center
  Purpose

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.


Condition Intervention
Pre-diabetes Dietary Supplement: placebo Dietary Supplement: resveratrol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Resveratrol on Insulin Sensitivity, Brown Adipose Tissue and Metabolic Profile in First-degree Relatives of Type 2 Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


  • intramyocellular lipid content [ Time Frame: 30 days after supplementation ]
    Skeletal muscle lipid accumulation measured by immunohistochemistry in muscle biopsy from vastus lateralis muscle

  • intrahepatic lipid content [ Time Frame: 30 days after supplementation ]
    Intrahepatic lipid content measured with H-MRS

  • intracardiac lipid content [ Time Frame: 30 days after supplementation ]
    Intracardiac lipid content measured with H-MRS

  • heart function [ Time Frame: 30 days after supplementation ]
    Cardiac function: diastolic and systolic heart function will be measured with ultrasound

  • 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 Outcome Measures:
  • Maximal aerobic capacity (VO2max) [ Time Frame: 27 days after supplementation ]
  • Blood pressure [ Time Frame: 30 days after supplementation ]

Enrollment: 15
Study Start Date: April 2014
Study Completion Date: July 31, 2017
Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Dietary Supplement: resveratrol
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 Name: 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.
Dietary Supplement: placebo
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.

  Eligibility

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129595


Locations
Netherlands
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands, 6200 MD
Sponsors and Collaborators
Maastricht University Medical Center
DSM Nutritional Products, Inc.
Diabetes Fonds
Investigators
Principal Investigator: Patrick Schrauwen, PhD Maastricht University Medical Centre
  More Information

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02129595     History of Changes
Other Study ID Numbers: 13-3-058
First Submitted: April 24, 2014
First Posted: May 2, 2014
Last Update Posted: August 8, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Maastricht University Medical Center:
Resveratrol
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Antimutagenic Agents
Anticarcinogenic Agents
Central Nervous System Agents
Brown Adipose Tissue

Additional relevant MeSH terms:
Resveratrol
Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Analgesics
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antineoplastic Agents, Phytogenic
Platelet Aggregation Inhibitors
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Sensory System Agents
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Antirheumatic Agents
Antioxidants
Protective Agents
Enzyme Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents