Resveratrol and First-degree Relatives of Type 2 Diabetic Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Maastricht University Medical Center
Sponsor:
Collaborators:
DSM Nutritional Products, Inc.
Diabetes Fonds
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT02129595
First received: April 24, 2014
Last updated: May 1, 2014
Last verified: May 2014
  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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Resveratrol on Insulin Sensitivity 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Skeletal muscle lipid accumulation measured by immunohistochemistry in muscle biopsy from vastus lateralis muscle

  • intrahepatic lipid content [ Time Frame: 30 days after supplementation ] [ Designated as safety issue: No ]
    Intrahepatic lipid content measured with H-MRS

  • intracardiac lipid content [ Time Frame: 30 days after supplementation ] [ Designated as safety issue: No ]
    Intracardiac lipid content measured with H-MRS

  • heart function [ Time Frame: 30 days after supplementation ] [ Designated as safety issue: No ]
    Cardiac function: diastolic and systolic heart function will be measured with ultrasound


Other Outcome Measures:
  • Maximal aerobic capacity (VO2max) [ Time Frame: 27 days after supplementation ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 30 days after supplementation ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: April 2014
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: resveratrol
resveratrol 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.
Dietary Supplement: resveratrol
resveratrol 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, 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 days, 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, twice daily. One pill will be provided with lunch, and the other pill will be provided with dinner.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02129595

Contacts
Contact: Marlies de Ligt, MSc 0031 43 3881311 marlies.deligt@maastrichtuniversity.nl
Contact: Patrick Schrauwen, PhD 0031 43 3881502 p.schrauwen@maastrichtuniversity.nl

Locations
Netherlands
Maastricht University Medical Centre Recruiting
Maastricht, Limburg, Netherlands, 6200 MD
Contact: Marlies de Ligt, MSc    0031 43 3881311    marlies.deligt@maastrichtuniversity.nl   
Contact: Patrick Schrauwen, PhD    0031 43 3881502    p.schrauwen@maastrichtuniversity.nl   
Sub-Investigator: Marlies de Ligt, MSc         
Principal Investigator: Patrick Schrauwen, PhD         
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

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02129595     History of Changes
Other Study ID Numbers: 13-3-058
Study First Received: April 24, 2014
Last Updated: May 1, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

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

ClinicalTrials.gov processed this record on October 21, 2014