- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02129595
Resveratrol and First-degree Relatives of Type 2 Diabetic Patients
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Limburg
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Maastricht, Limburg, Netherlands, 6200 MD
- Maastricht University Medical Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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
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Cardiac function: diastolic and systolic heart function will be measured with ultrasound
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30 days after supplementation
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brown adipose tissue activity
Time Frame: 34 days after supplementation
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subjects will be exposed to an individualized cooling protocol, after which an 18F-FDG PET/CT scan is made
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34 days after supplementation
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximal aerobic capacity (VO2max)
Time Frame: 27 days after supplementation
|
27 days after supplementation
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Blood pressure
Time Frame: 30 days after supplementation
|
30 days after supplementation
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Antioxidants
- Diabetes Mellitus
- Insulin Resistance
- Diabetes Mellitus, Type 2
- Antineoplastic Agents
- Enzyme Inhibitors
- Physiological Effects of Drugs
- Platelet Aggregation Inhibitors
- Resveratrol
- Central Nervous System Agents
- Peripheral Nervous System Agents
- Pharmacologic Actions
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Therapeutic Uses
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Antineoplastic Agents, Phytogenic
- Analgesics
- Anti-Inflammatory Agents
- Molecular Mechanisms of Pharmacological Action
- Hyperinsulinism
- Brown Adipose Tissue
- Antirheumatic Agents
- Hematologic Agents
- Analgesics, Non-Narcotic
- Protective Agents
- Anticarcinogenic Agents
- Antimutagenic Agents
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-3-058
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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