Clinical trial NCT02129595: Resveratrol and First-degree Relatives of Type 2 Diabetic Patients
Official title: Effects of Resveratrol on Insulin Sensitivity, Brown Adipose Tissue and Metabolic Profile in First-degree Relatives of Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-diabetes
Keywords: 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
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: DSM Nutritional Products, Inc.
name: Diabetes Fonds
First posted: 2014-05-02
Enrollment: 15
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: insulin sensitivity: overall, muscle- and liver specific
timeFrame: 30 days after supplementation
Secondary outcomes:
measure: muscle mitochondrial oxidative capacity (in vivo and ex vivo)
timeFrame: 30 days after supplementation
measure: intramyocellular lipid content
timeFrame: 30 days after supplementation
measure: intrahepatic lipid content
timeFrame: 30 days after supplementation
measure: intracardiac lipid content
timeFrame: 30 days after supplementation
measure: heart function
timeFrame: 30 days after supplementation
measure: brown adipose tissue activity
timeFrame: 34 days after supplementation
Other outcomes:
measure: Maximal aerobic capacity (VO2max)
timeFrame: 27 days after supplementation
measure: Blood pressure
timeFrame: 30 days after supplementation
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
state: Limburg
Study officials:
affiliation: Maastricht University Medical Centre
name: Patrick Schrauwen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Ligt M, Bruls YMH, Hansen J, Habets MF, Havekes B, Nascimento EBM, Moonen-Kornips E, Schaart G, Schrauwen-Hinderling VB, van Marken Lichtenbelt W, Schrauwen P. Resveratrol improves ex vivo mitochondrial function but does not affect insulin sensitivity or brown adipose tissue in first degree relatives of patients with type 2 diabetes. Mol Metab. 2018 Jun;12:39-47. doi: 10.1016/j.molmet.2018.04.004. Epub 2018 Apr 18.