Resveratrol and First-degree Relatives of Type 2 Diabetic Patients

NCT02129595 | Completed DMC

• 1 other identifier: 13-3-058
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• insulin sensitivity: overall, muscle- and liver specific

  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 Outcomes (6)

• muscle mitochondrial oxidative capacity (in vivo and ex vivo)

  30 days after supplementation

• intramyocellular lipid content

  30 days after supplementation

• intrahepatic lipid content

  30 days after supplementation

• intracardiac lipid content

  30 days after supplementation

• heart function

  30 days after supplementation

Other Outcomes (2)

• Maximal aerobic capacity (VO2max)

  27 days after supplementation

• Blood pressure

  30 days after supplementation

Study Arms (2)

resveratrol

ACTIVE COMPARATOR

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

placebo

PLACEBO COMPARATOR

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

Interventions

placebo DIETARY_SUPPLEMENT

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.

placebo

resveratrol DIETARY_SUPPLEMENT

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.

Also known as: resVida (99% pure trans-resveratrol)

resveratrol

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• DSM Nutritional Products, Inc.: collaborator
• Diabetes Fonds: collaborator

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Limburg, 6200 MD, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 29706321 DERIVED

MeSH Terms

Conditions

Glucose Intolerance; Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Hyperglycemia; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• Patrick Schrauwen, PhD

  Maastricht University Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: May 2, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: July 31, 2017
• Last Updated: August 8, 2017

Record last verified: 2016-08

Locations

NL (1)