Resveratrol and First-degree Relatives of Type 2 Diabetic Patients

NCT ID: NCT02129595

Last Updated: 2017-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2017-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

resveratrol

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

resVida (99% pure trans-resveratrol)

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

DSM Nutritional Products, Inc.

INDUSTRY

Sponsor Role: collaborator

Diabetes Fonds

OTHER

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Schrauwen, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Centre

Locations

Maastricht University Medical Centre

Maastricht, Limburg, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 29706321 (View on PubMed)

Other Identifiers

13-3-058

Identifier Type: -

Identifier Source: org_study_id