Resveratrol and Type 2 Diabetes

NCT ID: NCT01638780

Last Updated: 2014-09-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-12-31

Brief Summary

The main objective of the study is to investigate if resveratrol supplementation can improve overall and muscle-specific insulin sensitivity in 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.

Conditions

Type 2 Diabetes

Study Design

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

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

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.

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.

Group Type: ACTIVE_COMPARATOR

resveratrol

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

resVida (99% pure trans-resveratrol) provided by DSM Nutritional Products, Ltd.

Eligibility Criteria

Inclusion Criteria

• Male sex
• Age: 40-70 years
• Body fat percentage > 25, BMI 27-35 kg/m2
• Diagnosed with type 2 diabetes at least one year before the start of the study
• Well-controlled type 2 diabetics: HBA1C < 8.0%
• Oral glucose lowering medication (metformin only or in combination with sulfonylurea agents)
• Sedentary

• Not more than 2 hours of sports a week
• No active job that requires strenuous physical activity
• Stable dietary habits
• Willingness to abstain from resveratrol-containing food products

Exclusion Criteria

• Unstable body weight (weight gain or loss > 3kg in the last three months)
• Total body fat percentage < 25%
• Hemoglobin < 7.8 mmol/l
• Use of anticoagulants
• Engagement in programmed exercise > 2 hours total per week
• Impaired kidney and/or hepatic function Creatinine 50-100 umol/L Liver enzymes, within 2 times of normal range of laboratory standard (ASAT < 60 U/L, ALAT < 70 U/L, Billi <40 umol/L, gamma-GT < 80 U/L)
• No diabetes related co-morbidities like cardiovascular diseases, diabetic foot, polyneuropathy, retinopathy
• Insulin dependent Diabetic subjects
• Any medical condition except type 2 diabetes mellitus requiring treatment and/or medication use except metformin only or in combination with sulfonylurea agents
• Intake of dietary supplements except multivitamins and minerals
• 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.
• Participation in another biomedical study within 1 month before the first screening visit
• Any contraindication 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
• Or 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

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Silvie Timmers, PhD

Role: PRINCIPAL_INVESTIGATOR

Human Biology, Maastricht University Medical Center

Locations

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Countries

Netherlands

References

Timmers S, Konings E, Bilet L, Houtkooper RH, van de Weijer T, Goossens GH, Hoeks J, van der Krieken S, Ryu D, Kersten S, Moonen-Kornips E, Hesselink MKC, Kunz I, Schrauwen-Hinderling VB, Blaak E, Auwerx J, Schrauwen P. Calorie restriction-like effects of 30 days of resveratrol supplementation on energy metabolism and metabolic profile in obese humans. Cell Metab. 2011 Nov 2;14(5):612-22. doi: 10.1016/j.cmet.2011.10.002.

Reference Type: BACKGROUND

PMID: 22055504 (View on PubMed)

Other Identifiers

11-3-092

Identifier Type: -

Identifier Source: org_study_id