Text Size

Resveratrol and Type 2 Diabetes

This study is currently recruiting participants.
Verified July 2012 by Maastricht University Medical Center
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01638780
First received: May 30, 2012
Last updated: July 11, 2012
Last verified: July 2012
History of Changes

May 30, 2012
July 11, 2012
May 2012
May 2013   (final data collection date for primary outcome measure)
insulin sensitivity (overall, muscle- and liver specific) [ Time Frame: 30 days after supplementation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01638780 on ClinicalTrials.gov Archive Site
  • muscle mitochondrial oxidative capacity [ Time Frame: 30 days after supplementation ] [ Designated as safety issue: No ]
  • intramyocellular lipid content [ Time Frame: 30 days after supplementation ] [ Designated as safety issue: No ]
  • intrahepatic lipid content [ Time Frame: 30 days after supplementation ] [ Designated as safety issue: No ]
  • intracardiac lipid content [ Time Frame: 30 days after supplementation ] [ Designated as safety issue: No ]
  • heart function [ Time Frame: 30 days after supplementation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Resveratrol and Type 2 Diabetes
Effect of Resveratrol on Insulin Sensitivity and Metabolic Profile in Type 2 Diabetics

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes
  • Dietary Supplement: 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.
  • 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.
    Other Name: resVida (99% pure trans-resveratrol) provided by DSM Nutritional Products, Ltd.
  • Placebo Comparator: 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.
    Intervention: Dietary Supplement: placebo
  • Active Comparator: 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.
    Intervention: Dietary Supplement: resveratrol
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 MK, Kunz I, Schrauwen-Hinderling VB, Blaak EE, 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Male
40 Years to 70 Years
No
Contact: Silvie Timmers, PhD 0031 43 3881672 s.timmers@maastrichtuniversity.nl
Contact: Patrick Schrauwen, PhD 0031 43 3881502 p.schrauwen@maastrichtuniversity.nl
Netherlands
 
NCT01638780
11-3-092
No
Maastricht University Medical Center
Maastricht University Medical Center
DSM Nutritional Products, Inc.
Principal Investigator: Silvie Timmers, PhD Human Biology, Maastricht University Medical Center
Maastricht University Medical Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP