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Resveratrol and Type 2 Diabetes

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2014 by Maastricht University Medical Center.
Recruitment status was:  Active, not recruiting
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Maastricht University Medical Center Identifier:
First received: May 30, 2012
Last updated: September 3, 2014
Last verified: September 2014

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.

Condition Intervention
Type 2 Diabetes
Dietary Supplement: placebo
Dietary Supplement: resveratrol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Resveratrol on Insulin Sensitivity and Metabolic Profile in Type 2 Diabetics

Resource links provided by NLM:

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • insulin sensitivity (overall, muscle- and liver specific) [ Time Frame: 30 days after supplementation ]

Secondary Outcome Measures:
  • muscle mitochondrial oxidative capacity [ Time Frame: 30 days after supplementation ]
  • intramyocellular lipid content [ Time Frame: 30 days after supplementation ]
  • intrahepatic lipid content [ Time Frame: 30 days after supplementation ]
  • intracardiac lipid content [ Time Frame: 30 days after supplementation ]
  • heart function [ Time Frame: 30 days after supplementation ]

Estimated Enrollment: 24
Study Start Date: May 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.


Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01638780

Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6200MD
Sponsors and Collaborators
Maastricht University Medical Center
DSM Nutritional Products, Inc.
Principal Investigator: Silvie Timmers, PhD Human Biology, Maastricht University Medical Center
  More Information

Responsible Party: Maastricht University Medical Center Identifier: NCT01638780     History of Changes
Other Study ID Numbers: 11-3-092
Study First Received: May 30, 2012
Last Updated: September 3, 2014

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents processed this record on May 24, 2017