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Resveratrol and Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01638780
Recruitment Status : Unknown
Verified September 2014 by Maastricht University Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : July 12, 2012
Last Update Posted : September 4, 2014
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Maastricht University Medical Center

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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Dietary Supplement: placebo Dietary Supplement: resveratrol Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Resveratrol on Insulin Sensitivity and Metabolic Profile in Type 2 Diabetics
Study Start Date : May 2012
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol

Arm Intervention/treatment
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.




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

Secondary Outcome Measures :
  1. muscle mitochondrial oxidative capacity [ Time Frame: 30 days after supplementation ]
  2. intramyocellular lipid content [ Time Frame: 30 days after supplementation ]
  3. intrahepatic lipid content [ Time Frame: 30 days after supplementation ]
  4. intracardiac lipid content [ Time Frame: 30 days after supplementation ]
  5. heart function [ Time Frame: 30 days after supplementation ]


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01638780


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

Publications:
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01638780     History of Changes
Other Study ID Numbers: 11-3-092
First Posted: July 12, 2012    Key Record Dates
Last Update Posted: September 4, 2014
Last Verified: September 2014

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