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Resveratrol and Type 2 Diabetes

This study is ongoing, but not recruiting participants.
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: September 3, 2014
Last verified: September 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01638780     History of Changes
Other Study ID Numbers: 11-3-092
Study First Received: May 30, 2012
Last Updated: September 3, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

ClinicalTrials.gov processed this record on November 25, 2014