Resveratrol and Type 2 Diabetes
This study is currently recruiting participants.
Verified July 2012 by Maastricht University Medical Center
Sponsor:
Maastricht University Medical Center
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
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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: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01638780
Contacts
| Contact: Silvie Timmers, PhD | 0031 43 3881672 | s.timmers@maastrichtuniversity.nl |
| Contact: Patrick Schrauwen, PhD | 0031 43 3881502 | p.schrauwen@maastrichtuniversity.nl |
Locations
| Netherlands | |
| Maastricht University Medical Center | Recruiting |
| Maastricht, Limburg, Netherlands, 6200MD | |
| Contact: Silvie Timmers, PhD 0031 43 3881672 s.timmers@maastrichtuniversity.nl | |
| Contact: Patrick Schrauwen, PhD 0031 43 3881502 p.schrauwen@maastrichtuniversity.nl | |
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: | July 11, 2012 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Additional relevant MeSH terms:
|
Resveratrol Diabetes Mellitus Diabetes Mellitus, Type 2 Insulin Resistance Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Hyperinsulinism Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Antineoplastic Agents, Phytogenic Antineoplastic Agents Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Enzyme Inhibitors Platelet Aggregation Inhibitors Hematologic Agents Antimutagenic Agents Anticarcinogenic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013