Resveratrol and Type 2 Diabetes
Effect of Resveratrol on Insulin Sensitivity and Metabolic Profile in Type 2 Diabetics
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable type-2-diabetes
Started May 2012
Typical duration for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 30, 2012
CompletedFirst Posted
Study publicly available on registry
July 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedSeptember 4, 2014
September 1, 2014
2.3 years
May 30, 2012
September 3, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
insulin sensitivity (overall, muscle- and liver specific)
30 days after supplementation
Secondary Outcomes (5)
muscle mitochondrial oxidative capacity
30 days after supplementation
intramyocellular lipid content
30 days after supplementation
intrahepatic lipid content
30 days after supplementation
intracardiac lipid content
30 days after supplementation
heart function
30 days after supplementation
Study Arms (2)
placebo
PLACEBO COMPARATORA 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.
resveratrol
ACTIVE COMPARATORresveratrol 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maastricht University Medical Center
Maastricht, Limburg, 6200MD, Netherlands
Related Publications (1)
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 MKC, Kunz I, Schrauwen-Hinderling VB, Blaak E, 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. doi: 10.1016/j.cmet.2011.10.002.
PMID: 22055504BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Silvie Timmers, PhD
Human Biology, Maastricht University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2012
First Posted
July 12, 2012
Study Start
May 1, 2012
Primary Completion
September 1, 2014
Study Completion
December 1, 2014
Last Updated
September 4, 2014
Record last verified: 2014-09