Clinical trial NCT01638780: Resveratrol and Type 2 Diabetes
Official title: Effect of Resveratrol on Insulin Sensitivity and Metabolic Profile in Type 2 Diabetics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: DSM Nutritional Products, Inc.
First posted: 2012-07-12
Enrollment: 24
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: insulin sensitivity (overall, muscle- and liver specific)
timeFrame: 30 days after supplementation
Secondary outcomes:
measure: muscle mitochondrial oxidative capacity
timeFrame: 30 days after supplementation
measure: intramyocellular lipid content
timeFrame: 30 days after supplementation
measure: intrahepatic lipid content
timeFrame: 30 days after supplementation
measure: intracardiac lipid content
timeFrame: 30 days after supplementation
measure: heart function
timeFrame: 30 days after supplementation
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Human Biology, Maastricht University Medical Center
name: Silvie Timmers, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.