Resveratrol and Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Effect of Resveratrol on Insulin Sensitivity and Metabolic Profile in Type 2 Diabetics

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01638780
• Other study ID #: 11-3-092
• Status: Active, not recruiting
• Phase: N/A
• First received: May 30, 2012
• Last updated: September 3, 2014
• Start date: May 2012
• Est. completion date: December 2014

Study information

• Verified date: September 2014
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	DSM Nutritional Products, Inc.

Country where clinical trial is conducted

Netherlands, 

References & 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 MK, Kunz I, Schrauwen-Hinderling VB, Blaak EE, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin sensitivity (overall, muscle- and liver specific)		30 days after supplementation	No
Secondary	muscle mitochondrial oxidative capacity		30 days after supplementation	No
Secondary	intramyocellular lipid content		30 days after supplementation	No
Secondary	intrahepatic lipid content		30 days after supplementation	No
Secondary	intracardiac lipid content		30 days after supplementation	No
Secondary	heart function		30 days after supplementation	No