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Effect of resveratrol on insulin sensitivity and metabolic profile in type 2 diabetics

Completed
Conditions
10018424
10013317
obesitas and sugar
Registration Number
NL-OMON37515
Lead Sponsor
niversiteit Maastricht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
24
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
* 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.
* Anti-coagulants
* Insulin therapy
* Intake of dietary supplements except vitamins and minerals
* Unwillingness to restrict high-resveratrol-containing food products
* Current alcohol consumption > 20 grams/day
* Participation in another biomedical study within 1 month before the first screening visit
* Any contraindication to MRI scanning. These contra-indictations include patients with following devices:
o Central nervous system aneurysm clip
o Implanted neural stimulator
o Implanted cardiac pacemaker of defibrillator
o Cochlear implant
o Insulin pump
o Or metal containing corpora aliena in the eye or brains
* 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The main study endpoints are the differences in whole body- and muscle insulin<br /><br>sensitivity, and mitochondrial fat oxidative capacity after 30 days of<br /><br>resveratrol supplementation compared to the placebo trial.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary outcome measures are the changes in liver and muscle fat storage<br /><br>after 30 days of resveratrol or placebo supplementation.</p><br>
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