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Effects of resveratrol on insulin sensitivity, brown adipose tissue and metabolic profile in first-degree relatives of type 2 diabetic patients

Completed
Conditions
obesitas and sugar disease
10018424
10013317
Registration Number
NL-OMON45176
Lead Sponsor
niversiteit Maastricht
Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
30
Inclusion Criteria

* Male sex
* Age: 40-70 years
* BMI 27-35 kg/m2
* Has first-degree relative(s) diagnosed with type 2 diabetes
* Sedentary:
o Not more than 2 hours of sports a week
o No active job that requires strenuous physical activity
* Stable dietary habits: no weight gain or loss > 5kg in the last three months
* Insulin resistant: glucose clearance rate <350 ml/kg/min, as determined using OGIS120
* Willingness to abstain from resveratrol-containing food products
* Subjects will only be included when the dependent medical doctor of this study approves participation after evaluating data obtained during screening

Exclusion Criteria

* Use of anticoagulants
* Uncontrolled hypertension
* Haemoglobin <7.8 mmol/l
* In case of an abnormal ECG at rest: this will be discussed with the responsible medical doctor
* HBA1C > 6.5%
* Diagnosed with type 2 diabetes
* Medication use known to interfere with glucose homeostasis/metabolism
* 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.
* Subjects who intend to donate blood during the intervention or subjects who have donated blood less than three months before the start of the intervention.
* Participation in another biomedical study within 1 month before the screening visit
* Any contra-indication to MRI scanning:
o Central nervous system aneurysm clip
o Implanted neural stimulator
o Implanted cardiac pacemaker of defibrillator
o Cochlear implant
o Insulin pump
o Metal containing corpora aliena in the eye or brains
For the 18F-FDG PET-CT scan:
o Participation in earlier research or medical examinations that included PET/CT scanning

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. Also, in 9 subjects we<br /><br>want to determine brown adipose tissue activity on day 33. </p><br>
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