Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-24 @ 1:37 PM
NCT ID:
NCT02129595
Eligibility Criteria:
Inclusion Criteria:
* Male sex
* Age: 40-70 years
* BMI 27-35 kg/m2
* Has first-degree relative(s) diagnosed with type 2 diabetes
* Sedentary
* Not more than 2 hours of sports a week
* 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 below \< 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 in 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 first screening visit
* Any condition, disease or abnormal laboratory test result that, in the opinion of the Investigator, would interfere with the study outcome, affect trial participation or put the subject at undue risk
* Any contra-indication 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
* Metal containing corpora aliena in the eye or brains
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT02129595
Study Brief:
Protocol Section:
NCT02129595