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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT03278704
Eligibility Criteria:
Inclusion Criteria:
* Male sex
* White British/European
* Aged between 40 and 65 years at the time of screening
* Have a body mass index (BMI; body weight/height in m2) between 27 and 40 kg/m2
* Sedentary/untrained for at least 1 year (based on physical activity self-reports of fewer than two sessions of structured exercise per week last \<30 min)
* T2DM (American Diabetes Association 2014) for more than 1 year
* Central obesity (defined as waist circumference ≥94 cm for males)
Exclusion Criteria:
* Currently involved in research or have recently (\<6 months) been involved in any research prior to recruitment
* Any condition limiting or contraindicating physical activity; including diabetic peripheral neuropathy, and coronary or peripheral artery disease
* Previous myocardial infarction, previous or current angina, shortness of breath, or other symptoms suggestive of heart failure
* Insulin medication
* HbA1c more than 75 mmol/mol (9%)
* Uncontrollable hypertension: systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥100 mmHg
* Not weight stable for the last three months
* Smokers (within the last 12 months)
* Anticoagulant medication, such as warfarin or newer anticoagulant drugs. If participants are on aspirin medication, this would need to be stopped for 3 days prior to and during the day of any biopsy visit unless contraindicated (in which case participants would be excluded).
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT03278704
Study Brief:
Protocol Section:
NCT03278704