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 @ 7:09 PM
Ignite Modification Date:
2025-12-24 @ 7:09 PM
NCT ID:
NCT04178603
Eligibility Criteria:
Inclusion Criteria for Study Subjects
* Healthy persons (no known disease) without diabetes in the family
* No use of medications
* Non-smokers
* Men
* Age 25-40 years
* Physical activity level (VO2peak) between 30-50 mL O2/min/kg
Specific for the persons of normal weight:
* BMI between 18.0 and 25.0
* HOMA-IR ≤ 1.5
* Glucose tolerant (intact response in relation to oral glucose tolerance test, OGTT)
* Without metabolic syndrome (defined by the International Diabetes Federation in 2006)
Specific for the persons with overweight and insulin resistance:
* BMI between 28.0 and 35.0
* HOMA-IR ≥ 2.2
* Glucose tolerant (intact response in relation to OGTT)
Exclusion criteria
* Women
* Elevated blood pressure (systolic above 140 mmHg, diastolic above 90 mmHg).
* Persons who show signs of metabolic diseases, hematologic diseases, reduced liver function or other signs of disease that may affect the outcome of the study or the study subject's wellbeing will be excluded.
Exclusion after Inclusion
* If disease appears or is identified and/or a need for medication arises after inclusion but before initiation of the study.
* Disease during conclusion of the study
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
25 Years
Maximum Age:
40 Years
Study:
NCT04178603
Study Brief:
Protocol Section:
NCT04178603