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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT03537235
Eligibility Criteria:
Inclusion Criteria:
* BMI 30.0-39.9 kg/m2,
* serum fasting glucose and insulin in normal ranges (- glucose ≤ 100 mg/dl, insulin ≤ 15 uIU/ml)
* HOMA-IR \< 2.5 (normal range for insulin sensitivity among Polish population),
* stable body mass in the last 3 months (not more than 2 kg),
* do not use any hypocaloric diet in the last 6 months,
* not changed then realized before physical activity in the last 3 months,
* the lack of any known comorbidities,
* do not use any drugs including contraceptive
* capability to understand the study procedures and provide written informed consent.
Exclusion Criteria:
* All chronic and acute disease of the digestive tract in medical history,
* smoking,
* more than 3 alcoholic drinks per week (bear, glass of wine, and 50 ml vodka)
* no patient co-operation.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
35 Years
Study:
NCT03537235
Study Brief:
Protocol Section:
NCT03537235