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:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 1:16 AM
NCT ID:
NCT03387293
Eligibility Criteria:
Inclusion Criteria:
* Aged 12-18 years
* Age- and sex-specific body mass index (BMI) ≥95th percentile of the World Health Organization (WHO) growth-reference data
* New diagnosis and not receiving any treatment
* Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) \>3.16
Exclusion Criteria:
* Hypertension, cardiovascular disease, diabetes mellitus or any other significant metabolic, endocrine or gastrointestinal disease
* Use of tobacco or alcohol
* Taking any medications
* Having difficulties for physical activity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT03387293
Study Brief:
Protocol Section:
NCT03387293