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 @ 9:22 PM
Ignite Modification Date:
2025-12-24 @ 9:22 PM
NCT ID:
NCT01410604
Eligibility Criteria:
Inclusion Criteria:
* Obesity defined as Body Mass Index (BMI) ≥ percentile 95
* Tanner stage ≥ 2
* Insulin resistance defined as Basal insulin \> 15 µU/mL or Homeostasis Model Assessment index (HOMA) \> 4.5
* Patients' parents signed written consents when they and their adolescent children agreed to enroll
Exclusion Criteria:
* Glucose intolerance
* Diabetes mellitus (type 1 or 2)
* Anemia (Hb \< 10 g/dL)
* Plasma creatinine \> 1.4 mg/dL
* Abnormal hepatic function
* Any associated Disease (Pulmonary, Infection, Autoimmune Disease)
* History of lactic acidosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
9 Years
Maximum Age:
18 Years
Study:
NCT01410604
Study Brief:
Protocol Section:
NCT01410604