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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT00461994
Eligibility Criteria:
Inclusion Criteria:
1. Obese preadolescent children 6-11 year-old with BMI\> 95th percentile for age and gender.
2. A signed informed consent will be taken from patients and their parents.
3. Agreement to a follow-up of one year.
Exclusion Criteria:
1. Cardiac problems (arrhythmia, Congestive heart disease)
2. Uncontrolled hypertension
3. Severe hepatic impairment (liver enzymes above 3 folds the upper normal values)
4. Renal failure
5. Genetic syndromes associated with obesity
6. Presence of untreated hypothyroidism
7. Participation in a clinical study during the last month
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
11 Years
Study:
NCT00461994
Study Brief:
Protocol Section:
NCT00461994