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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT01312051
Eligibility Criteria:
Inclusion Criteria:
Protocols 1 \& 4:
* Age 11-17 years
* Male or Female
* Healthy
* Obese, BMI ≥ 95 percentile
* Pubertal/Tanner Stage II-V
* African American or White American, based on self identity with no admixture for 3 generations
Protocol 2:
* Age 11-17 years
* Male or Female
* Healthy
* Normal Weight, BMI 10- 95 percentile
* Pubertal/Tanner Stage II-V
* African American or White American, based on self-identity with no admixture for 3 generations
Protocol 3:
* Age 8-12 years
* Male or Female
* Healthy
* Normal Weight, BMI 10-95 percentile
* Prepubertal/Tanner Stage I
* African American or White American, based on self-identity with no admixture for 3 generations
Exclusion Criteria:
* Medications which interfere with metabolism
* Hemocue \< 12 gm/dl in pubertal subjects and \<11gm/dl in prepubertal subjects
* Positive serum pregnancy test
* Recent significant weight change or dieting
* Presence of disease (i.e.diabetes, hypothyroidism, genetic dyslipidemia, etc)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
17 Years
Study:
NCT01312051
Study Brief:
Protocol Section:
NCT01312051