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 @ 2:23 PM
Ignite Modification Date:
2025-12-24 @ 2:23 PM
NCT ID:
NCT00928759
Eligibility Criteria:
Inclusion Criteria:
* Peripubertal (Tanner stage 1 to 5) girl, age 8-16 years
* Obesity (BMI-for-age ≥ 95th percentile)
* Generally healthy (save for exogenous obesity)
* Ability and willingness of subject/parents to provide informed assent/consent
Exclusion Criteria:
* Age \< 8 or \> 16 y
* Greater than 4 y post-menarche
* Obesity associated with a diagnosed (genetic) syndrome (e.g., Prader-Willi syndrome, leptin deficiency), obesity related to medications (e.g., glucocorticoids), etc.
* Pregnancy or lactation
* Virilization
* Total testosterone \> 150 ng/dl, which suggests the possibility of a virilizing neoplasm
* DHEAS greater than twice upper limit of age-appropriate normal range
* 17-OHP greater than 250 ng/dl, which suggests the possibility of congenital adrenal hyperplasia (if postmenarcheal, the 17-OHP will be collected during the follicular phase, or \> 60 if oligomenorrheic) NOTE: If a 17-OHP \> 250 ng/dl is confirmed on repeat testing, an ACTH stimulation test will be offered, with a post-ACTH 17-OHP \< 1000 ng/dl being required for study participation
* History of premature adrenarche (i.e., appearance of pubic and/or axillary hair before age 8)
* Fasting glucose \> 125 mg/dl or hemoglobin A1c \> 7.0%
* Abnormal TSH or prolactin
* Evidence of Cushing's syndrome by history or physical exam (e.g., history of impaired growth, striae)
* Hematocrit \< 36% or hemoglobin \< 12 g/dl
* Significant and current cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure; asthma requiring systemic intermittent corticosteroids; etc.)
* Abnormal liver enzymes, age-specific alkaline phosphatase, or a bilirubin \> 1.5 times upper limit of normal
* Abnormal sodium, potassium, bicarbonate concentrations, or elevated creatinine concentration
* Weight less than 34 kg is an exclusion criterion (to ensure safe blood withdrawal)
* Subjects using restricted medication (see restrictions below) are excluded unless the subject's primary care provider approves stopping the medication
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
8 Years
Maximum Age:
16 Years
Study:
NCT00928759
Study Brief:
Protocol Section:
NCT00928759