Status:
UNKNOWN
Etiological Factors of Obesity-Associated Hyperandrogenemia in Peripubertal Girls
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Obesity
Hyperandrogenemia
Eligibility:
FEMALE
8-16 years
Brief Summary
The purpose of this study is to learn if obese pre- and early pubertal girls with hyperandrogenemia (HA) are more insulin resistant (i.e., have lower insulin-stimulated glucose disposal) compared to o...
Detailed Description
A number of pathophysiological mechanisms underlie the polycystic ovary syndrome (PCOS). Neuroendocrine abnormalities play a significant role in most women with PCOS, and PCOS is associated with relat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00928759
Start Date
March 1 2008
End Date
August 1 2023
Last Update
May 18 2022
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22908