Etiological Factors of Obesity-Associated Hyperandrogenemia in Peripubertal Girls (NCT00928759) | Clinical Trial Compass
UnknownNot Applicable
Etiological Factors of Obesity-Associated Hyperandrogenemia in Peripubertal Girls
United States40 participantsStarted 2008-03
Plain-language 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 obese peripubertal girls without HA; and that overnight mean luteinizing hormone (LH) concentration is also an independent predictor of free testosterone concentrations, especially in mid- to late pubertal girls.
Who can participate
Age range8 Years – 16 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 c…