Last updated on February 2018

Etiological Factors of Obesity-Associated Hyperandrogenemia in Peripubertal Girls

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Obesity | Polycystic Ovary Syndrome | Hyperandrogenemia
  • Age: Between 8 - 16 Years
  • Gender: Female

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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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