Clinical trial: Etiological Factors of Obesity-Associated Hyperandrogenemia in Peripubertal Girls (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
Female
Accepts Healthy Volunteers
Subject must be at least 8 Years old.
Subject must be at most 16 Years

Patient description (medical language): A 19-year-old male came to clinic with some sexual concern.  He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates.  On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH.

Patient description (patient's own words): I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels.

Does the patient match the trial criteria? Contradiction