Etiological Factors of Obesity-Associated Hyperandrogenemia in Peripubertal Girls

• Register: ClinicalTrials.gov
• Last refreshed on: 21 January 2013
• Main ID: NCT00928759
• Date of registration: 28/10/2008
• Primary sponsor: University of Virginia
• Public title: Etiological Factors of Obesity-Associated Hyperandrogenemia in Peripubertal Girls CRM002
• Scientific title: Etiological Factors of Obesity-Associated Hyperandrogenemia in Peripubertal Girls
• Date of first enrolment: March 2008
• Target sample size: 40
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00928759
• Study type: Observational
• Study design: Observational Model: Case-Only, Time Perspective: Prospective

Countries of recruitment

United States

Contacts

• Name: Anne Gabel, BSc

• Name: Anne Gabel, BSc

• Name: Christopher McCartney, MD
• Affiliation: University of Virginia

Key inclusion & exclusion 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



Age minimum: 8 Years
Age maximum: 16 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Hyperandrogenemia

Obesity

Polycystic Ovary Syndrome

Primary Outcome(s)

Insulin-stimulated glucose disposal [Time Frame: 0900 to 1100 hours]

Morning free testosterone [Time Frame: 0700 to 0900 hours]

Secondary Outcome(s)

Estimated 24-hour mean insulin concentration [Time Frame: 24 hours]

Luteinizing hormone pulse frequency [Time Frame: 1800 to 0900 hours]

Mean luteinizing hormone concentration [Time Frame: 1800 to 0900 hours]

Secondary ID(s)

13552

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institutes of Health (NIH)