The Adrenal Contribution to Androgen Production in Girls During Puberty

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

In girls with elevated androgens the precise source of androgen excess throughout puberty and early adolescence has not been carefully examined. The investigators propose to examine whether the adrenal gland produces the majority of androgens during puberty by studying the differences in androgen responses to adrenocorticotropin hormone (ACTH) administration in normal weight (NW) and obese (OB) girls ages 7-18. The investigators' analyses will compare steroid changes before and 60 min after ACTH administration in NW and OB girls.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Diego
• Treatments: Adrenocorticotropic Hormone; Androgens; BB 1101; beta-Endorphin; Cosyntropin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Hormones; Melanocyte-Stimulating Hormones; Polystyrene sulfonic acid

Criteria

Inclusion Criteria:

• Normal CBC (Hemoglobin must be at least 11mg/dl)

• Normal renal and liver function tests (AST& ALT 10-45 IU/L; Albumin 3.3-5 g/dL; Alk phos 30-130 IU/L;

• direct bili <0.2 mg/dL;

• total bili <1.2 mg/dL; total protein 6.0-8.0 g/dL) Normal vital signs including normal blood pressure (pulse 60-100/min, respirations 12-20/min, BP 80/60-130/80)

Exclusion Criteria:

• Pregnancy

• On oral contraceptives

• On insulin lowering drugs

• On anti-androgens (i.e., spironolactone, flutamide, finasteride, etc)

• On medications that will influence androgen metabolism or clearance

• On medications that will inhibit the cytochrome P450 enzyme system (cimetidine, ketoconazole, etc)

• Subjects with morning cortisol<5 ug/dL will be excluded and asked to see their primary care physician.

• Subjects with 17-OHP>250 ng/dL) will be excluded and asked to see their primary care physician.

• Subject with a history of Cushing syndrome or adrenal insufficiency will be excluded