Clinical trial NCT01062568: The Adrenal Contribution to Androgen Production in Girls During Puberty
Official title: The Adrenal Contribution to Androgen Production in Girls During Puberty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Development
Keywords: adolescents
puberty
androgens
hyperandrogenemia
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2010-02-04
Enrollment: 50
Sex: FEMALE
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, 0.25 mg adrenocorticotropin hormone (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.

Eligibility 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

Primary outcomes:
measure: 17-hydroxyprogesterone Response to ACTH
timeFrame: 0 and 60 minutes after ACTH administration
Secondary outcomes:
measure: Free Testosterone Response to ACTH
timeFrame: 0 and 60 min after ACTH administration
measure: Androstenedione Response to ACTH
timeFrame: 0 and 60 min after ACTH administration
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of california, san diego
state: California
Study officials:
affiliation: UCSD
name: R J Chang, MD
role: PRINCIPAL_INVESTIGATOR
References: