The Adrenal Contribution to Androgen Production in Girls During Puberty

Phase 3

Completed

• Conditions: Development
• Interventions: Drug: Adrenocorticotropin; Drug: Dexamethasone

• Registration Number: NCT01062568
• Lead Sponsor: University of California, San Diego

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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-03
• Study First Submitted QC: 2010-02-03
• Study First Posted: 2010-02-04
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Results First Submitted: 2019-06-10
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-08
• Last Update Submitted: 2019-08-08
• Results First Posted: 2019-08-26
• Last Update Posted: 2019-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Obese group	Adrenocorticotropin	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, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.
Nonobese group	Adrenocorticotropin	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, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.
Obese group	Dexamethasone	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, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.
Nonobese group	Dexamethasone	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, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.

Primary Outcome Measures

Name	Time	Method
17-hydroxyprogesterone Response to ACTH	0 and 60 minutes after ACTH administration	17-hyrooxyprogesterone levels before and after ACTH

Secondary Outcome Measures

Name	Time	Method
Free Testosterone Response to ACTH	0 and 60 min after ACTH administration	Free Testosteorne levels before and after ACTH
Androstenedione Response to ACTH	0 and 60 min after ACTH administration	Androstenedione levels before and after ACTH

Trial Locations

Locations (1)

University of california, san diego; 🇺🇸 La Jolla, California, United States