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Development | The Adrenal Contribution to Androgen Production in Girls During Puberty

Development research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - Normal CBC (Hemoglobin must be at least 11mg/dl) - Normal renal and liver function tests (AST 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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Development

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:AdrenocorticotropinSubjects 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 Cosyntropin, blood samples will be obtained for repeat hormone measurements.

Drug:DexamethasoneSubjects 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 (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 Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Obese groupSubjects 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 groupSubjects 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.

Study Status

Completed

Start Date: February 2010

Completed Date: July 2014

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: 17-hydroxyprogesterone Response to ACTH

Secondary Outcome: Free Testosterone Response to ACTH

Study sponsors, principal investigator, and references

Principal Investigator: R J Chang, MD

Lead Sponsor: University of California, San Diego

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01062568

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