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Completed

NCT Number: NCT01062568

The Adrenal Contribution to Androgen Production in Girls During Puberty

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.

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Key information

Conditions

Age range

7 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of california, san diego

La Jolla, California, 92037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adrenocorticotropin

Drug

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

Other names: Cosyntropin, ACTH

Dexamethasone

Drug

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 (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.

Other names: dex

Primary outcomes

  1. 17-hydroxyprogesterone Response to ACTH

    Time frame: 0 and 60 minutes after ACTH administration

    17-hyrooxyprogesterone levels before and after ACTH

Secondary outcomes

  1. Free Testosterone Response to ACTH

    Time frame: 0 and 60 min after ACTH administration

    Free Testosteorne levels before and after ACTH

  2. Androstenedione Response to ACTH

    Time frame: 0 and 60 min after ACTH administration

    Androstenedione levels before and after ACTH

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Feb 4, 2010
Registry last updated
Aug 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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