The Adrenal Contribution to Androgen Production in Girls During Puberty

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of California, San Diego
Sponsor:
Information provided by (Responsible Party):
Jeffrey Chang, MD, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01062568
First received: February 3, 2010
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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, 30 min, and 60 min after ACTH administration in NW and OB girls.


Condition Intervention Phase
Development
Drug: Adrenocorticotropin (ACTH)
Drug: Dexamethasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Adrenal Contribution to Androgen Production in Girls During Puberty

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 17-hydroxyprogesterone levels [ Time Frame: 0, 30, 60 minutes after ACTH administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • testosterone and androstenedione responses to ACTH [ Time Frame: 0, 30, and 60 min after ACTH administration ] [ Designated as safety issue: No ]

Estimated Enrollment: 84
Study Start Date: February 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Obese group
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.
Drug: Adrenocorticotropin (ACTH)
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 Name: Cosyntropin
Drug: 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, 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.
Experimental: Nonobese group
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.
Drug: Adrenocorticotropin (ACTH)
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 Name: Cosyntropin
Drug: 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, 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.

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

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062568

Contacts
Contact: R J Chang, MD 8585348930 rjchang@ucsd.edu

Locations
United States, California
University of california, san diego Recruiting
La Jolla, California, United States, 92037
Contact: R J Chang, MD    858-534-8930    rjchang@ucsd.edu   
Principal Investigator: R J Chang, MD         
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: R J Chang, MD UCSD
  More Information

No publications provided

Responsible Party: Jeffrey Chang, MD, Principal Investigator, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01062568     History of Changes
Other Study ID Numbers: 091676
Study First Received: February 3, 2010
Last Updated: January 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Diego:
adolescents
puberty
androgens
hyperandrogenemia

Additional relevant MeSH terms:
Adrenocorticotropic Hormone
Androgens
BB 1101
Beta-Endorphin
Cosyntropin
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014