- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01062568
The Adrenal Contribution to Androgen Production in Girls During Puberty
August 8, 2019 updated by: Jeffrey Chang, MD, University of California, San Diego
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
La Jolla, California, United States, 92037
- University of California, San Diego
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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:
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:
|
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.
|
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:
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
17-hydroxyprogesterone Response to ACTH
Time Frame: 0 and 60 minutes after ACTH administration
|
17-hyrooxyprogesterone levels before and after ACTH
|
0 and 60 minutes after ACTH administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Free Testosterone Response to ACTH
Time Frame: 0 and 60 min after ACTH administration
|
Free Testosteorne levels before and after ACTH
|
0 and 60 min after ACTH administration
|
Androstenedione Response to ACTH
Time Frame: 0 and 60 min after ACTH administration
|
Androstenedione levels before and after ACTH
|
0 and 60 min after ACTH administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: R J Chang, MD, UCSD
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
February 3, 2010
First Submitted That Met QC Criteria
February 3, 2010
First Posted (Estimate)
February 4, 2010
Study Record Updates
Last Update Posted (Actual)
August 26, 2019
Last Update Submitted That Met QC Criteria
August 8, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
- Cosyntropin
- Adrenocorticotropic Hormone
- Melanocyte-Stimulating Hormones
- beta-Endorphin
Other Study ID Numbers
- 091676
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Development
-
Hugo W. Moser Research Institute at Kennedy Krieger...Johns Hopkins UniversityNot yet recruitingChild Development | Developmental Delay | Infant Development | Language Development
-
Children's Hospital of PhiladelphiaNational Institute on Minority Health and Health Disparities (NIMHD)Active, not recruitingDevelopment Delay | Development, ChildUnited States
-
Seattle Children's HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development...UnknownCognitive Development | Emotional DevelopmentUnited States
-
Bundang CHA HospitalCompletedDelayed;Development;Physical | Delayed; Development, Intellectual
-
Central Hospital, Nancy, FranceCompletedDisease | Child Development | Denial (Psychology) | Personality DevelopmentFrance
-
Annamalai UniversityJohns Hopkins Bloomberg School of Public Health; Global Alliance for Improved... and other collaboratorsUnknownChild Development | Morbidity | Cognitive Development | Physical GrowthBangladesh
-
Swiss Tropical & Public Health InstituteSwiss National Science Foundation; University of Basel; Lao Tropical and Public...Active, not recruitingDevelopment, Infant | Breastfeeding | Development, Child | Breast Feeding, ExclusiveLao People's Democratic Republic
-
Indonesia UniversityGrand Challenges CanadaActive, not recruitingChild Development | Health Behavior | Infant Development | Maternal ExposureIndonesia
-
Swiss Tropical & Public Health InstituteSwiss National Science Foundation; University of Sao Paulo; University of BaselNot yet recruitingDevelopment, Infant | Breastfeeding | Development, Child | Breast Feeding, ExclusiveBrazil
-
University of California, IrvineEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsActive, not recruitingChild Development | Brain Development | Household and Family ProcessesUnited States
Clinical Trials on Adrenocorticotropin
-
Radboud University Medical CenterDutch Kidney FoundationCompletedIdiopathic Membranous NephropathyNetherlands
-
Ann & Robert H Lurie Children's Hospital of ChicagoThrasher Research FundUnknownWest SyndromeUnited States
-
Neurologique Foundation, Inc.MallinckrodtTerminated
-
University of California, San DiegoCompletedPolycystic Ovary SyndromeUnited States