Evaluation of Adrenal Androgens in Normal and Obese Girls After Suppression and Stimulation

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Virginia
Sponsor:
Collaborators:
University of California, San Diego
Information provided by (Responsible Party):
John Marshall, University of Virginia
ClinicalTrials.gov Identifier:
NCT01421797
First received: August 19, 2011
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

Women with polycystic ovary syndrome (PCOS) often have irregular menstrual periods, too much facial and body hair, and weight gain. Women with PCOS also have a hard time becoming pregnant. Girls with high levels of the male hormone testosterone often develop PCOS as adults. Some girls with high levels of male hormone will develop normal hormone levels as they grow up, but most girls continue to have high levels of male hormone as adults. The purpose of this study is to understand where the male and female hormones come from in girls as they get older. The investigators think the adrenal gland, makes most of the hormones in young girls and that the ovary and the adrenal gland make these hormones in older girls. The investigators would like to find out whether an overactive adrenal gland makes these hormones higher in girls who are overweight, compared to those who are not overweight.


Condition Intervention
Hyperandrogenemia
Polycystic Ovary Syndrome
Obesity
Drug: Dexamethasone
Drug: Cortrosyn

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Evaluation of Adrenal Androgens in Normal and Obese Girls After Suppression and Stimulation (JCM022)

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Change in progesterone concentrations from the 2100-2300 time block to the 0500-0700 time block in normal weight girls compared to overweight girls. [ Time Frame: Time frame for the study will be 14 hours (Sampling begins at 1900 hrs and proceeds through 0800 hours the following morning). ] [ Designated as safety issue: No ]
    A primary endpoint for analysis in this study is the change in progesterone concentrations from the 2100-2300 time block to the 0500-0700 time block in normal weight girls compared to overweight girls.


Secondary Outcome Measures:
  • Overnight changes in male and female hormones in response to ACTH suppression [ Time Frame: 14 hours (Sampling begins at 1900 hours and proceeds through 0800 the following morning) ] [ Designated as safety issue: No ]
    Secondary endpoints will include overnight changes in testosterone, estradiol, cortisol, dehydroepiandrosterone (DHEA), and luteinizing hormone (LH) pulse patterns in response to adrenocorticotropic hormone (ACTH) suppression. These secondary endpoints will be evaluated in a similar manner to the primary endpoint.

  • Response to ACTH stimulation in normal weight and overweight girls [ Time Frame: 14 hours (1900 - 0800 hrs) ] [ Designated as safety issue: No ]
    Examine the differences in hormone responses to ACTH in normal weight and overweight girls.


Estimated Enrollment: 84
Study Start Date: October 2006
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexamethasone, Cortrosyn
Dexamethasone given 1 mg PO Cortrosyn given single IV bolus 0f 0.25 mg
Drug: Dexamethasone
1 mg PO
Drug: Cortrosyn
single IV bolus of 0.25 mg will be administered

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal and obese (>95th BMI%) females
  • Weight of 24 kg or more
  • Early to late puberty (expected age range 7-18)
  • Screening labs within age-appropriate normal range, with the exception of a mildly low hematocrit (see below) and the hormonal abnormalities inherent in obesity which could include mildly elevated LH, lipids, testosterone, prolactin, DHEAS, E2, glucose, and insulin; and decreased follicle-stimulating hormone (FSH) and/or sex hormone-binding globulin (SHBG)

Exclusion Criteria:

  • Screening labs outside of age-appropriate normal range
  • Hemoglobin <12 mg/dL and hematocrit<36% (Subjects will be offered the opportunity to take iron supplementation for 60 days if their hematocrit is slightly low (33-36%) (suggestive of iron deficiency anemia) and will then return for retesting of their hemoglobin/hematocrit. If still <36%, they will be excluded.)
  • Morning Cortisol <5 g/dL
  • 17-hydroxyprogesterone >295 ng/dL
  • Weight<24 kg
  • History of Cushing's syndrome or adrenal insufficiency
  • Pregnant (self reported)
  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: NCT01421797

Contacts
Contact: Anne C Gabel, BSc 434-243-6911 pcos@virginia.edu
Contact: Christine Burt Solorzano, MD 434-243-6911 pcos@virginia.edu

Locations
United States, Virginia
University of Virginia Center for Research in Reproduction Recruiting
Charlottesville, Virginia, United States, 22902
Contact: Anne C Gabel, BSc    434-243-6911    pcos@virginia.edu   
Principal Investigator: John C Marshall, MD, PhD         
Sub-Investigator: Christine Burt Solorzano, MD         
Sponsors and Collaborators
University of Virginia
University of California, San Diego
Investigators
Principal Investigator: John C Marshall, MD, PhD University of Virginia
  More Information

No publications provided

Responsible Party: John Marshall, Director, Center for Research in Reproduction, University of Virginia
ClinicalTrials.gov Identifier: NCT01421797     History of Changes
Other Study ID Numbers: 12702, JCM022, U54HD028934-18, 12702
Study First Received: August 19, 2011
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Polycystic Ovary Syndrome
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Androgens
Cosyntropin
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
BB 1101
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 22, 2014