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

NCT ID: NCT01421797

Last Updated: 2023-10-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-10
• Study Completion Date: 2024-12-31

Brief Summary

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.

Detailed Description

We propose that the adrenal gland is the predominant source of the early morning rise in progesterone and testosterone which is more marked in early puberty. Specifically, we hypothesize that dexamethasone administration at 22:00 will be associated with a dampened progesterone and testosterone rise the subsequent morning in normal girls. We also propose that the adrenal gland is the source of the excess androgen production in young obese girls, and that dexamethasone will decrease their early morning testosterone and progesterone levels. We will explore the hypothesis that functional adrenal hyperandrogenism, or ACTH hyperresponsiveness, is one mechanism underlying this excess adrenal androgen production seen in obesity.

Conditions

Hyperandrogenemia; Polycystic Ovary Syndrome; Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Dexamethasone, Cortrosyn

Dexamethasone given 1 mg PO Cortrosyn given single IV bolus 0f 0.25 mg

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: DRUG

1 mg PO

Cortrosyn

Intervention Type: DRUG

single IV bolus of 0.25 mg will be administered

Interventions

Dexamethasone

1 mg PO

Intervention Type: DRUG

Cortrosyn

single IV bolus of 0.25 mg will be administered

Intervention Type: DRUG

Other Intervention Names

ACTH

Eligibility 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)

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Christine Burt Solorzano

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christine Burt Solorzano, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia Center for Research in Reproduction

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

JCM022

Identifier Type: OTHER

Identifier Source: secondary_id

U54HD028934-18

Identifier Type: NIH

Identifier Source: secondary_id

View Link

12702

Identifier Type: OTHER

Identifier Source: secondary_id

12702

Identifier Type: -

Identifier Source: org_study_id