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

Primary Purpose

Hyperandrogenemia, Polycystic Ovary Syndrome, Obesity

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Dexamethasone

Cortrosyn

About this trial

This is an interventional basic science trial for Hyperandrogenemia

Eligibility Criteria

7 Years - 18 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

University of Virginia Center for Research in ReproductionRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dexamethasone, Cortrosyn

Arm Description

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

Outcomes

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.

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

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

Examine the differences in hormone responses to ACTH in normal weight and overweight girls.

Full Information

NCT ID

NCT01421797

First Posted

August 19, 2011

Last Updated

July 28, 2022

Sponsor

University of Virginia

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of California, San Diego

1. Study Identification

Unique Protocol Identification Number

NCT01421797

Brief Title

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

Official Title

Evaluation of Adrenal Androgens in Normal and Obese Girls After Suppression and Stimulation (JCM022)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 10, 2006 (Actual)

Primary Completion Date

August 27, 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Virginia

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of California, San Diego

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperandrogenemia, Polycystic Ovary Syndrome, Obesity

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dexamethasone, Cortrosyn

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

1 mg PO

Intervention Type

Drug

Intervention Name(s)

Cortrosyn

Other Intervention Name(s)

ACTH

Intervention Description

single IV bolus of 0.25 mg will be administered

Primary Outcome Measure Information:

Title

Change in progesterone concentrations from the 2100-2300 time block to the 0500-0700 time block in normal weight girls compared to overweight girls.

Description

Time Frame

Time frame for the study will be 14 hours (Sampling begins at 1900 hrs and proceeds through 0800 hours the following morning).

Secondary Outcome Measure Information:

Title

Overnight changes in male and female hormones in response to ACTH suppression

Description

Time Frame

14 hours (Sampling begins at 1900 hours and proceeds through 0800 the following morning)

Title

Response to ACTH stimulation in normal weight and overweight girls

Description

Examine the differences in hormone responses to ACTH in normal weight and overweight girls.

Time Frame

14 hours (1900 - 0800 hrs)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Melissa G Gilrain, BS

Phone

434-243-6911

pcos@virginia.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Christine Burt Solorzano, MD

Phone

434-243-6911

pcos@virginia.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christine Burt Solorzano, MD

Organizational Affiliation

University of Virginia

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Virginia Center for Research in Reproduction

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22902

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Melissa Gilrain

Phone

434-243-6911

pcos@virginia.edu

First Name & Middle Initial & Last Name & Degree

John C Marshall, MD, PhD

First Name & Middle Initial & Last Name & Degree

Christine Burt Solorzano, MD

12. IPD Sharing Statement

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

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