Trials / Unknown
UnknownNCT01421797
Evaluation of Adrenal Androgens in Normal and Obese Girls After Suppression and Stimulation
Evaluation of Adrenal Androgens in Normal and Obese Girls After Suppression and Stimulation (JCM022)
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- Sponsor
- University of Virginia · Academic / Other
- Sex
- Female
- Age
- 7 Years – 18 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dexamethasone | 1 mg PO |
| DRUG | Cortrosyn | single IV bolus of 0.25 mg will be administered |
Timeline
- Start date
- 2006-10-10
- Primary completion
- 2024-08-27
- Completion
- 2024-12-01
- First posted
- 2011-08-23
- Last updated
- 2023-10-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01421797. Inclusion in this directory is not an endorsement.