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| ID | Type | Description | Link |
|---|---|---|---|
| JCM022 | Other Identifier | University of Virginia | |
| U54HD028934-18 | U.S. NIH Grant/Contract | View source | |
| 12702 | Other Identifier | University of Virginia Institutional Review Board for Health Sciences Research |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| University of California, San Diego | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone, Cortrosyn | Experimental | Dexamethasone given 1 mg PO Cortrosyn given single IV bolus 0f 0.25 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | 1 mg PO |
| |
| Cortrosyn |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Time frame for the study will be 14 hours (Sampling begins at 1900 hrs and proceeds through 0800 hours the following morning). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 hours (Sampling begins at 1900 hours and proceeds through 0800 the following morning) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Burt Solorzano, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Center for Research in Reproduction | Charlottesville | Virginia | 22902 | United States |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D003366 | Cosyntropin |
| D000324 | Adrenocorticotropic Hormone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Drug |
single IV bolus of 0.25 mg will be administered |
|
|
| Response to ACTH stimulation in normal weight and overweight girls | Examine the differences in hormone responses to ACTH in normal weight and overweight girls. | 14 hours (1900 - 0800 hrs) |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D053486 | Melanocortins |
| D011333 | Pro-Opiomelanocortin |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |