Obesity Clinical Trial
Official title:
Adrenal Hyperplasia Among Young Patients With Polycystic Ovarian Syndrome
Verified date | October 24, 2017 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background:
- Polycystic ovarian syndrome (PCOS) is a group of disorders related to problems with the
secretion of certain hormones, which can lead to reproductive and other issues in women.
Frequent complications of PCOS include irregular menstruation, development of ovarian cysts,
and insulin resistance. The adrenal glands, which sit on top of the kidney, are involved in
the production of certain hormones and the regulation of steroid levels in the blood, and may
be affected in women with PCOS. Researchers are interested in studying possible connections
between the adrenal glands and PCOS in young women who have been diagnosed with PCOS and
healthy volunteers with normal menstrual function.
Objectives:
- To investigate possible connections between adrenal gland steroid hormone secretion and
polycystic ovarian syndrome.
Eligibility:
- Women between 16 and 29 years of age who have been diagnosed with PCOS, or who are
healthy volunteers with normal menstrual function.
- Participants must be willing to discontinue the use of oral contraceptives or any other
medications that alter steroid hormone production for at least 1 month before the start
of the study.
Design:
- Participants will be screened with a physical examination, medical history, and blood
and urine tests. All participants will also have a pelvic (ovarian) ultrasound.
- All participants will be admitted to the hospital for a 1-week testing period, which
will involve the following tests:
- Regular blood draws for two 2-hour periods (late evening and early morning) to measure
hormone levels
- Fasting blood draws with a dose of corticotropin to test the body's adrenal function
- Hormone level measurement following regular doses of dexamethasone (a drug that controls
the function of the adrenal gland)
- Daily urine collection for 6 days.
- Other studies, such as imaging studies of the adrenal glands, may be conducted as
required by the study researchers.
Status | Completed |
Enrollment | 96 |
Est. completion date | October 24, 2017 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 16 Years to 29 Years |
Eligibility |
- INCLUSION CRITERIA FOR PATIENTS: Women 16-24 years old with PCOS defined as biochemical hyperandrogenism with associated findings of either menstrual irregularity and /or polycystic ovaries on ultrasound; hyperandrogenism defined as elevation of any of the following androgens: free testosterone, total testosterone, DHEAS, DHEA, 17 0H progesterone, androstenedione, 17OH pregnenolone; a polycystic ovary on ultrasound should either have 12 follicles measuring 2-9 mm in diameter, or have an increased ovarian volume of 10 CC or greater; menstrual irregularity defined as: Amenorrhea refers to absence of bleeding for at least three usual cycle lengths; oligomenorrhea refers to bleeding that occurs at an interval greater than 35 days. We would like patients to have oligomenorrhea for at least six usual cycle lengths. Patients have to be off oral contraceptive pills or any other medications that alter steroidogenesis for at least one month prior to participating in the study INCLUSION CRITERIA FOR CONTROLS: Women 18-25 years old with normal menstrual function; they have to be off oral contraceptive pills or any other medications that alter steroidogenesis for at least one month prior to participating in the study. EXCLUSION CRITERIA FOR PATIENTS: Patients who have hyperandrogenism due to 21 hydroxylase deficiency non- classic adrenal hyperplasia androgen secreting neoplasms Women with known or suspected androgenic/anabolic drug use Women with severe insulin resistance-acanthosis nigricans syndrome; Fasting insulin levels are obtained to rule out syndromes of severe insulin resistance and hyperandrogenism; if insulin is above 80 mU/mL in the fasting state, and/or >300 mU/mL following a 2- or 3-hour oral glucose tolerance test (obtained elsewhere), patients are not eligible. Women with thyroid dysfunction, hyperprolactinemia, (defined as prolactin level greater than or equal to 3 times the upper reference limit), less than 2 years post menarche, and patients on medications that alter steroidogenesis such as oral contraceptive pills, for less than a month prior to the date of inclusion in the study. (see above: patients have to be off oral contraceptive pills or any other medications that alter steroidogenesis for at least one month prior to participating in the study) Women with prior history of pregnancy. EXCLUSION CRITERIA FOR CONTROLS: Young women with hyperandrogenemia, hirsutism or known adrenal tumors or other endocrine diseases, patients on multiple medications, known insulin resistance, or any other chronic or acute illness are not eligible as controls for this study. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Karch S, Manzambi ZA, Salaun JJ. Field trials with Vectolex (Bacillus sphaericus) and Vectobac (Bacillus thuringiensis (H-14)) against Anopheles gambiae and Culex quinquefasciatus breeding in Zaire. J Am Mosq Control Assoc. 1991 Jun;7(2):176-9. — View Citation
Krone N, Arlt W. Genetics of congenital adrenal hyperplasia. Best Pract Res Clin Endocrinol Metab. 2009 Apr;23(2):181-92. doi: 10.1016/j.beem.2008.10.014. Review. — View Citation
Rosenfield RL. What every physician should know about polycystic ovary syndrome. Dermatol Ther. 2008 Sep-Oct;21(5):354-61. doi: 10.1111/j.1529-8019.2008.00217.x. Review. — View Citation
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