Clinical Trial: Adrenal Hyperplasia Among Young People With PCOS

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Adrenal Hyperplasia Among Young Patients With Polycystic Ovarian Syndrome

Brief Summary:

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:<
  

  Detailed Summary:

  Polycystic ovarian syndrome (PCOS) is a heterogeneous group of disorders presenting with hyperandrogenism in adolescents and young women. The etiology of this condition remains unknown, despite its many identified links to insulin resistance, hypertension and metabolic syndrome, as well as its potential connection to the various forms of congenital adrenal hyperplasia (CAH).

  The adrenal glands are the only source in the body of adrenocortical steroids. In normal physiology, the pituitary hormone ACTH regulates the secretion of glucocorticoids, while the secretion of mineralocorticoids is controlled by the renin-angiotensin system. In addition to these two steroids, the adrenal gland secretes lesser amounts of intermediate metabolites of these steroids, as well as the sex-steroids DHEA, DHEAS, androstenedione, testosterone, estrogen, and estrone. Dysregulated secretion of any of these hormones can be caused by the development of hyperplasia of the adrenocortical tissue, which may be mild and lead to specific clinical syndromes depending on the identity of the secreted hormones. Bilateral adrenocortical hyperplasia (BAH) is now an increasingly diagnosed cause of adrenal dysfunction.

  We propose that there is a subgroup of patients with PCOS who actually have non-CAH primary forms of BAH. To investigate this possibility, we propose to study the hypothalamic-pituitary-adrenal axis (HPAA) over the next 2 years in 120 young girls and women (ages 16 to 25 years) that we will compare to 30 age- and race-matched normal females. Patients will be recruited primarily (although not exclusively) from a busy New York City clinic run by the Pediatric Endocrine Division at the Infants and Children's Hospital of Brooklyn at Maimonides and SUNY Downstate. All patients will undergo standard testing of the HPAA including oral low- and high-dose
  Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  

  Current Primary Outcome:
  
  

  Original Primary Outcome:
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: National Institutes of Health Clinical Center (CC)
  

  Dates:
  Date Received: March 10, 2011
  Date Started: March 4, 2011
  Date Completion:
  Last Updated: April 20, 2017
  Last Verified: September 30, 2016