Clinical Trial: Cortisol Regulation in Polycystic Ovary Syndrome (PCOS)

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Cortisol Regulation in Polycystic Ovary Syndrome

Brief Summary: The purpose of this study is to determine if insulin resistance (how well the body uses insulin and clears sugar) can affect cortisol levels in normal healthy women and women with polycystic ovary syndrome of all body weights.

Detailed Summary:

PCOS is a common clinical problem affecting young women, characterized by oligomenorrhea and hyperandrogenism. Central obesity and insulin resistance are also prominent features of PCOS, and in addition are important risk factors for development of hypertension, hyperlipidemia and atherosclerotic heart disease. Previous studies have suggested that cortisol is dysregulated in PCOS, primarily through increased hypothalamic-pituitary-adrenal (HPA) axis activity and enhanced cortisol secretion. Increased adrenocorticotropic hormone (ACTH) secretion could also potentially lead to elevated adrenal androgen production in PCOS. Techniques used in previous studies have been inconsistent, however, and a link between increased HPA axis activity and the phenotypic changes in PCOS has not been clearly demonstrated. Cortisol is also produced from cortisone in peripheral adipose tissue by the enzyme 11beta-hydroxysteroid dehydrogenase type 1 (HSD 1), suggesting another potential point of dysregulation that may contribute to central obesity and insulin resistance in PCOS. Further investigation of both central and peripheral regulation of cortisol is necessary to better understand the pathophysiology of PCOS.

Specific Aim 1: To perform a cross-sectional study of women with PCOS and normal controls matched for age and body mass index, and measure insulin sensitivity and visceral fat, as well as (a) 24-hour CPR, ACTH, free cortisol, and cortisol binding globulin (CBG), (b) adipocyte, liver, and whole body HSD 1 activity, and (c) androgen levels.

Specific Aim 2: To prospectively administer pioglitazone or metformin to women with PCOS in a placebo-controlled trial, and after one month and six months of therapy measure (a) 24-hour CPR, ACTH, free cortisol, and CBG, (b) adipocyte, liver, and whole body HSD 1 activity, and (c) insulin sensitivity
Sponsor: Oregon Health and Science University

Current Primary Outcome: The comparison of body surface area adjusted cortisol production rate (CPR/BSA) before and after insulin sensitizing therapy in women with PCOS. [ Time Frame: Before and after 6 months of insulin sensitizing therapy ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Comparisons of 24-hour values for adrenocorticotropic hormone , free-cortisol, and cortisol binding globulin. [ Time Frame: Before and after 6 months of insulin sensitizing therapy ]

Original Secondary Outcome: Same as current

Information By: Oregon Health and Science University

Dates:
Date Received: June 6, 2008
Date Started: October 2006
Date Completion: July 2011
Last Updated: August 3, 2010
Last Verified: August 2010