Cortisol Regulation in Polycystic Ovary Syndrome (PCOS)

Status Completed

Clinical Trial 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.

Clinical Trial Description

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, visceral fat, and androgen levels. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00694759
Study type	Interventional
Source	Oregon Health and Science University
Contact
Status	Completed
Phase	N/A
Start date	October 2006
Completion date	July 2011

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03142633` - MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome
Completed	`NCT06158932` - A Single Group Study to Evaluate the Effects of a Myo-Inositol and D-Chiro Inositol Supplement on Symptoms Associated With Polycystic Ovary Syndrome and Hormone Imbalance	N/A
Completed	`NCT03644524` - Heat Therapy and Cardiometabolic Health in Obese Women	N/A
Active, not recruiting	`NCT02500147` - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS)	Phase 4
Completed	`NCT04932070` - Berberine and Polycystic Ovary Syndrome	N/A
Suspended	`NCT03652987` - Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
Completed	`NCT03480022` - Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS	Phase 3
Active, not recruiting	`NCT03043924` - Functional Study of the Hypothalamus in Magnetic Resonance Imaging (MRI) in Polycystic Ovary Syndrome (PCOS)	N/A
Completed	`NCT05246306` - Aerobic Capacity and Physical Fitness Level of Adolescents With PCOS
Completed	`NCT05981742` - Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS	Phase 2
Completed	`NCT05702957` - Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome	Phase 2/Phase 3
Completed	`NCT05029492` - Effect of Visceral Manipulation on PCOS	N/A
Completed	`NCT02924025` - Motivational Interviewing as an Intervention for PCOS	N/A
Not yet recruiting	`NCT02255578` - Endobarrier Treatment in Women With PCOS	Phase 3
Completed	`NCT02098668` - Mathematical Model for the Human Menstrual Cycle, Endocrinological Diseases and Fertility Treatment-PAEON	N/A
Not yet recruiting	`NCT00883259` - Metformin and Gestational Diabetes in High-risk Patients: a RCTs	Phase 4
Withdrawn	`NCT01638988` - Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin	Phase 3
Completed	`NCT01462864` - Development of a Structured Education Programme for Women With Polycystic Ovary Syndrome	N/A
Recruiting	`NCT01431352` - Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS)	N/A
Completed	`NCT00989781` - Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.