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Sponsored by: |
Oregon Health and Science University |
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Information provided by: | Oregon Health and Science University |
ClinicalTrials.gov Identifier: | NCT00694759 |
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.
Condition | Intervention |
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Polycystic Ovary Syndrome |
Drug: pioglitazone Drug: metformin Drug: placebo |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Open Label, Placebo Control, Parallel Assignment |
Official Title: | Cortisol Regulation in Polycystic Ovary Syndrome |
Estimated Enrollment: | 107 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Pioglitazone will be given to women with PCOS. 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.
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Drug: pioglitazone
30 mg for 2 weeks, then 45 mg daily
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B: Active Comparator
Metformin will be given to women with PCOS. 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.
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Drug: metformin
500mg twice daily for 1 week, then 1000 mg twice daily
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C: Placebo Comparator
Placebo will be given to women with PCOS. 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.
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Drug: placebo
capsule twice daily
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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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria (Healthy controls):
Additional Inclusion Criteria (Subjects with PCOS):
Exclusion Criteria (Healthy controls):
Additional Exclusion Criteria (Subjects with PCOS):
Contact: Bethany J Klopfenstein, MD | 503-494-4020 | klopfens@ohsu.edu |
Contact: Jonathan Q Purnell | 503-494-1056 | purnellj@ohsu.edu |
United States, Oregon | |
Oregon Health & Science University | Recruiting |
Portland, Oregon, United States, 97239 | |
Principal Investigator: Bethany J. Klopfenstein, MD |
Principal Investigator: | Bethany J. Klopfenstein, MD | Oregon Health and Science University |
Responsible Party: | Oregon Health & Science University ( Bethany Klopfenstein, MD ) |
Study ID Numbers: | OHSUIRB00002532 |
Study First Received: | June 6, 2008 |
Last Updated: | June 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00694759 |
Health Authority: | United States: Institutional Review Board |
Polycystic ovary syndrome insulin PCOS cortisol regulation regulation |
Hydrocortisone Pioglitazone Cortisol succinate Gonadal Disorders Metformin Endocrine System Diseases Ovarian Diseases |
Cysts Insulin Genital Diseases, Female Polycystic Ovary Syndrome Endocrinopathy Hydrocortisone acetate Ovarian Cysts |
Anti-Inflammatory Agents Neoplasms Hypoglycemic Agents Pathologic Processes Disease |
Therapeutic Uses Syndrome Physiological Effects of Drugs Pharmacologic Actions Adnexal Diseases |