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| Sponsors and Collaborators: |
University of Chicago Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Duke University |
|---|---|
| Information provided by: | University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00696111 |
Purpose
The purpose of this study is to look at the metabolic (use of energy) and hormonal features of sleep problems in women with polycystic ovary syndrome (PCOS).
| Condition | Intervention |
|---|---|
|
Polycystic Ovary Syndrome Obstructive Sleep Apnea |
Drug: Depot Lupron followed by estrogen plus placebo Drug: Depot Lupron followed by progesterone plus placebo. Device: CPAP |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Factorial Assignment, Efficacy Study |
| Official Title: | PCOS, Sleep Apnea and Metabolic Risk in Women |
| Estimated Enrollment: | 80 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1A: Experimental
Randomized to receive depot Lupron for 6 weeks. Then randomized again to receive estrogen plus placebo for another 6 weeks.
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Drug: Depot Lupron followed by estrogen plus placebo
A single intramuscular dose of depot lupron (11.25 mg). Six weeks after injection, subjects will receive daily oral doses of estrogen (2mg) plus placebo for six weeks.
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1B: Experimental
Randomized to receive depot Lupron for 6 weeks. Then randomized again to receive progesterone plus placebo for another 6 weeks.
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Drug: Depot Lupron followed by progesterone plus placebo.
A single intramuscular dose of depot lupron (11.25 mg). Six weeks after injection, subjects will receive daily oral doses of progesterone (200mg) plus placebo for six weeks.
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3: Experimental
Randomized to receive CPAP (continuous positive airway pressure) treatment for 6 weeks.
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Device: CPAP
CPAP (continuous positive airway pressure) treatment at home for six weeks.
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The prevalence of obesity and chronic sleep loss are at record levels among Americans and evidence continues to emerge to support a causal link between the two conditions. Metabolic abnormalities related to sleep disruption are particularly evident in individuals with obstructive sleep apnea (OSA), a disorder traditionally associated with male gender. While more prevalent in men, OSA is underrecognized in women in part because its clinical and polysomnographic features differ from those of men. Women with polycystic ovary syndrome (PCOS) are particularly susceptible to OSA with at least a 5-fold higher risk for its development compared to obese women without PCOS. This study will enroll obese women with PCOS, with and without OSA. Those with OSA will be randomized to receive CPAP or to receive depot leuprolide to suppress ovarian steroid output over 12 weeks, reassessed at 6 weeks, and then randomized (double-blind, placebo controlled) to 6 weeks of either micronized estrogen + placebo or micronized progestin + placebo. The independent effects of androgen, estrogen, and progesterone on OSA and metabolic function will be assessed. In addition, primary human adipocytes will be prepared from fat biopsies obtained from subjects. Insulin sensitivity will be determined by phospho-specific immunoblotting in conjunction with glucose uptake and anti-lipolysis assays. In parallel, adipocytes from these subjects will be cultured for 1-5 days prior to metabolic assays to ascertain if removal of from circulating factors will improve insulin signaling, or if insulin resistance persists in vitro. Finally, there will be an interface with the Metabolomics Laboratory at Duke University (C. Newgard, Lab Director), and metabolomics assessment will be done on blood and urine samples.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Abeer Rue | 773-702-4295 | ahaddad@medicine.bsd.uchicago.edu |
| Contact: Karla A Temple, PhD,RD | 773-702-3334 | katemple@uchicago.edu |
| United States, Illinois | |
| University of Chicago Department of Medicine, Section of Endocrinology, Diabetes & Metabolism | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Principal Investigator: David A Ehrmann, MD | |
| Principal Investigator: | David A Ehrmann, MD | University of Chicago |
More Information
| Responsible Party: | The University of Chicago ( David A. Ehrmann, M.D., Professor of Medicine ) |
| Study ID Numbers: | 15872B, 1P50HD057796 |
| Study First Received: | June 9, 2008 |
| Last Updated: | June 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00696111 |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
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PCOS OSA Metabolism Diabetes |
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Sleep Apnea Syndromes Progesterone Gonadal Disorders Apnea Sleep Apnea, Obstructive Respiration Disorders Diabetes Mellitus Dyssomnias Sleep Disorders Endocrine System Diseases Ovarian Diseases |
Cysts Sleep Disorders, Intrinsic Genital Diseases, Female Signs and Symptoms Respiratory Tract Diseases Leuprolide Polycystic Ovary Syndrome Signs and Symptoms, Respiratory Endocrinopathy Ovarian Cysts |
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Disease Antineoplastic Agents, Hormonal Antineoplastic Agents Nervous System Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Hormones Pharmacologic Actions |
Adnexal Diseases Neoplasms Pathologic Processes Fertility Agents, Female Therapeutic Uses Syndrome Progestins Fertility Agents |
