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Randomized to receive depot Lupron for 6 weeks. Then randomized again to receive estrogen plus placebo for another 6 weeks.

Randomized to receive depot Lupron for 6 weeks. Then randomized again to receive progesterone plus placebo for another 6 weeks.

Randomized to receive CPAP (continuous positive airway pressure) treatment for 6 weeks.

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.

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 progesterone (200mg) plus placebo for six weeks.

Depot Lupron followed by progesterone plus placebo.

CPAP (continuous positive airway pressure) treatment at home for six weeks.

CPAP

David A Ehrmann, MD

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).

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.

Metabolic Study of Women With Polycystic Ovary Syndrome and Sleep Apnea

PCOS, Sleep Apnea and Metabolic Risk in Women

Duke University

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

University of Chicago

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Metabolic Study of Women With Polycystic Ovary Syndrome and Sleep Apnea	NCT00696111	Polycystic Ovar... Obstructive Sle...	Depot Lupron fo... Depot Lupron fo... CPAP	18 Years - 40 Years	University of Chicago
Metabolic Study of Women With Polycystic Ovary Syndrome and Sleep Apnea	NCT00696111	Polycystic Ovar... Obstructive Sle...	Depot Lupron fo... Depot Lupron fo... CPAP	18 Years - 40 Years	University of Chicago

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