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PCOS, Sleep Apnea and Metabolic Risk in Women

18 Years
40 Years
Open (Enrolling)
Polycystic Ovary Syndrome, Obstructive Sleep Apnea

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Trial Information

PCOS, Sleep Apnea and Metabolic Risk in Women

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.

Inclusion Criteria:

- Clinical diagnosis of PCOS

- Obese (BMI of at least 30 kg/m2)

Exclusion Criteria:

- Diagnosis of nonclassic 21-hydroxylase deficiency, Cushing syndrome, hypothyroidism,
or significant elevations in prolactin

- Taking steroid preparations (including oral contraceptives), medications known to
alter insulin secretion and/or action, or medications known to influence sleep during
the 2 months prior to starting the study

- Positive pregnancy test

- Diagnosis of diabetes mellitus

- Hypertension (systolic > 140 mmHg and/or diastolic > 90 mmhg) not well-controlled on
stable medication with either ACE inhibitors or diuretics

- Habitual alcohol use

- Excessive caffeine intake of more than 300 mg/day

- Known peanut allergies, or allergies to medications used in the study

- Hemoglobin < 11g/dL and/or hematocrit < 33%

- Systemic illnesses, including heart, renal, liver, or malignant disease

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Sex steroid levels

Outcome Time Frame:

After treatment (6 weeks)

Safety Issue:


Principal Investigator

David A Ehrmann, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago


United States: Food and Drug Administration

Study ID:




Start Date:

December 2007

Completion Date:

August 2012

Related Keywords:

  • Polycystic Ovary Syndrome
  • Obstructive Sleep Apnea
  • PCOS
  • OSA
  • Metabolism
  • Diabetes
  • Apnea
  • Polycystic Ovary Syndrome
  • Sleep Apnea Syndromes
  • Sleep Apnea, Obstructive



University of Chicago Department of Medicine, Section of Endocrinology, Diabetes & Metabolism Chicago, Illinois  60637