Metabolic Study of Women With Polycystic Ovary Syndrome and Sleep Apnea

This study is currently recruiting participants.
Verified April 2012 by University of Chicago
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00696111
First received: June 9, 2008
Last updated: September 4, 2013
Last verified: April 2012

June 9, 2008
September 4, 2013
December 2007
August 2017   (final data collection date for primary outcome measure)
  • Sex steroid levels [ Time Frame: After treatment (6 weeks) ] [ Designated as safety issue: No ]
  • Sleep recording/polysomnography [ Time Frame: After treatment (6 weeks) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00696111 on ClinicalTrials.gov Archive Site
  • Frequently sampled IVGTT [ Time Frame: After treatment (6 weeks) ] [ Designated as safety issue: No ]
  • 24-hour hormonal profiles [ Time Frame: After treatment (6 weeks) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Metabolic Study of Women With Polycystic Ovary Syndrome and Sleep Apnea
PCOS, Sleep Apnea and Metabolic Risk in Women

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Polycystic Ovary Syndrome
  • Obstructive Sleep Apnea
  • 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.
  • 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.
  • Device: CPAP
    CPAP (continuous positive airway pressure) treatment at home for six weeks.
  • Experimental: 1A
    Randomized to receive depot Lupron for 6 weeks. Then randomized again to receive estrogen plus placebo for another 6 weeks.
    Intervention: Drug: Depot Lupron followed by estrogen plus placebo
  • Experimental: 1B
    Randomized to receive depot Lupron for 6 weeks. Then randomized again to receive progesterone plus placebo for another 6 weeks.
    Intervention: Drug: Depot Lupron followed by progesterone plus placebo.
  • Experimental: 3
    Randomized to receive CPAP (continuous positive airway pressure) treatment for 6 weeks.
    Intervention: Device: CPAP

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
August 2017
August 2017   (final data collection date for primary outcome measure)

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
Female
18 Years to 40 Years
No
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
 
NCT00696111
15872B, 1P50HD057796
Yes
University of Chicago
University of Chicago
Duke University
Principal Investigator: David A Ehrmann, MD University of Chicago
University of Chicago
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP