Metabolic Study of Women With Polycystic Ovary Syndrome and Sleep Apnea

This study is currently recruiting participants. (see Contacts and Locations)
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
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PCOS, Sleep Apnea and Metabolic Risk in Women

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: December 2007
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1A
Randomized to receive depot Lupron for 6 weeks. Then randomized again to receive estrogen plus placebo for another 6 weeks.
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.
Experimental: 1B
Randomized to receive depot Lupron for 6 weeks. Then randomized again to receive progesterone plus placebo for another 6 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.
Experimental: 3
Randomized to receive CPAP (continuous positive airway pressure) treatment for 6 weeks.
Device: CPAP
CPAP (continuous positive airway pressure) treatment at home for six weeks.

Detailed Description:

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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696111

Contacts
Contact: Abeer Rue 773-702-4295 ahaddad@medicine.bsd.uchicago.edu
Contact: Karla A Temple, PhD,RD 773-702-3334 katemple@uchicago.edu

Locations
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         
Sponsors and Collaborators
University of Chicago
Duke University
Investigators
Principal Investigator: David A Ehrmann, MD University of Chicago
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00696111     History of Changes
Other Study ID Numbers: 15872B, 1P50HD057796
Study First Received: June 9, 2008
Last Updated: September 4, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Chicago:
PCOS
OSA
Metabolism
Diabetes

Additional relevant MeSH terms:
Ovarian Cysts
Apnea
Polycystic Ovary Syndrome
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Estrogens
Progesterone
Leuprolide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Progestins
Fertility Agents, Female
Fertility Agents

ClinicalTrials.gov processed this record on August 28, 2014