Overview

This trial is active, not recruiting.

Conditions polycystic ovary syndrome, obstructive sleep apnea
Treatments depot lupron followed by estrogen plus placebo, depot lupron followed by progesterone plus placebo., cpap
Sponsor University of Chicago
Collaborator Duke University
Start date December 2007
End date August 2017
Trial size 80 participants
Trial identifier NCT00696111, 15872B, 1P50HD057796

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Randomized to receive depot Lupron for 6 weeks. Then randomized again to receive estrogen plus placebo for another 6 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 estrogen (2mg) plus placebo for six weeks.
(Experimental)
Randomized to receive depot Lupron for 6 weeks. Then randomized again to receive progesterone plus placebo for another 6 weeks.
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)
Randomized to receive CPAP (continuous positive airway pressure) treatment for 6 weeks.
cpap
CPAP (continuous positive airway pressure) treatment at home for six weeks.

Primary Outcomes

Measure
Sex steroid levels
time frame: After treatment (6 weeks)
Sleep recording/polysomnography
time frame: After treatment (6 weeks)

Secondary Outcomes

Measure
Frequently sampled IVGTT
time frame: After treatment (6 weeks)
24-hour hormonal profiles
time frame: After treatment (6 weeks)

Eligibility Criteria

Female participants from 18 years up to 40 years old.

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

Additional Information

Official title PCOS, Sleep Apnea and Metabolic Risk in Women
Principal investigator David A Ehrmann, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Chicago.