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Metabolic Study of Women With Polycystic Ovary Syndrome and Sleep Apnea
This study is ongoing, but not recruiting participants.
Sponsor:
University of Chicago
Collaborator:
Duke University
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00696111
First received: June 9, 2008
Last updated: August 23, 2016
Last verified: August 2016
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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 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) ]
- Sleep recording/polysomnography [ Time Frame: After treatment (6 weeks) ]
Secondary Outcome Measures:
- Frequently sampled IVGTT [ Time Frame: After treatment (6 weeks) ]
- 24-hour hormonal profiles [ Time Frame: After treatment (6 weeks) ]
| 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 (Adult) |
| Sexes 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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00696111
Locations
| United States, Illinois | |
| University of Chicago Department of Medicine, Section of Endocrinology, Diabetes & Metabolism | |
| Chicago, Illinois, United States, 60637 | |
Sponsors and Collaborators
University of Chicago
Duke University
Investigators
| Principal Investigator: | David A Ehrmann, MD | University of Chicago |
More Information
Additional Information:
Publications:
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 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | June 9, 2008 |
| Last Updated: | August 23, 2016 |
Keywords provided by University of Chicago:
|
PCOS OSA Metabolism Diabetes |
Additional relevant MeSH terms:
|
Syndrome Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Polycystic Ovary Syndrome Disease Pathologic Processes Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |
Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases Progesterone Estrogens Leuprolide Progestins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 22, 2017