Metabolic Study of Sleep Apnea in Men and Women
Recruitment status was Recruiting
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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 men and women.
| Condition | Intervention |
|---|---|
|
Obstructive Sleep Apnea (OSA) |
Device: CPAP |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Sleep and Metabolism in Obesity: Impact of Gender |
- Sleep recording/polysomnography [ Time Frame: After treatment (6 weeks) ] [ Designated as safety issue: No ]
- Frequently sampled IVGTT [ Time Frame: After treatment (6 weeks) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol.
|
Device: CPAP
CPAP (continuous positive airway pressure) treatment at home for 6 weeks
|
|
No Intervention: 2
Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol
|
Detailed Description:
Obesity is a major risk factor for obstructive sleep apnea (OSA), a condition characterized by repetitive respiratory disturbances, intermittent hypoxia, sleep fragmentation by frequent microarousals and low amounts of deep slow wave sleep (SWS). Today, more than 10 million American women suffer from OSA. OSA has been identified as an independent risk factor for the metabolic syndrome. Because OSA is more prevalent in men than in women, a disproportionate number of studies of OSA and its consequences have been conducted in men. Thus, OSA has been characterized as a disorder associated with gender-based health care inequity. Recent evidence, including data from our group, suggests that reduced amounts and intensity of SWS (i.e. slow-wave activity [SWA]) may play a pivotal role in the development of metabolic and cardiovascular disturbances in obese men and women, particularly those with OSA. This project will focus on sex differences in SWA and their relationship with daytime sleepiness and metabolic vulnerability in obese men and women with and without OSA. We propose to simultaneously characterize: 1. sleep-wake regulation; 2. measures of diabetes risk; 3. measures of cardiovascular risk; and 4. profiles of sex steroids, cortisol and adipokines in a. obese men without OSA, b. obese men with OSA before and after treatment with continuous positive airway pressure (CPAP), c. obese pre-menopausal women without OSA, and d. obese pre-menopausal women with OSA before and after CPAP treatment. The completion of these interdisciplinary studies will provide a unique data set contrasting in obese women versus obese men the relationships between sleep and the metabolic syndrome, OSA and the metabolic syndrome and the impact of CPAP treatment on the metabolic syndrome. This work will provide important insights regarding the pathophysiology of OSA and its adverse consequences in obese men and women, and the basis for the development of effective sex-specific prevention and treatment strategies.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Obese (BMI of at least 30 kg/m2)
Exclusion Criteria:
- Clinically significant depression
- 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
- Hemoglobin < 11g/dL and/or hematocrit < 33%
- Systemic illnesses, including heart, renal, liver, or malignant disease
- 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
- Travel across time zones during the 4 weeks prior to starting the study
- Irregular sleeping habits (including shift work)
Contacts and Locations| Contact: Annette Miller, RN | 773-834-8871 | amiller@medicine.bsd.uchicago.edu |
| United States, Illinois | |
| University of Chicago Department of Medicine, Section of Endocrinology, Diabetes & Metabolism | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Principal Investigator: Eve Van Cauter, Ph.D. | |
| Principal Investigator: | Eve Van Cauter, Ph.D. | University of Chicago |
More Information
Additional Information:
Publications:
| Responsible Party: | Eve Van Cauter, Ph.D., The University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00706511 History of Changes |
| Other Study ID Numbers: | 15870, 1P50HD057796 |
| Study First Received: | June 25, 2008 |
| Last Updated: | January 20, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Chicago:
|
OSA Diabetes Metabolism Gender |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013