View Clinical Trial (Medical Research Study)
Sleep and Metabolism in Obesity: Impact of Gender
| City: |
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Chicago |
| State: |
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Illinois |
| Zip Code: |
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60637 |
| Conditions: |
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Obstructive Sleep Apnea (OSA) |
| Purpose: |
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The purpose of this study is to look at the metabolic (use of energy) and hormonal features
of sleep problems in men and women.
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| Study Summary: |
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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.
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| Criteria: |
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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)
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| NCT ID: |
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NCT00706511 |
| Primary Contact: |
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Principal Investigator
Eve Van Cauter, Ph.D.
University of Chicago
Annette Miller, RN
Phone: 773-834-8871
Email: amiller@medicine.bsd.uchicago.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Chicago, Illinois 60637
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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