Metabolic Study of Sleep Apnea in Men and Women - Full Text View

Sponsors and Collaborators:	University of Chicago Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Duke University
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00706511

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

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Sleep and Metabolism in Obesity: Impact of Gender

Further study details as provided by University of Chicago:

Primary Outcome Measures:

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 ]

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
1: Experimental 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
2: No Intervention 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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706511

Contacts

Contact: Annette Miller, RN

773-834-8871

amiller@medicine.bsd.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: Eve Van Cauter, Ph.D.

Sponsors and Collaborators

University of Chicago

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Duke University

Investigators

Principal Investigator:

Eve Van Cauter, Ph.D.

University of Chicago

More Information

Additional Information:

University of Chicago Sleep Disorders Center This link exits the ClinicalTrials.gov site

Publications:

Tasali E, Leproult R, Ehrmann DA, Van Cauter E. Slow-wave sleep and the risk of type 2 diabetes in humans. Proc Natl Acad Sci U S A. 2008 Jan 22;105(3):1044-9. Epub 2008 Jan 2.

Tasali E, Van Cauter E, Ehrmann DA. Relationships between sleep disordered breathing and glucose metabolism in polycystic ovary syndrome. J Clin Endocrinol Metab. 2006 Jan;91(1):36-42. Epub 2005 Oct 11.

Tasali E, Mokhlesi B, Van Cauter E. Obstructive sleep apnea and type 2 diabetes: interacting epidemics. Chest. 2008 Feb;133(2):496-506. Review.

Knutson KL, Spiegel K, Penev P, Van Cauter E. The metabolic consequences of sleep deprivation. Sleep Med Rev. 2007 Jun;11(3):163-78. Epub 2007 Apr 17. Review.

Van Cauter E, Holmback U, Knutson K, Leproult R, Miller A, Nedeltcheva A, Pannain S, Penev P, Tasali E, Spiegel K. Impact of sleep and sleep loss on neuroendocrine and metabolic function. Horm Res. 2007;67 Suppl 1:2-9. Epub 2007 Feb 15. Review.

Knutson KL, Ryden AM, Mander BA, Van Cauter E. Role of sleep duration and quality in the risk and severity of type 2 diabetes mellitus. Arch Intern Med. 2006 Sep 18;166(16):1768-74.

Latta F, Leproult R, Tasali E, Hofmann E, L'Hermite-Balériaux M, Copinschi G, Van Cauter E. Sex differences in nocturnal growth hormone and prolactin secretion in healthy older adults: relationships with sleep EEG variables. Sleep. 2005 Dec 1;28(12):1519-24.

Responsible Party:	The University of Chicago ( Eve Van Cauter, Ph.D. )
Study ID Numbers:	15870, 1P50HD057796
Study First Received:	June 25, 2008
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00706511
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Chicago:

OSA
Diabetes
Metabolism
Gender

Study placed in the following topic categories:

Signs and Symptoms
Obesity
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders

Sleep Apnea, Obstructive
Diabetes Mellitus
Dyssomnias
Sleep Disorders
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on February 12, 2009