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Sleep Apnea in Look AHEAD Participants - Ancillary to Look AHEAD

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ClinicalTrials.gov Identifier: NCT00031239
Recruitment Status : Completed
First Posted : February 28, 2002
Last Update Posted : July 29, 2016
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:
To assess the effects of weight loss on sleep disordered breathing in obese, Type 2 diabetics with obstructive sleep apnea.

Condition or disease
Sleep Apnea Syndromes Diabetes Mellitus, Non-insulin Dependent Obesity Diabetes Mellitus

Detailed Description:

BACKGROUND:

Weight loss is a frequently recommended treatment for obese patients with obstructive sleep apnea (OSA). The empirical support for this recommendation is lacking. Based on descriptive studies, weight loss appears to improve but not abolish sleep disordered breathing. Moreover, the degree of improvement in OSA is quite variable and not directly proportional to weight loss. The lack of randomized trials, the study of predominantly male samples, and the absence of follow-up evaluations leave physicians and patients unsure about the utility of weight loss treatment in obese OSA patients.

The study is ancillary to the Look AHEAD clinical trial which is sponsored primarily by the National Institute of Diabetes and Digestive and Kidney Diseases and secondarily by the National Heart, Lung, and Blood Institute, the National Institute of Nursing Research, the Office of Research on Women's Health, the National Center on Minority Health and Health Disparities, and the Centers for Disease Control and Prevention. The Look AHEAD study is a multicenter, randomized clinical trial to examine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss in overweight diabetics.

DESIGN NARRATIVE:

The study will assess the effects of weight loss on sleep disordered breathing in 120 obese, Type 2 diabetics with obstructive sleep apnea (respiratory disturbance index [RDI] greater than or equal to 15) who are randomly assigned to either weight loss (n=60) or usual care (n=60) treatments within the context of the Look AHEAD study. Home polysomnography studies will be performed before treatment and at one and two years. Among the 60 weight loss subjects, the investigators will assess the relative importance of changes in neck and abdominal fat in explaining the variability of changes in sleep disordered breathing after weight loss. Finally, they will examine the relationship between changes in sleep-disordered breathing and changes in blood pressure after weight loss in the 60 weight loss participants. Specifically, this research will: 1) determine the efficacy of a weight loss program in reducing sleep disordered breathing in obese Type 2 diabetics; 2) identify sources of variability in sleep disordered breathing associated with weight loss; and 3) examine the role of sleep disordered breathing in mediating changes in blood pressure associated with weight loss. The results of this study will provide an empirical basis for making recommendations about the effectiveness of weight loss in Type 2 diabetics with OSA.

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Study Type : Observational
Study Start Date : September 2001
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea





Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
An estimated 176 obese, diabetic subjects with obstructive sleep apnea, 50% women and 40% minorities.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00031239


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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OverallOfficial: Gary Foster University of Pennsylvania

Publications:
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ClinicalTrials.gov Identifier: NCT00031239    
Other Study ID Numbers: 994
R01HL070301 ( U.S. NIH Grant/Contract )
First Posted: February 28, 2002    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: May 2009
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases