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Sleep Apnea in Look AHEAD (Action for Health in Diabetes)

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ClinicalTrials.gov Identifier: NCT00194259
Recruitment Status : Unknown
Verified January 2008 by Temple University.
Recruitment status was:  Active, not recruiting
First Posted : September 19, 2005
Last Update Posted : March 7, 2014
University of Pennsylvania
Information provided by (Responsible Party):
Temple University

Brief Summary:
This study will assess the effects of weight loss on sleep-disordered breathing (SDB) in 120 obese, type 2 diabetics with obstructive sleep apnea (OSA) from four Look AHEAD sites. Changes in SDB will be compared between subjects randomized to weight loss (Lifestyle Intervention Group) versus non-weight loss (Diabetes Education and Support Group) conditions within the context of the Look AHEAD Study. Weight loss is frequently recommended for obese patients with OSA, but the empirical foundation for this recommendation is not well substantiated. Weight loss in obese apneics improves but does not eliminate SDB. Moreover, the degree of improvement is not correlated with the amount of weight loss. This study will assess SDB before treatment and at 1 and 2 years. We will also investigate clinical measures of fat distribution that may mediate the non-linear relationship between weight loss and improvements in SDB. Finally, we will examine the role of SDB in mediating changes in blood pressure associated with weight loss.

Condition or disease
Obstructive Sleep Apnea Type 2 Diabetes

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Study Type : Observational
Estimated Enrollment : 320 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sleep Apnea in Look AHEAD (Action for Health in Diabetes)
Study Start Date : August 2001
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Primary Outcome Measures :
  1. Effects of OSA on weight [ Time Frame: 10 years ]

Biospecimen Retention:   Samples Without DNA
Saliva Samples

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
Sampling Method:   Non-Probability Sample
Study Population
Patients with Type II diabetes previously enrolled into the "Look-AHEAD" Study. Comid diagnosis of sleep apnea

Inclusion Criteria:

  • Enrollment in LookAhead
  • Type II Diabetes and Sleep Apnea

Exclusion Criteria:

  • Determined by parent study, LookAhead

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): NCT00194259

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United States, New York
St. Luke's Roosevelt Hospital
New York, New York, United States, 10025
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Temple University
University of Pennsylvania
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Principal Investigator: Gary D Foster, Ph.D. Temple University
Principal Investigator: Richard Millman, M.D. Brown University
Principal Investigator: Mark Sanders, AB, MD, FCCP, D'ABSM University of Pittsburgh
Principal Investigator: Gary Zammit, Ph.D. St. Luke's-Roosevelt Hospital Center
Principal Investigator: Samuel T Kuna, M.D. University of Pennsylvania
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT00194259    
Obsolete Identifiers: NCT00350740
Other Study ID Numbers: HL70301
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: March 7, 2014
Last Verified: January 2008
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases