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

NCT00194259 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 320

Last updated 2014-03-07

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

Principal Investigators

  • Gary D Foster, Ph.D. · Temple University

  • Richard Millman, M.D. · Brown University

  • Mark Sanders, AB, MD, FCCP, D'ABSM · University of Pittsburgh

  • Gary Zammit, Ph.D. · St. Luke's-Roosevelt Hospital Center

  • Samuel T Kuna, M.D. · University of Pennsylvania

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-08-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00194259 on ClinicalTrials.gov