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| Sponsor: | Temple University |
|---|---|
| Collaborator: |
University of Pennsylvania |
| Information provided by: | Temple University |
| ClinicalTrials.gov Identifier: | NCT00194259 |
Purpose
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 |
|---|
|
Obstructive Sleep Apnea Type 2 Diabetes |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Sleep Apnea in Look AHEAD (Action for Health in Diabetes) |
Saliva Samples
| Enrollment: | 320 |
| Study Start Date: | August 2001 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Show Detailed Description Eligibility| Ages Eligible for Study: | 45 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with Type II diabetes previously enrolled into the "Look-AHEAD" Study. Comid diagnosis of sleep apnea
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 | |
| 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 |
More Information
| Responsible Party: | Temple University ( Gary Foster, PhD ) |
| Study ID Numbers: | HL70301 |
| Study First Received: | September 13, 2005 |
| Last Updated: | March 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00194259 History of Changes |
| Health Authority: | United States: Federal Government |
|
Sleep Apnea Syndromes Metabolic Diseases Apnea Nervous System Diseases Sleep Apnea, Obstructive Respiration Disorders Diabetes Mellitus Sleep Disorders |
Dyssomnias Endocrine System Diseases Sleep Disorders, Intrinsic Signs and Symptoms Respiratory Tract Diseases Diabetes Mellitus, Type 2 Signs and Symptoms, Respiratory Glucose Metabolism Disorders |
