Sleep Apnea in Look AHEAD (Action for Health in Diabetes)
Recruitment status was Active, not recruiting
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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: | Observational Model: Cohort Time Perspective: 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:
- Enrollment in LookAhead
- Type II Diabetes and Sleep Apnea
Exclusion Criteria:
- Determined by parent study, LookAhead
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
No publications provided by Temple University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Gary Foster, PhD, Temple University |
| ClinicalTrials.gov Identifier: | NCT00194259 History of Changes |
| Obsolete Identifiers: | NCT00350740 |
| Other Study ID Numbers: | HL70301 |
| Study First Received: | September 13, 2005 |
| Last Updated: | March 13, 2009 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Apnea Diabetes Mellitus Diabetes Mellitus, Type 2 Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013