Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031239
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
2002-02-27
Brief Title:
Sleep Apnea in Look AHEAD Participants - Ancillary to Look AHEAD
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2009-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the effects of weight loss on sleep disordered breathing in obese Type 2 diabetics with obstructive sleep apnea
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 Womens 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 n60 or usual care n60 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
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 Womens 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 n60 or usual care n60 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL070301 | NIH | None | httpsreporternihgovquickSearchR01HL070301 |