Sleep Apnea in Look AHEAD (Action for Health in Diabetes)
1 other identifier
observational
320
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2001
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedMarch 7, 2014
January 1, 2008
12.8 years
September 13, 2005
March 5, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Effects of OSA on weight
10 years
Eligibility Criteria
Patients with Type II diabetes previously enrolled into the "Look-AHEAD" Study. Comid diagnosis of sleep apnea
You may qualify if:
- Enrollment in LookAhead
- Type II Diabetes and Sleep Apnea
You may not qualify if:
- Determined by parent study, LookAhead
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Temple Universitylead
- University of Pennsylvaniacollaborator
Study Sites (4)
St. Luke's Roosevelt Hospital
New York, New York, 10025, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Brown University
Providence, Rhode Island, 02903, United States
Related Publications (5)
Shechter A, Foster GD, Lang W, Reboussin DM, St-Onge MP, Zammit G, Newman AB, Millman RP, Wadden TA, Jakicic JM, Strotmeyer ES, Wing RR, Pi-Sunyer FX, Kuna ST; Sleep Ahead Research Group of the Look Ahead Research Group. Effects of a lifestyle intervention on REM sleep-related OSA severity in obese individuals with type 2 diabetes. J Sleep Res. 2017 Dec;26(6):747-755. doi: 10.1111/jsr.12559. Epub 2017 May 31.
PMID: 28560832DERIVEDKline CE, Reboussin DM, Foster GD, Rice TB, Strotmeyer ES, Jakicic JM, Millman RP, Pi-Sunyer FX, Newman AB, Wadden TA, Zammit G, Kuna ST; Sleep AHEAD Research Group of the Look AHEAD Research Group. The Effect of Changes in Cardiorespiratory Fitness and Weight on Obstructive Sleep Apnea Severity in Overweight Adults with Type 2 Diabetes. Sleep. 2016 Feb 1;39(2):317-25. doi: 10.5665/sleep.5436.
PMID: 26446118DERIVEDShechter A, St-Onge MP, Kuna ST, Zammit G, RoyChoudhury A, Newman AB, Millman RP, Reboussin DM, Wadden TA, Jakicic JM, Pi-Sunyer FX, Wing RR, Foster GD; Sleep AHEAD Research Group of the Look AHEAD Research Group. Sleep architecture following a weight loss intervention in overweight and obese patients with obstructive sleep apnea and type 2 diabetes: relationship to apnea-hypopnea index. J Clin Sleep Med. 2014 Nov 15;10(11):1205-11. doi: 10.5664/jcsm.4202.
PMID: 25325608DERIVEDFoster GD, Borradaile KE, Sanders MH, Millman R, Zammit G, Newman AB, Wadden TA, Kelley D, Wing RR, Pi-Sunyer FX, Reboussin D, Kuna ST; Sleep AHEAD Research Group of Look AHEAD Research Group. A randomized study on the effect of weight loss on obstructive sleep apnea among obese patients with type 2 diabetes: the Sleep AHEAD study. Arch Intern Med. 2009 Sep 28;169(17):1619-26. doi: 10.1001/archinternmed.2009.266.
PMID: 19786682DERIVEDFoster GD, Sanders MH, Millman R, Zammit G, Borradaile KE, Newman AB, Wadden TA, Kelley D, Wing RR, Sunyer FX, Darcey V, Kuna ST; Sleep AHEAD Research Group. Obstructive sleep apnea among obese patients with type 2 diabetes. Diabetes Care. 2009 Jun;32(6):1017-9. doi: 10.2337/dc08-1776. Epub 2009 Mar 11.
PMID: 19279303DERIVED
Biospecimen
Saliva Samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 19, 2005
Study Start
August 1, 2001
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
March 7, 2014
Record last verified: 2008-01