NCT00194259|UnknownDMC
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Sponsor study identifier
observational
320
1 country
4
Study Start
August 2001
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2001
Date type not reportedThis date has not been verified as actual or estimated.
September 13, 2005
Actual (reported)September 19, 2005
Actual (reported)June 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Effects of OSA on weight
10 years
Patients with Type II diabetes previously enrolled into the "Look-AHEAD" Study. Comid diagnosis of sleep apnea
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
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.
Kline 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.
Saliva Samples
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
First Submitted
September 13, 2005
First Posted
September 19, 2005
Study Start
August 2001
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2014
Estimated (date passed)Effects of Continuous Positive Airway Pressure (CPAP) Treatment on Glucose Control in Patients With Type 2 Diabetes
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Shechter 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.
Foster 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.
Foster 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.
Samuel T Kuna, M.D.
University of Pennsylvania
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 7, 2014
Record last verified: 2008-01
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