Sleep Apnea in Look AHEAD (Action for Health in Diabetes)
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ClinicalTrials.gov Identifier: NCT00194259
Recruitment Status : Unknown
Verified January 2008 by Temple University. Recruitment status was: Active, not recruiting
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.
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Layout table for eligibility information
Ages Eligible for Study:
45 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with Type II diabetes previously enrolled into the "Look-AHEAD" Study. Comid diagnosis of sleep apnea