Obesity Clinical Trial
To assess the effects of weight loss on sleep disordered breathing in obese, Type 2 diabetics with obstructive sleep apnea.
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 Women's 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 (n=60) or usual care
(n=60) 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.
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