Sleep Apnea in Look AHEAD Participants - Ancillary to Look AHEAD
Condition: Sleep Apnea Syndromes; Diabetes Mellitus, Non-insulin Dependent; Obesity; Diabetes Mellitus
MeSH terms: Sleep Apnea Syndromes; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

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 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.