Obesity, Sleep Apnea, and Insulin Resistance
Obstructive sleep apnea (OSA) and type 2 diabetes confer increasing economic, social, and public health burdens in the United States. That these diseases appear to co-exist and together increase one's risk of cardiovascular disease renders investigation into their shared pathophysiology even more urgent. Investigators will assess prevalence of insulin resistance, a precursor to diabetes, among overweight patients with OSA. Among those at highest risk of diabetes, investigators will randomize participants to pioglitazone or placebo to see the efficacy of the intervention on improving OSA, insulin resistance, and/or insulin secretion. In a separate intervention, investigators will evaluate the cardiometabolic benefits of continuous positive airway pressure (CPAP) for 12 weeks in patients with OSA. Investigators will also study subjects from the community without known sleep apnea, and assess whether insulin-resistant individuals are at risk for sleep apnea using clinical screening questionnaires.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
|Official Title:||Interfacing Adiposity, Sleep Apnea, and Insulin Resistance|
- Change in apnea-hypopnea index (AHI) outcome measure in response to pioglitazone or placebo [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]To evaluate the effects of pioglitazone versus placebo on AHI in patients with OSA.
- Change in insulin sensitivity outcome measure in response to pioglitazone or placebo [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Change in insulin sensitivity in patients with OSA randomized to pioglitazone or placebo.
- Change in insulin sensitivity outcome measure in response to CPAP [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Evaluate the effect of CPAP on insulin resistance and cardiometabolic risk factors in patients with OSA.
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Active Comparator: pioglitazone
pioglitazone 45 mg, oral, daily
45 mg daily Insulin sensitizing
Placebo Comparator: placebo
Placebo, one pill daily
Compare with pioglitazone
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