NCT01156116

Effective Treatment of Sleep Apnea in Prediabetes to Reduce Cardiometabolic Risk

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Although obstructive sleep apnea (OSA) is associated with impaired glucose tolerance and diabetes, it remains unclear whether OSA treatment with continuous positive airway pressure (CPAP) has metabolic benefits. The objective of this study is to determine the effect of 8-hour nightly CPAP treatment on glucose metabolism in individuals with prediabetes and OSA.

Detailed description

Although obstructive sleep apnea (OSA) is associated with impaired glucose tolerance and diabetes, it remains unclear whether OSA treatment with continuous positive airway pressure (CPAP) has metabolic benefits. To determine the effect of 8-hour nightly CPAP treatment on glucose metabolism in individuals with prediabetes and OSA. In a randomized, controlled parallel group study, 39 participants were randomized (2:1) to receive either 8-hour nightly CPAP (n=26) or oral placebo (n=13). Sleep was polysomnographically recorded in the laboratory on each night. CPAP adherence was ensured by continuous supervision. Participants continued their daily daytime routine activities outside the laboratory. Glucose metabolism was assessed at baseline and after 2-weeks of assigned treatment using both the oral and intravenous glucose tolerance tests (OGTT and ivGTT, respectively). The primary outcome was the overall glucose response as quantified by the area under the curve for glucose during 2-hour oral glucose tolerance testing.

Conditions

• Diabetes
• Sleep Apnea

Interventions

Type	Name	Description
DEVICE	CPAP mask	The subjects who are randomized to CPAP treatment will undergo an overnight CPAP titration in the laboratory, which will be performed manually by a registered technician according to American Academy of Sleep Medicine (AASM) guidelines .Subjects will be admitted in the early evening and will receive positive airway pressure education, hands on demonstration, careful mask fitting and acclimatization prior to titration. The goal during the titration will be to determine the optimal CPAP pressure setting that eliminates obstructive respiratory events, restore oxygen saturations and sleep continuity. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
DRUG	Placebo	oral placebo tablet

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2010-07-02
• Last updated: 2015-05-27
• Results posted: 2015-05-27

Locations

1 site across 1 country: United States