Effective Treatment of Sleep Apnea in Prediabetes to Reduce Cardiometabolic Risk

Not Applicable

Completed

• Conditions: Diabetes; Sleep Apnea
• Interventions: Drug: Placebo; Device: CPAP mask

• Registration Number: NCT01156116
• Lead Sponsor: University of Chicago

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-06-23
• Study First Submitted QC: 2010-07-01
• Study First Posted: 2010-07-02
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Results First Submitted: 2015-04-29
• Status Verified: 2015-05
• Results First Submitted QC: 2015-05-22
• Last Update Submitted: 2015-05-22
• Results First Posted: 2015-05-27
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Overweight or obese adults (age ≥45 yrs and BMI ≥25 kg/m2)
• prediabetes and OSA (AHI ≥ 5)
• regular life styles and schedules (no shift work in the past 6 months, no travel across time zones during the past 4 weeks)
• habitual bedtimes of at least 6 hours but not exceeding 9 hours will be eligible.
• not to take any medications during the study period with the exception of antihypertensives and lipid lowering agents
• not on hormone replacement therapy.
• have sedentary activities and no competitive athletes or subjects with high exercise levels.

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Exclusion Criteria

• previous or current treatment with supplemental oxygen
• requirement of supplemental oxygen or bi-level positive airway pressure for OSA treatment during titration
• presence of active infection, psychiatric disease or history of other significant illness (e.g., myocardial infarction, congestive heart failure, stroke, arrhythmia, chronic kidney or liver disease0
• clinical depression as evidenced by a score >16 in CES-D scale
• smoking, or routine alcohol use (more than 2 drinks per day), or excessive caffeine intake (>300mg per day)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	2 weeks of oral administration of a placebo tablet 30min before bedtime
Continuous positive airway pressure	CPAP mask	2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Area Under the Curve (AUC) Glucose at Week 2	Baseline and Week 2	The area under the glucose time curve, between 0 and 120 minutes of the OGTT, was calculated for each patient using the trapezoidal rule .; Change = Week 2 - Baseline.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Insulin Sensitivity (SI) at Week 2	Baseline and Week 2	SI is estimated from modeling of the insulin and glucose values during the intravenous glucose tolerance test (ivGTT).; Change = Week 2 - Baseline.
Change From Baseline in 24-hr Systolic Blood Pressure (mmHg) at Week 2	Baseline and Week 2	The average systolic blood pressure measured over a 24-hr period was calculated for each patient.; Change = Week 2 - Baseline.
Change From Baseline in 24-hr Diastolic Blood Pressure (mmHg) at Week 2	Baseline and Week 2	The average diastolic blood pressure over a 24-hr period was calculated for each patient.; Change = Week 2 - Baseline

Trial Locations

Locations (1)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States