Effective Treatment of Sleep Apnea in Prediabetes to Reduce Cardiometabolic Risk

The University of Chicago

Status: Completed

Conditions: Diabetes; Sleep Apnea

Treatments: Drug: Placebo; Device: CPAP mask

Study type: Interventional

Funder types: Other

Identifiers

NCT01156116

09-249-A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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.

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups, including a placebo group

Continuous positive airway pressure

Active Comparator group

Description:

2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night

Treatment:

Device: CPAP mask

Placebo

Placebo Comparator group

Description:

2 weeks of oral administration of a placebo tablet 30min before bedtime

Treatment:

Drug: Placebo