Clinical trial NCT01156116: Effective Treatment of Sleep Apnea in Prediabetes to Reduce Cardiometabolic Risk
Official title: Effective Treatment of Sleep Apnea in Prediabetes to Reduce Cardiometabolic Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Sleep Apnea
Keywords: CPAP
diabetes
sleep apnea
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2010-07-02
Enrollment: 39
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change From Baseline in Area Under the Curve (AUC) Glucose at Week 2
timeFrame: Baseline and Week 2
Secondary outcomes:
measure: Change From Baseline in Insulin Sensitivity (SI) at Week 2
timeFrame: Baseline and Week 2
measure: Change From Baseline in 24-hr Systolic Blood Pressure (mmHg) at Week 2
timeFrame: Baseline and Week 2
measure: Change From Baseline in 24-hr Diastolic Blood Pressure (mmHg) at Week 2
timeFrame: Baseline and Week 2
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Esra Tasali, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pamidi S, Chapotot F, Wroblewski K, Whitmore H, Polonsky T, Tasali E. Optimal Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea Reduces Daytime Resting Heart Rate in Prediabetes: A Randomized Controlled Study. J Am Heart Assoc. 2020 Oct 20;9(19):e016871. doi: 10.1161/JAHA.120.016871. Epub 2020 Oct 1.
citation: Pamidi S, Wroblewski K, Stepien M, Sharif-Sidi K, Kilkus J, Whitmore H, Tasali E. Eight Hours of Nightly Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea Improves Glucose Metabolism in Patients with Prediabetes. A Randomized Controlled Trial. Am J Respir Crit Care Med. 2015 Jul 1;192(1):96-105. doi: 10.1164/rccm.201408-1564OC.