N/A
N=39
Effective Treatment of Sleep Apnea in Prediabetes to Reduce Cardiometabolic Risk
Diabetes · Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT01156116 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Change From Baseline in Area Under the Curve (AUC) Glucose at Week 2 — -794.2; 482.7 (mg/dL)*min — p=0.03
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CPAP mask (Device); Placebo (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Area Under the Curve (AUC) Glucose at Week 2 |
-794.2; 482.7 | 0.03 sig |
| SECONDARY Change From Baseline in Insulin Sensitivity (SI) at Week 2 |
0.31; -0.46 | 0.04 sig |
| SECONDARY Change From Baseline in 24-hr Systolic Blood Pressure (mmHg) at Week 2 |
-1.9; 7.6 | 0.009 sig |
| SECONDARY Change From Baseline in 24-hr Diastolic Blood Pressure (mmHg) at Week 2 |
-2.6; 4.5 | <0.001 sig |
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.
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)
Data sourced from ClinicalTrials.gov (NCT01156116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.