Effective Treatment of Sleep Apnea in Prediabetes to Reduce Cardiometabolic Risk

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Sleep Apnea
• Intervention / Treatment: Device: CPAP mask; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Continuous positive airway pressure; 2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night	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. ________________________________________; Other Names: continuous positive airway pressure therapy
Placebo Comparator: Placebo; 2 weeks of oral administration of a placebo tablet 30min before bedtime	Drug: Placebo; oral placebo tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Area Under the Curve (AUC) Glucose at 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.	Baseline and Week 2

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Chicago

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: June 23, 2010
• First Submitted That Met QC Criteria: July 1, 2010
• First Posted (Estimate): July 2, 2010

Study Record Updates

• Last Update Posted (Estimate): May 27, 2015
• Last Update Submitted That Met QC Criteria: May 22, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: diabetes; CPAP; sleep apnea
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Endocrine System Diseases; Diabetes Mellitus; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Apnea; Prediabetic State
• Other Study ID Numbers: 09-249-A