Effective Treatment of Sleep Apnea in Prediabetes to Reduce Cardiometabolic Risk

• ClinicalTrials.gov Identifier: NCT01156116
• Recruitment Status: Completed
• First Posted: July 2, 2010
• Results First Posted: May 27, 2015
• Last Update Posted: May 27, 2015
• Sponsor: University of Chicago
• Information provided by (Responsible Party): University of Chicago

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetes; Sleep Apnea	Device: CPAP mask; Drug: Placebo	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effective Treatment of Sleep Apnea in Prediabetes to Reduce Cardiometabolic Risk
• Study Start Date: October 2009
• Actual Primary Completion Date: October 2012
• Actual Study Completion Date: October 2012

Arms and Interventions

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 Name: 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

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Area Under the Curve (AUC) Glucose at Week 2 [ Time Frame: 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 :

1. Change From Baseline in Insulin Sensitivity (SI) at Week 2 [ Time Frame: 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.

2. Change From Baseline in 24-hr Systolic Blood Pressure (mmHg) at Week 2 [ Time Frame: Baseline and Week 2 ]

   The average systolic blood pressure measured over a 24-hr period was calculated for each patient.

   Change = Week 2 - Baseline.

3. Change From Baseline in 24-hr Diastolic Blood Pressure (mmHg) at Week 2 [ Time Frame: Baseline and Week 2 ]

   The average diastolic blood pressure over a 24-hr period was calculated for each patient.

   Change = Week 2 - Baseline

Eligibility Criteria

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

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)

Contacts and Locations

Locations

United States, Illinois

The University of Chicago

Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

Investigators

• Principal Investigator: Esra Tasali, MD; University of Chicago

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT01156116
• Other Study ID Numbers: 09-249-A
• First Posted: July 2, 2010
• Results First Posted: May 27, 2015
• Last Update Posted: May 27, 2015
• Last Verified: May 2015

Keywords provided by University of Chicago:

CPAP; diabetes; sleep apnea

Additional relevant MeSH terms:

Apnea; Sleep Apnea Syndromes; Prediabetic State; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases