Effective Treatment of Sleep Apnea in Prediabetes to Reduce Cardiometabolic Risk

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01156116
First received: June 23, 2010
Last updated: May 22, 2015
Last verified: May 2015
  Purpose

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 Intervention
Diabetes
Sleep Apnea
Device: CPAP mask
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effective Treatment of Sleep Apnea in Prediabetes to Reduce Cardiometabolic Risk

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Change From Baseline in Area Under the Curve (AUC) Glucose at Week 2 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]

    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:
  • Change From Baseline in Insulin Sensitivity (SI) at Week 2 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]

    SI is estimated from modeling of the insulin and glucose values during the intravenous glucose tolerance test (ivGTT).

    Change = Week 2 - Baseline.


  • Change From Baseline in 24-hr Systolic Blood Pressure (mmHg) at Week 2 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]

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

    Change = Week 2 - Baseline.


  • Change From Baseline in 24-hr Diastolic Blood Pressure (mmHg) at Week 2 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]

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

    Change = Week 2 - Baseline



Enrollment: 39
Study Start Date: October 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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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

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

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156116

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

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01156116     History of Changes
Other Study ID Numbers: 09-249-A
Study First Received: June 23, 2010
Results First Received: April 29, 2015
Last Updated: May 22, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
CPAP
diabetes
sleep apnea

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on August 30, 2015