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Completed

NCT Number: NCT01156116

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.

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Key information

Conditions

Diabetes Apnea Diabetes Mellitus Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Chicago

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CPAP mask

Device

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 names: continuous positive airway pressure therapy

Placebo

Drug

oral placebo tablet

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jul 2, 2010
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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