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

June 23, 2010
May 22, 2015
October 2009
October 2012   (final data collection date for primary outcome measure)
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.

Glucose levels (mg/dl) [ Time Frame: end of 2 weeks intervention ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01156116 on ClinicalTrials.gov Archive Site
  • 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

Blood pressure (mmHg) [ Time Frame: end of 2 weeks intervention ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effective Treatment of Sleep Apnea in Prediabetes to Reduce Cardiometabolic Risk
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Sleep Apnea
  • 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
  • Drug: Placebo
    oral placebo tablet
  • 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
    Intervention: Device: CPAP mask
  • Placebo Comparator: Placebo
    2 weeks of oral administration of a placebo tablet 30min before bedtime
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
October 2012
October 2012   (final data collection date for primary outcome measure)

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)
Both
45 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01156116
09-249-A
Yes
University of Chicago
University of Chicago
Not Provided
Principal Investigator: Esra Tasali, MD University of Chicago
University of Chicago
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP