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Effective Treatment of Sleep Apnea in Prediabetes to Reduce Cardiometabolic Risk

Primary Purpose

Diabetes, Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CPAP mask
Placebo
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes focused on measuring CPAP, diabetes, sleep apnea

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Continuous positive airway pressure

Placebo

Arm Description

2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night

2 weeks of oral administration of a placebo tablet 30min before bedtime

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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

Full Information

First Posted
June 23, 2010
Last Updated
May 22, 2015
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT01156116
Brief Title
Effective Treatment of Sleep Apnea in Prediabetes to Reduce Cardiometabolic Risk
Official Title
Effective Treatment of Sleep Apnea in Prediabetes to Reduce Cardiometabolic Risk
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Sleep Apnea
Keywords
CPAP, diabetes, sleep apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous positive airway pressure
Arm Type
Active Comparator
Arm Description
2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 weeks of oral administration of a placebo tablet 30min before bedtime
Intervention Type
Device
Intervention Name(s)
CPAP mask
Other Intervention Name(s)
continuous positive airway pressure therapy
Intervention Description
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. ________________________________________
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral placebo tablet
Primary Outcome Measure Information:
Title
Change From Baseline in Area Under the Curve (AUC) Glucose at Week 2
Description
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.
Time Frame
Baseline and Week 2
Secondary Outcome Measure Information:
Title
Change From Baseline in Insulin Sensitivity (SI) at Week 2
Description
SI is estimated from modeling of the insulin and glucose values during the intravenous glucose tolerance test (ivGTT). Change = Week 2 - Baseline.
Time Frame
Baseline and Week 2
Title
Change From Baseline in 24-hr Systolic Blood Pressure (mmHg) at Week 2
Description
The average systolic blood pressure measured over a 24-hr period was calculated for each patient. Change = Week 2 - Baseline.
Time Frame
Baseline and Week 2
Title
Change From Baseline in 24-hr Diastolic Blood Pressure (mmHg) at Week 2
Description
The average diastolic blood pressure over a 24-hr period was calculated for each patient. Change = Week 2 - Baseline
Time Frame
Baseline and Week 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esra Tasali, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32998624
Citation
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.
Results Reference
derived
PubMed Identifier
25897569
Citation
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.
Results Reference
derived

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Effective Treatment of Sleep Apnea in Prediabetes to Reduce Cardiometabolic Risk

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