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
Results First Received: April 29, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Diabetes
Sleep Apnea
Interventions: Device: CPAP mask
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Continuous Positive Airway Pressure 2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
Placebo 2 weeks of oral administration of a placebo tablet 30min before bedtime

Participant Flow:   Overall Study
    Continuous Positive Airway Pressure     Placebo  
STARTED     26     13  
COMPLETED     21     12  
NOT COMPLETED     5     1  
Withdrawal by Subject                 3                 1  
CPAP intolerance                 2                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Continuous Positive Airway Pressure 2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
Placebo 2 weeks of oral administration of a placebo tablet 30min before bedtime
Total Total of all reporting groups

Baseline Measures
    Continuous Positive Airway Pressure     Placebo     Total  
Number of Participants  
[units: participants]
  26     13     39  
Age  
[units: years]
Mean (Standard Deviation)
  53.8  (6.2)     55.2  (8.4)     54.3  (6.9)  
Gender  
[units: participants]
     
Female     10     3     13  
Male     16     10     26  
Region of Enrollment  
[units: participants]
     
United States     26     13     39  



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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Esra Tasali
Organization: University of Chicago
phone: 773-702-1497
e-mail: etasali@medicine.bsd.uchicago.edu


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