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Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT01629862
Recruitment Status : Completed
First Posted : June 28, 2012
Results First Posted : February 16, 2018
Last Update Posted : March 15, 2018
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Sanjay R Patel, University of Pittsburgh

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Sleep Apnea, Obstructive
Diabetes Mellitus
Interventions: Device: Continuous positive airway pressure
Device: Sham continuous positive airway pressure

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Active CPAP

Therapeutic continuous positive airway pressure (CPAP).

Continuous positive airway pressure: CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia).

Sham CPAP

Sham (non-therapeutic) continuous positive airway pressure.

Sham continuous positive airway pressure: CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia).


Participant Flow:   Overall Study
    Active CPAP   Sham CPAP
STARTED   28   25 
COMPLETED   26   23 
NOT COMPLETED   2   2 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Active CPAP

Therapeutic continuous positive airway pressure (CPAP).

Continuous positive airway pressure: CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia).

Sham CPAP

Sham (non-therapeutic) continuous positive airway pressure.

Sham continuous positive airway pressure: CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia).

Total Total of all reporting groups

Baseline Measures
   Active CPAP   Sham CPAP   Total 
Overall Participants Analyzed 
[Units: Participants]
 28   25   53 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      22  78.6%      20  80.0%      42  79.2% 
>=65 years      6  21.4%      5  20.0%      11  20.8% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      10  35.7%      9  36.0%      19  35.8% 
Male      18  64.3%      16  64.0%      34  64.2% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      1   3.6%      0   0.0%      1   1.9% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      11  39.3%      6  24.0%      17  32.1% 
White      14  50.0%      14  56.0%      28  52.8% 
More than one race      0   0.0%      1   4.0%      1   1.9% 
Unknown or Not Reported      2   7.1%      4  16.0%      6  11.3% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   28   25   53 


  Outcome Measures

1.  Primary:   Absolute Change in Brachial Artery Flow-mediated Dilation (FMD).   [ Time Frame: 3 months (compared to baseline) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Sanjay Patel
Organization: University of Pittsburgh
phone: 412-692-2035
e-mail: patelsr2@upmc.edu



Responsible Party: Sanjay R Patel, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01629862     History of Changes
Other Study ID Numbers: 8354706
First Submitted: May 8, 2012
First Posted: June 28, 2012
Results First Submitted: January 22, 2018
Results First Posted: February 16, 2018
Last Update Posted: March 15, 2018