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
The investigators will examine the possible synergistic effects of obstructive sleep apnea (OSA) and type II diabetes mellitus (DM) on vascular functioning by performing a two-part investigation:
- A cross-sectional study comparing subjects with OSA+DM, OSA only, DM only, and healthy controls.
- A three-month randomized placebo-controlled trial of continuous positive airway pressure (CPAP) in subjects with OSA+DM.
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea, Obstructive Diabetes Mellitus||Device: Continuous positive airway pressure Device: Sham continuous positive airway pressure||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea.|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||February 2017|
Active Comparator: Active CPAP
Therapeutic continuous positive airway pressure (CPAP).
Device: Continuous positive airway pressure
CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia).
Placebo Comparator: Sham CPAP
Sham (non-therapeutic) continuous positive airway pressure.
Device: Sham continuous positive airway pressure
CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia).
- Absolute Change in Brachial Artery Flow-mediated Dilation (FMD). [ Time Frame: 3 months (compared to baseline) ]Brachial artery flow-mediated dilation is measured as the percent change in brachial artery diameter post-occlusion relative to pre-occlusion. The change in brachial artery flow mediated dilation is the difference in this percent change at 3-months compared to baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01629862
|United States, Massachusetts|
|Brigham & Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Aristidis Veves, MD||Beth Israel Deaconess Medical Center|
|Principal Investigator:||Sanjay R Patel, MD||University of Pittsburgh|