Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea
|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|
|Primary Completion Date :||February 2017|
|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.
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|