Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea
NCT ID: NCT01629862
Last Updated: 2019-05-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
53 participants
INTERVENTIONAL
2012-04-30
2017-02-28
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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).
Interventions
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Continuous positive airway pressure
CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia).
Sham continuous positive airway pressure
CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia).
Eligibility Criteria
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Inclusion Criteria
* DM subjects: clinical diagnosis of DM and glycated hemoglobin \< 8.0%
Exclusion Criteria
* Pregnancy
* Infectious/collagen vascular/hepatic or renal/cardiopulmonary disease
18 Years
70 Years
ALL
Yes
Sponsors
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Beth Israel Deaconess Medical Center
OTHER
Brigham and Women's Hospital
OTHER
National Institutes of Health (NIH)
NIH
Sanjay R Patel
OTHER
Responsible Party
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Sanjay R Patel
Principal Investigator
Principal Investigators
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Aristidis Veves, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Sanjay R Patel, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Brigham & Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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References
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Bakker JP, Baltzis D, Tecilazich F, Chan RH, Manning WJ, Neilan TG, Wallace ML, Hudson M, Malhotra A, Patel SR, Veves A. The Effect of Continuous Positive Airway Pressure on Vascular Function and Cardiac Structure in Diabetes and Sleep Apnea. A Randomized Controlled Trial. Ann Am Thorac Soc. 2020 Apr;17(4):474-483. doi: 10.1513/AnnalsATS.201905-378OC.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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8354706
Identifier Type: -
Identifier Source: org_study_id
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