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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Brigham and Women's Hospital
Sponsor:
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Sanjay Rajnikant Patel, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01629862
First received: May 8, 2012
Last updated: November 13, 2014
Last verified: November 2014

May 8, 2012
November 13, 2014
April 2012
December 2016   (final data collection date for primary outcome measure)
Change in brachial artery flow-mediated dilation. [ Time Frame: Between baseline & 3-month follow-up. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01629862 on ClinicalTrials.gov Archive Site
Not Provided
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Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea
Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea.

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Sleep Apnea, Obstructive
  • Diabetes Mellitus
  • Device: Continuous positive airway pressure
    CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia).
  • Device: Sham continuous positive airway pressure
    CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia).
  • Active Comparator: Active CPAP
    Therapeutic continuous positive airway pressure (CPAP).
    Intervention: Device: Continuous positive airway pressure
  • Placebo Comparator: Sham CPAP
    Sham (non-therapeutic) continuous positive airway pressure.
    Intervention: Device: Sham continuous positive airway pressure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
55
December 2016
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • OSA subjects: apnea-hypopnea index >=10 and <100
  • DM subjects: clinical diagnosis of DM and glycated hemoglobin < 8.0%

Exclusion Criteria:

  • Hematocrit < 32
  • Pregnancy
  • Infectious/collagen vascular/hepatic or renal/cardiopulmonary disease
Both
18 Years to 70 Years
Yes
Contact: Jessie P Bakker, PhD 617 732 5987 jpbakker@partners.org
United States
 
NCT01629862
8354706
Yes
Sanjay Rajnikant Patel, MD, Brigham and Women's Hospital
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Principal Investigator: Sanjay R Patel, MD Brigham and Women's Hospital
Principal Investigator: Aristidis Veves, MD Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP