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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

May 8, 2012
June 28, 2012
January 22, 2018
February 16, 2018
March 15, 2018
April 2012
February 2017   (Final data collection date for primary outcome measure)
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.
Change in brachial artery flow-mediated dilation. [ Time Frame: Between baseline & 3-month follow-up. ]
Complete list of historical versions of study NCT01629862 on ClinicalTrials.gov Archive Site
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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.
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Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
175
February 2017
February 2017   (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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01629862
8354706
Yes
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Sanjay R Patel, University of Pittsburgh
Sanjay R Patel
  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
  • National Institutes of Health (NIH)
Principal Investigator: Aristidis Veves, MD Beth Israel Deaconess Medical Center
Principal Investigator: Sanjay R Patel, MD University of Pittsburgh
University of Pittsburgh
February 2018

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