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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01629862
First received: May 8, 2012
Last updated: May 26, 2017
Last verified: May 2017
  Purpose

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 Intervention Phase
Sleep Apnea, Obstructive Diabetes Mellitus Device: Continuous positive airway pressure Device: Sham continuous positive airway pressure Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea.

Resource links provided by NLM:


Further study details as provided by Sanjay R Patel, University of Pittsburgh:

Primary Outcome Measures:
  • Change in brachial artery flow-mediated dilation. [ Time Frame: Between baseline & 3-month follow-up. ]

Enrollment: 53
Study Start Date: April 2012
Study Completion Date: February 2017
Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01629862

Locations
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
University of Pittsburgh
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
National Institutes of Health (NIH)
Investigators
Principal Investigator: Aristidis Veves, MD Beth Israel Deaconess Medical Center
Principal Investigator: Sanjay R Patel, MD University of Pittsburgh
  More Information

Responsible Party: Sanjay R Patel, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01629862     History of Changes
Other Study ID Numbers: 8354706
Study First Received: May 8, 2012
Last Updated: May 26, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on June 28, 2017