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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 October 2016 by University of Pittsburgh
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: October 31, 2016
Last verified: October 2016
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 University of Pittsburgh:

Primary Outcome Measures:
  • Change in brachial artery flow-mediated dilation. [ Time Frame: Between baseline & 3-month follow-up. ] [ Designated as safety issue: No ]

Estimated Enrollment: 55
Study Start Date: April 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (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)
Genders Eligible for Study:   Both
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

Contacts
Contact: Kaylee J Klingensmith, BS 412-246-6009 kjm94@pitt.edu
Contact: Sanjay R Patel, MD, MS 412-692-2035 patelsr2@upmc.edu

Locations
United States, Massachusetts
Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jessie P Bakker, PhD    617-732-5987    jpbakker@bwh.harvard.edu   
Principal Investigator: Jessie P Bakker, PhD         
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Aristidis Veves, MD    617-632-7075    aveves@bidmc.harvard.edu   
Principal Investigator: Aristidis Veves, MD         
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: October 31, 2016
Health Authority: United States: Institutional Review Board

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 December 02, 2016