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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 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: April 8, 2014
Last verified: April 2014
  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 4

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 Brigham and Women's Hospital:

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 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
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: Jessie P Bakker, PhD 617 732 5987 jpbakker@partners.org

Locations
United States, Massachusetts
Division of Sleep Medicine, Brigham & Women's Hospital, Harvard Medical School Recruiting
Boston, Massachusetts, United States, 02115
Sub-Investigator: Jessie P Bakker, PhD         
Principal Investigator: Sanjay R Patel, MD         
Microcirculatory Laboratory, Beth Israel Deaconess Medical Center, Harvard Medical School Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Aristidis Veves, MD         
Sponsors and Collaborators
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Sanjay R Patel, MD Brigham and Women's Hospital
Principal Investigator: Aristidis Veves, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Sanjay Rajnikant Patel, MD, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01629862     History of Changes
Other Study ID Numbers: 8354706
Study First Received: May 8, 2012
Last Updated: April 8, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 22, 2014