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

History of Changes

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:

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

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 22, 2017

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