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

This study is currently recruiting participants.

Verified February 2013 by Brigham and Women's Hospital

Sponsor:

Collaborator:

Beth Israel Deaconess Medical Center

Information provided by (Responsible Party):

Atul Malhotra, MD, Brigham and Women's Hospital

ClinicalTrials.gov Identifier:

NCT01629862

First received: May 8, 2012

Last updated: February 14, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

May 8, 2012

Last Updated Date

February 14, 2013

Start Date ^ICMJE

April 2012

Estimated Primary Completion Date

December 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01629862 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Sleep Apnea, Obstructive
Diabetes Mellitus

Intervention ^ICMJE

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).

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

175

Completion Date

Not Provided

Estimated Primary Completion Date

December 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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
Glomerular filtration rate > 40
Pregnancy
Infectious/collagen vascular/hepatic or renal/cardiopulmonary disease

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Jessie P Bakker, PhD

617 732 5987

jpbakker@partners.org

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01629862

Other Study ID Numbers ^ICMJE

8354706

Has Data Monitoring Committee

Yes

Responsible Party

Atul Malhotra, MD, Brigham and Women's Hospital

Study Sponsor ^ICMJE

Brigham and Women's Hospital

Collaborators ^ICMJE

Beth Israel Deaconess Medical Center

Investigators ^ICMJE

Principal Investigator:	Atul Malhotra, MD	Brigham and Women's Hospital
Principal Investigator:	Aristidis Veves, MD	Beth Israel Deaconess Medical Center

Information Provided By

Brigham and Women's Hospital

Verification Date

February 2013

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

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