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

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.

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Key information

Conditions

Sleep Apnea, Obstructive Apnea Diabetes Mellitus Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Positive Airway Pressure

Device

CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia).

Sham continuous positive airway pressure

Device

CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia).

Primary outcomes

Absolute Change in Brachial Artery Flow-mediated Dilation (FMD).

Time frame: 3 months (compared to baseline)

Brachial artery flow-mediated dilation is measured as the percent change in brachial artery diameter post-occlusion relative to pre-occlusion. The change in brachial artery flow mediated dilation is the difference in this percent change at 3-months compared to baseline.

Sponsors and collaborators

Lead sponsor

Sanjay R Patel

Other

Collaborators

Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2017
Study completion: 2017
First posted: Jun 28, 2012
Registry last updated: May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed