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

Phase 2

Completed

• Conditions: Diabetes Mellitus; Sleep Apnea, Obstructive
• Interventions: Device: Continuous positive airway pressure; Device: Sham continuous positive airway pressure

• Registration Number: NCT01629862
• Lead Sponsor: Sanjay R Patel

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 available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-05-08
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-28
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Results First Submitted: 2018-01-22
• Results First Submitted QC: 2018-01-22
• Results First Posted: 2018-02-19
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-24
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active CPAP	Continuous positive airway pressure	Therapeutic continuous positive airway pressure (CPAP).
Sham CPAP	Sham continuous positive airway pressure	Sham (non-therapeutic) continuous positive airway pressure.

Primary Outcome Measures

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

Trial Locations

Locations (2)

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States