NCT01629862

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Sanjay R Patel · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sleep Apnea, Obstructive
• Diabetes Mellitus

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2012-04-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2012-06-28
• Last updated: 2019-05-28
• Results posted: 2018-02-19

Locations

2 sites across 1 country: United States