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

Completed · Phase 2 · Has a placebo group

Conditions studied: Sleep Apnea, Obstructive, Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT01629862

Run by

Sanjay R Patel

People needed

53

Starts

2012-04-01

Expected to finish

2017-02-01

Last updated by the study team

2019-05-28

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• OSA subjects: apnea-hypopnea index >=10 and <100
• DM subjects: clinical diagnosis of DM and glycated hemoglobin < 8.0%

You may not qualify if…

• Hematocrit < 32
• Pregnancy
• Infectious/collagen vascular/hepatic or renal/cardiopulmonary disease

Where it is running

• Brigham & Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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