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

Sanjay R Patel

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus; Sleep Apnea, Obstructive

Treatments: Device: Continuous positive airway pressure; Device: Sham continuous positive airway pressure

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01629862

8354706

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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53 participants in 2 patient groups, including a placebo group

Active CPAP

Active Comparator group

Description:

Therapeutic continuous positive airway pressure (CPAP).

Treatment:

Device: Continuous positive airway pressure

Sham CPAP

Placebo Comparator group

Description:

Sham (non-therapeutic) continuous positive airway pressure.

Treatment:

Device: Sham continuous positive airway pressure