Phase 2
N=53
Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea
Sleep Apnea, Obstructive · Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT01629862 ↗Enrolled (actual)
53
Serious AEs
7.6%
Results posted
Feb 2018
Primary outcome: Primary: Absolute Change in Brachial Artery Flow-mediated Dilation (FMD). — 2.26; 1.59 percentage of brachial artery diameter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Continuous positive airway pressure (Device); Sham continuous positive airway pressure (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanjay R Patel
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change in Brachial Artery Flow-mediated Dilation (FMD). |
2.26; 1.59 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01629862). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.