Diabetes Mellitus, Sleep Apnea, Obstructive
Conditions
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.
Interventions
DEVICEContinuous positive airway pressure
CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia).
CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia).
Sponsors
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
National Institutes of Health (NIH)
Sanjay R Patel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active CPAP Therapeutic continuous positive airway pressure (CPAP).
Continuous positive airway pressure: CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia). | 28 |
| Sham CPAP Sham (non-therapeutic) continuous positive airway pressure.
Sham continuous positive airway pressure: CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia). | 25 |
| Total | 53 |
Baseline characteristics
| Characteristic | Active CPAP | Sham CPAP | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 5 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 20 Participants | 42 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 6 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) White | 14 Participants | 14 Participants | 28 Participants |
| Region of Enrollment United States | 28 Participants | 25 Participants | 53 Participants |
| Sex: Female, Male Female | 10 Participants | 9 Participants | 19 Participants |
| Sex: Female, Male Male | 18 Participants | 16 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 25 |
| other Total, other adverse events | 1 / 28 | 5 / 25 |
| serious Total, serious adverse events | 3 / 28 | 1 / 25 |
Outcome results
Primary
Absolute Change in Brachial Artery Flow-mediated Dilation (FMD).
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.
Time frame: 3 months (compared to baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active CPAP | Absolute Change in Brachial Artery Flow-mediated Dilation (FMD). | 2.26 percentage of brachial artery diameter | Standard Deviation 3.8 |
| Sham CPAP | Absolute Change in Brachial Artery Flow-mediated Dilation (FMD). | 1.59 percentage of brachial artery diameter | Standard Deviation 4.85 |