Trial Outcomes & Findings for Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea (NCT NCT01629862)
NCT ID: NCT01629862
Last Updated: 2019-05-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
3 months (compared to baseline)
Results posted on
2019-05-28
Participant Flow
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
25
|
|
Overall Study
COMPLETED
|
26
|
23
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea
Baseline characteristics by cohort
| Measure |
Active CPAP
n=28 Participants
Therapeutic continuous positive airway pressure (CPAP).
Continuous positive airway pressure: CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia).
|
Sham CPAP
n=25 Participants
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).
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Active CPAP
n=26 Participants
Therapeutic continuous positive airway pressure (CPAP).
Continuous positive airway pressure: CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia).
|
Sham CPAP
n=23 Participants
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).
|
|---|---|---|
|
Absolute Change in Brachial Artery Flow-mediated Dilation (FMD).
|
2.26 percentage of brachial artery diameter
Standard Deviation 3.80
|
1.59 percentage of brachial artery diameter
Standard Deviation 4.85
|
Adverse Events
Active CPAP
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Sham CPAP
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active CPAP
n=28 participants at risk
Therapeutic continuous positive airway pressure (CPAP).
Continuous positive airway pressure: CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia).
|
Sham CPAP
n=25 participants at risk
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).
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal cancer
|
3.6%
1/28 • Number of events 1 • 3 months
Regular investigator assessment of adverse events (at each visit and follow-up phone call)
|
0.00%
0/25 • 3 months
Regular investigator assessment of adverse events (at each visit and follow-up phone call)
|
|
Cardiac disorders
Coronary artery bypass surgery
|
0.00%
0/28 • 3 months
Regular investigator assessment of adverse events (at each visit and follow-up phone call)
|
4.0%
1/25 • Number of events 1 • 3 months
Regular investigator assessment of adverse events (at each visit and follow-up phone call)
|
|
Injury, poisoning and procedural complications
Hematoma
|
3.6%
1/28 • Number of events 1 • 3 months
Regular investigator assessment of adverse events (at each visit and follow-up phone call)
|
0.00%
0/25 • 3 months
Regular investigator assessment of adverse events (at each visit and follow-up phone call)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
3.6%
1/28 • Number of events 1 • 3 months
Regular investigator assessment of adverse events (at each visit and follow-up phone call)
|
0.00%
0/25 • 3 months
Regular investigator assessment of adverse events (at each visit and follow-up phone call)
|
Other adverse events
| Measure |
Active CPAP
n=28 participants at risk
Therapeutic continuous positive airway pressure (CPAP).
Continuous positive airway pressure: CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia).
|
Sham CPAP
n=25 participants at risk
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).
|
|---|---|---|
|
Psychiatric disorders
Asthenia
|
0.00%
0/28 • 3 months
Regular investigator assessment of adverse events (at each visit and follow-up phone call)
|
4.0%
1/25 • Number of events 1 • 3 months
Regular investigator assessment of adverse events (at each visit and follow-up phone call)
|
|
Injury, poisoning and procedural complications
Broken arm
|
0.00%
0/28 • 3 months
Regular investigator assessment of adverse events (at each visit and follow-up phone call)
|
4.0%
1/25 • Number of events 1 • 3 months
Regular investigator assessment of adverse events (at each visit and follow-up phone call)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/28 • 3 months
Regular investigator assessment of adverse events (at each visit and follow-up phone call)
|
4.0%
1/25 • Number of events 1 • 3 months
Regular investigator assessment of adverse events (at each visit and follow-up phone call)
|
|
Injury, poisoning and procedural complications
IV infiltration
|
3.6%
1/28 • Number of events 1 • 3 months
Regular investigator assessment of adverse events (at each visit and follow-up phone call)
|
0.00%
0/25 • 3 months
Regular investigator assessment of adverse events (at each visit and follow-up phone call)
|
|
Cardiac disorders
Vasovagal reaction
|
0.00%
0/28 • 3 months
Regular investigator assessment of adverse events (at each visit and follow-up phone call)
|
4.0%
1/25 • Number of events 1 • 3 months
Regular investigator assessment of adverse events (at each visit and follow-up phone call)
|
|
Injury, poisoning and procedural complications
Hit by falling snow
|
0.00%
0/28 • 3 months
Regular investigator assessment of adverse events (at each visit and follow-up phone call)
|
4.0%
1/25 • Number of events 1 • 3 months
Regular investigator assessment of adverse events (at each visit and follow-up phone call)
|
|
Injury, poisoning and procedural complications
Persistent bleeding at skin biopsy site
|
0.00%
0/28 • 3 months
Regular investigator assessment of adverse events (at each visit and follow-up phone call)
|
4.0%
1/25 • Number of events 1 • 3 months
Regular investigator assessment of adverse events (at each visit and follow-up phone call)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place