Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea
Sponsor
Sanjay R Patel (Other)
Overall Status
Completed
CT.gov ID
NCT01629862
Collaborator
Beth Israel Deaconess Medical Center (Other), Brigham and Women's Hospital (Other), National Institutes of Health (NIH) (NIH)
53
2
2
58.1
26.5
0.5
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
53 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea.
Study Start Date
:
Apr 1, 2012
Actual Primary Completion Date
:
Feb 1, 2017
Actual Study Completion Date
:
Feb 1, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Active CPAP Therapeutic continuous positive airway pressure (CPAP). |
Device: Continuous positive airway pressure
CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia).
|
| Placebo Comparator: Sham CPAP Sham (non-therapeutic) continuous positive airway pressure. |
Device: Sham continuous positive airway pressure
CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia).
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brigham & Women's Hospital | Boston | Massachusetts | United States | 02115 |
| 2 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
Sponsors and Collaborators
- Sanjay R Patel
- Beth Israel Deaconess Medical Center
- Brigham and Women's Hospital
- National Institutes of Health (NIH)
Investigators
- Principal Investigator: Aristidis Veves, MD, Beth Israel Deaconess Medical Center
- Principal Investigator: Sanjay R Patel, MD, University of Pittsburgh
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Sanjay R Patel,
Principal Investigator,
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01629862
Other Study ID Numbers:
- 8354706
First Posted:
Jun 28, 2012
Last Update Posted:
May 28, 2019
Last Verified:
May 1, 2019
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Active CPAP | Sham CPAP |
|---|---|---|
| Arm/Group Description | Therapeutic continuous positive airway pressure (CPAP). Continuous positive airway pressure: CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia). | 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). |
| Period Title: Overall Study | ||
| STARTED | 28 | 25 |
| COMPLETED | 26 | 23 |
| NOT COMPLETED | 2 | 2 |
Baseline Characteristics
| Arm/Group Title | Active CPAP | Sham CPAP | Total |
|---|---|---|---|
| Arm/Group Description | Therapeutic continuous positive airway pressure (CPAP). Continuous positive airway pressure: CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia). | 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 of all reporting groups |
| Overall Participants | 28 | 25 | 53 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
22
78.6%
|
20
80%
|
42
79.2%
|
| >=65 years |
6
21.4%
|
5
20%
|
11
20.8%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
10
35.7%
|
9
36%
|
19
35.8%
|
| Male |
18
64.3%
|
16
64%
|
34
64.2%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
3.6%
|
0
0%
|
1
1.9%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
11
39.3%
|
6
24%
|
17
32.1%
|
| White |
14
50%
|
14
56%
|
28
52.8%
|
| More than one race |
0
0%
|
1
4%
|
1
1.9%
|
| Unknown or Not Reported |
2
7.1%
|
4
16%
|
6
11.3%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
28
100%
|
25
100%
|
53
100%
|
Outcome Measures
| Title | Absolute Change in Brachial Artery Flow-mediated Dilation (FMD). |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Active CPAP | Sham CPAP |
|---|---|---|
| Arm/Group Description | Therapeutic continuous positive airway pressure (CPAP). Continuous positive airway pressure: CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia). | 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). |
| Measure Participants | 26 | 23 |
| Mean (Standard Deviation) [percentage of brachial artery diameter] |
2.26
(3.80)
|
1.59
(4.85)
|
Adverse Events
| Time Frame | 3 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Regular investigator assessment of adverse events (at each visit and follow-up phone call) | |||
| Arm/Group Title | Active CPAP | Sham CPAP | ||
| Arm/Group Description | Therapeutic continuous positive airway pressure (CPAP). Continuous positive airway pressure: CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia). | 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). | ||
All Cause Mortality |
||||
| Active CPAP | Sham CPAP | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/28 (0%) | 0/25 (0%) | ||
Serious Adverse Events |
||||
| Active CPAP | Sham CPAP | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/28 (10.7%) | 1/25 (4%) | ||
| Cardiac disorders | ||||
| Coronary artery bypass surgery | 0/28 (0%) | 0 | 1/25 (4%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Hematoma | 1/28 (3.6%) | 1 | 0/25 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Spinal cancer | 1/28 (3.6%) | 1 | 0/25 (0%) | 0 |
| Skin cancer | 1/28 (3.6%) | 1 | 0/25 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Active CPAP | Sham CPAP | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/28 (3.6%) | 5/25 (20%) | ||
| Cardiac disorders | ||||
| Vasovagal reaction | 0/28 (0%) | 0 | 1/25 (4%) | 1 |
| Gastrointestinal disorders | ||||
| Vomiting | 0/28 (0%) | 0 | 1/25 (4%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Broken arm | 0/28 (0%) | 0 | 1/25 (4%) | 1 |
| IV infiltration | 1/28 (3.6%) | 1 | 0/25 (0%) | 0 |
| Hit by falling snow | 0/28 (0%) | 0 | 1/25 (4%) | 1 |
| Persistent bleeding at skin biopsy site | 0/28 (0%) | 0 | 1/25 (4%) | 1 |
| Psychiatric disorders | ||||
| Asthenia | 0/28 (0%) | 0 | 1/25 (4%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Sanjay Patel |
|---|---|
| Organization | University of Pittsburgh |
| Phone | 412-692-2035 |
| patelsr2@upmc.edu |
Responsible Party:
Sanjay R Patel,
Principal Investigator,
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01629862
Other Study ID Numbers:
- 8354706
First Posted:
Jun 28, 2012
Last Update Posted:
May 28, 2019
Last Verified:
May 1, 2019