Sleep Apnea, ObstructivePhase 2NCT01629862
Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea
A Phase 2 study testing Continuous positive airway pressure in people with Sleep Apnea, Obstructive and Diabetes Mellitus, run by Sanjay R Patel at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive, Diabetes Mellitus
- What is being tested?
- Continuous positive airway pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2012to Feb 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- OSA subjects: apnea-hypopnea index >=10 and <100
- DM subjects: clinical diagnosis of DM and glycated hemoglobin < 8.0%
Who cannot join
- Hematocrit < 32
- Pregnancy
- Infectious/collagen vascular/hepatic or renal/cardiopulmonary disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea.
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.
- Conditions
- Sleep Apnea, Obstructive, Diabetes Mellitus
- Being tested
- Continuous positive airway pressure, Sham continuous positive airway pressure
- Medical subject headings
- Sleep Apnea, Obstructive, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressureDevice
CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia).
Sham continuous positive airway pressureDevice
CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia).
| Study group | Role | What they receive |
|---|---|---|
| Active CPAP | Active comparator | Therapeutic continuous positive airway pressure (CPAP). Receives: Device: Continuous positive airway pressure |
| Sham CPAP | Placebo comparator | Sham (non-therapeutic) continuous positive airway pressure. Receives: Device: Sham continuous positive airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months (compared to baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startApr 2012
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanjay R Patel
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, National Institutes of Health (NIH)
- Responsible party
- Sponsor-investigator, Sanjay R Patel, University of Pittsburgh
- Investigators
- Aristidis Veves, MD, Principal investigator, Beth Israel Deaconess Medical CenterSanjay R Patel, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629862
- Sponsor's protocol ID
- 8354706
- Status last verified
- May 2019
- First submitted
- 8 May 2012
- Last updated
- 28 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bakker JP, Baltzis D, Tecilazich F, Chan RH, Manning WJ, Neilan TG, Wallace ML, Hudson M, Malhotra A, Patel SR, Veves A. The Effect of Continuous Positive Airway Pressure on Vascular Function and Cardiac Structure in Diabetes and Sleep Apnea. A Randomized Controlled Trial. Ann Am Thorac Soc. 2020 Apr;17(4):474-483. doi: 10.1513/AnnalsATS.201905-378OC.
PubMed 31922899
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea.
- ClinicalTrials.gov ID
- NCT01629862
- Acronym / sponsor ID
- 8354706
- Conditions
- Sleep Apnea, Obstructive, Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Sanjay R PatelUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, National Institutes of Health (NIH)
- Study start
- Apr 2012
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 28 Jun 2012 (estimated)
- Results
- Posted 19 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active CPAP | Active comparator | Device: Continuous positive airway pressureTherapeutic continuous positive airway pressure (CPAP). |
| Sham CPAP | Placebo comparator | Device: Sham continuous positive airway pressureSham (non-therapeutic) continuous positive airway pressure. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- OSA subjects: apnea-hypopnea index >=10 and <100
- DM subjects: clinical diagnosis of DM and glycated hemoglobin < 8.0%
Key exclusion criteria (3 listed)
- Hematocrit < 32
- Pregnancy
- Infectious/collagen vascular/hepatic or renal/cardiopulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous positive airway pressureCPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia). | Device | Active CPAP |
| Sham continuous positive airway pressureCPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia). | Device | Sham CPAP |
Primary outcome
Absolute Change in Brachial Artery Flow-mediated Dilation (FMD).
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31922899Bakker JP, Baltzis D, Tecilazich F, Chan RH, Manning WJ, Neilan TG, Wallace ML, Hudson M, Malhotra A, Patel SR, Veves A. The Effect of Continuous Positive Airway Pressure on Vascular Function and Cardiac Structure in Diabetes and Sleep Apnea. A Randomized Controlled Trial. Ann Am Thorac Soc. 2020 Apr;17(4):474-483. doi: 10.1513/AnnalsATS.201905-378OC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aristidis Veves, MD principal investigator
Beth Israel Deaconess Medical Center
Sanjay R Patel, MD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Continuous positive airway pressure in people with Sleep Apnea, Obstructive and Diabetes Mellitus, run by Sanjay R Patel at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute Change in Brachial Artery Flow-mediated Dilation (FMD). (time frame: 3 months (compared to baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01629862, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.