Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01629862 |
Recruitment Status :
Completed
First Posted : June 28, 2012
Results First Posted : February 19, 2018
Last Update Posted : May 28, 2019
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
---|---|---|
Sleep Apnea, Obstructive Diabetes Mellitus | Device: Continuous positive airway pressure Device: Sham continuous positive airway pressure | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
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 : | April 2012 |
Actual Primary Completion Date : | February 2017 |
Actual Study Completion Date : | February 2017 |
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). |
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01629862
United States, Massachusetts | |
Brigham & Women's Hospital | |
Boston, Massachusetts, United States, 02115 | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 |
Principal Investigator: | Aristidis Veves, MD | Beth Israel Deaconess Medical Center | |
Principal Investigator: | Sanjay R Patel, MD | University of Pittsburgh |
Documents provided by Sanjay R Patel, University of Pittsburgh:
Responsible Party: | Sanjay R Patel, Principal Investigator, University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT01629862 |
Other Study ID Numbers: |
8354706 |
First Posted: | June 28, 2012 Key Record Dates |
Results First Posted: | February 19, 2018 |
Last Update Posted: | May 28, 2019 |
Last Verified: | May 2019 |
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |