Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea
This study is currently recruiting participants.
Verified February 2013 by Brigham and Women's Hospital
Sponsor:
Brigham and Women's Hospital
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Atul Malhotra, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01629862
First received: May 8, 2012
Last updated: February 14, 2013
Last verified: February 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Sleep Apnea, Obstructive Diabetes Mellitus |
Device: Continuous positive airway pressure Device: Sham continuous positive airway pressure |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea. |
Resource links provided by NLM:
Further study details as provided by Brigham and Women's Hospital:
Primary Outcome Measures:
- Change in brachial artery flow-mediated dilation. [ Time Frame: Between baseline & 3-month follow-up. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 175 |
| Study Start Date: | April 2012 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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).
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
- Glomerular filtration rate > 40
- Pregnancy
- Infectious/collagen vascular/hepatic or renal/cardiopulmonary disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01629862
Contacts
| Contact: Jessie P Bakker, PhD | 617 732 5987 | jpbakker@partners.org |
Locations
| United States, Massachusetts | |
| Division of Sleep Medicine, Brigham & Women's Hospital, Harvard Medical School | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Sub-Investigator: Jessie P Bakker, PhD | |
| Principal Investigator: Atul Malhotra, MD | |
| Microcirculatory Laboratory, Beth Israel Deaconess Medical Center, Harvard Medical School | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: Aristidis Veves, MD | |
Sponsors and Collaborators
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Investigators
| Principal Investigator: | Atul Malhotra, MD | Brigham and Women's Hospital |
| Principal Investigator: | Aristidis Veves, MD | Beth Israel Deaconess Medical Center |
More Information
No publications provided
| Responsible Party: | Atul Malhotra, MD, Associate Professor, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT01629862 History of Changes |
| Other Study ID Numbers: | 8354706 |
| Study First Received: | May 8, 2012 |
| Last Updated: | February 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Apnea Diabetes Mellitus Diabetes Mellitus, Type 2 Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013