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Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea

Primary Purpose

Sleep Apnea, Obstructive, Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Continuous positive airway pressure
Sham continuous positive airway pressure
Sponsored by
Sanjay R Patel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Brigham & Women's Hospital
  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active CPAP

Sham CPAP

Arm Description

Therapeutic continuous positive airway pressure (CPAP).

Sham (non-therapeutic) continuous positive airway pressure.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 8, 2012
Last Updated
May 24, 2019
Sponsor
Sanjay R Patel
Collaborators
Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01629862
Brief Title
Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea
Official Title
Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sanjay R Patel
Collaborators
Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active CPAP
Arm Type
Active Comparator
Arm Description
Therapeutic continuous positive airway pressure (CPAP).
Arm Title
Sham CPAP
Arm Type
Placebo Comparator
Arm Description
Sham (non-therapeutic) continuous positive airway pressure.
Intervention Type
Device
Intervention Name(s)
Continuous positive airway pressure
Intervention Description
CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia).
Intervention Type
Device
Intervention Name(s)
Sham continuous positive airway pressure
Intervention Description
CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia).
Primary Outcome Measure Information:
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 Pregnancy Infectious/collagen vascular/hepatic or renal/cardiopulmonary disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aristidis Veves, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sanjay R Patel, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31922899
Citation
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.
Results Reference
derived

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Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea

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