NCT01629862

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2012

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 8, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
1 year until next milestone

Results Posted

Study results publicly available

February 19, 2018

Completed
Last Updated

May 28, 2019

Status Verified

May 1, 2019

Enrollment Period

4.8 years

First QC Date

May 8, 2012

Results QC Date

January 22, 2018

Last Update Submit

May 24, 2019

Conditions

Sleep Apnea, ObstructiveDiabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months (compared to baseline)

Study Arms (2)

Active CPAP

ACTIVE COMPARATOR

Therapeutic continuous positive airway pressure (CPAP).

Device: Continuous positive airway pressure

Sham CPAP

PLACEBO COMPARATOR

Sham (non-therapeutic) continuous positive airway pressure.

Device: Sham continuous positive airway pressure

Interventions

Continuous positive airway pressureDEVICE

CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia).

Active CPAP
Sham continuous positive airway pressureDEVICE

CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia).

Sham CPAP

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • OSA subjects: apnea-hypopnea index \>=10 and \<100
  • DM subjects: clinical diagnosis of DM and glycated hemoglobin \< 8.0%

You may not qualify if:

  • Hematocrit \< 32
  • Pregnancy
  • Infectious/collagen vascular/hepatic or renal/cardiopulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • 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.

    PMID: 31922899DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveDiabetes Mellitus

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Results Point of Contact

Title
Sanjay Patel
Organization
University of Pittsburgh
patelsr2@upmc.edu
412-692-2035

Study Officials

  • Aristidis Veves, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

  • Sanjay R Patel, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 8, 2012

First Posted

June 28, 2012

Study Start

April 1, 2012

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

May 28, 2019

Results First Posted

February 19, 2018

Record last verified: 2019-05

Locations

US(2)