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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01629862
• Other study ID #: 8354706
• Status: Completed
• Phase: Phase 2
• Start date: April 2012
• Est. completion date: February 2017

Study information

• Verified date: May 2019
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

• A three-month randomized placebo-controlled trial of continuous positive airway pressure (CPAP) in subjects with OSA+DM.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Continuous positive airway pressure
CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia).
• Sham continuous positive airway pressure
CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia).

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham & Women's Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Sanjay R Patel	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)