Effects of Continuous Positive Airway Pressure (CPAP)Treatment on Glucose Control

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01136785
First received: April 13, 2010
Last updated: December 19, 2014
Last verified: December 2014
  Purpose

The overall goal of the proposed protocol is to rigorously test the hypothesis that CPAP treatment has beneficial effects on glycemic control in patients with both type 2 diabetes (T2DM) and obstructive sleep apnea (OSA). If our hypothesis were to be proven, this would imply that CPAP treatment of OSA in patients with T2DM is an essential component of their glycemic control. The proposed work is thus expected to provide additional preventive and therapeutic approaches in the management of millions of patients with T2DM.


Condition Intervention
Obstructive Sleep Apnea
Type 2 Diabetes
Device: Continuous Positive Airway Pressure (CPAP) Therapy (active or placebo)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effects of Continuous Positive Airway Pressure (CPAP) Treatment on Glucose Control in Patients With Type 2 Diabetes

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 24 hour blood sampling [ Time Frame: after 1 week of CPAP therapy in the laboratory ] [ Designated as safety issue: No ]
    24 hour blood sampling will include frequent sampling of glucose, insulin, c-peptide levels at baseline and after one week of active or sham CPAP therapy

  • 36-40 hours of Continuous Glucose Monitoring [ Time Frame: after 1 week of active or sham CPAP therapy in the laboratory ] [ Designated as safety issue: No ]
    Continuous Glucose monitoring will provide interstitial glucose levels for 36-40 hours at baseline and after one week of active or sham CPAP therapy


Secondary Outcome Measures:
  • 24-hr profiles of other hormones and other blood constituents. [ Time Frame: after 1 week of active or sham CPAP therapy in the laboratory ] [ Designated as safety issue: No ]
    Levels of the 2 counter regulatory hormones cortisol and GH will be examined as potential mediators of overnight glucose levels.


Estimated Enrollment: 56
Study Start Date: September 2009
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Sham CPAP
7 days of sham CPAP in the laboratory.
Device: Continuous Positive Airway Pressure (CPAP) Therapy (active or placebo)
CPAP is approved for the treatment of Obstructive Sleep Apnea
Active Comparator: CPAP
7 days of treatment in the laboratory with active CPAP.
Device: Continuous Positive Airway Pressure (CPAP) Therapy (active or placebo)
CPAP is approved for the treatment of Obstructive Sleep Apnea

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects with type 2 diabetes on a stable medication regimen (no change in diabetic medications in the previous 3 months) will be eligible.

Exclusion Criteria:

  • Subjects on insulin will be excluded.
  • Subjects with unstable cardiopulmonary disease, painful neuropathy, significant psychiatric illness, cognitive impairment and pregnancy will be excluded.
  • Shift workers
  • Subjects having traveled across >2 time zones less than one month prior to the study
  • Diagnosis of a sleep disorder other than OSA by screening polysomnography
  • Previous treatment with positive airway pressure or supplemental oxygen
  • Requirement of supplemental oxygen or bi-level positive airway pressure for OSA treatment during titration
  • Claustrophobia or other conditions of CPAP intolerance,
  • Presence of active infection.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01136785

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Eve Van Cauter, PhD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01136785     History of Changes
Other Study ID Numbers: 14-0547
Study First Received: April 13, 2010
Last Updated: December 19, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on March 26, 2015