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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Chicago.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT01136785
First received: April 13, 2010
Last updated: June 2, 2010
Last verified: June 2010
History of Changes
  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: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

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

  • 48 hours of Continuous Glucose Monitoring [ Time Frame: after 1 week of active or placebo CPAP therapy in the laboratory ] [ Designated as safety issue: No ]
    Continuous Glucose monitoring will provide interstitial glucose levels for 48 hours at baseline and after one week of active or placebo CPAP therapy

  • 24 hours of continuous glucose monitoring [ Time Frame: after 3 months of active CPAP therapy at home ] [ Designated as safety issue: No ]
    Continuous Glucose monitoring will provide interstitial glucose levels for 24 hours after 3 months of active CPAP therapy at home


Estimated Enrollment: 56
Study Start Date: September 2009
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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), including insulin, will be eligible.

Exclusion Criteria:

  • Subjects on an insulin pump 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, and presence of active infection.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136785

Locations
United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Eve Van Cauter, PhD     773-702-0169     evcauter@medicine.bsd.uchicago.edu    
Contact: Esra Tasali, MD     773-702-0169     etasali@medicine.bsd.uchicago.edu    
Principal Investigator: Eve Van Cauter, PhD            
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Eve Van Cauter, PhD University of Chicago
  More Information

No publications provided

Responsible Party: Eve Van Caute, PhD, Professor, The University of Chicago
ClinicalTrials.gov Identifier: NCT01136785     History of Changes
Other Study ID Numbers: 09-092-A
Study First Received: April 13, 2010
Last Updated: June 2, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on June 17, 2013