Overview

This trial is active, not recruiting.

Conditions obstructive sleep apnea, type 2 diabetes
Treatment continuous positive airway pressure (cpap) therapy (active or placebo)
Sponsor University of Chicago
Start date September 2009
End date February 2017
Trial size 56 participants
Trial identifier NCT01136785, 14-0547

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Sham Comparator)
7 days of sham CPAP in the laboratory.
continuous positive airway pressure (cpap) therapy (active or placebo)
CPAP is approved for the treatment of Obstructive Sleep Apnea
(Active Comparator)
7 days of treatment in the laboratory with active CPAP.
continuous positive airway pressure (cpap) therapy (active or placebo)
CPAP is approved for the treatment of Obstructive Sleep Apnea

Primary Outcomes

Measure
24 hour blood sampling
time frame: after 1 week of CPAP therapy in the laboratory
36-40 hours of Continuous Glucose Monitoring
time frame: after 1 week of active or sham CPAP therapy in the laboratory

Secondary Outcomes

Measure
24-hr profiles of other hormones and other blood constituents.
time frame: after 1 week of active or sham CPAP therapy in the laboratory

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Effects of Continuous Positive Airway Pressure (CPAP) Treatment on Glucose Control in Patients With Type 2 Diabetes
Principal investigator Eve Van Cauter, PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University of Chicago.