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

Type 2 Diabetes Clinical Trial

— CPAP  

Official title:

Effects of Continuous Positive Airway Pressure (CPAP) Treatment on Glucose Control in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01136785
• Other study ID #: 14-0547
• Status: Completed
• Phase: N/A
• First received: April 13, 2010
• Last updated: September 29, 2016
• Start date: September 2009
• Est. completion date: August 2015

Study information

• Verified date: September 2016
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• Continuous Positive Airway Pressure (CPAP) Therapy (active or placebo)
CPAP is approved for the treatment of Obstructive Sleep Apnea

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (1)

Mokhlesi B, Grimaldi D, Beccuti G, Abraham V, Whitmore H, Delebecque F, Van Cauter E. Effect of One Week of 8-Hour Nightly Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea on Glycemic Control in Type 2 Diabetes: A Proof-of-Concept — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hour blood sampling	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	after 1 week of CPAP therapy in the laboratory	No
Primary	36-40 hours of Continuous Glucose Monitoring	Continuous Glucose monitoring will provide interstitial glucose levels for 36-40 hours at baseline and after one week of active or sham CPAP therapy	after 1 week of active or sham CPAP therapy in the laboratory	No
Secondary	24-hr profiles of other hormones and other blood constituents.	Levels of the 2 counter regulatory hormones cortisol and GH will be examined as potential mediators of overnight glucose levels.	after 1 week of active or sham CPAP therapy in the laboratory	No