Effects of Continuous Positive Airway Pressure (CPAP) Treatment on Glucose Control in Patients With Type 2 Diabetes
CPAP
1 other identifier
interventional
22
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 13, 2010
CompletedFirst Posted
Study publicly available on registry
June 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
April 10, 2017
CompletedApril 10, 2017
February 1, 2017
5.8 years
April 13, 2010
December 22, 2016
February 24, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
Change From Baseline to End of 7-day Intervention in Mean Plasma Glucose Derived From 24 Hour Blood Sampling
24 hour blood sampling will be performed at baseline and at the end of the 7-day intervention. Glucose levels will be measured on each sample. Mean glucose level for all baseline samples will be calculated for each participant. Mean glucose levels for all samples collected at the end of the intervention will be calculated. Change in mean glucose level from baseline to end of intervention will be calculated for each participant.
after 1 week of CPAP therapy in the laboratory
Change From Baseline in Mean Glucose From Continuous Interstitial Glucose Monitoring Over 36-40 Hours
Continuous Glucose monitoring will provide interstitial glucose levels for 36-40 hours at baseline and after one week of active or sham CPAP therapy. The mean glucose level of all samples collected at baseline will be calculated for each participant. The mean glucose level of all samples collected at the end of the 7-day intervention will be calculated for each participant. For each participant, we will calculate the change in mean glucose level from baseline till end of the intervention.
change in mean interstitial glucose after 1 week of active or sham CPAP therapy in the laboratory
Change in Mean Serum Insulin Derived From 24 Hour Blood Sampling
Serum insulin levels will be measured on each sample collected during 24-h sampling at baseline and at the end of the 7-day intervention. Mean insulin level over 24 hours will be calculated for each participant at baseline and at the end of the intervention. For each participant, we will calculate the change in mean insulin level from baseline.
after 1 week of therapy in the laboratory
Secondary Outcomes (3)
Change in Mean Plasma Cortisol Level From 24-h Sampling
after 1 week of active CPAP therapy in the laboratory
24-hr Profile of Plasma Growth Hormone
after 1 week of active CPAP therapy in the laboratory
Change in 24-h Mean Level of Plasma Norepinephrine
after 1 week of active CPAP therapy in the laboratory
Study Arms (2)
Active CPAP therapy
ACTIVE COMPARATOR7 days of treatment in the laboratory with active CPAP therapy.
Sham CPAP therapy
SHAM COMPARATOR7 days of sham CPAP therapy in the laboratory.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Chicago
Chicago, Illinois, 60637, United States
Related Publications (2)
Mokhlesi B, Grimaldi D, Beccuti G, Van Cauter E. Effect of one week of CPAP treatment of obstructive sleep apnoea on 24-hour profiles of glucose, insulin and counter-regulatory hormones in type 2 diabetes. Diabetes Obes Metab. 2017 Mar;19(3):452-456. doi: 10.1111/dom.12823. Epub 2016 Dec 12.
PMID: 27860160BACKGROUNDMokhlesi 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 Study. Am J Respir Crit Care Med. 2016 Aug 15;194(4):516-9. doi: 10.1164/rccm.201602-0396LE. No abstract available.
PMID: 27525461RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
One limitation of the study is that two subjects assigned to sham CPAP received defective sham devices that delivered therapeutic pressure.
Results Point of Contact
- Title
- Dr. Eve Van Cauter/Dr. Babak Mokhlesi
- Organization
- The University of Chicago
Study Officials
- PRINCIPAL INVESTIGATOR
Eve Van Cauter, PhD
University of Chicago
- PRINCIPAL INVESTIGATOR
Babak Mokhlesi, MD
University of Chicago
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2010
First Posted
June 3, 2010
Study Start
November 1, 2009
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
April 10, 2017
Results First Posted
April 10, 2017
Record last verified: 2017-02