Effects of Continuous Positive Airway Pressure (CPAP) Treatment on Glucose Control in Patients With Type 2 Diabetes
CPAP
CPAP
Sponsor study identifier
interventional
22
1 country
1
Study Start
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2015
Actual (reported)Study Completion
August 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
April 13, 2010
Actual (reported)June 3, 2010
Actual (reported)August 2015
Actual (reported)August 2015
Actual (reported)April 10, 2017
Actual (reported)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
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
7 days of treatment in the laboratory with active CPAP therapy.
7 days of sham CPAP therapy in the laboratory.
7 days of active CPAP therapy
7 days of sham CPAP therapy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The University of Chicago
Chicago, Illinois, 60637, United States
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.
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 Study. Am J Respir Crit Care Med. 2016 Aug 15;194(4):516-9. doi: 10.1164/rccm.201602-0396LE. No abstract available.
One limitation of the study is that two subjects assigned to sham CPAP received defective sham devices that delivered therapeutic pressure.
Eve Van Cauter, PhD
University of Chicago
Babak Mokhlesi, MD
University of Chicago
22 participants (actual enrollment reported by the registry).
First Submitted
April 13, 2010
First Posted
June 3, 2010
Study Start
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
Screening for Obstructive Sleep Apnea in High-risk Patients in a Danish Rural Population: A Pilot Feasibility Study
Contact the study team to confirm eligibility.
Primary Completion
August 2015
Actual (reported)Study Completion
August 2015
Actual (reported)Last Updated
April 10, 2017
Results First Posted
April 10, 2017
Record last verified: 2017-02
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Source: ClinicalTrials.gov.
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