Clinical trial NCT01136785: Effects of Continuous Positive Airway Pressure (CPAP) Treatment on Glucose Control in Patients With Type 2 Diabetes
Official title: Effects of Continuous Positive Airway Pressure (CPAP) Treatment on Glucose Control in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Type 2 Diabetes
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2010-06-03
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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) 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.

Primary outcomes:
measure: Change From Baseline to End of 7-day Intervention in Mean Plasma Glucose Derived From 24 Hour Blood Sampling
timeFrame: after 1 week of CPAP therapy in the laboratory
measure: Change From Baseline in Mean Glucose From Continuous Interstitial Glucose Monitoring Over 36-40 Hours
timeFrame: change in mean interstitial glucose after 1 week of active or sham CPAP therapy in the laboratory
measure: Change in Mean Serum Insulin Derived From 24 Hour Blood Sampling
timeFrame: after 1 week of therapy in the laboratory
Secondary outcomes:
measure: Change in Mean Plasma Cortisol Level From 24-h Sampling
timeFrame: after 1 week of active CPAP therapy in the laboratory
measure: 24-hr Profile of Plasma Growth Hormone
timeFrame: after 1 week of active CPAP therapy in the laboratory
measure: Change in 24-h Mean Level of Plasma Norepinephrine
timeFrame: after 1 week of active CPAP therapy in the laboratory
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Eve Van Cauter, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Babak Mokhlesi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.