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

NCT ID: NCT01136785

Last Updated: 2017-04-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Sleep Apnea Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Active CPAP therapy

7 days of treatment in the laboratory with active CPAP therapy.

Group Type ACTIVE_COMPARATOR

active CPAP Therapy

Intervention Type DEVICE

7 days of active CPAP therapy

Sham CPAP therapy

7 days of sham CPAP therapy in the laboratory.

Group Type SHAM_COMPARATOR

sham CPAP therapy

Intervention Type DEVICE

7 days of sham CPAP therapy

Interventions

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active CPAP Therapy

7 days of active CPAP therapy

Intervention Type DEVICE

sham CPAP therapy

7 days of sham CPAP therapy

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eve Van Cauter, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Babak Mokhlesi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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The University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 27860160 (View on PubMed)

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.

Reference Type RESULT
PMID: 27525461 (View on PubMed)

Other Identifiers

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14-0547

Identifier Type: -

Identifier Source: org_study_id

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