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

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The University of Chicago

Status

Completed

Conditions

Type 2 Diabetes
Obstructive Sleep Apnea

Treatments

Device: sham CPAP therapy
Device: active CPAP Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01136785
14-0547

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

22 participants in 2 patient groups

Active CPAP therapy
Active Comparator group
Description:
7 days of treatment in the laboratory with active CPAP therapy.
Treatment:
Device: active CPAP Therapy
Sham CPAP therapy
Sham Comparator group
Description:
7 days of sham CPAP therapy in the laboratory.
Treatment:
Device: sham CPAP therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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