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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01136785
First Posted: June 3, 2010
Last Update Posted: April 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Chicago
  Purpose
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.

Condition Intervention
Obstructive Sleep Apnea Type 2 Diabetes Device: active CPAP Therapy Device: sham CPAP therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Continuous Positive Airway Pressure (CPAP) Treatment on Glucose Control in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Change From Baseline to End of 7-day Intervention in Mean Plasma Glucose Derived From 24 Hour Blood Sampling [ Time Frame: after 1 week of CPAP therapy in the laboratory ]
    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.

  • Change From Baseline in Mean Glucose From Continuous Interstitial Glucose Monitoring Over 36-40 Hours [ Time Frame: change in mean interstitial glucose after 1 week of active or sham CPAP therapy in the laboratory ]
    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 Serum Insulin Derived From 24 Hour Blood Sampling [ Time Frame: after 1 week of therapy in the laboratory ]
    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.


Secondary Outcome Measures:
  • Change in Mean Plasma Cortisol Level From 24-h Sampling [ Time Frame: after 1 week of active CPAP therapy in the laboratory ]
    The mean plasma cortisol level will be calculated for all samples collected at baseline and for all samples collected at the end of the intervention in participants randomized to the active CPAP arm. The goal of the analysis of cortisol, growth hormone and norepinephrine levels was to explore putative mechanisms underlying the effects of active CPAP therapy. Examining putative hormonal mechanisms underlying changes in glucose levels in the sham CPAP arm was not part of our aims. For each participant, the change in mean cortisol level from baseline to end of intervention will be calculated.

  • 24-hr Profile of Plasma Growth Hormone [ Time Frame: after 1 week of active CPAP therapy in the laboratory ]
    The mean plasma growth hormone level will be calculated for all samples collected at baseline and for all samples collected at the end of the intervention in participants randomized to the active CPAP arm. The goal of the analysis of cortisol, growth hormone and norepinephrine levels was to explore putative mechanisms underlying the effects of active CPAP therapy. Examining putative hormonal mechanisms underlying changes in glucose levels in the sham CPAP arm was not part of our aims. For each participant, the change in mean cortisol level from baseline to end of intervention will be calculated.

  • Change in 24-h Mean Level of Plasma Norepinephrine [ Time Frame: after 1 week of active CPAP therapy in the laboratory ]
    The mean plasma norepinephrine level will be calculated for all samples collected at baseline and for all samples collected at the end of the intervention in participants randomized to the active CPAP arm. The goal of the analysis of cortisol, growth hormone and norepinephrine levels was to explore putative mechanisms underlying the effects of active CPAP therapy. Examining putative hormonal mechanisms underlying changes in glucose levels in the sham CPAP arm was not part of our aims. For each participant, the change in mean norepinephine level from baseline to end of intervention will be calculated.


Enrollment: 22
Study Start Date: November 2009
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active CPAP therapy
7 days of treatment in the laboratory with active CPAP therapy.
Device: active CPAP Therapy
7 days of active CPAP therapy
Sham Comparator: Sham CPAP therapy
7 days of sham CPAP therapy in the laboratory.
Device: sham CPAP therapy
7 days of sham CPAP therapy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01136785


Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Eve Van Cauter, PhD University of Chicago
Principal Investigator: Babak Mokhlesi, MD University of Chicago
  More Information

Publications:
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01136785     History of Changes
Other Study ID Numbers: 14-0547
First Submitted: April 13, 2010
First Posted: June 3, 2010
Results First Submitted: December 22, 2016
Results First Posted: April 10, 2017
Last Update Posted: April 10, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Sleep Apnea, Obstructive
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases