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Completed

NCT Number: NCT01136785

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Diabetes Mellitus Diabetes Mellitus, Type 2 Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Type 2 Diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Chicago

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

active CPAP Therapy

Device

7 days of active CPAP therapy

sham CPAP therapy

Device

7 days of sham CPAP therapy

Primary outcomes

  1. 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.

  2. 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.

  3. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Acronym: CPAP

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Jun 3, 2010
Registry last updated
Apr 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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