Obstructive Sleep ApneaCPAPNCT01136785

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

A study testing active CPAP Therapy in people with Obstructive Sleep Apnea and Type 2 Diabetes, run by University of Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Obstructive Sleep Apnea, Type 2 Diabetes
What is being tested?: active CPAP Therapy
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: 1 siteUnited States
Study dates: Nov 2009to Aug 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 9Show fewer

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 locations and contacts

1 site in 1 country.

United States1 site

The University of Chicago
Chicago, Illinois, 60637

Other trials in United States

About this study

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.

Conditions: Obstructive Sleep Apnea, Type 2 Diabetes
Being tested: active CPAP Therapy, sham CPAP therapy
Medical subject headings: Sleep Apnea, Obstructive, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

active CPAP TherapyDevice
7 days of active CPAP therapy
sham CPAP therapyDevice
7 days of sham CPAP therapy

Study groups in NCT01136785
Study group	Role	What they receive
Active CPAP therapy	Active comparator	7 days of treatment in the laboratory with active CPAP therapy. Receives: Device: active CPAP Therapy
Sham CPAP therapy	Sham comparator	7 days of sham CPAP therapy in the laboratory. Receives: Device: sham CPAP therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to End of 7-day Intervention in Mean Plasma Glucose Derived From 24 Hour Blood Sampling
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.
Measured: after 1 week of CPAP therapy in the laboratory
Change From Baseline in Mean Glucose From Continuous Interstitial Glucose Monitoring Over 36-40 Hours
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.
Measured: change in mean interstitial glucose after 1 week of active or sham CPAP therapy in the laboratory
Change in Mean Serum Insulin Derived From 24 Hour Blood Sampling
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.
Measured: after 1 week of therapy in the laboratory

Secondary outcomes (3)

Change in Mean Plasma Cortisol Level From 24-h Sampling
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.
Measured: after 1 week of active CPAP therapy in the laboratory
24-hr Profile of Plasma Growth Hormone
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.
Measured: after 1 week of active CPAP therapy in the laboratory
Change in 24-h Mean Level of Plasma Norepinephrine
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.
Measured: after 1 week of active CPAP therapy in the laboratory

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009Aug 2015

First posted3 Jun 2010 (estimated)
Study startNov 2009
Primary completionAug 2015
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
More trials run by University of ChicagoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01136785
Sponsor's protocol ID: 14-0547
Acronym: CPAP
Status last verified: Feb 2017
First submitted: 13 Apr 2010
Last updated: 10 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 27860160
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.
PubMed 27525461

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

All Obstructive Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Continuous Positive Airway Pressure (CPAP) Treatment on Glucose Control in Patients With Type 2 Diabetes
ClinicalTrials.gov ID: NCT01136785
Acronym / sponsor ID: CPAP / 14-0547
Conditions: Obstructive Sleep Apnea, Type 2 Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: University of ChicagoUniversity, hospital or other
Study start: Nov 2009
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 3 Jun 2010 (estimated)
Results: Posted 10 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Active CPAP therapy	Active comparator	Device: active CPAP Therapy7 days of treatment in the laboratory with active CPAP therapy.
Sham CPAP therapy	Sham comparator	Device: sham CPAP therapy7 days of sham CPAP therapy in the laboratory.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
active CPAP Therapy7 days of active CPAP therapy	Device	Active CPAP therapy
sham CPAP therapy7 days of sham CPAP therapy	Device	Sham CPAP therapy

Primary outcome

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.

3 secondary outcomes

Change in Mean Plasma Cortisol Level From 24-h Sampling
Time frame: after 1 week of active CPAP therapy in the laboratory
24-hr Profile of Plasma Growth Hormone
Time frame: after 1 week of active CPAP therapy in the laboratory
Change in 24-h Mean Level of Plasma Norepinephrine
Time frame: after 1 week of active CPAP therapy in the laboratory

Results and safety

Results posted to the registry on 10 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active CPAP	15	13
Sham CPAP	7	6

Primary outcome: 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. Mean (Standard Error). Unit: mg/dl

Measure	Active CPAP n = 13	Sham CPAP n = 6
Value	-13.7 (3.6)	-2.9 (1.4)

Active CPAP vs Sham CPAP: p = 0.01, t-test, 2 sided

Primary outcome: 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. Mean (Standard Error). Unit: mg/dL

Measure	Active CPAP n = 10	Sham CPAP n = 4
Value	-12.4 (3.9)	1.5 (2.2)

Sham CPAP: p = 0.011, 2-sided Paired t-test

Population analysed: Due to sensor failures, valid profiles of interstitial glucose were available in 10 participants with the active CPAP group and 4 participants in the sham CPAP group.

Primary outcome: Change in Mean Serum Insulin Derived From 24 Hour Blood Sampling

Time frame: after 1 week of therapy in the laboratory. Mean (Standard Error). Unit: pmol/L

Measure	Active CPAP n = 13	CPAP n = 6
Value	-25.8 (16.5)	28.4 (21.6)

Active CPAP vs CPAP: p = 0.071, t-test, 2 sided

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active CPAP	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Sham CPAP	0 of 7 (0%)	0 of 7 (0%)	0 of 7

Limitations and caveats (from the sponsor): One limitation of the study is that two subjects assigned to sham CPAP received defective sham devices that delivered therapeutic pressure.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27860160Mokhlesi 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.
Results publication: PubMed 27525461Mokhlesi 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.

Related trials for Obstructive Sleep Apnea

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eve Van Cauter, PhD principal investigator

University of Chicago

Babak Mokhlesi, MD principal investigator

University of Chicago

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing active CPAP Therapy in people with Obstructive Sleep Apnea and Type 2 Diabetes, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01136785, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2017.