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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active CPAP therapy | Active Comparator | 7 days of treatment in the laboratory with active CPAP therapy. |
|
| Sham CPAP therapy | Sham Comparator | 7 days of sham CPAP therapy in the laboratory. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active CPAP Therapy | Device | 7 days of active CPAP therapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | after 1 week of therapy in the laboratory |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eve Van Cauter, PhD | University of Chicago | Principal Investigator |
| Babak Mokhlesi, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27860160 | Background | 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. | |
| 27525461 | Result |
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In a 2:1 ratio (2 active CPAP: 1 sham CPAP), 22 eligible subjects who had completed baseline assessments underwent 1 week of in-laboratory active CPAP or sham CPAP therapy and completed the post-treatment assessments. Two subjects assigned to the CPAP group and one subject assigned to the sham group were excluded for protocol violations.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active CPAP | 7 days of treatment in the laboratory with active CPAP. Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea |
| FG001 | Sham CPAP | 7 days of sham CPAP in the laboratory. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
In a 2:1 ratio (2 active CPAP: 1 sham CPAP), 22 eligible subjects who had completed baseline assessments underwent 1 week of in-laboratory active CPAP or sham CPAP therapy and completed the post-treatment assessments. Two subjects assigned to the CPAP group and one subject assigned to the sham group were excluded for protocol violations.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active CPAP | 7 days of treatment in the laboratory with active CPAP. Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea |
| BG001 | Sham CPAP |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | mg/dl | after 1 week of CPAP therapy in the laboratory |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active CPAP | 7 days of treatment in the laboratory with active CPAP. Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea |
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One limitation of the study is that two subjects assigned to sham CPAP received defective sham devices that delivered therapeutic pressure.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eve Van Cauter/Dr. Babak Mokhlesi | The University of Chicago | 773-702-0169 or 773-702-2181 | evcauter@medicine.bsd.uchicago.edu; bmokhles@medicine.bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| sham CPAP therapy |
| Device |
7 days of sham CPAP therapy |
|
| 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. | 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. | after 1 week of active CPAP therapy in the laboratory |
| 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. |
7 days of sham CPAP in the laboratory.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Sham CPAP |
7 days of sham CPAP in the laboratory. |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Error | mg/dL | change in mean interstitial glucose after 1 week of active or sham CPAP therapy in the laboratory |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Error | pmol/L | after 1 week of therapy in the laboratory |
|
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | microgram/dL | after 1 week of active CPAP therapy in the laboratory |
|
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | ng/ml | after 1 week of active CPAP therapy in the laboratory |
|
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | pg/ml | after 1 week of active CPAP therapy in the laboratory |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Sham CPAP | 7 days of sham CPAP in the laboratory. | 0 | 7 | 0 | 7 | 0 | 7 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |