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Although obstructive sleep apnea (OSA) is associated with impaired glucose tolerance and diabetes, it remains unclear whether OSA treatment with continuous positive airway pressure (CPAP) has metabolic benefits. The objective of this study is to determine the effect of 8-hour nightly CPAP treatment on glucose metabolism in individuals with prediabetes and OSA.
Although obstructive sleep apnea (OSA) is associated with impaired glucose tolerance and diabetes, it remains unclear whether OSA treatment with continuous positive airway pressure (CPAP) has metabolic benefits. To determine the effect of 8-hour nightly CPAP treatment on glucose metabolism in individuals with prediabetes and OSA. In a randomized, controlled parallel group study, 39 participants were randomized (2:1) to receive either 8-hour nightly CPAP (n=26) or oral placebo (n=13). Sleep was polysomnographically recorded in the laboratory on each night. CPAP adherence was ensured by continuous supervision. Participants continued their daily daytime routine activities outside the laboratory. Glucose metabolism was assessed at baseline and after 2-weeks of assigned treatment using both the oral and intravenous glucose tolerance tests (OGTT and ivGTT, respectively). The primary outcome was the overall glucose response as quantified by the area under the curve for glucose during 2-hour oral glucose tolerance testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous positive airway pressure | Active Comparator | 2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night |
|
| Placebo | Placebo Comparator | 2 weeks of oral administration of a placebo tablet 30min before bedtime |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP mask | Device | The subjects who are randomized to CPAP treatment will undergo an overnight CPAP titration in the laboratory, which will be performed manually by a registered technician according to American Academy of Sleep Medicine (AASM) guidelines .Subjects will be admitted in the early evening and will receive positive airway pressure education, hands on demonstration, careful mask fitting and acclimatization prior to titration. The goal during the titration will be to determine the optimal CPAP pressure setting that eliminates obstructive respiratory events, restore oxygen saturations and sleep continuity. ________________________________________ |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Area Under the Curve (AUC) Glucose at Week 2 | The area under the glucose time curve, between 0 and 120 minutes of the OGTT, was calculated for each patient using the trapezoidal rule . Change = Week 2 - Baseline. | Baseline and Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Insulin Sensitivity (SI) at Week 2 | SI is estimated from modeling of the insulin and glucose values during the intravenous glucose tolerance test (ivGTT). Change = Week 2 - Baseline. | Baseline and Week 2 |
| Change From Baseline in 24-hr Systolic Blood Pressure (mmHg) at Week 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esra Tasali, 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 |
|---|---|---|---|
| 32998624 | Derived | Pamidi S, Chapotot F, Wroblewski K, Whitmore H, Polonsky T, Tasali E. Optimal Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea Reduces Daytime Resting Heart Rate in Prediabetes: A Randomized Controlled Study. J Am Heart Assoc. 2020 Oct 20;9(19):e016871. doi: 10.1161/JAHA.120.016871. Epub 2020 Oct 1. | |
| 25897569 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuous Positive Airway Pressure | 2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night |
| FG001 | Placebo | 2 weeks of oral administration of a placebo tablet 30min before bedtime |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Continuous Positive Airway Pressure | 2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night |
| BG001 | Placebo |
| 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 in Area Under the Curve (AUC) Glucose at Week 2 | The area under the glucose time curve, between 0 and 120 minutes of the OGTT, was calculated for each patient using the trapezoidal rule . Change = Week 2 - Baseline. | One patient in the Placebo group who withdrew prior to any testing was excluded from the analysis. | Posted | Mean | 95% Confidence Interval | (mg/dL)*min | Baseline and Week 2 |
|
2 weeks
Only treatment related adverse events were collected.
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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 | Continuous Positive Airway Pressure | 2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Esra Tasali | University of Chicago | 773-702-1497 | etasali@medicine.bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
|
| Placebo | Drug | oral placebo tablet |
|
The average systolic blood pressure measured over a 24-hr period was calculated for each patient. Change = Week 2 - Baseline. |
| Baseline and Week 2 |
| Change From Baseline in 24-hr Diastolic Blood Pressure (mmHg) at Week 2 | The average diastolic blood pressure over a 24-hr period was calculated for each patient. Change = Week 2 - Baseline | Baseline and Week 2 |
| Pamidi S, Wroblewski K, Stepien M, Sharif-Sidi K, Kilkus J, Whitmore H, Tasali E. Eight Hours of Nightly Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea Improves Glucose Metabolism in Patients with Prediabetes. A Randomized Controlled Trial. Am J Respir Crit Care Med. 2015 Jul 1;192(1):96-105. doi: 10.1164/rccm.201408-1564OC. |
2 weeks of oral administration of a placebo tablet 30min before bedtime
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Change From Baseline in Insulin Sensitivity (SI) at Week 2 | SI is estimated from modeling of the insulin and glucose values during the intravenous glucose tolerance test (ivGTT). Change = Week 2 - Baseline. | One patient from each group was excluded from the analysis since they were missing SI data at both Baseline and Week 2. | Posted | Mean | 95% Confidence Interval | [mU/L]^-1·[min]^-1 | Baseline and Week 2 |
|
|
|
|
| Secondary | Change From Baseline in 24-hr Systolic Blood Pressure (mmHg) at Week 2 | The average systolic blood pressure measured over a 24-hr period was calculated for each patient. Change = Week 2 - Baseline. | Patients were excluded from the analysis if they were missing blood pressure data at both Baseline and Week 2. | Posted | Mean | 95% Confidence Interval | mmHg | Baseline and Week 2 |
|
|
|
|
| Secondary | Change From Baseline in 24-hr Diastolic Blood Pressure (mmHg) at Week 2 | The average diastolic blood pressure over a 24-hr period was calculated for each patient. Change = Week 2 - Baseline | Patients were excluded from the analysis if they were missing blood pressure data at both Baseline and Week 2. | Posted | Mean | 95% Confidence Interval | mmHg | Baseline and Week 2 |
|
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Placebo | 2 weeks of oral administration of a placebo tablet 30min before bedtime | 0 | 13 | 0 | 13 |
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| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |