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| Name | Class |
|---|---|
| University College Dublin | OTHER |
| Health Research Board, Ireland | OTHER |
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This is an explorative, proof-of-concept study exploring the potential therapeutic role of a Liraglutide-based weight loss regimen versus standard CPAP or the combination of both on metabolic parameters, blood pressure, endothelial function, coronary artery calcification, vascular inflammation and apnea/hypopnea index in non-diabetic patients with moderate to severe obstructive sleep apnea
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous positive airway pressure (CPAP) | Active Comparator | Standard CPAP Therapy |
|
| Liraglutide-based weight loss regimen | Experimental | Once daily s.c. injections of Liraglutide, starting at a dose of 0.6 mg with weekly 0.6 mg increments to 3.0 mg in adjunct to advice on a weight-reduction diet and physical exercise |
|
| Combination CPAP/Liraglutide | Experimental | Combination of both interventions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml | Drug | GLP-1 analogue treatment in combination with advice on diet and physical exercise |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin resistance | Improvement in insulin resistance defined by HOMA-IR | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Change in body mass index | 6 months |
| Glucose tolerance | Change in glucose tolerance measured by oral glucose tolerance test | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Silke Ryan, PhD, MD | St Vincent's University Hospital, University College Dublin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Vincent's University Hospital | Dublin | Dublin 4 | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38096106 | Derived | O'Donnell C, Crilly S, O'Mahony A, O'Riordan B, Traynor M, Gitau R, McDonald K, Ledwidge M, O'Shea D, Murphy DJ, Dodd JD, Ryan S. Continuous Positive Airway Pressure but Not GLP1-mediated Weight Loss Improves Early Cardiovascular Disease in Obstructive Sleep Apnea: A Randomized Proof-of-Concept Study. Ann Am Thorac Soc. 2024 Mar;21(3):464-473. doi: 10.1513/AnnalsATS.202309-821OC. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| Continuous positive airway pressure treatment | Device | Gold standard treatment for obstructive sleep apnea |
|
| Liraglutide and CPAP | Combination Product | Combination of both treatments |
|
| OSA Severity | Change in apnea/hypopnea index as per polysomnography | 6 months |
| Blood pressure | Change in 24-hour blood pressure | 6 months |
| Endothelial function | Change in microvascular endothelial function measured by EndoPat | 6 months |
| Coronary artery calcification | Change in coronary artery calcification score determined by Coronary artery CT | 6 months |
| Vascular inflammation | Change in vascular inflammation determined via FDG-PET scan | 6 months |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |