Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-01-07 @ 6:55 PM
Study NCT ID:
NCT04186494
Status:
COMPLETED
Last Update Posted:
2023-12-18
First Post:
2019-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Liraglutide vs CPAP on Cardiometabolic Outcomes in Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069450', 'term': 'Liraglutide'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-15', 'studyFirstSubmitDate': '2019-12-02', 'studyFirstSubmitQcDate': '2019-12-02', 'lastUpdatePostDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin resistance', 'timeFrame': '6 months', 'description': 'Improvement in insulin resistance defined by HOMA-IR'}], 'secondaryOutcomes': [{'measure': 'Weight', 'timeFrame': '6 months', 'description': 'Change in body mass index'}, {'measure': 'Glucose tolerance', 'timeFrame': '6 months', 'description': 'Change in glucose tolerance measured by oral glucose tolerance test'}, {'measure': 'OSA Severity', 'timeFrame': '6 months', 'description': 'Change in apnea/hypopnea index as per polysomnography'}, {'measure': 'Blood pressure', 'timeFrame': '6 months', 'description': 'Change in 24-hour blood pressure'}, {'measure': 'Endothelial function', 'timeFrame': '6 months', 'description': 'Change in microvascular endothelial function measured by EndoPat'}, {'measure': 'Coronary artery calcification', 'timeFrame': '6 months', 'description': 'Change in coronary artery calcification score determined by Coronary artery CT'}, {'measure': 'Vascular inflammation', 'timeFrame': '6 months', 'description': 'Change in vascular inflammation determined via FDG-PET scan'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Liraglutide', 'Continuous positive airway pressure', 'Insulin resistance', 'Vascular inflammation'], 'conditions': ['Sleep Apnea, Obstructive']}, 'referencesModule': {'references': [{'pmid': '38096106', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed moderate-severe OSA (by standard PSG)\n* Body mass index between 30 - 40\n* Age 18 - 60 years\n* Able to provide written, informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Requirement for supplemental oxygen\n* Previous diagnosis of OSA or previous CPAP treatment\n* Diagnosis of Diabetes\n* Previous treatment with GLP-1 analogue\n* Previous surgical treatment for obesity\n* Active treatment for malignancy or severe psychiatric disorder\n* Acute coronary syndrome or stroke within 3 months prior to study\n* History of decompensated heart failure\n* Professional drivers or drivers with a history of road-traffic accident due to sleepiness\n* Severe excessive daytime sleepiness defined as Epworth sleepiness scale \\>15'}, 'identificationModule': {'nctId': 'NCT04186494', 'briefTitle': 'Effect of Liraglutide vs CPAP on Cardiometabolic Outcomes in Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': "St Vincent's University Hospital, Ireland"}, 'officialTitle': 'The Benefit of a Liraglutide-based Weight Management Alone or in Addition to Standard CPAP Therapy on Metabolic Function in Patients With Obstructive Sleep Apnoea (OSA) - an Explorative, Proof-of-concept Study', 'orgStudyIdInfo': {'id': 'RS19-023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous positive airway pressure (CPAP)', 'description': 'Standard CPAP Therapy', 'interventionNames': ['Device: Continuous positive airway pressure treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Liraglutide-based weight loss regimen', 'description': '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', 'interventionNames': ['Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml']}, {'type': 'EXPERIMENTAL', 'label': 'Combination CPAP/Liraglutide', 'description': 'Combination of both interventions', 'interventionNames': ['Combination Product: Liraglutide and CPAP']}], 'interventions': [{'name': 'Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml', 'type': 'DRUG', 'description': 'GLP-1 analogue treatment in combination with advice on diet and physical exercise', 'armGroupLabels': ['Liraglutide-based weight loss regimen']}, {'name': 'Continuous positive airway pressure treatment', 'type': 'DEVICE', 'description': 'Gold standard treatment for obstructive sleep apnea', 'armGroupLabels': ['Continuous positive airway pressure (CPAP)']}, {'name': 'Liraglutide and CPAP', 'type': 'COMBINATION_PRODUCT', 'description': 'Combination of both treatments', 'armGroupLabels': ['Combination CPAP/Liraglutide']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dublin', 'state': 'Dublin 4', 'country': 'Ireland', 'facility': "St Vincent's University Hospital", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}], 'overallOfficials': [{'name': 'Silke Ryan, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St Vincent's University Hospital, University College Dublin"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St Vincent's University Hospital, Ireland", 'class': 'OTHER'}, 'collaborators': [{'name': 'University College Dublin', 'class': 'OTHER'}, {'name': 'Health Research Board, Ireland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Consultant in Respiratory and Sleep Medicine', 'investigatorFullName': 'Dr Silke Ryan', 'investigatorAffiliation': "St Vincent's University Hospital, Ireland"}}}}