Effect of Liraglutide vs CPAP on Cardiometabolic Outcomes in Obstructive Sleep Apnea
NCT ID: NCT04186494
Last Updated: 2023-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2019-12-02
2022-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Continuous positive airway pressure (CPAP)
Standard CPAP Therapy
Continuous positive airway pressure treatment
Gold standard treatment for obstructive sleep apnea
Liraglutide-based weight loss regimen
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
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml
GLP-1 analogue treatment in combination with advice on diet and physical exercise
Combination CPAP/Liraglutide
Combination of both interventions
Liraglutide and CPAP
Combination of both treatments
Interventions
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Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml
GLP-1 analogue treatment in combination with advice on diet and physical exercise
Continuous positive airway pressure treatment
Gold standard treatment for obstructive sleep apnea
Liraglutide and CPAP
Combination of both treatments
Eligibility Criteria
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Inclusion Criteria
* Body mass index between 30 - 40
* Age 18 - 60 years
* Able to provide written, informed consent
Exclusion Criteria
* Requirement for supplemental oxygen
* Previous diagnosis of OSA or previous CPAP treatment
* Diagnosis of Diabetes
* Previous treatment with GLP-1 analogue
* Previous surgical treatment for obesity
* Active treatment for malignancy or severe psychiatric disorder
* Acute coronary syndrome or stroke within 3 months prior to study
* History of decompensated heart failure
* Professional drivers or drivers with a history of road-traffic accident due to sleepiness
* Severe excessive daytime sleepiness defined as Epworth sleepiness scale \>15
18 Years
60 Years
ALL
No
Sponsors
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University College Dublin
OTHER
Health Research Board, Ireland
OTHER
St Vincent's University Hospital, Ireland
OTHER
Responsible Party
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Dr Silke Ryan
Associate Professor, Consultant in Respiratory and Sleep Medicine
Principal Investigators
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Silke Ryan, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
St Vincent's University Hospital, University College Dublin
Locations
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St Vincent's University Hospital
Dublin, Dublin 4, Ireland
Countries
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References
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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.
Other Identifiers
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RS19-023
Identifier Type: -
Identifier Source: org_study_id