Effect of Liraglutide vs CPAP on Cardiometabolic Outcomes in Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive
• Interventions: Combination Product: Liraglutide and CPAP; Device: Continuous positive airway pressure treatment; Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml

• Registration Number: NCT04186494
• Lead Sponsor: St Vincent's University Hospital, Ireland

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-02
• Study First Submitted: 2019-12-02
• Study First Submitted QC: 2019-12-02
• Study First Posted: 2019-12-04
• Primary Completion: 2021-12-31
• Study Completion: 2022-07-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-15
• Last Update Posted: 2023-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Newly diagnosed moderate-severe OSA (by standard PSG)
• Body mass index between 30 - 40
• Age 18 - 60 years
• Able to provide written, informed consent

Exclusion Criteria

• Pregnancy
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination CPAP/Liraglutide	Liraglutide and CPAP	Combination of both interventions
Continuous positive airway pressure (CPAP)	Continuous positive airway pressure treatment	Standard CPAP Therapy
Liraglutide-based weight loss regimen	Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml	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

Primary Outcome Measures

Name	Time	Method
Insulin resistance	6 months	Improvement in insulin resistance defined by HOMA-IR

Secondary Outcome Measures

Name	Time	Method
Weight	6 months	Change in body mass index
Glucose tolerance	6 months	Change in glucose tolerance measured by oral glucose tolerance test
Endothelial function	6 months	Change in microvascular endothelial function measured by EndoPat
OSA Severity	6 months	Change in apnea/hypopnea index as per polysomnography
Blood pressure	6 months	Change in 24-hour blood pressure
Coronary artery calcification	6 months	Change in coronary artery calcification score determined by Coronary artery CT
Vascular inflammation	6 months	Change in vascular inflammation determined via FDG-PET scan

Trial Locations

Locations (1)

St Vincent's University Hospital; 🇮🇪 Dublin, Dublin 4, Ireland