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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml
* Device: Continuous positive airway pressure treatment
* Combination Product: Liraglutide and CPAP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous positive airway pressure (CPAP)<br>Standard CPAP Therapy | Device: Continuous positive airway pressure treatment<br>* Gold standard treatment for obstructive sleep apnea<br>|
| Experimental: Liraglutide-based weight loss regimen<br>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 | Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml<br>* GLP-1 analogue treatment in combination with advice on diet and physical exercise<br>|
| Experimental: Combination CPAP/Liraglutide<br>Combination of both interventions | Combination Product: Liraglutide and CPAP<br>* Combination of both treatments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance | Improvement in insulin resistance defined by HOMA-IR | 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liraglutide, Continuous positive airway pressure, Insulin resistance, Vascular inflammation