Sleep Apnea, Obstructive
Conditions
Keywords
Liraglutide, Continuous positive airway pressure, Insulin resistance, Vascular inflammation
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
Interventions
GLP-1 analogue treatment in combination with advice on diet and physical exercise
Gold standard treatment for obstructive sleep apnea
Combination of both treatments
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin resistance | 6 months | Improvement in insulin resistance defined by HOMA-IR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose tolerance | 6 months | Change in glucose tolerance measured by oral glucose tolerance test |
| OSA Severity | 6 months | Change in apnea/hypopnea index as per polysomnography |
| Blood pressure | 6 months | Change in 24-hour blood pressure |
| Weight | 6 months | Change in body mass index |
| 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 |
| Endothelial function | 6 months | Change in microvascular endothelial function measured by EndoPat |
Countries
Ireland