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

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04186494
• Other study ID #: RS19-023
• Status: Completed
• Phase: N/A
• Start date: December 2, 2019
• Est. completion date: July 31, 2022

Study information

• Verified date: December 2023
• Source: St Vincent's University Hospital, Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml
GLP-1 analogue treatment in combination with advice on diet and physical exercise

Device:
• Continuous positive airway pressure treatment
Gold standard treatment for obstructive sleep apnea

Combination Product:
• Liraglutide and CPAP
Combination of both treatments

Locations

Country	Name	City	State
Ireland	St Vincent's University Hospital	Dublin	Dublin 4

Sponsors (3)

Lead Sponsor	Collaborator
St Vincent's University Hospital, Ireland	Health Research Board, Ireland, University College Dublin

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin resistance	Improvement in insulin resistance defined by HOMA-IR	6 months
Secondary	Weight	Change in body mass index	6 months
Secondary	Glucose tolerance	Change in glucose tolerance measured by oral glucose tolerance test	6 months
Secondary	OSA Severity	Change in apnea/hypopnea index as per polysomnography	6 months
Secondary	Blood pressure	Change in 24-hour blood pressure	6 months
Secondary	Endothelial function	Change in microvascular endothelial function measured by EndoPat	6 months
Secondary	Coronary artery calcification	Change in coronary artery calcification score determined by Coronary artery CT	6 months
Secondary	Vascular inflammation	Change in vascular inflammation determined via FDG-PET scan	6 months