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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04186494
Enrollment
30
Registered
2019-12-04
Start date
2019-12-02
Completion date
2022-07-31
Last updated
2023-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea, Obstructive

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_PRODUCTLiraglutide and CPAP

Combination of both treatments

Sponsors

University College Dublin
CollaboratorOTHER
Health Research Board, Ireland
CollaboratorOTHER
St Vincent's University Hospital, Ireland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Insulin resistance6 monthsImprovement in insulin resistance defined by HOMA-IR

Secondary

MeasureTime frameDescription
Glucose tolerance6 monthsChange in glucose tolerance measured by oral glucose tolerance test
OSA Severity6 monthsChange in apnea/hypopnea index as per polysomnography
Blood pressure6 monthsChange in 24-hour blood pressure
Weight6 monthsChange in body mass index
Coronary artery calcification6 monthsChange in coronary artery calcification score determined by Coronary artery CT
Vascular inflammation6 monthsChange in vascular inflammation determined via FDG-PET scan
Endothelial function6 monthsChange in microvascular endothelial function measured by EndoPat

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026