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

What Was Tested

This registered not phased trial tested Liraglutide for sleep apnea (obstructive).

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.

It had three arms (groups): Continuous positive airway pressure (CPAP) (active comparator), Liraglutide-based weight loss regimen (experimental) and Combination CPAP/Liraglutide (experimental).

Standard CPAP Therapy.

Combination of both interventions.

The registry classes the interventions as combination product, device and drug.

Who Took Part

Enrollment: 30 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Newly diagnosed moderate-severe OSA (by standard PSG). Body mass index between 30 - 40. Age 18 - 60 years. Able to provide written, informed consent.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: requirement for supplemental oxygen; previous diagnosis of osa or previous cpap treatment; diagnosis of diabetes.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the sleep apnea (obstructive) participants stayed in one arm throughout.

Only one side, usually the sleep apnea (obstructive) participants, was kept unaware of whether Liraglutide was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2019-12-02 with completion listed for 2021-12-31.

It ran at 1 site in Ireland.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Insulin resistance (time frame: 6 months).

It also tracked 7 secondary outcomes, for example Weight, Glucose tolerance, OSA Severity, Blood pressure, Endothelial function and Coronary artery calcification.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Liraglutide in 30 people with sleep apnea (obstructive).

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, Sleep apnea (obstructive) research.