Effects of Agonists of Glucagon Like Peptide - 1 Receptors (GLP-1R) on Arterial Stiffness, Endothelial Glycocalyx and Coronary Flow Reserve in Patients With Coronary Artery Disease and Patients With Diabetes Mellitus

What Was Tested

The trial (not phased) is built around Liraglutide.

Moreover, the integrity of endothelial glycocalyx plays a vital role in vascular permeability, inflammation and elasticity.

Agonists of Glucagon like peptide - 1 receptors (GLP-1R) used in the treatment of type 2 diabetes mellitus (T2DM).

It had two arms (groups): liraglutide (active comparator) and Metformin (active comparator).

The registry classes the interventions as drug.

More on the Plan

The investigators will study three groups matched for age and sex: 30 patients with type 2 diabetes mellitus (T2DM) without coronary artery disease (CAD), 30 patients with T2DM and CAD and 30 obese patients (BMI \>30 Kg/m²) with abnormal oral glucose tolerance test (OGTT).

It will be a randomized study with metformin or GLP-1R agonist treatment for 1 year.

All subjects will receive for 1 year: (a) GLP-1R agonist or (b) metformin.

At 0, 3, 6 and 12 months, where 0 is the starting point of treatment, blood samples will be collected.

Who Took Part

The registry lists 60 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Patients with type 2 diabetes mellitus (T2DM) without coronary artery disease (CAD). Patients with T2DM and CAD. Obese patients (BMI \>30 Kg/m²) with abnormal oral glucose tolerance test (OGTT).

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: valvular heart disease; congestive heart failure; peripheral vascular disease.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

The Liraglutide group and the comparison group ran side by side rather than switching.

In this single-blind Liraglutide study one party knew the assignments and the other did not.

Those kept unaware of assignments: investigator.

It started in 2015-11 with completion listed for 2017-06.

It ran at 1 site in Greece.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Differences in Pulse Wave Velocity at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R (time frame: Baseline, 3 months, 6 months and 12 months). Differences in Augmentation Index at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R (time frame: Baseline, 3 months, 6 months, and 12 months). Differences in Coronary Flow Reserve at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R (time frame: Baseline, 3 months, 6 months, and 12 months).

It also tracked 2 secondary outcomes, for example Endothelial Glycocalyx and Pulse Wave Velocity and Endothelial Glycocalyx and Coronary Flow Reserve.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Liraglutide in 60 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Liraglutide compound page, all human trials.