Haemodynamic Effects of GLP-1 and Glucagon in Healthy Male Volunteers

What Was Tested

This registered not phased trial tested Exenatide and Glucagon.

The study seeks to explore the cardiovascular effects of co-agonism at two peptide receptors, GLP-1 and glucagon.

Overall, the aim of the study is to further their understanding on the role these endogenous substances play (both in isolation and combination) in haemodynamic regulation.

It had six arms (groups): Part A - Infusion A (placebo comparator), Part A - Infusion B (active comparator), Part B - Infusion A (active comparator), Part B - Infusion B (active comparator) and Part B - Infusion C (active comparator).

The registry classes the interventions as drug.

More on the Plan

However, there is a lack of data on the effects that co-agonism has on haemodynamic regulation.

These will occur in a predefined but random order so that participants will be blinded to the infusion they are receiving.

Each infusion visit will comprise of 15 minute baseline followed by a 120 minute infusion.

Detailed non-invasive cardiovascular measurements (including peripheral/central blood pressure, heart rate, stroke volume, heart rate variability) and bloods (including insulin, glucose, GLP-1, glucagon) will be collected as part of the study.

Who Took Part

The registry lists 26 actual participants took part.

It was open to men only aged from 18 years up to 40 years.

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

Examples of who could join: Written informed consent to participate. Aged 18 to 40. BMI \>18.0 and \<30kg/m2.

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: sustained hypertension (sustained bp \>160/100mmhg) or hypotension (systolic bp below 90 mmhg); implanted heart pace-maker or implantable cardioverter defibrillator (icd); known active malignancy.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

Those kept unaware of assignments: participant.

It started in 2019-02-11 with completion listed for 2021-11-01.

It ran at 1 site in United Kingdom.

Its stated primary purpose is basic science.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Exenatide and Glucagon in 26 people.

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 Exenatide compound page and the Glucagon compound page, all human trials.