The Role of the Kidneys and Liver in the Elimination of Glucagon

What Was Tested

In this not phased trial, researchers set out to test Glucagon.

The study aims to evaluate the kinetics and effect of glucagon in patients with chronic kidney disease and liver cirrhosis and matched healthy subjects, respectively.

It had three arms (groups): Healthy control subjects (experimental), Patients with End-stage Renal Disease (experimental) and Patients with liver cirrhosis (experimental).

Healthy control subjects, matched for age, sex and BMI.

Patients with hemodialysis-treated ESRD.

Patients with Child-Pugh A or B Cirrhosis.

The registry classes the interventions as biological.

More on the Plan

In the present project the investigators wish to identify whether the effect, elimination and degradation of glucagon differ between healthy control subjects and patients with Chronic Kidney Disease (CKD) and liver cirrhosis, respectively.

Who Took Part

The registry lists 48 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Men/women between 18 and 75 years of age. CKD stage 4 or 5. Normal liver function (alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), albumin and coagulation factor II, VII and X (INR) within normal range,. Men/women between 18 and 75 years of age. Verified diagnosis of cirrhosis - Child-Pugh Score of 5-12.

The full record lists 12 inclusion and 10 exclusion criteria; among the exclusions: previous kidney transplantation with remaining kidney graft; present treatment with oral glucocorticoids; polycystic kidney disease.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

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

Everyone knew when Glucagon was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2020-08-01 with completion listed for 2023-03-28.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

It also tracked 11 secondary outcomes, for example Tracers, Insulin, Glucagon-like peptide 1, Lipid metabolism, Vital parameter 1 and Vital parameter 2.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Glucagon in 48 people.

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

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