The Effect of Lifestyle-induced Hepatic Steatosis on Glucagon-stimulated Amino Acid Turnover

What Was Tested

The trial (not phased) is built around Glucagon and Somatostatin for fatty liver & elevated liver enzymes.

Many patients with type 2 diabetes exhibit elevated plasma concentrations of the glucose-mobilising pancreatic hormone glucagon; i.e. hyperglucagonaemia.

It had 1 arm (groups): one (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 20 actual participants took part.

It was open to men only aged from 20 years up to 65 years.

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

Examples of who could join: Body mass index (BMI) between 18.5 and 25 kg/m2. Age between 20 and 65 years. Oral and written informed consent.

The full record lists 6 inclusion and 13 exclusion criteria; among the exclusions: first-degree relatives with diabetes; known liver disease and/or alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) \>2 × normal values; signs of liver fibrosis and/or steatosis evaluated by fibroscan (cap value \>2380 db/m and/or kpa \>65.0) and/or fib-4 score (\>1.45).

How the Study Was Run

The set-up was single-group and open-label.

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.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2021-02-08 with completion listed for 2021-12-09.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Nadir of the total amino acid concentration during a two-hour high physiological glucagon infusion during a pancreatic clamp with somatostatin (time frame: depending on the nadir between time 60 minutes and time 180 minutes).

It also tracked 3 secondary outcomes, for example average slope of the curve describing the change in the total amino acid concentration during 'supraphysiological' glucagon infusion and the incremental area under the curve (iAUC) for total amino acid concentrations during 'supraphysiological' glucagon infusion.

What This Means in Plain Language

Put simply, this is a not phased trial of Glucagon and Somatostatin in 20 people with fatty liver & elevated liver enzymes.

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 Glucagon compound page and the Somatostatin compound page, Fatty liver & elevated liver enzymes research.