Hepatic Metabolic Changes in Response to Glucagon Infusion

What Was Tested

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

The objective of the study is to investigate how exogenously administered glucagon affects hepatic lipid, glucose and protein metabolism as well as appetite, food intake and resting energy expenditure.

It had two arms (groups): Glucagon (active comparator) and Saline (placebo comparator).

3 hours i.v. infusion of saline.

The registry classes the interventions as drug.

More on the Plan

Most research has focused on the role of the pancreatic hormone, insulin, and insulin signalling (or lack of) in the development of NAFLD.

Who Took Part

The registry lists 27 actual participants took part.

It was open to people of any sex aged from 30 years up to 80 years.

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

Examples of who could join: Patients who have undergone total pancreatectomy. Caucasian between 30-80. Caucasian between 30-80. Caucasian between 30-80.

The full record lists 12 inclusion and 10 exclusion criteria; among the exclusions: inflammatory bowel disease; gastrointestinal resection (other than the gastro-duodenectomy performed in connection with total pancreatectomy) and/or ostomy; known liver disease (excluding non-alcoholic fatty liver disease).

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

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

In the crossover set-up each of the fatty liver & elevated liver enzymes participants took both Glucagon and the comparison in turn, acting as their own control.

Neither the fatty liver & elevated liver enzymes participants nor the staff measuring them knew who was on Glucagon, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2018-05-01 with completion listed for 2019-06-12.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Hepatic lipid metabolism (time frame: -120,-30,-15,0,30,60,90,120,135,150 minutes).

It also tracked 7 secondary outcomes, for example Changes in plasma concentration of lipids, Changes in plasma concentration of amino acids, Changes in plasma concentration of fibroblast growth factor 21 (FGF-21), Endogenous glucose production, Changes in resting energy expenditure and oxidation rate and Food intake.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glucagon in 27 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, Fatty liver & elevated liver enzymes research.