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Glucagon Resistance in Patients With NAFLD

Plain-language guide to NCT04042142: not phased non-randomized trial of Glucagon, fatty liver & elevated liver enzymes, 28 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04042142
Phase
not phased
Status
completed
Start
2019-10-05
Completion (planned or actual)
2022-06-30
Participants
28 (actual)
Design
non-randomized, open label (everyone knows who gets what), basic_science
Conditions studied
Non-Alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis; Glucose Metabolism Disorders
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Glucagon for fatty liver & elevated liver enzymes.

The investigators propose that the sensitivity to glucagon in hepatic lipid metabolism is impaired in subjects with non-alcoholic fatty liver disease (NAFLD) and steatohepatitis (NASH).

It had three arms (groups): Healthy overweight subjects (active comparator), Subjects with non-alcoholic fatty liver disease (active comparator) and Subjects with non-alcoholic steatohepatitis (active comparator).

MR spectroscopy verified no steatosis.

MR spectroscopy verified steatosis, no steatohepatitis on liver biopsy.

MR spectroscopy verified steatosis, steatohepatitis on liver biopsy.

The registry classes the interventions as other.

Who Took Part

The registry lists 28 actual participants took part.

It was open to people of any sex aged from 38 years up to 68 years.

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

Examples of who could join: BMI \> 28 kg/m2.

The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: active smoking; comorbidity other than hypertension and hyperlipidemia; blood donation (within 3 months).

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

Groups ran in parallel: each of the fatty liver & elevated liver enzymes participants stayed in one arm throughout.

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 2019-10-05 with completion listed for 2022-06-30.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: VLDL-triglyceride kinetics (appearance rate (µmol/min) and oxidation (µmol/min)) (time frame: 30 minutes at steady-state).

It also tracked 4 secondary outcomes, for example LPL-activity (lipoprotein lipase, µmol/h), VLDL-triglyceride-fatty acid uptake in muscle and fatty tissue (%), Expression of relevant genes in tissues and Fatty acid turnover (µmol/min).

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Glucagon in 28 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.

Our Notes on the Compound

Glucagon: A 29-amino-acid pancreatic hormone that raises blood glucose; used as a rescue medicine for severe low blood sugar and as a diagnostic aid.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.