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Direct Versus Indirect Effect of Amino Acids on Hepatokines
Plain-language guide to NCT06240039: not phased interventional trial of Glucagon and Octreotide, fatty liver & elevated liver enzymes, 30 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06240039
- Phase
- not phased
- Status
- active, not recruiting
- Start
- 2024-02-11
- Completion (planned or actual)
- 2025-04-16
- Participants
- 30 (estimated)
- Design
- na, open label (everyone knows who gets what), basic_science
- Conditions studied
- Non-Alcoholic Fatty Liver Disease; Obesity
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Glucagon and Octreotide for fatty liver & elevated liver enzymes.
The underlying mechanisms driving the elevated levels are currently unknown and presents a major challenge in understanding the interplay between liver hormones and fatty liver disease.
It had 1 arm (groups): Evaluating the direct and indirect effect of amino acids on the regulation of hepatokines (experimental).
Participants will be subjected to four experimental days.
The registry classes the interventions as other.
More on the Plan
The liver secretes signaling molecules, (termed hepatokines) to the blood circulation which are powerful metabolic regulators and biomarkers of liver disease.
However, the underlying mechanisms driving the elevated levels in metabolic disease are currently unknown.
The study aims to explore the direct and indirect effect of amino acids on the regulation of hepatokines in individuals with and without MASLD.
Who Took Part
The registry lists 30 planned participants were the target.
It was open to people of any sex aged from 25 years up to 65 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Male or female between 25-65 years of age at time of screening. Body mass index of 18.6-25 kg/m2.
The full record lists 2 inclusion and 27 exclusion criteria; among the exclusions: contraindications for mri-scan; severe liver disease (estimated by fib4 score \> 3.25); type 2 diabetes according to ada criteria.
How the Study Was Run
It was run as a single-group and open-label study.
Being open-label, the Glucagon study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2024-02-11 with completion listed for 2025-04-16.
It ran at 1 site in Denmark.
Its stated primary purpose is basic science.
What Was Measured
Primary outcome: The direct (amino acid + somatostatin) versus the indirect (amino acid + placebo) effect of amino acids on circulating levels of follistatin (time frame: From blood sample at minute 0 until blood sample at minute 300).
It also tracked 6 secondary outcomes, for example The direct versus the indirect effect of amino acids on circulating levels of hepatokines (follistatin, FGF21 and GDF15) and Differences in glucagon, insulin and C-peptide concentrations between study day B and C in healthy and MASLD.
What This Means in Plain Language
Put simply, this is a not phased trial of Glucagon and Octreotide in 30 people with fatty liver & elevated liver enzymes.
Its size is small, so on its own it can only give an early look.
Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Glucagon compound page and the Octreotide compound page, Fatty liver & elevated liver enzymes research.
Our Notes on the Compounds
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.
Octreotide: An 8-amino-acid somatostatin analog (Sandostatin, Mycapssa) used for acromegaly and certain hormone-secreting tumors.
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.