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NCT06240039
NA

Direct Versus Indirect Effect of Amino Acids on Hepatokines

Sponsor: University of Copenhagen

View on ClinicalTrials.gov

Summary

Liver hormones are key metabolic regulators and increased in metabolic diseases, including fatty liver disease. 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. The project aims to investigate what stimulates the liver to secrete its hormones and why the secretion is increased in patients with fatty liver disease. The investigator (Associate Prof. Nicolai J Wewer Albrechtsen) will investigate the direct and indirect effects of an amino acid amino infusion on the secretion of hepatokines in individuals with and without metabolic dysfunction-associated steatotic liver disease (MASLD).

Official title: Direct Versus Indirect Effect of Amino Acids on Hepatokines in Healthy Subjects and Patients With Non-alcoholic Fatty Liver Disease

Key Details

Gender

All

Age Range

25 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-02

Completion Date

2026-12

Last Updated

2024-02-02

Healthy Volunteers

Yes

Interventions

OTHER

Evaluating the acute effect of an amino acid infusion with and without a concomitant infusion of the somatostatin analogue octreotide to eliminate endogenous production of glucagon

The experimental days consist of four study days: 1. Assessment of liver fat and visceral fat by magnetic resonance imaging (MRI; 6-point Dixon) (study day A) 2. Somatostatin infusion (4 hours) plus amino acid infusion (45 minutes) (study day B) 3. Saline infusion (4 hours) plus amino acid infusion (45 minutes) (study day C) 4. Somatostatin infusion (4 hours) plus saline infusion (45 minutes) (study day D) The subjects will participate in the experimental days (study day B to D) in randomized order on three different days. For study day B to D, at timepoint t = -75, subjects will receive either; a 240-minute intravenous infusion of a somatostatin analogue (at 200 ng/kg/min (infusion rate will not exceed 1000 µg/hour) or saline. After 75 minutes (timepoint t = 0), the subjects will receive a 45-minute intravenous infusion of amino acids or saline at 3.885 ml/kg/hour. In total, blood will be sampled 11 times over a period of 6 hours and 15 minutes.

Locations (1)

Bispebjerg University Hospital

Copenhagen, Denmark