Clinical trial

Direct Versus Indirect Effect of Amino Acids on Hepatokines

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06240039

Active, not recruitingNot applicableInterventional

What this study is about

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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age25 Years to 65 Years

SexAll

Healthy volunteersAccepted

ConditionNon-Alcoholic Fatty Liver Disease, Obesity

Full registry criteria

Group 1: (Lean controls) Inclusion Criteria: * Male or female between 25-65 years of age at time of screening * Body mass index of 18.6-25 kg/m2 Exclusion Criteria: * Contraindications for MRI-scan * Severe liver disease (estimated by FIB4 score \> 3.25) * Type 2 diabetes according to ADA criteria * Significant history of alcoholism or drug/chemical abuse as per investigators judgement * Amino acid related diseases * Kidney disease * Cardiac problems * Cancer within the past 1 year * Anemia * Pregnancy or breast feeding * Smoking * Any medicine, acute illness (within the last two weeks) or other circumstances that in the opinion of the investigator might endanger the participants' safety or compliance with the protocol Group 2 (individuals with hepatic steatosis): Inclusion Criteria: * Male or female between 25-65 years of age at time of screening * Body mass index of 25-40 kg/m2 * Hepatic non-alcoholic steatosis verified by liver biopsy, fibroscan or ultrasound Exclusion Criteria: * Contraindications for MRI-scan * Severe liver disease (estimated by FIB4 score \> 3.25) * Type 2 diabetes according to ADA criteria * Significant history of alcoholism or drug/chemical abuse as per investigators judgement * Amino acid related diseases * Kidney disease * Cardiac problems * Cancer within the past 1 year * Anemia * Pregnancy or breast feeding * Smoking * Any medicine, acute illness (within the last two weeks) or other circumstances that in the opinion of the investigator might endanger the participants' safety or compliance with the protocol

Treatments and study arms

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

Other

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.

Primary outcomes

The direct (amino acid + somatostatin) versus the indirect (amino acid + placebo) effect of amino acids on circulating levels of follistatin.From blood sample at minute 0 until blood sample at minute 300.

Defined as the difference in incremental AUC0-300 min (iAUC) of follistatin between study day B and study day C in healthy individuals.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Bispebjerg University Hospital🇩🇰 Copenhagen, Denmark

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