Active — Not RecruitingNot Applicable

Direct Versus Indirect Effect of Amino Acids on Hepatokines

Denmark30 participantsStarted 2024-02-11

Plain-language 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).

Who can participate

Age range25 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 mi…

What they're measuring

The direct (amino acid + somatostatin) versus the indirect (amino acid + placebo) effect of amino acids on circulating levels of follistatin.

Timeframe: From blood sample at minute 0 until blood sample at minute 300.

Trial details

NCT IDNCT06240039

SponsorUniversity of Copenhagen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-16