Direct Versus Indirect Effect of Amino Acids on Hepatokines

Launched by UNIVERSITY OF COPENHAGEN · Jan 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how certain proteins called amino acids affect hormones produced by the liver, particularly in people with non-alcoholic fatty liver disease (NAFLD) and obesity. The goal is to understand why these liver hormones are often higher in individuals with fatty liver disease and what causes the liver to release them. Researchers will compare the effects of an amino acid infusion on hormone secretion in two groups: those who are lean and healthy and those who have fatty liver disease.

To participate, individuals must be between 25 and 65 years old. Lean controls should have a healthy weight (BMI of 18.6-25), while those with fatty liver disease should have a BMI of 25-40 and a confirmed diagnosis through medical imaging. However, there are some restrictions; people with severe liver disease, type 2 diabetes, or certain health conditions like kidney issues or recent cancer are not eligible. Participants can expect to undergo assessments that may include imaging tests, and their safety will be closely monitored throughout the study. This research is important as it could help improve the understanding and treatment of fatty liver disease.

Gender

ALL

Eligibility 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