Suspended

Mapping of Metabolic Liver Functions in Patients With Non-alcoholic Fatty Liver Disease

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What is being collected

Data Collection

Collected from today forward - Prospective
DNA Samples
Who is being recruted

Cardiovascular Diseases+5

+ Digestive System Diseases

+ Fatty Liver

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Observational
Study Start: June 2015
See protocol details

Summary

Principal SponsorUniversity of Aarhus
Study ContactPeter Lykke Eriksen, MD
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2015

Actual date on which the first participant was enrolled.

Background: Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in the western world and an important cause of morbidity and mortality including risk of cardiovascular disease. A ruling dogma is that a fatty liver is well-functioning. Recent studies imply the contrary but quantitative measurements of metabolic liver function have not been systematically investigated in NAFLD. Objectives: To study and quantify specific metabolic liver functions in varying degrees of NAFLD. Furthermore to map the coagulation system of patients with NAFLD. Methods: A human clinical study. Metabolic liver functions are studied by a series of functional tests (Galactose elimination capacity (GEC), Aminopyrine breath test (ABT), Indocyanine green plasma disappearance rate (ICG-PDR), Functional hepatic nitrogen clearance (FHNC)). Regional liver function evaluated by 2-\[18F\]fluoro-2-deoxy-D-galactose (FDGal) PET/CT is compared to fat infiltration assessed by Magnetic resonance imaging (MRI). Primary and secondary hemostasis, natural anti-coagulants and fibrinolysis are evaluated. Perspectives: To challenge the dogma, that hepatic metabolic function is not affected in NAFLD, improving the understanding of the relationship between the clinical degree of NAFLD, histology, metabolic functions, and imaging. Furthermore to disclose a proposed procoagulant imbalance in NAFLD.

Official TitleMapping of Metabolic Liver Functions in Patients With Non-alcoholic Fatty Liver Disease
NCT02488941
Principal SponsorUniversity of Aarhus
Study ContactPeter Lykke Eriksen, MD
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesDigestive System DiseasesFatty LiverLiver DiseasesThrombosisVascular DiseasesEmbolism and ThrombosisNon-alcoholic Fatty Liver Disease

Criteria

3 inclusion criteria required to participate
Age ≥ 18

Hepatic steatosis found on ultrasound

Clinical indication for liver biopsy (typically persistently elevated alanine transaminase (ALT) levels)

7 exclusion criteria prevent from participating
Prednisolone treatment within last 8 weeks

Other liver pathology

Alcohol consumption > 20g/day

Chronic inflammatory disease, current infection or cancer

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Department of Hepatology & Gastroenterology

Aarhus, DenmarkOpen Department of Hepatology & Gastroenterology in Google Maps
SuspendedOne Study Center