Clinical trial NCT02488941: Mapping of Metabolic Liver Functions in Patients With Non-alcoholic Fatty Liver Disease
Official title: Mapping of Metabolic Liver Functions in Patients With Non-alcoholic Fatty Liver Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-alcoholic Fatty Liver Disease
Keywords: Liver Function Tests
Blood Coagulation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2015-07-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with varying degrees of NAFLD

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Hepatic steatosis found on ultrasound
* Clinical indication for liver biopsy (typically persistently elevated alanine transaminase (ALT) levels)

Exclusion Criteria:

* Other liver pathology
* Alcohol consumption \> 20g/day
* Chronic inflammatory disease, current infection or cancer
* Diabetes mellitus type I, II or HbA1c ≥ 48 mmol/mol (6.5 %)
* Prednisolone treatment within last 8 weeks
* Pregnancy within last 12 months
* Contraindication for MRI

Primary outcomes:
measure: Metabolic Liver Function assessed by GEC
timeFrame: Baseline
measure: Metabolic Liver Function assessed by FHNC
timeFrame: Baseline
measure: Metabolic Liver Function assessed by ABT
timeFrame: Baseline
measure: Metabolic Liver Function assessed by ICG-PDR
timeFrame: Baseline
measure: Regional metabolic liver function evaluated by FDGal PET/CT
timeFrame: Baseline
measure: Regional fat infiltration assessed by MRI
timeFrame: Baseline
Secondary outcomes:
measure: Primary hemostasis
timeFrame: Baseline
measure: Secondary hemostasis
timeFrame: Baseline
measure: Natural anti-coagulants
timeFrame: Baseline
measure: Fibrinolysis
timeFrame: Baseline
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Hepatology & Gastroenterology
Study officials:
affiliation: Department of Hepatology & Gastroenterology, Aarhus University Hospital
name: Hendrik Vilstrup, Professor
role: STUDY_DIRECTOR
References: