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

• Conditions: Non-alcoholic Fatty Liver Disease

• Registration Number: NCT02488941
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-06
• Study Start: 2015-06
• Study First Submitted: 2015-06-17
• Study First Submitted QC: 2015-06-30
• Last Update Submitted: 2015-06-30
• Study First Posted: 2015-07-02
• Last Update Posted: 2015-07-02
• Primary Completion: 2018-05
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Metabolic Liver Function assessed by ABT	Baseline
Regional metabolic liver function evaluated by FDGal PET/CT	Baseline	100 megabecquerel FDGal is injected intravenously in the beginning of a 20 min PET recording and 3D images of regional metabolic liver function expressed in terms of hepatic metabolic clearance of FDGal is created.
Metabolic Liver Function assessed by GEC	Baseline
Metabolic Liver Function assessed by ICG-PDR	Baseline
Regional fat infiltration assessed by MRI	Baseline
Metabolic Liver Function assessed by FHNC	Baseline

Secondary Outcome Measures

Name	Time	Method
Primary hemostasis	Baseline
Secondary hemostasis	Baseline
Fibrinolysis	Baseline
Natural anti-coagulants	Baseline

Trial Locations

Locations (1)

Department of Hepatology & Gastroenterology; 🇩🇰 Aarhus, Denmark