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

NCT02488941 | Unknown

• 1 other identifier: Metabolic liver function NAFLD
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

Liver Function Tests; Blood Coagulation

Outcome Measures

Primary Outcomes (6)

• Metabolic Liver Function assessed by GEC

  Baseline

• Metabolic Liver Function assessed by FHNC

  Baseline

• Metabolic Liver Function assessed by ABT

  Baseline

• Metabolic Liver Function assessed by ICG-PDR

  Baseline

• Regional metabolic liver function evaluated by FDGal PET/CT

  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.

  Baseline

• Regional fat infiltration assessed by MRI

  Baseline

Secondary Outcomes (4)

• Primary hemostasis

  Baseline

• Secondary hemostasis

  Baseline

• Natural anti-coagulants

  Baseline

• Fibrinolysis

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with varying degrees of NAFLD

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Hepatology & Gastroenterology

Aarhus, 8000, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Liver biopsy Blood : serum and plasma

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Thrombosis

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hendrik Vilstrup, Professor

  Department of Hepatology & Gastroenterology, Aarhus University Hospital

  STUDY DIRECTOR

Central Study Contacts

Peter Lykke Eriksen, MD

CONTACT

+45 7846 4076; ple@clin.au.dk

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: July 2, 2015
• Study Start: June 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: July 2, 2015

Record last verified: 2015-06

Locations

DK (1)