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

June 30, 2015 updated by: University of Aarhus

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Peter Lykke Eriksen, MD
  • Phone Number: +45 7846 4076
  • Email: ple@clin.au.dk

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Recruiting
        • Department of Hepatology & Gastroenterology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with varying degrees of NAFLD

Description

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

Study Plan

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

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic Liver Function assessed by GEC
Time Frame: Baseline
Baseline
Metabolic Liver Function assessed by FHNC
Time Frame: Baseline
Baseline
Metabolic Liver Function assessed by ABT
Time Frame: Baseline
Baseline
Metabolic Liver Function assessed by ICG-PDR
Time Frame: Baseline
Baseline
Regional metabolic liver function evaluated by FDGal PET/CT
Time Frame: 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.
Baseline
Regional fat infiltration assessed by MRI
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Primary hemostasis
Time Frame: Baseline
Baseline
Secondary hemostasis
Time Frame: Baseline
Baseline
Natural anti-coagulants
Time Frame: Baseline
Baseline
Fibrinolysis
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Study Director: Hendrik Vilstrup, Professor, Department of Hepatology & Gastroenterology, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

June 17, 2015

First Submitted That Met QC Criteria

June 30, 2015

First Posted (Estimate)

July 2, 2015

Study Record Updates

Last Update Posted (Estimate)

July 2, 2015

Last Update Submitted That Met QC Criteria

June 30, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Metabolic liver function NAFLD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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