sCD163 and sMR in Wilsons Disease - Associations With Disease Severity and Fibrosis

November 1, 2022 updated by: University of Aarhus

Macrophages and the Macrophage Activation Markers sCD163 and Mannose Receptor (sMR) in Patients With Wilsons Disease - Associations With Liver Disease Severity and Fibrosis

The aim is to investigate macrophage activation markers and correlations to liver fibrosis in patients with Wilsons Disease. Researchers wish to investigate associations to neurologic and metabolic liver function. Researchers will assess this by comparing blood samples with fibrosis and liver function analyses. This study provides new insight into macrophages and their involvement in Wilsons Disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Department of Hepatology and Gastroenterology, Aarhus University Hospital

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 to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosed with Wilsons disease

Exclusion Criteria:

-

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wilsons disease
All patients will receive all interventions (galactose elimination capacity test , ultrasound, fibroscan, continuous reaction time test and functional hepatic nitrogen clearance ), except liver biopsy.
Procedure: Fibroscan
Liver fibrosis will be determined using fibroscan, and reported as changes in the amount of fibrosis in the liver. The fibroscan is a non-invasive procedure
Procedure: Ultrasound
Ultrasound is a non-invasive procedure
Drug: Galactose

Galactose elimination capacity is performed to evaluate metabolic liver function.

The metabolic liver function test galactose elimination capacity requires a 6-hour fast, the infusion of galactose, blood sampling from the ear lobe, and collection of urine for 4 hours.

Other Names:
  • Galactose elimination capacity
Procedure: Liver biopsy
Histological disease activity at time of diagnosis evaluating if any liver fibrosis
Procedure: Functional hepatic nitrogen clearance
Functional hepatic nitrogen clearance to evaluate metabolic liver function Functional hepatic nitrogen clearance requires a 12-hour fast, two venflons, the infusion of alanine, and urine sampling for 4 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of the macrophage activation markers sCD163
Time Frame: Baseline, 1 year, 2 year, 3 year
For the investigations a total of 100 ml of blood is drawn, all stored in a research biobank.
Baseline, 1 year, 2 year, 3 year
Measurement of soluble mannose receptor (sMR)
Time Frame: Baseline, 1 year, 2 year, 3 year
For the investigations a total of 100 ml of blood is drawn, all stored in a research biobank.
Baseline, 1 year, 2 year, 3 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary copper excretion in 24 hour urine collection
Time Frame: Baseline, 1 year, 2 year, 3 year
The patient collects urine for 24 hours at home in a designated container, which is handed out at the department. The container is kept refrigerated and is brought to the control
Baseline, 1 year, 2 year, 3 year
Ultrasound is performed for signs of liver cirrhosis.
Time Frame: Baseline, 1 year, 2 year, 3 year
Ultrasound is a non-invasive procedure. Signs og liver cirrhosis by ultrasound are surface modularity, a smaller liver, heterogeneous echo texture and signs of portal hypertension.
Baseline, 1 year, 2 year, 3 year
Fibroscan is performed to evaluate liver stiffness (fibrosis)
Time Frame: Baseline, 1 year, 2 year, 3 year
Liver fibrosis will be determined using fibroscan, and reported as changes in the amount of fibrosis in the liver. The fibroscan is a non-invasive procedure.
Baseline, 1 year, 2 year, 3 year
Continous Reaction Time to evaluate brain dysfunction
Time Frame: Baseline, 1 year, 2 year, 3 year
Continous Reaction Time is a computerized 10 minutes test that measures and combines motor reaction speed and sustained attention.
Baseline, 1 year, 2 year, 3 year
Galactose elimination capacity is performed to evaluate metabolic liver function
Time Frame: Baseline, 1 year, 2 year, 3 year
The metabolic liver function test Galactose elimination capacity requires a 6-hour fast, the infusion of galactose, blood sampling from the ear lobe, and collection of urine for 4 hours.
Baseline, 1 year, 2 year, 3 year
Histological disease activity at time of diagnosis and liver biopsy, evaluating if any liver fibrosis
Time Frame: Baseline, 1 year, 2 year, 3 year
Liver fibrosis will be also be determined on liver biopsies.
Baseline, 1 year, 2 year, 3 year
Functional hepatic nitrogen clearance to evaluate metabolic liver function
Time Frame: Baseline, 1 year, 2 year, 3 year
Functional hepatic nitrogen clearancerequires a 12-hour fast, two venflons, the infusion of alanine, and urine sampling for 4 hours. It evaluates the metabolic liver function by measuring the clearance of alanine from blod by analyzing the amount og urea in the urine collected 4 hours after the start og the alanine infusion.
Baseline, 1 year, 2 year, 3 year
The Portosystemic Encephalopathy to evaluate brain dysfunction
Time Frame: Baseline, 1 year, 2 year, 3 year
The Portosystemic Encephalopathy test is a 15-minute paper-pencil test battery comprised of 5 sub-tests: Digit Symbol test (DST), Number Connection Test A (NCT-A), Number Connection Test B (NCT-B), Serial Dotting Test (SDOT), and Line Tracing Test (LTT, time and errors).
Baseline, 1 year, 2 year, 3 year

Collaborators and Investigators

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

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital

Investigators

  • Principal Investigator: Henning Grønbæk, Professor, Aarhus University Hospital, Nørrebrogade 44, Aarhus C, Denmark, 8000

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

February 1, 2016

Primary Completion (Actual)

February 1, 2020

Study Completion (Actual)

February 1, 2022

Study Registration Dates

First Submitted

February 26, 2016

First Submitted That Met QC Criteria

March 7, 2016

First Posted (Estimate)

March 9, 2016

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Wilson sCD163

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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