sCD163 and sMR in Wilsons Disease - Associations With Disease Severity and Fibrosis
NCT ID: NCT02702765
Last Updated: 2022-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2016-02-29
2022-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
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
Ultrasound
Ultrasound is a non-invasive procedure
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.
Liver biopsy
Histological disease activity at time of diagnosis evaluating if any liver fibrosis
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
Interventions
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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
Ultrasound
Ultrasound is a non-invasive procedure
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.
Liver biopsy
Histological disease activity at time of diagnosis evaluating if any liver fibrosis
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
100 Years
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Henning Grønbæk, Professor
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital, Nørrebrogade 44, Aarhus C, Denmark, 8000
Locations
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Department of Hepatology and Gastroenterology, Aarhus University Hospital
Aarhus, , Denmark
Countries
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References
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Bjorklund J, Laursen TL, Sandahl TD, Moller HJ, Vilstrup H, Ott P, Gronbaek H. High hepatic macrophage activation and low liver function in stable Wilson patients - a Danish cross-sectional study. Orphanet J Rare Dis. 2018 Sep 21;13(1):169. doi: 10.1186/s13023-018-0910-7.
Other Identifiers
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Wilson sCD163
Identifier Type: -
Identifier Source: org_study_id
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