A pilot study to determine if the Glyco Liver Profile is a suitable blood test for measuring liver inflammation in non-alcoholic steatohepatitis (NASH) patients

Not Applicable

Completed

• Conditions: onalcoholic steatohepatitis (NASH); Digestive System; Other specified inflammatory liver diseases

• Registration Number: ISRCTN18100919
• Lead Sponsor: Hull University Teaching Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-19
• Study Completion: 2020-12-11
• Last Update Posted: 5 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. 18 years or older on day of consent
2. Must be diagnosed with NAFLD with no liver biopsy planned (group 1)
or
Must be diagnosed with NAFLD with a planned liver biopsy (group 2)
or
Must not have a diagnosis of NAFLD (group 3)

Exclusion Criteria

1. Must be less than 80 years old on day of consent
2. Unable to provide informed consent
3. Must not have a confirmed diagnosis of any liver disease other than NAFLD (group 1 and 2)
4. Must not have a diagnosis of any liver disease (group 3)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Journey mapping of the sample from clinic to lab to final result, to demonstrate logistical feasibility<br>2. Patient acceptability of having the test, assessed by direct questioning

Secondary Outcome Measures

Name	Time	Method
Analysis of participants' Glyco and liver biopsy results, alongside other clinical data, to determine if there is preliminary evidence of correlation (not statistically powered)