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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN18100919
Enrollment
30
Registered
2019-08-19
Start date
2019-06-11
Completion date
Unknown
Last updated
2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonalcoholic steatohepatitis (NASH) Digestive System Other specified inflammatory liver diseases

Interventions

Patients with a diagnosis of NAFLD prospectively attending the liver clinic will be approached and asked if they would like to participate. If in agreement, they will be asked to sign a consent form.

Sponsors

Hull University Teaching Hospitals NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
1. Journey mapping of the sample from clinic to lab to final result, to demonstrate logistical feasibility 2. Patient acceptability of having the test, assessed by direct questioning

Secondary

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

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026