TrUSt-NAFLD
Research type
Research Study
Full title
Translating the potential of the urine steroid metabolome to stage NAFLD
IRAS ID
300260
Contact name
Jeremy Tomlinson
Contact email
Sponsor organisation
Clinical Trials and Research Governance (CTRG) Team
Eudract number
2016-003060-40
Clinicaltrials.gov Identifier
PID15635, R&D reference number
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Research Summary:
Fat deposition in the liver (so called non-alcoholic fatty liver disease, NAFLD) is now the commonest chronic liver condition, affecting one-in-three individuals. It can lead to liver problems including cirrhosis and liver cancer as well as increasing your risk of heart attacks and strokes.
Simple blood tests are often normal, and the current gold-standard test for assessing NAFLD severity is a liver biopsy. This is an invasive procedure that is associated with significant complications, including pain and bleeding. We have developed a urine test that measures natural steroid hormones and provides an accurate reflection of how the liver is functioning in patients with NAFLD.
We wish to extend our preliminary findings to a large cohort of patients with NAFLD to ensure that our test is accurate and reliable. We will ask patients who are scheduled to have a routine liver biopsy to assess the severity of their NAFLD (as part of their NHS care) to provide a urine sample as well as additional blood tests. Our aim is to see if the analysis from their urine samples can accurately predict the results of the liver biopsy. We will also collect urine and blood samples and undertake ultrasound scans in healthy control subjects without NAFLD to see if our urine test is also able to correctly identify those individuals who do, and do not have NAFLD.
If successful, our urine test could be used by GPs and hospitals reducing liver biopsies and making a significant advance to patient care
Summary of Results:
The TrUSt NAFLD study recruited a group of participants with metabolic dysfunction-associated steatotic liver disease (MASLD) and a group of healthy participants with the aim of evaluating the accuracy of a urine test. The urine test involved measuring the concentration of break down products of steroids in the urine of these participants. It was able to distinguish between the early and advanced stages of MASLD with similar accuracy to commonly used tests. The test was also able to distinguish between healthy participants and those with MASLD with good accuracy. The test has the advantage of being the first validated urine test which has high patient acceptability compared to blood tests or other tests. Future research aims to understand whether this urine test can predict the outcomes of patients with MASLD. The full results of the study will be published in the next 12 months. We are grateful to the participants who took part in the study.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
21/WM/0177
Date of REC Opinion
17 Aug 2021
REC opinion
Further Information Favourable Opinion