PRELUDE-1
Research type
Research Study
Full title
Feasibility and acceptability of a primary care liver fibrosis testing pathway centred on the diabetes annual review: PRELUDE1
IRAS ID
299934
Contact name
William Alazawi
Contact email
Sponsor organisation
Queen Mary, University of London
Duration of Study in the UK
1 years, 11 months, 29 days
Research summary
Non-alcoholic fatty liver disease, or fatty liver for short, is the most common cause of long-term liver problems worldwide and affects one in four people living in the UK. Around one in six people with fatty liver develops a serious form of the condition in which fat irritates the liver and cause scarring or fibrosis. Fibrosis leads to cirrhosis and people with cirrhosis can develop life-threatening liver cancer or liver failure. Fatty liver is often seen in people with type 2 diabetes who are also at highest risk of fibrosis. We want to identify people who will develop serious liver disease in earlier stages, when something can be done to stop progression.
For most people, there are no symptoms of fatty liver, fibrosis or even cirrhosis until the latest stages of disease when treatment is not effective. Routine blood tests do not diagnose fibrosis or cirrhosis, but it is possible to calculate scores from these tests, such as the Fib-4 used in this study to accurately rule out significant disease. If Fib-4 is negative, we can be fairly confident that patients do not have significant fibrosis. If Fib-4 is positive, then patients should have further specialist investigations.
We will focus on people in GP practices with diabetes because they have an annual review that includes blood tests, to which we will add a Fib-4 test. Patients who have positive test results will be referred for further testing and treatment either in their local hospital or in GP practice. If Fib-4 testing in the annual review identifies more patients with fibrosis and is cost-effective, we would introduce this test across the NHS, target treatment and so reduce the number of people who develop liver cancer or liver failure.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
21/EE/0269
Date of REC Opinion
16 Feb 2022
REC opinion
Further Information Favourable Opinion