Reflex testing for MAFLD in patients with type 2 diabetes
Research type
Research Study
Full title
Reflex testing for metabolic associated fatty liver disease (MAFLD) in patients living with type 2 diabetes compared to usual care - a randomised controlled trial
IRAS ID
326212
Contact name
Linda Hammond
Contact email
Sponsor organisation
University of Southampton
ISRCTN Number
ISRCTN17017677
Duration of Study in the UK
9 years, 11 months, 31 days
Research summary
Research, including our work, has shown that 15% of people living with type 2 diabetes (T2DM) have liver scarring (fibrosis) equivalent to the histological grade of F2 fibrosis (called moderate liver fibrosis). A further 4% of patients living with T2DM will have severe liver fibrosis (equivalent to F3/F4 fibrosis). These people are at high risk of more severe liver disease (cirrhosis and primary liver cancer). Identifying liver fibrosis brings benefits for patients because they can make key lifestyle changes; start medications that can stop the disease getting worse; or have regular liver surveillance to detect and treat development of potentially fatal liver cancer. Despite this, assessment of liver disease in patients living with T2DM is not currently recommended. In 2021, NICE highlighted a lack of evidence in this area and called for further research.
The aim of our study is to test a new way of identifying liver disease in people living T2DM. We will compare testing everyone with T2DM for liver disease, using a blood test and non-invasive liver scan (vibration-controlled transient elastography (VCTE) also called FibroScan) against the existing care pathway - where only those with another risk factor get tested.
There are two co-primary outcomes:
1. The number of people diagnosed with moderate liver disease (defined as a liver stiffness of ≥8.2 kPa on VCTE which has been validated as equivalent to ≥F2-fibrosis).
2. The number of people with significant liver disease (defined as ≥12.1 kPa on VCTE) and referred for liver cancer surveillance.REC name
West of Scotland REC 3
REC reference
23/WS/0102
Date of REC Opinion
2 Aug 2023
REC opinion
Further Information Favourable Opinion