Development of a non-invasive screening tool to predict NAFLD
Research type
Research Study
Full title
Development of a screening tool to identify NAFLD in healthy Volunteers and patient populations
IRAS ID
306287
Contact name
Jorg Taubel
Contact email
Sponsor organisation
Richmond Research Institute
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 2 days
Research summary
An increasing problem worldwide is a condition called non-alcoholic fatty liver disease (NAFLD), where the liver tissue becomes infiltrated with fat. This is a very variable condition, affecting up to 25% of the global adult population, and the effects can vary from very mild changes only visible on a scan without any health problems, all the way to liver inflammation, a condition called non-alcoholic steatohepatitis (NASH), liver scarring (cirrhosis) and even liver cancer. When we perform clinical trials of new medications a very common reason to stop or withdraw patients from these trials is liver reactions. It is recognised that patients with underlying fatty liver are more prone to these types of reactions, but it is very difficult to identify these patients without performing a scan or even a tissue sample to confirm the diagnosis, something which is expensive and difficult to do for every patient. We have new technology now, including a quick and harmless device to measure of body fat and skeletal muscle called bioimpedance vector analysis, as well as new technology to combine multiple factors from a single patient - including their age, sex, ethnicity, past medical history, blood tests and body measurements, with bioimpedance data, to better predict which patients may or may not have fatty liver. We can utilise artificial intelligence, also known as machine learning, to process this complex data into a simple formula or tool. Using this tool we would then be able to safely and more accurately screen volunteers for clinical trials, and allow safer and more effective development of new medications.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
21/WM/0266
Date of REC Opinion
16 Dec 2021
REC opinion
Further Information Favourable Opinion