NAFLD BioResource
Research type
Research Study
Full title
The NAFLD BioResource, part of the NIHR BioResource – A Research Study to Characterise Novel Clinical and Genetic Phenotypes, and Understand the Natural History of Non-Alcoholic Fatty Liver Disease (NAFLD)
IRAS ID
259099
Contact name
Philip Newsome
Contact email
Sponsor organisation
University Hospital Birmingham NHS Foundation Trust
Duration of Study in the UK
2 years, 5 months, 31 days
Research summary
NAFLD (Non-alcoholic Fatty Liver Disease), defined as the accumulation of excess fat in the liver, is now the commonest cause of liver disease in Western countries and affects approximately 30-40% of the UK population. Data suggest that NAFLD progresses to NASH (Non-alcoholic steatohepatitis) in about 20% of cases of which 20–25% may progress on to more advanced stages of hepatic fibrosis and cirrhosis, although predicting which individual patients will progress to develop advanced fibrosis is challenging. \n\nWeight loss, as part of lifestyle change, is the only recommended intervention, with a >10% loss associated with an improvement in fibrosis. As attaining and sustaining weight loss is difficult there have also been concerted efforts to develop pharmacological therapies for patients with NASH. A major challenge has been slow recruitment to clinical trials due to the lack of recallable databases. Patient factors including genotyping/phenotyping will play an ever-more significant role in optimising the choice of pharmacotherapy for patients.\n\nWorking with the NIHR Bioresource, we are proposing to develop a centralised national recallable BioResource up to 7500 patients with NAFLD to support scientific and clinical NAFLD research.\n\nKEY AIMS\n1) To characterise novel clinical and genetic phenotypes across NAFLD\n2) To investigate impact and interaction of co-morbidities across NAFLD \n3) To understand the natural history of NAFLD in the UK \n\nSECONDARY AIMS\n4) To collect and store blood (for DNA extraction, plasma, serum and other biological components storage) as well as clinical and health and lifestyle data from up to 7,500 participants who have been diagnosed with NAFLD\n5) Create a resource of recallable volunteers to help with future research, by obtaining consent from participants that they agree to be approached in the future and invited to further studies.\n
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
19/YH/0331
Date of REC Opinion
30 Sep 2019
REC opinion
Favourable Opinion