NAFLD Outcomes
Research type
Research Study
Full title
Long-term outcomes of Non-alcoholic fatty liver disease
IRAS ID
204213
Contact name
Quentin Anstee
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Duration of Study in the UK
4 years, 7 months, 29 days
Research summary
Non-alcoholic fatty liver disease (NAFLD) is recognised as one of the leading causes of liver disease worldwide, affecting 17-46% of the population in the developed world.
The term NAFLD covers a spectrum of liver disease ranging from steatosis (fat infiltration of liver cells without liver cell injury) which is associated with a good prognosis to the more progressive form, non-alcoholic steatohepatitis (NASH; fat deposition with liver cell injury and inflammation +/- fibrosis), which can in time progress onto cirrhosis (scarring) and end-stage liver disease.
NASH occurs in 10-30% of cases and is associated with liver related complications such as variceal bleeding and liver cancers. As well being associated with increased risk of liver complications, there is also an increased risk of cardiovascular disease (such as heart attacks or strokes), which is most common cause of death in these patients.
There have been few retrospective studies aimed at investigating the clinical factors which may predict mortality and other significant clinical events in patients with NAFLD. These have shown that those with diabetes or progressively increasing body weight are more likely to have progressive disease.
However, the studies reporting these associations have been small and retrospective, with relatively short follow-up periods.
Given the very variable natural history of NAFLD there is a great need to more clearly define the progression of the disease and develop models to predict long-term outcomes.
This study aims to gain a greater understanding of the natural history of NAFLD by assessing a large cohort of up to 700 patients with biopsies taken over a 30year period. The outcomes of these patients will be explored; specifically the frequency of significant clinical outcomes such as hepatic decompensation (clinical deterioration in patients with chronic liver disease often requiring hospitalisation of patients), development of liver cancer, death, transplantation and cardiovascular events.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
19/NE/0092
Date of REC Opinion
23 Apr 2019
REC opinion
Favourable Opinion