ALTER-10 study v1.0
Research type
Research Study
Full title
ALTER-10 study: 10 year outcomes of minimally deranged serum alanine transferase in a community population.
IRAS ID
149311
Contact name
Mark Hudson
Contact email
Sponsor organisation
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Research summary
The burden of liver disease is increasing in the UK, largely due to an increase in alcoholic liver disease (ALD) and non-alcoholic fatty liver disease (NAFLD). Early identification of patients with liver disease in primary care is challenging, partly due to a lack of suitable, cheap and non-invasive diagnostic tests.
However, Liver Function Tests (LFTs) are routinely carried out for a variety of indications and may provide evidence of underlying liver disease. In particular, transaminases (Alanine Transaminase (ALT) or Aspartate Transaminase (AST)) may be elevated in the context of liver injury but often these enzymes are only minimally elevated which may be falsely reassuring. There is a lack of consensus on the most appropriate course of action when minimally deranged transaminases are identified in primary care.
An audit was carried out in 2003 of all LFTs requested by primary care within the Newcastle area. 56,131 individual tests were carried out, of which 5489 (9.8%) ALT levels were elevated in the range 1-2x the Upper Limit of Normal (ULN) and 968 (1.7%) were elevated >2x ULN. In the group with ALTs 1-2x ULN, only 6% of patients were referred but 58% of these patients had evidence of significant liver disease. The vast majority were due to NAFLD and 7% of all patients referred were found to have cirrhosis. This suggests there were considerable missed opportunities for early diagnosis of liver disease. This study will explore the 10 year outcome of patients with minimally deranged ALT results. Specifically data will be collected on mortality rates, causes of death and the incidence of clinically significant liver disease for patients with minimally deranged ALT and for matched controls with normal ALT. The study should provide an evidence base from which to derive guidelines for the future management of these patients.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
14/NE/0153
Date of REC Opinion
28 May 2014
REC opinion
Favourable Opinion