Abstract
INTRODUCTION: Non-alcoholic fatty liver disease is the most common chronic liver disease worldwide affecting 20%-25% in the USA and Europe with a 60%-80% lifetime prevalence for people with type 2 diabetes (T2D). Fibrosis has repeatedly been demonstrated to be the major determinant of liver disease morbidity and mortality and there is currently no routine screening for liver fibrosis in at-risk T2D population.
METHODS AND ANALYSIS: This 12-month prospective cohort study of automated fibrosis testing uses the fibrosis-4 score (FIB-4) in patients with T2D linked to the investigation of hospital-based versus community-based second-tier transient elastography (TE) testing. We plan to include >5000 participants across 10 General Practitioner (GP) practices in East London and Bristol. This will determine the rate of undiagnosed significant liver fibrosis in a T2D population, the feasibility of two-tier liver fibrosis screening using FIB-4 at the diabetes annual review and subsequent TE delivered either in the community or secondary care settings. This will include an intention-to-treat analysis for all those invited to attend for diabetes annual review. A qualitative substudy regarding the acceptability of the fibrosis screening pathway will comprise semistructured interviews/focus groups with primary care staff (GPs and practice nurses), and patients taking part in the wider study.
ETHICS AND DISSEMINATION: This study received a favourable opinion from the Cambridge East research ethics committee. The results of this study will be disseminated in peer-reviewed scientific journals, conference presentations and local diabetes lay panel meetings.
TRIAL REGISTRATION NUMBER: ISRCTN14585543.
| Original language | English |
|---|---|
| Article number | e066493 |
| Number of pages | 6 |
| Journal | BMJ Open |
| Volume | 13 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - 19 May 2023 |
Bibliographical note
Funding Information:This work was funded by Gilead sciences, grant number IN-UK-989-5852 GBR, who will not be involved in study design, delivery or data collection or analysis.
Publisher Copyright:
© 2023 BMJ Publishing Group. All rights reserved.
Keywords
- Humans
- Diabetes Mellitus, Type 2/diagnosis
- Feasibility Studies
- Prospective Studies
- Liver Cirrhosis/diagnosis
- Fibrosis
- Non-alcoholic Fatty Liver Disease
- Primary Health Care
Access to Document
- Full-text PDF (final published version)
This is the final published version of the article (version of record). It first appeared online via BMJ Publications at http://dx.doi.org/10.1136/bmjopen-2022-066493. Please refer to any applicable terms of use of the publisher.