Non-alcoholic fatty liver disease Digestive System
Conditions
Interventions
The urinary steroid metabolome of patients with non-alcoholic fatty liver disease (NAFLD) and healthy controls will be analysed using mass spectroscopy followed by the application of generalized matri
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: NAFLD Participants: 1. Participant is willing and able to give informed consent for participation in the study 2. Patients with a diagnosis of NAFLD who are scheduled for a liver biopsy OR patients who have had a liver biopsy with a confirmed diagnosis of NAFLD within the last 12 months 3. Aged =18 years Healthy participants (recruited via the Oxford Biobank https://www.oxfordbiobank.org.uk): 1. BMI 20-35kg/m2 2. HOMA-IR in the bottom 25 percentiles of their respective BMI 3. Fasting triglyceride level <2 mmol/l Only individuals with normal liver biochemistry, and non-invasive serum markers (including the enhanced liver fibrosis panel, ELF) indicating low-risk of advanced NAFLD will be included in the study
Exclusion criteria
Exclusion criteria: 1. Insufficient understanding of written and verbal English 2. The participant has not had sufficient time to read the Patient Information Leaflet (PIL) and understand the study requirements 3. Hepatic steatosis, inflammation or fibrosis with a primary aetiology other than NAFLD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The urine collected at the study visit will be analysed using mass spectroscopy to generate quantities of 32 steroid metabolites. An area under the curve (AUC) of the receiver operator characteristic (ROC) curve will be generated following the generalized matrix learning vector quantization (GMLVQ) analysis of the urinary steroid metabolome of each patient to aim to distinguish those with early fibrosis (F0-2) from those with advanced fibrosis (F3-4) at one timepoint | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Area under the curve (AUC) of the receiver operator characteristic (ROC) curve following generalized matrix learning vector quantization (GMLVQ) analysis of the urinary steroid metabolome (generated by mass spectroscopy of the urine samples provided at the study visit) compared with AUC ROC using FIB-4, NAFLD fibrosis score, ELF, transient elastography measured using patient details recorded on the case report form at the study visit 2. GMLVQ analysis of urinary steroids (measured using mass spectroscopy of the urine collected at the study visit) in patients with biopsy-proven NAFLD compared with control participants without NAFLD at one timepoint 3. The levels of steroid hormones and other metabolites in serum/plasma measured using laboratory analysis of the blood samples taken at the study visit | — |
Countries
England, United Kingdom
Contacts
Public ContactJeremy Tomlinson
Outcome results
None listed