None listed
Conditions
Brief summary
This is a prospective cohort study for patients undergoing bariatric surgery who have risk factors for NAFLD, to investigate efficacy of non-invasive tests in diagnosing and monitoring NAFLD. Patients who are already scheduled for bariatric surgery who fit criteria for likely NAFLD will be recruited to undergo an intraoperative liver and adipose tissue biopsy. Each participant will be required to attend regular follow-up appointments (0, 1, 3, and 12 months), blood tests (0, 1, 3 and 12 months), FibroScan (0, 3 and 12 months) and MRS (0 and 12 months) over a 12-month study period. Patients with significant liver disease on initial biopsy (NAFLD activity score (NAS) greater than 4, any fibrosis, any inflammation or greater than 33% steatosis) will be offered a follow-up liver biopsy at 12-months post-operatively. Liver tissues and serum will be investigated for markers that may indicate disease presence and prognosis.
Interventions
MAGNETIC RESONANCE SPECTROSCOPY (MRS) This is an MRI scan, where the patient lies flat on a platform which is moved through the MRI tunnel. The procedure takes approximately 30 minutes and is carried out by the radiographer. The test is performed at baseline, and follow-up MRS is performed at 1 year after bariatric surgery. Patients will be seen in clinic prior to their scans to arrange a suitable time. Attendance will be checked by the study investigator and rescheduled if required. TRANSIENT ELASTOGRAPHY/FIBROSCAN This test looks at liver stiffness. Patients are scheduled for 3 scans during their year long follow-up (baseline, 3 and 12 months after bariatric surgery). The scan is performed in an outpatient clinic, with a probe on the right upper abdomen, similar to an ultrasound. The procedure takes approximately 10 minutes. It is not painful and there are no risks. The procedure is performed by trained Gastroenterologists. Attendance will be checked by the study investigator and rescheduled if required. SERUM BIOMARKERS Blood tests are taken from the patient at 0, 1, 3 and 12 months after bariatric surgery at their scheduled outpatient appointments. Approximately 20-30ml of blood will be taken at each time point. Tests of interest include routine blood tests, as well as the novel biomarker TNFSF14 (LIGHT) and other circulating cytokines. BARIATRIC SURGERY Surgery will occur as planned by their treating team.
Sponsors
Study design
Eligibility
Inclusion criteria
Patients >17 years undergoing bariatric surgery and any of: - AST or ALT > 0.5 upper limit normal - GGT > upper limit normal - Abnormal transient elastography - Abnormal ultrasound suggesting NAFLD
Exclusion criteria
Other cause of liver disease Past or current excessive ETOH