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Non-invasive diagnosis and monitoring of non-alcoholic fatty liver disease in bariatric surgical patients

Efficacy of non-invasive tests in diagnosing and monitoring NAFLD in adult bariatric surgical patients

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000875505
Enrollment
190
Registered
2015-08-21
Start date
2015-06-29
Completion date
2016-12-04
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

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

Centre for Obesity Research and Education, Monash University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 4, 2026