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

Not Applicable

Completed

• Conditions: Obesity; Non-alcoholic fatty liver disease; Bariatric surgery; Diet and Nutrition - Obesity; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Surgery - Other surgery

• Registration Number: ACTRN12615000875505
• Lead Sponsor: Centre for Obesity Research and Education, Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 190

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of serum biomarkers in measuring NAFLD in the bariatric cohort by comparison to liver biopsy[Baseline (comparing to intraoperative liver biopsy), 1 month, 3 months and 1 year (comparing to percutaneous liver biopsy)];Efficacy of transient elastography in measuring NAFLD in the bariatric cohort by comparison with liver biopsy[Baseline (around time of bariatric surgery - comparing to intraoperative liver biopsy), 3 months and 1 year (comparing to percutaneous liver biopsy)];Efficacy of MR spectroscopy in measuring NAFLD in the bariatric cohort by comparison to liver biopsy[Baseline (comparing to intraoperative liver biopsy) and 1 year (comparing to percutaneous liver biopsy)]

Secondary Outcome Measures

Name	Time	Method
Change in NAFLD with surgically induced weight loss as measured by liver biopsy[Baseline and 1 year];Correlation of mRNA profile of adipose tissue with liver biopsy in patients with NAFLD. [Baseline]