Pathophysiology and treatment of nonalcoholic fatty liver disease (NAFLD): Effects of bariatric surgery

• Register: ANZCTR
• Last refreshed on: 9 November 2020
• Main ID: ACTRN12615000874516
• Date of registration: 21/08/2015
• Prospective Registration: No
• Primary sponsor: Centre for Obesity Research and Education, Monash University
• Public title: Pathophysiology and treatment of nonalcoholic fatty liver disease (NAFLD): Effects of bariatric surgery
• Scientific title: Efficacy of bariatric surgery for the treatment of NAFLD in obese patients
• Date of first enrolment: 29/06/2015
• Target sample size: 100
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000874516.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Blinded (masking used);Assignment: Single group;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Geraldine Ooi

• Name: Dr Geraldine Ooi

Key inclusion & exclusion criteria

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


Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Obesity ;Non-alcoholic fatty liver disease ;Bariatric Surgery;
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

Intervention(s)

Bariatric Surgery:
- Laparoscopic adjustable gastric banding [approximately 1 hour]
- sleeve gastrectomy (laparoscopic or open) [approximately 1-2 hours]
- gastric bypass (laparoscopic or open) [approximately 2-3 hours]
- BPD [approximately 2-3 hours]
Choice of bariatric surgery will be at patient and clinician discretion.

Liver biopsy and adipose tissue biopsy will be taken during the operation.
- Liver biopsy may sometimes be taken by the surgeon if there is obvious liver disease macroscopically, or pre-operative suspicion. It is not routine for all patients.
- Adipose tissue biopsy is not part of routine clinical care and is taken for research purposes only.

Primary Outcome(s)

Changes in liver histology with surgically induced weight loss (comparison of baseline liver biopsy with follow-up liver biopsy)[1 year]

Secondary Outcome(s)

Changes in immune cell infiltrate and expression of TNFSF14/LIGHT (immune cell related marker) in NASH with weight loss (as investigated via immunohistochemistry of liver). [1 year]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Centre for Obesity Research and Education, Monash University

The Alfred Research Trust

Secondary Sponsor(s)

Department of Gastroenterology and Department of Upper Gastrointestinal Surgery, The Alfred Hospital

Ethics review

Status: Approved
Approval date: 09/06/2015
Contact:

Status: Approved
Approval date: 17/06/2015
Contact:

Results

• Results available: Yes
• Date Posted: 17/06/2019
• Date Completed: 05/08/2019