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Trial registered on ANZCTR


Registration number
ACTRN12615000874516
Ethics application status
Approved
Date submitted
28/07/2015
Date registered
21/08/2015
Date last updated
3/11/2020
Date data sharing statement initially provided
17/06/2019
Type of registration
Retrospectively registered

Titles & IDs
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
Secondary ID [1] 287163 0
Nil
Universal Trial Number (UTN)
U1111-1173-0844
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity
 295730 0
Non-alcoholic fatty liver disease
 295731 0
Bariatric Surgery 295873 0
Condition category
Condition code
Diet and Nutrition 296008 296008 0 0
Obesity
Oral and Gastrointestinal 296009 296009 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 296125 296125 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 292438 0
Treatment: Surgery
Comparator / control treatment
No control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295679 0
Changes in liver histology with surgically induced weight loss (comparison of baseline liver biopsy with follow-up liver biopsy)
Timepoint [1] 295679 0
1 year
Secondary outcome [1] 316553 0
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).
Timepoint [1] 316553 0
1 year

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other cause of liver disease
Past or current excessive ETOH

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consecutive patients undergoing bariatric surgery who meet inclusion criteria will be invited to participate.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size has been powered to observe a difference in mean NALFD activity score of 0.90, based on previous data of histological changes in paired liver biopsies [Mathurin et al, 2009]. In this study, the pre-operative mean NAS was 1.97 +/- 1.33, and post-operative mean NAS was 1.07 +/- 1.26. This created an effect size of 0.694. The G*power 3.1 program was used to calculated the power with alpha error of 0.05 and power of 0.90. Two tailed t-test using differences between the mean was used. The determined sample size calculated was 24 patients.
To account for 75% of patients consenting to further biopsy, we would need 36 patients with NASH. With a 25-50% incidence of NASH in the obese, we would be aiming for approximately 100 patients.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/06/2015
Actual
29/06/2015
Date of last participant enrolment
Anticipated
30/05/2016
Actual
4/12/2016
Date of last data collection
Anticipated
27/01/2020
Actual
5/08/2019
Sample size
Target
100
Accrual to date
Final
190
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291732 0
Charities/Societies/Foundations
Name [1] 291732 0
The Alfred Research Trust
Country [1] 291732 0
Australia
Funding source category [2] 291733 0
University
Name [2] 291733 0
Centre for Obesity Research and Education, Monash University
Country [2] 291733 0
Australia
Primary sponsor type
University
Name
Centre for Obesity Research and Education, Monash University
Address
Level 6, The Alfred Centre
99 Commercial Road
Prahran,
Victoria, 3181
Country
Australia
Secondary sponsor category [1] 290407 0
Hospital
Name [1] 290407 0
Department of Gastroenterology and Department of Upper Gastrointestinal Surgery, The Alfred Hospital
Address [1] 290407 0
99 Commercial Road,
Prahran
Victoria 3181
Country [1] 290407 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293254 0
The Alfred Hospital HREC
Ethics committee address [1] 293254 0
99 Commercial Road
Prahran
Victoria 3181
Ethics committee country [1] 293254 0
Australia
Date submitted for ethics approval [1] 293254 0
Approval date [1] 293254 0
09/06/2015
Ethics approval number [1] 293254 0
195/15
Ethics committee name [2] 293255 0
Monash University HREC
Ethics committee address [2] 293255 0
Monash University
Room 111, Chancellery Building E
24 Sports Walk, Clayton Campus
Wellington Road, Clayton, VICTORIA, 3800
Ethics committee country [2] 293255 0
Australia
Date submitted for ethics approval [2] 293255 0
Approval date [2] 293255 0
17/06/2015
Ethics approval number [2] 293255 0
CF15/2419-2015000971

Summary
Brief summary
This is a prospective cohort study for patients undergoing bariatric surgery who have risk factors for NAFLD, to investigate the impact of surgical weight loss on the liver.
Patients who are already scheduled for bariatric surgery who fit criteria for likely NAFLD will be recruited from The Alfred Hospital, to undergo an intraoperative liver and adipose tissue biopsy. Patients with significant liver disease on initial biopsy (NAFLD activity score (NAS) greater than 4 or fibrosis score greater than F1) will be offered a follow-up liver biopsy at 12-months post-operatively.
Liver tissues will be investigated for markers that may indicate disease prognosis and underlying pathophysiology, particularly immune cell markers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59106 0
Dr Geraldine Ooi
Address 59106 0
Centre for Obesity Research and Education, Monash University
Level 6, The Alfred Centre
99 Commercial Road, Prahran
Victoria, 3181
Country 59106 0
Australia
Phone 59106 0
+613 9903 0725
Fax 59106 0
Email 59106 0
[email protected]
Contact person for public queries
Name 59107 0
Geraldine Ooi
Address 59107 0
Centre for Obesity Research and Education, Monash University
Level 6, The Alfred Centre
99 Commercial Road, Prahran
Victoria, 3181
Country 59107 0
Australia
Phone 59107 0
+613 9903 0725
Fax 59107 0
Email 59107 0
[email protected]
Contact person for scientific queries
Name 59108 0
Geraldine Ooi
Address 59108 0
Centre for Obesity Research and Education, Monash University
Level 6, The Alfred Centre
99 Commercial Road, Prahran
Victoria, 3181
Country 59108 0
Australia
Phone 59108 0
+613 9903 0725
Fax 59108 0
Email 59108 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.