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Trial registered on ANZCTR


Trial ID
ACTRN12605000287639
Ethics application status
Approved
Date submitted
24/08/2005
Date registered
5/09/2005
Date last updated
2/12/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Analysis of the effect of a 6 week very low calorie diet (VLCD) on patients at high risk of NASH as shown by changes of liver biopsy, liver biochemistry and CT scan.
Scientific title
Analysis of the effect of a 6 week very low calorie diet (VLCD) on patients at high risk of Non alcoholic steato hepatitis as shown by changes of liver biopsy, liver biochemistry and CT scan.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non alcoholic steato hepatitis (NASH) 375 0
Condition category
Condition code
Diet and Nutrition 444 444 0 0
Inflammatory and Immune System 445 445 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients presenting for obesity surgery who are at high risk of NASH by having all three of Type 2 diabetes or insulin resistance, hypertension and abnormal liver function tests (LFT) will undergo a 6 week program of weight loss finishing just prior to surgery using a VLCD (Optifast). Prior to VLCD intervention, biochemistry will be collected and a percutaneous liver biopsy and liver CT performed. Repeat measures of biochemistry and liver CT will be performed on completion of the VLCD course and the liver biopsy will be repeated during laparoscopy for the obesity surgery.
Intervention code [1] 250 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 503 0
Change in liver histology
Timepoint [1] 503 0
At 6 weeks.
Secondary outcome [1] 1086 0
Change in liver volume
Timepoint [1] 1086 0
At 6 weeks.
Secondary outcome [2] 1087 0
Changes in liver enzymes
Timepoint [2] 1087 0
At 6 weeks.
Secondary outcome [3] 1088 0
Change in weight
Timepoint [3] 1088 0
At 6 weeks.

Eligibility
Key inclusion criteria
Have body weight less than 150kg and stable within ±5kg over the previous 3 months. In addition they must have all 3 of the following: blood pressure >140/90 or treated hypertension, Type 2 diabetes or FBG>6.1mmol/L and have one or more abnormal liver function tests. Patients must also be able to understand and agree to comply with the requirements of the VLCD and monitoring over the 6 weeks and be able to provide informed consent to participate in the study.
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medical contra-indications for use of a VLCD (based on the Optifast VLCD treatment protocol, May 2003) which include: pancreatitis, advancing renal disease, pregnancy and lactation, acute cerebrovascular or cardiovascular disease, overt psychosis, type 1 diabetes and porphyria, inability to complete the 6-week VLCD program and monitoring requirements, inability to understand the requirements for optimal effectiveness of VLCD.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 495 0
University
Name [1] 495 0
Centre for Obesity Research and Education (CORE) Monash University
Address [1] 495 0
Country [1] 495 0
Australia
Primary sponsor type
University
Name
Centre for Obesity Research and Education (CORE) Monash University,
Address
Country
Australia
Secondary sponsor category [1] 404 0
None
Name [1] 404 0
none
Address [1] 404 0
Country [1] 404 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1471 0
The Avenue Hospital
Ethics committee address [1] 1471 0
Melbourne
Ethics committee country [1] 1471 0
Australia
Date submitted for ethics approval [1] 1471 0
Approval date [1] 1471 0
Ethics approval number [1] 1471 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36092 0
Address 36092 0
Country 36092 0
Phone 36092 0
Fax 36092 0
Email 36092 0
Contact person for public queries
Name 9439 0
Ms Susan Colles
Address 9439 0
Centre for Obesity Research and Education (CORE)
Monash University Medical School
Alfred Hospital
Commercial Road
Melbourne VIC 3004
Country 9439 0
Australia
Phone 9439 0
+61 3 99030721
Fax 9439 0
+61 3 95103365
Email 9439 0
susan.colles@med.monash.edu.au
Contact person for scientific queries
Name 367 0
Associate Professor John Dixon
Address 367 0
Centre for Obesity Research and Education (CORE)
Monash University Medical School
Alfred Hospital
Commercial Road
Melbourne VIC 3004
Country 367 0
Australia
Phone 367 0
+61 3 99030721
Fax 367 0
+61 3 95103365
Email 367 0
john.dixon@med.monash.edu.au