Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000284662
Ethics application status
Approved
Date submitted
24/08/2005
Date registered
2/09/2005
Date last updated
2/12/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective observational study of the effect of a pre-operative 12 week very low calorie diet (VLCD) on liver volume and intra-abdominal fat mass in severely obese patients presenting for obesity surgery.
Scientific title
A prospective observational study of the effect of a pre-operative 12 week very low calorie diet (VLCD) on liver volume and intra-abdominal fat mass in severely obese patients presenting for obesity surgery.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fatty liver 372 0
Condition category
Condition code
Diet and Nutrition 438 438 0 0
Obesity
Surgery 439 439 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
40 consecutive consenting patients presenting for obesity surgery will undergo a 12 week preoperative program of weight loss using a VLCD (Optifast) . An abdominal CT scan will be taken at baseline to measure liver volume and intraabdominal fat mass at baseline and a repeat CT scan will be taken at completion of the 12-week VLCD. Ten subjects who are noted to have larger livers on initial CT scan will be invited to undergo 5 serial MRI scans-baseline, 2-weeks, 4-weeks, 8-weeks and 12-weeks in order to assess the pattern of liver size reduction during intervention. Changes in pre-existing obesity related comorbidities, biochemistry and health related quality of life as well as patient acceptability and compliance to the 12-week VLCD will also examined.
Intervention code [1] 249 0
Treatment: Drugs
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 499 0
Change in liver volume
Timepoint [1] 499 0
At 12 weeks
Secondary outcome [1] 1075 0
Change in intra-abdominal fat
Timepoint [1] 1075 0
At 12 weeks.
Secondary outcome [2] 1076 0
Changes in liver enzymes
Timepoint [2] 1076 0
At 12 weeks.
Secondary outcome [3] 1077 0
Change in weight
Timepoint [3] 1077 0
At 12 weeks.
Secondary outcome [4] 1078 0
Change in biochemistry
Timepoint [4] 1078 0
At 12 weeks.
Secondary outcome [5] 1079 0
Quality of life
Timepoint [5] 1079 0
At 12 weeks.
Secondary outcome [6] 1080 0
Comorbidity of obesity
Timepoint [6] 1080 0
At 12 weeks.

Eligibility
Key inclusion criteria
Have body weight less than 150kg and stable within ±5kg over the previous 3 months, have a pre-operative body mass index greater than 50kg/m2 for women or greater than 40kg/m2 for men or of lower BMI if they fulfill the criteria for a diagnosis of the metabolic syndrome by having 3 or more of the following: waist circumference women >88cm, men>102cm, serum triglycerides>1.69mmol/L, HDL-cholesterol women <1.29mmol/L, men<1.04mmol/L, blood pressure >130/85,FBG>6.1mmol/L, be able to understand and agree to comply with the requirements of the VLCD and monitoring over the 12 weeks, be able to provide informed consent to participate in the study.
Minimum age
18 Years
Maximum age
60 Years
Sex
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, severe hepatic disease, advancing renal disease, pregnancy and lactation, acute cerebrovascular or cardiovascular disease, overt psychosis, type 1 diabetes, porphyria, inability to complete the 12-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
Completed
Date of first participant enrolment
Anticipated
1/07/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 491 0
University
Name [1] 491 0
Centre for Obesity Research and Education (CORE) Monash University
Country [1] 491 0
Australia
Funding source category [2] 492 0
Commercial sector/Industry
Name [2] 492 0
Novartis
Country [2] 492 0
Australia
Primary sponsor type
University
Name
Centre for Obesity Research and Education (CORE)
Address
Monash Medical School
Commercial Road
Melbourne 3004
Country
Australia
Secondary sponsor category [1] 394 0
None
Name [1] 394 0
none
Address [1] 394 0
Country [1] 394 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1467 0
The Avenue Hospital
Ethics committee address [1] 1467 0
Melbourne
Ethics committee country [1] 1467 0
Australia
Date submitted for ethics approval [1] 1467 0
Approval date [1] 1467 0
Ethics approval number [1] 1467 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Colles SL, Dixon JB, Marks P, Strauss BJ, O'Brien P E. Preoperative weight loss with a very-low-energy diet: quantitation of changes in liver and abdominal fat by serial imaging. Am J Clin Nutr 2006;84:304-11.
Public notes

Contacts
Principal investigator
Name 35415 0
Address 35415 0
Country 35415 0
Phone 35415 0
Fax 35415 0
Email 35415 0
Contact person for public queries
Name 9438 0
Ms Susan Colles
Address 9438 0
Centre for Obesity Research and Education (CORE)
Monash University Medical School
Alfred Hospital
Commercial Road
Melbourne VIC 3004
Country 9438 0
Australia
Phone 9438 0
+61 3 99030721
Fax 9438 0
+61 3 95103365
Email 9438 0
[email protected]
Contact person for scientific queries
Name 366 0
Assoc. Prof John Dixon
Address 366 0
Monash University
School of Primary Health Care
Building 1, 270 Ferntree Gully Road
Notting Hill 3168
Country 366 0
Australia
Phone 366 0
+61 3 9501 2431
Fax 366 0
+61 3 8575 2233
Email 366 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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