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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.

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12605000284662
Enrollment
40
Registered
2005-09-02
Start date
2004-07-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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 or

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.

Sponsors

Centre for Obesity Research and Education (CORE)
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026