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.

Not Applicable

Completed

• Conditions: Fatty liver; Diet and Nutrition - Obesity; Surgery - Other surgery

• Registration Number: ACTRN12605000284662
• Lead Sponsor: Centre for Obesity Research and Education (CORE)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in liver volume[At 12 weeks]

Secondary Outcome Measures

Name	Time	Method
Change in intra-abdominal fat[At 12 weeks.];Changes in liver enzymes[At 12 weeks.];Change in weight[At 12 weeks.];Change in biochemistry[At 12 weeks.];Quality of life[At 12 weeks.];Comorbidity of obesity[At 12 weeks.]