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.

Centre for Obesity Research and Education (CORE)0 sites40 target enrollmentSeptember 2, 2005

Overview

No summary available.

Registry

who.int

Start Date

September 2, 2005

End Date

TBD

Last Updated

6 years ago

Study Type

Observational

Sex

All

Sponsor

Centre for Obesity Research and Education (CORE)

•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.

•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.