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.
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.
Centre for Obesity Research and Education (CORE) Monash University,
10 participants
Jun 1, 2005
Observational
Conditions
Eligibility
Inclusion Criteria1
- 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.
Exclusion Criteria1
- 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.
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Interventions
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.
Locations(1)
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ACTRN12605000287639