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.
- Conditions
- on alcoholic steato hepatitis (NASH)Non alcoholic steato hepatitis (NASH)Diet and Nutrition -Inflammatory and Immune System - Other inflammatory or immune system disorders
- Registration Number
- ACTRN12605000287639
- Lead Sponsor
- Centre for Obesity Research and Education (CORE) Monash University,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
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.
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in liver histology[At 6 weeks.]
- Secondary Outcome Measures
Name Time Method Change in liver volume[At 6 weeks.];Changes in liver enzymes[At 6 weeks.];Change in weight [At 6 weeks.]