RecruitingACTRN12605000287639

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.


Sponsor

Centre for Obesity Research and Education (CORE) Monash University,

Enrollment

10 participants

Start Date

Jun 1, 2005

Study Type

Observational

Conditions


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at whether following a very low calorie diet (VLCD) for 6 weeks can improve liver health in people who are at high risk of a serious liver condition called NASH (non-alcoholic steatohepatitis). NASH is caused by fat build-up in the liver and can lead to liver damage over time. Researchers will check whether the diet improves liver test results and reduces fat in the liver using blood tests, CT scans, and in some cases, liver biopsy. You may be eligible if: - You are between 18 and 60 years old - Your body weight is under 150 kg and has been stable for the last 3 months - You have high blood pressure (above 140/90) or are treated for it - You have Type 2 diabetes or a fasting blood sugar above 6.1 mmol/L - You have one or more abnormal liver function test results - You are willing and able to follow the very low calorie diet for 6 weeks You may NOT be eligible if: - You have pancreatitis, advancing kidney disease, or type 1 diabetes - You are pregnant or breastfeeding - You have acute stroke or heart disease - You have porphyria or a serious mental health condition - You are unable to complete the 6-week program Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

Australia

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ACTRN12605000287639


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