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.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12605000287639

Enrollment

Registered

2005-09-05

Start date

2005-06-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

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 criteria

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.

Outcome results