Treatment of Non Alcoholic Fatty Liver Disease With n-3 Fatty Acids
Non alcoholic fatty liver disease (NAFLD) imposes a high and increasing burden on the NHS, yet there is presently no licensed treatment or validated approach to management. NAFLD predisposes to increased risk of type 2 diabetes, increased risk of cardiovascular disease and may progress to chronic irreversible liver disease.
In NAFLD patients, the investigators will test the hypothesis that treatment with long chain n-3 fatty acid supplementation for 18 months favourably influences bio-markers for NAFLD and risk factors for cardiovascular disease and type 2 diabetes.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||The Effects of Purified n-3 Fatty Acids on Serum Fibrosis Markers and Cardiovascular Risk Markers in a Randomized Placebo Controlled Trial in Patients With Non Alcoholic Fatty Liver Disease|
- Change in biomarkers for NAFLD and change in liver fat [ Time Frame: 18 months ] [ Designated as safety issue: No ]The primary end-points of the study are: a) to assess change in serum biomarkers with treatment b) to validate changes in biomarkers with changes in Kleiner liver biopsy score in a sub-group of volunteers who opt for a follow-up liver biopsy and c) to validate changes in biomarkers with changes in liver fat measured by MR scan of liver for the whole study population.
- Change in risk factors for cardiovascular disease and type 2 diabetes [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Secondary end-points of the study are:
a) to assess changes in measures of insulin sensitivity, microvascular function, carotid intima-media thickness, echocardiographic parameters, plasma cardiovascular risk markers, ankle brachial pressure index and pulse wave velocity and analysis (see below) with treatment.
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
We will recruit people with NAFLD who have been diagnosed as part of their NHS care with having this condition. At present there is no treatment for this condition. Over time a proportion of people with NAFLD.
Purpose and design
We are asking the research question ' Does treatment with purified long chain n-3 fatty acids (purified fish oil) improve non alcoholic fatty liver disease and risk factors for heart disease and type 2 (adult) diabetes that are strongly linked to this liver condition?'
Presently there is no treatment for this liver condition. Research evidence suggests that purified long chain n-3 fatty acids might be beneficial for this condition.
To address this research question we want to undertake a randomised double blind placebo controlled trial recruiting people who have been diagnosed with a liver biopsy as having the liver condition.
|Southamption General Hospital|
|Southampton, Hants, United Kingdom, SO166YD|