Clinical Trial: Treatment of Non Alcoholic Fatty Liver Disease With n-3 Fatty Acids

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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 Li

Brief Summary:

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.


Detailed Summary:

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.

A protocol change that were approved during in the course of the study in October 2011.

In the protocol, we have deleted information regarding liver biopsy that was to be offered at the end of the study.

Having collated volunteer opinion and local consultant opinion, whereas a high proportion of volunteers were happy to undergo a follow up liver biopsy, our local hepatologists now consider that in 2011, the small risk of morbidity and mortality of volunteers undergoing liver biopsy is unacceptable, within the context of a research study. Their opinions have changed since 2008 when the initial LREC approval was granted.

Liver biopsy was always an optional extra and would only have b
Sponsor: University Hospital Southampton NHS Foundation Trust

Current Primary Outcome: Change in biomarkers for NAFLD and change in liver fat [ Time Frame: 18 months ]

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.


Original Primary Outcome: Change in biomarkers for NAFLD [ Time Frame: 18 months ]

Current Secondary Outcome: Change in risk factors for cardiovascular disease and type 2 diabetes [ Time Frame: 18 months ]

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.



Original Secondary Outcome: Change in risk factors for cardiovascular disease and type 2 diabetes [ Time Frame: 18 months ]

Information By: University Hospital Southampton NHS Foundation Trust

Dates:
Date Received: September 25, 2008
Date Started: November 2009
Date Completion: February 2017
Last Updated: April 14, 2016
Last Verified: April 2016