Treatment of Non Alcoholic Fatty Liver Disease With n-3 Fatty Acids
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Alcoholic Fatty Liver Disease |
Drug: OMACOR |
Phase 2 |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 100 |
| 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) |
-
Drug: OMACOR
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Steatohepatitis diagnosed on normal clinical grounds including in most cases liver biopsy and assessed by Kleiner scoring system to assess severity, with no known aetiological factors for underlying liver disease (e.g. exclusion of hepatitis A, B & C, primary biliary cirrhosis, autoimmune hepatitis, haemochromatosis).
- Steatosis diagnosed by ultrasound, CT or magnetic resonance imaging who also have either diabetes and/or features of the metabolic syndrome, without evidence of known aetiological factors for underlying liver disease (e.g. exclusion of hepatitis A, B & C, primary biliary cirrhosis, autoimmune hepatitis, haemochromatosis).
Liver biopsy or liver scan will be within 3 years of recruitment to the study. Age: men & women >18 years. Alcohol consumption <35 units / week for women <50 units / week for men).
Exclusion criteria:
- Decompensated acute or chronic liver disease, or harmful drinking (> 35 u/week in women > 50 u /week in men).
Contacts and Locations| United Kingdom | |
| Southamption General Hospital | |
| Southampton, Hants, United Kingdom, SO166YD | |
More Information
No publications provided by University Hospital Southampton NHS Foundation Trust.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University Hospital Southampton NHS Foundation Trust. |
| ClinicalTrials.gov Identifier: | NCT00760513 History of Changes |
| Other Study ID Numbers: | 25-12-59. (R&D: RHM MED 0836), EudraCT number 2008-003766-26 |
| Study First Received: | September 25, 2008 |
| Last Updated: | June 11, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: National Health Service |
Keywords provided by University Hospital Southampton NHS Foundation Trust.:
|
non alcoholic fatty liver disease NAFLD fish oil |
intervention RCT biomarkers |
Additional relevant MeSH terms:
|
Fatty Liver Liver Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013