Postprandial Lipid Metabolism in Familial Hypercholesterolaemia:Effects of Fish Oils

Study Overview
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Brief Summary
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The purpose of this study is to determine whether fish oil supplementation is effective in the treatment of abnormal fat metabolism in subjects with elevated cholesterolaemia.

Detailed Description
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The use of statin therapy in familial hypercholesterolaemia (FH) is known to reduce cardiovascular risk and is a first line recommendation, however, there is considerable residual risk predicted by the presence of fasting and post-prandial hypertriglyceridaemia. This study will examine the effect of oral n-3 fatty acid ethyl esters supplementation (4g/day, Omacor) on postprandial hypertriglyceridaemia and post-prandial arterial function when administrated to FH patients at increased risk of cardiovascular disease due to their residual fasting hypertriglyceridaemia.

Official Title
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Effect of Fish Oil Supplementation on Postprandial Lipid Metabolism in Familial Hypercholesterolaemia

Conditions
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Hypertriglyceridaemia, Familial Hypercholesterolaemia

Intervention / Treatment
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* Dietary Supplement: Fish oil capsule
* Drug: HMG Coenzyme reductase


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with FH (genetically defined LDL-receptor mutation or Dutch score >8) on statin treatment only Hypertriglyceridaemia on a random blood sample (triglycerides >1.5mml/L) Exclusion Criteria: Subjects with diabetes mellitus major systemic illness or use of steroids or other lipid-regulating drugs (such as niacin, fibrate and colesevelam) patients on hypocaloric diets or LDL apheresis; anaemia, haemorrhage and pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fish oil<br> | Dietary Supplement: Fish oil capsule<br>* 4g Omega capsule for 12 weeks<br>* Other names: Omacor;|
| Placebo Comparator: Placebo<br>FH subjects with standard treatment (statin treatment) | Drug: HMG Coenzyme reductase<br>* All FH subjects are on standard statin treatment during study period<br>* Other names: Statin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial changes in triglyceride-rich lipoprotein concentrations | Incremental area-under-the-curve (AUC) for triglycerides, apoB-48 and retinyl palmitate | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglyceride-rich lipoprotein kinetics | Kinetic studies of apoB48 and apoB-100 kinetics | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Familial hypercholesterolaemia, Postprandial dyslipidaemia, Fish oil treatment, Cardiovascular disease