Familial Hypercholesterolaemia, Hypertriglyceridaemia
Conditions
Keywords
Familial hypercholesterolaemia, Postprandial dyslipidaemia, Fish oil treatment, Cardiovascular disease
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTFish oil capsule
4g Omega capsule for 12 weeks
DRUGHMG Coenzyme reductase
All FH subjects are on standard statin treatment during study period
Sponsors
National Health and Medical Research Council, Australia
The University of Western Australia
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial changes in triglyceride-rich lipoprotein concentrations | 12 weeks | Incremental area-under-the-curve (AUC) for triglycerides, apoB-48 and retinyl palmitate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Triglyceride-rich lipoprotein kinetics | 12 weeks | Kinetic studies of apoB48 and apoB-100 kinetics |
Countries
Australia
Contacts
Primary ContactDick Chan, PhD
Outcome results
None listed