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Postprandial Lipid Metabolism in Familial Hypercholesterolaemia:Effects of Fish Oils (FIFH)

Primary Purpose

Hypertriglyceridaemia, Familial Hypercholesterolaemia

Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Fish oil capsule
HMG Coenzyme reductase
Sponsored by
The University of Western Australia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertriglyceridaemia focused on measuring Familial hypercholesterolaemia, Postprandial dyslipidaemia, Fish oil treatment, Cardiovascular disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • School of Medicine & Pharmacology,University of Western Australia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Fish oil

Placebo

Arm Description

FH subjects with standard treatment (statin treatment)

Outcomes

Primary Outcome Measures

Postprandial changes in triglyceride-rich lipoprotein concentrations
Incremental area-under-the-curve (AUC) for triglycerides, apoB-48 and retinyl palmitate

Secondary Outcome Measures

Triglyceride-rich lipoprotein kinetics
Kinetic studies of apoB48 and apoB-100 kinetics

Full Information

First Posted
April 10, 2012
Last Updated
April 11, 2012
Sponsor
The University of Western Australia
Collaborators
National Health and Medical Research Council, Australia
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1. Study Identification

Unique Protocol Identification Number
NCT01577056
Brief Title
Postprandial Lipid Metabolism in Familial Hypercholesterolaemia:Effects of Fish Oils
Acronym
FIFH
Official Title
Effect of Fish Oil Supplementation on Postprandial Lipid Metabolism in Familial Hypercholesterolaemia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Western Australia
Collaborators
National Health and Medical Research Council, Australia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridaemia, Familial Hypercholesterolaemia
Keywords
Familial hypercholesterolaemia, Postprandial dyslipidaemia, Fish oil treatment, Cardiovascular disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fish oil
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
FH subjects with standard treatment (statin treatment)
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish oil capsule
Other Intervention Name(s)
Omacor
Intervention Description
4g Omega capsule for 12 weeks
Intervention Type
Drug
Intervention Name(s)
HMG Coenzyme reductase
Other Intervention Name(s)
Statin
Intervention Description
All FH subjects are on standard statin treatment during study period
Primary Outcome Measure Information:
Title
Postprandial changes in triglyceride-rich lipoprotein concentrations
Description
Incremental area-under-the-curve (AUC) for triglycerides, apoB-48 and retinyl palmitate
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Triglyceride-rich lipoprotein kinetics
Description
Kinetic studies of apoB48 and apoB-100 kinetics
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dick Chan, PhD
Phone
61-8-92240268
Email
dick.chan@uwa.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dick Chan, Phd
Organizational Affiliation
The University of Western Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Medicine & Pharmacology,University of Western Australia
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dick Chan, PhD
Phone
61-8-92240268
Email
dick.chan@uwa.edu.au

12. IPD Sharing Statement

Citations:
PubMed Identifier
27614801
Citation
Chan DC, Pang J, Barrett PH, Sullivan DR, Mori TA, Burnett JR, van Bockxmeer FM, Watts GF. Effect of omega-3 fatty acid supplementation on arterial elasticity in patients with familial hypercholesterolaemia on statin therapy. Nutr Metab Cardiovasc Dis. 2016 Dec;26(12):1140-1145. doi: 10.1016/j.numecd.2016.07.012. Epub 2016 Aug 3.
Results Reference
derived
PubMed Identifier
27490922
Citation
Chan DC, Pang J, Barrett PH, Sullivan DR, Burnett JR, van Bockxmeer FM, Watts GF. omega-3 Fatty Acid Ethyl Esters Diminish Postprandial Lipemia in Familial Hypercholesterolemia. J Clin Endocrinol Metab. 2016 Oct;101(10):3732-3739. doi: 10.1210/jc.2016-2217. Epub 2016 Aug 4.
Results Reference
derived

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Postprandial Lipid Metabolism in Familial Hypercholesterolaemia:Effects of Fish Oils

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