Effect of Lipid Modifying Drugs on HDL Function in Patients With Hyperlipidemia

Not Applicable

Completed

• Conditions: Hyperlipidemia
• Interventions: Drug: Omega-3 2g; Drug: Atorvastatin 20 mg; Drug: Concurrent with Atorvastatin 5 mg + Ezetimibe 10 mg; Behavioral: Lifestyle modification; Drug: Cholestyramine 8 g

• Registration Number: NCT02942602
• Lead Sponsor: Yonsei University

Brief Summary

1) to test HDL function comprehensively in healthy and diseased individuals; 2) to evaluate if this test correlates with cardiovascular risk, independent of traditional risk factors; 3) and to differentiate effects of lipid-modifying or antiatherosclerotic drugs on HDL function and composition

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-03
• Primary Completion: 2016-05-23
• Study Completion: 2016-05-23
• Study First Submitted: 2016-10-17
• Study First Submitted QC: 2016-10-21
• Study First Posted: 2016-10-24
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-15
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy
• Aged over 20
• Consent form signed

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Exclusion Criteria

• pregnant or lactating women
• subjects with familial hypercholesterolemia
• uncontrolled hypertension or DM
• Thyroid dysfunction
• Active liver disease (transaminase or bilirubin > 1.5 x NL)
• Serum creatinine > 2 mg/dL
• Included in other clinical trials within 3 months
• using of other medication: fish oil, fibric acid derivatives, niacin, systemic corticosteroid, thiazolidinedione

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omega-3 (EPA+DHA) 2 g	Omega-3 2g	lipid lowering treatment
Atorvastatin 20 mg	Atorvastatin 20 mg	lipid lowering treatment
Atorvastatin 5 mg + Ezetimibe 10 mg	Concurrent with Atorvastatin 5 mg + Ezetimibe 10 mg	lipid lowering treatment
Life style modification for management of dyslipidemia	Lifestyle modification	-
Cholestyramine 8 g	Cholestyramine 8 g	lipid lowering treatment

Primary Outcome Measures

Name	Time	Method
Cholesterol efflux capacity (%)	Change of HDL functions from baseline to 8 weeks	\[3H-cholesterol (µCi) in medium containing HDL/(3H-cholesterol {µCi} in medium containing HDL+µCi of 3H-cholesterol {µCi} in cells)\] x 100
Endothelial NO production (Arbitrary unit)	up to 8 weeks	measured with nitrate assay kit and expressed as relative amount compared to control (no HDL treatment sample)
VCAM-1 expression (Arbitrary unit)	up to 8 weeks	western blotting of VCAM-1 protein and expressed as relative amount compared to control (no HDL treatment sample)
ROS generation (Arbitrary unit)	up to 8 weeks	fluorescence intensity measurement using dichlorodihydrofluorescein diacetate and expressed as relative amount compared to control (no HDL treatment sample)

Secondary Outcome Measures

Name	Time	Method
ApoC-III	Change of HDL associated proteins from each patient at baseline and at 8 weeks	quantitation of intensity of western blot and expresses as relative amount to control (no HDL treatment sample)
ApoC-II	Change of HDL associated proteins from each patient at baseline and at 8 weeks	quantitation of intensity of western blot and expresses as relative amount to control (no HDL treatment sample)
ApoA-I	Change of HDL associated proteins from each patient at baseline and at 8 weeks	quantitation of intensity of western blot and expresses as relative amount to control (no HDL treatment sample)
ApoA-II	Change of HDL associated proteins from each patient at baseline and at 8 weeks	quantitation of intensity of western blot and expresses as relative amount to control (no HDL treatment sample)
ApoC-I	Change of HDL associated proteins from each patient at baseline and at 8 weeks	quantitation of intensity of western blot and expresses as relative amount to control (no HDL treatment sample)

Trial Locations

Locations (1)

Division of Cardiology, Department of Internal Medicine,; 🇰🇷 Seoul, Korea, Republic of