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

Hyperlipidemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02942602
• Other study ID #: 4-2013-0281
• Status: Completed
• Phase: N/A
• Start date: April 3, 2014
• Est. completion date: May 23, 2016

Study information

• Verified date: July 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 23, 2016
• Est. primary completion date: May 23, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Drug:
• Atorvastatin 20 mg
The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups.
• Cholestyramine 8 g
The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups.
• Omega-3 2g
The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups.
• Concurrent with Atorvastatin 5 mg + Ezetimibe 10 mg
The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups.

Behavioral:
• Lifestyle modification
The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups.

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Department of Internal Medicine,	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cholesterol efflux capacity (%)	[3H-cholesterol (µCi) in medium containing HDL/(3H-cholesterol {µCi} in medium containing HDL+µCi of 3H-cholesterol {µCi} in cells)] x 100	Change of HDL functions from baseline to 8 weeks
Primary	Endothelial NO production (Arbitrary unit)	measured with nitrate assay kit and expressed as relative amount compared to control (no HDL treatment sample)	up to 8 weeks
Primary	VCAM-1 expression (Arbitrary unit)	western blotting of VCAM-1 protein and expressed as relative amount compared to control (no HDL treatment sample)	up to 8 weeks
Primary	ROS generation (Arbitrary unit)	fluorescence intensity measurement using dichlorodihydrofluorescein diacetate and expressed as relative amount compared to control (no HDL treatment sample)	up to 8 weeks
Secondary	ApoA-I	quantitation of intensity of western blot and expresses as relative amount to control (no HDL treatment sample)	Change of HDL associated proteins from each patient at baseline and at 8 weeks
Secondary	ApoA-II	quantitation of intensity of western blot and expresses as relative amount to control (no HDL treatment sample)	Change of HDL associated proteins from each patient at baseline and at 8 weeks
Secondary	ApoC-I	quantitation of intensity of western blot and expresses as relative amount to control (no HDL treatment sample)	Change of HDL associated proteins from each patient at baseline and at 8 weeks
Secondary	ApoC-II	quantitation of intensity of western blot and expresses as relative amount to control (no HDL treatment sample)	Change of HDL associated proteins from each patient at baseline and at 8 weeks
Secondary	ApoC-III	quantitation of intensity of western blot and expresses as relative amount to control (no HDL treatment sample)	Change of HDL associated proteins from each patient at baseline and at 8 weeks