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

Primary Purpose

Hyperlipidemia

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Atorvastatin 20 mg

Cholestyramine 8 g

Omega-3 2g

Concurrent with Atorvastatin 5 mg + Ezetimibe 10 mg

Lifestyle modification

About this trial

This is an interventional basic science trial for Hyperlipidemia

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Division of Cardiology, Department of Internal Medicine,

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Arm Label

Atorvastatin 20 mg

Cholestyramine 8 g

Omega-3 (EPA+DHA) 2 g

Atorvastatin 5 mg + Ezetimibe 10 mg

Life style modification for management of dyslipidemia

Arm Description

lipid lowering treatment

Outcomes

Primary Outcome Measures

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

Endothelial NO production (Arbitrary unit)

measured with nitrate assay kit and expressed as relative amount compared to control (no HDL treatment sample)

VCAM-1 expression (Arbitrary unit)

western blotting of VCAM-1 protein and expressed as relative amount compared to control (no HDL treatment sample)

ROS generation (Arbitrary unit)

fluorescence intensity measurement using dichlorodihydrofluorescein diacetate and expressed as relative amount compared to control (no HDL treatment sample)

Secondary Outcome Measures

ApoA-I

quantitation of intensity of western blot and expresses as relative amount to control (no HDL treatment sample)

ApoA-II

quantitation of intensity of western blot and expresses as relative amount to control (no HDL treatment sample)

ApoC-I

quantitation of intensity of western blot and expresses as relative amount to control (no HDL treatment sample)

ApoC-II

quantitation of intensity of western blot and expresses as relative amount to control (no HDL treatment sample)

ApoC-III

quantitation of intensity of western blot and expresses as relative amount to control (no HDL treatment sample)

Full Information

NCT ID

NCT02942602

First Posted

October 17, 2016

Last Updated

July 15, 2018

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02942602

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

April 3, 2014 (Actual)

Primary Completion Date

May 23, 2016 (Actual)

Study Completion Date

May 23, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperlipidemia

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Atorvastatin 20 mg

Arm Type

Experimental

Arm Description

lipid lowering treatment

Arm Title

Cholestyramine 8 g

Arm Type

Experimental

Arm Description

lipid lowering treatment

Arm Title

Omega-3 (EPA+DHA) 2 g

Arm Type

Experimental

Arm Description

lipid lowering treatment

Arm Title

Atorvastatin 5 mg + Ezetimibe 10 mg

Arm Type

Experimental

Arm Description

lipid lowering treatment

Arm Title

Life style modification for management of dyslipidemia

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Atorvastatin 20 mg

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Cholestyramine 8 g

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Omega-3 2g

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Concurrent with Atorvastatin 5 mg + Ezetimibe 10 mg

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Lifestyle modification

Intervention Description

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.

Primary Outcome Measure Information:

Title

Cholesterol efflux capacity (%)

Description

[3H-cholesterol (µCi) in medium containing HDL/(3H-cholesterol {µCi} in medium containing HDL+µCi of 3H-cholesterol {µCi} in cells)] x 100

Time Frame

Change of HDL functions from baseline to 8 weeks

Title

Endothelial NO production (Arbitrary unit)

Description

measured with nitrate assay kit and expressed as relative amount compared to control (no HDL treatment sample)

Time Frame

up to 8 weeks

Title

VCAM-1 expression (Arbitrary unit)

Description

western blotting of VCAM-1 protein and expressed as relative amount compared to control (no HDL treatment sample)

Time Frame

up to 8 weeks

Title

ROS generation (Arbitrary unit)

Description

fluorescence intensity measurement using dichlorodihydrofluorescein diacetate and expressed as relative amount compared to control (no HDL treatment sample)

Time Frame

up to 8 weeks

Secondary Outcome Measure Information:

Title

ApoA-I

Description

quantitation of intensity of western blot and expresses as relative amount to control (no HDL treatment sample)

Time Frame

Change of HDL associated proteins from each patient at baseline and at 8 weeks

Title

ApoA-II

Description

quantitation of intensity of western blot and expresses as relative amount to control (no HDL treatment sample)

Time Frame

Change of HDL associated proteins from each patient at baseline and at 8 weeks

Title

ApoC-I

Description

quantitation of intensity of western blot and expresses as relative amount to control (no HDL treatment sample)

Time Frame

Change of HDL associated proteins from each patient at baseline and at 8 weeks

Title

ApoC-II

Description

quantitation of intensity of western blot and expresses as relative amount to control (no HDL treatment sample)

Time Frame

Change of HDL associated proteins from each patient at baseline and at 8 weeks

Title

ApoC-III

Description

quantitation of intensity of western blot and expresses as relative amount to control (no HDL treatment sample)

Time Frame

Change of HDL associated proteins from each patient at baseline and at 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Division of Cardiology, Department of Internal Medicine,

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28245873

Citation

Lee CJ, Choi S, Cheon DH, Kim KY, Cheon EJ, Ann SJ, Noh HM, Park S, Kang SM, Choi D, Lee JE, Lee SH. Effect of two lipid-lowering strategies on high-density lipoprotein function and some HDL-related proteins: a randomized clinical trial. Lipids Health Dis. 2017 Feb 28;16(1):49. doi: 10.1186/s12944-017-0433-6.

Results Reference

derived

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

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