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

NCT02942602 | Completed

• 1 other identifier: 4-2013-0281
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (5)

• ApoA-I

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

• ApoA-II

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

• ApoC-I

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

• ApoC-II

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

• ApoC-III

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

Study Arms (5)

Atorvastatin 20 mg

EXPERIMENTAL

lipid lowering treatment

Drug: Atorvastatin 20 mg

Cholestyramine 8 g

EXPERIMENTAL

lipid lowering treatment

Drug: Cholestyramine 8 g

Omega-3 (EPA+DHA) 2 g

EXPERIMENTAL

lipid lowering treatment

Drug: Omega-3 2g

Atorvastatin 5 mg + Ezetimibe 10 mg

EXPERIMENTAL

lipid lowering treatment

Drug: Concurrent with Atorvastatin 5 mg + Ezetimibe 10 mg

Life style modification for management of dyslipidemia

ACTIVE COMPARATOR

Behavioral: Lifestyle modification

Interventions

Atorvastatin 20 mg DRUG

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.

Atorvastatin 20 mg

Cholestyramine 8 g DRUG

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

Omega-3 2g DRUG

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 (EPA+DHA) 2 g

Concurrent with Atorvastatin 5 mg + Ezetimibe 10 mg DRUG

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.

Atorvastatin 5 mg + Ezetimibe 10 mg

Lifestyle modification BEHAVIORAL

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.

Life style modification for management of dyslipidemia

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Division of Cardiology, Department of Internal Medicine,

Seoul, 03722, South Korea

Location

Related Publications (1)

• 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.

  PMID: 28245873 DERIVED

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Atorvastatin; Cholestyramine Resin; Docosahexaenoic Acids; Ezetimibe

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Polystyrenes; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fatty Acids, Unsaturated; Fish Oils; Oils; Azetidines; Azetines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 24, 2016
• Study Start: April 3, 2014
• Primary Completion: May 23, 2016
• Study Completion: May 23, 2016
• Last Updated: July 18, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)