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OpenTrials
Completed

NCT Number: NCT02942602

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

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

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Cardiology, Department of Internal Medicine,

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

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.

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.

Primary outcomes

  1. Cholesterol efflux capacity (%)

    Time frame: 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

  2. Endothelial NO production (Arbitrary unit)

    Time frame: up to 8 weeks

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

  3. VCAM-1 expression (Arbitrary unit)

    Time frame: up to 8 weeks

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

  4. ROS generation (Arbitrary unit)

    Time frame: up to 8 weeks

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

Secondary outcomes

  1. ApoA-I

    Time frame: 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)

  2. ApoA-II

    Time frame: 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)

  3. ApoC-I

    Time frame: 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)

  4. ApoC-II

    Time frame: 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)

  5. ApoC-III

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 24, 2016
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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