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

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ClinicalTrials.gov Identifier: NCT02942602
Recruitment Status : Recruiting
First Posted : October 24, 2016
Last Update Posted : October 24, 2016
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Hyperlipidemia Drug: Atorvastatin 20 mg Drug: Cholestyramine 8 g Drug: Omega-3 2g Drug: Concurrent with Atorvastatin 5 mg + Ezetimibe 10 mg Behavioral: Lifestyle modification Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : June 2013
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017

Arm Intervention/treatment
Experimental: Atorvastatin 20 mg
lipid lowering treatment
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.

Experimental: Cholestyramine 8 g
lipid lowering treatment
Drug: 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.

Experimental: Omega-3 (EPA+DHA) 2 g
lipid lowering treatment
Drug: 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.

Experimental: Atorvastatin 5 mg + Ezetimibe 10 mg
lipid lowering treatment
Drug: 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.

Active Comparator: Life style modification for management of dyslipidemia 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02942602


Contacts
Contact: Sang-Hak Lee, MD 82-2-2228-8456 SHL1106@yuhs.ac

Locations
Korea, Republic of
Division of Cardiology, Department of Internal Medicine, Recruiting
Seoul, Korea, Republic of, 03722
Contact: Sang-Hak Lee, MD    82-2-2228-8456    SHL1106@yuhs.ac   
Sponsors and Collaborators
Yonsei University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02942602     History of Changes
Other Study ID Numbers: 4-2013-0281
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: October 24, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Ezetimibe
Cholestyramine Resin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors