Hyperlipidemia
Conditions
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
Interventions
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.
DRUGCholestyramine 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.
DRUGOmega-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.
DRUGConcurrent 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.
BEHAVIORALLifestyle 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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cholesterol efflux capacity (%) | 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 |
| Endothelial NO production (Arbitrary unit) | up to 8 weeks | measured with nitrate assay kit and expressed as relative amount compared to control (no HDL treatment sample) |
| VCAM-1 expression (Arbitrary unit) | up to 8 weeks | western blotting of VCAM-1 protein and expressed as relative amount compared to control (no HDL treatment sample) |
| ROS generation (Arbitrary unit) | up to 8 weeks | fluorescence intensity measurement using dichlorodihydrofluorescein diacetate and expressed as relative amount compared to control (no HDL treatment sample) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ApoA-I | 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) |
| ApoC-III | 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) |
| ApoA-II | 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) |
| ApoC-I | 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) |
| ApoC-II | 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) |
Countries
South Korea
Outcome results
None listed