HyperlipidemiaNCT02942602
Effect of Lipid Modifying Drugs on HDL Function in Patients With Hyperlipidemia
A study testing Atorvastatin 20 mg, Cholestyramine 8 g and Omega-3 2g in people with Hyperlipidemia, run by Yonsei University at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Atorvastatin 20 mg, Cholestyramine 8 g and Omega-3 2g
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Apr 2014to 23 May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Cardiology, Department of Internal Medicine,
Seoul, 03722
About this study
- 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
- Being tested
- Atorvastatin 20 mg, Cholestyramine 8 g, Omega-3 2g, Concurrent with Atorvastatin 5 mg + Ezetimibe 10 mg, Lifestyle modification
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 20 mgDrug
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 gDrug
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 2gDrug
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 mgDrug
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 modificationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin 20 mg | Experimental | lipid lowering treatment Receives: Drug: Atorvastatin 20 mg |
| Cholestyramine 8 g | Experimental | lipid lowering treatment Receives: Drug: Cholestyramine 8 g |
| Omega-3 (EPA+DHA) 2 g | Experimental | lipid lowering treatment Receives: Drug: Omega-3 2g |
| Atorvastatin 5 mg + Ezetimibe 10 mg | Experimental | lipid lowering treatment Receives: Drug: Concurrent with Atorvastatin 5 mg + Ezetimibe 10 mg |
| Life style modification for management of dyslipidemia | Active comparator | Not described Receives: Behavioral: Lifestyle modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: up to 8 weeks
Secondary outcomes (5)
ApoA-I
quantitation of intensity of western blot and expresses as relative amount to control (no HDL treatment sample)
Measured: Change of HDL associated proteins from each patient at baseline and at 8 weeks
ApoA-II
quantitation of intensity of western blot and expresses as relative amount to control (no HDL treatment sample)
Measured: Change of HDL associated proteins from each patient at baseline and at 8 weeks
ApoC-I
quantitation of intensity of western blot and expresses as relative amount to control (no HDL treatment sample)
Measured: Change of HDL associated proteins from each patient at baseline and at 8 weeks
ApoC-II
quantitation of intensity of western blot and expresses as relative amount to control (no HDL treatment sample)
Measured: Change of HDL associated proteins from each patient at baseline and at 8 weeks
ApoC-III
quantitation of intensity of western blot and expresses as relative amount to control (no HDL treatment sample)
Measured: Change of HDL associated proteins from each patient at baseline and at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study start3 Apr 2014
- Primary completion23 May 2016
- Study completion23 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942602
- Sponsor's protocol ID
- 4-2013-0281
- Status last verified
- Jul 2018
- First submitted
- 17 Oct 2016
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28245873
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lipid Modifying Drugs on HDL Function in Patients With Hyperlipidemia
- ClinicalTrials.gov ID
- NCT02942602
- Acronym / sponsor ID
- 4-2013-0281
- Conditions
- Hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 3 Apr 2014 (actual)
- Primary completion
- 23 May 2016 (actual)
- Study completion
- 23 May 2016 (actual)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin 20 mg | Experimental | Drug: Atorvastatin 20 mglipid lowering treatment |
| Cholestyramine 8 g | Experimental | Drug: Cholestyramine 8 glipid lowering treatment |
| Omega-3 (EPA+DHA) 2 g | Experimental | Drug: Omega-3 2glipid lowering treatment |
| Atorvastatin 5 mg + Ezetimibe 10 mg | Experimental | Drug: Concurrent with Atorvastatin 5 mg + Ezetimibe 10 mglipid lowering treatment |
| Life style modification for management of dyslipidemia | Active comparator | Behavioral: Lifestyle modification |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- pregnant or lactating women
- subjects with familial hypercholesterolemia
- uncontrolled hypertension or DM
- Thyroid dysfunction
- Active liver disease (transaminase or bilirubin > 1.5 x NL)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin 20 mgThe patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups. | Drug | Atorvastatin 20 mg |
| Cholestyramine 8 gThe patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups. | Drug | Cholestyramine 8 g |
| Omega-3 2gThe patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups. | Drug | Omega-3 (EPA+DHA) 2 g |
| Concurrent with Atorvastatin 5 mg + Ezetimibe 10 mgThe patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups. | Drug | Atorvastatin 5 mg + Ezetimibe 10 mg |
| Lifestyle modificationThe patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups. | Behavioural | Life style modification for management of dyslipidemia |
Primary outcome
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
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)
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)
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)
5 secondary outcomes
ApoA-I
Time frame: Change of HDL associated proteins from each patient at baseline and at 8 weeks
ApoA-II
Time frame: Change of HDL associated proteins from each patient at baseline and at 8 weeks
ApoC-I
Time frame: Change of HDL associated proteins from each patient at baseline and at 8 weeks
ApoC-II
Time frame: Change of HDL associated proteins from each patient at baseline and at 8 weeks
ApoC-III
Time frame: Change of HDL associated proteins from each patient at baseline and at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Derived from this study: PubMed 28245873Lee 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.
- Individual participant dataSharing planned: No
Related trials for Hyperlipidemia
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atorvastatin 20 mg, Cholestyramine 8 g and Omega-3 2g in people with Hyperlipidemia, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cholesterol efflux capacity (%) (time frame: Change of HDL functions from baseline to 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02942602, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.