Lipid DisordersNCT06747000
Lipoprotein Interactions and Platelet Function in Healthy Individuals and Those With Lipid Disorders
An observational study of Lipid Disorders, run by The Miriam Hospital at 2 sites in United States.
Trial summary
This study looks at how lipoproteins, which are particles in the blood that transport cholesterol, influence heart and blood vessel health. Beyond just their levels, the way these particles function plays a key role in preventing or contributing to disease. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipid Disorders
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jul 2024to 18 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We Planning to start recruiting process in July 2024. We will identify potential subjects who are seen in the lipid clinic of Lifespan hospitals by EMR review. We will contact potential subjects at a routine care lipid clinic visit or by phone independent of their routine care visits. Recruitment will take place at the Lipid Clinic at Lifespan Hospital, the Brown campus, and our research lab.
Who may be able to join
- Healthy volunteers
- Abnormalities in lipid panels
- Able to provide informed consent
- Between the age of 18 and 69
Who cannot join
- Drug or alcohol abuse within 6 months or significant mental/psychological impairment
- Current smokers
- Subjects with known bleeding disorders (for example, hemophilia)
- Subjects requiring regular transfusions for any reason
- No ethnic/racial groups will be excluded
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Brown University Health Lipid Clinic
East Providence, Rhode Island, 02914
Wenliang Song, MD, 4014449851, WSong@brownhealth.org
Daria Salamevich, 7343588165, DSalamevich@brownhealth.org
- Recruiting
Cardiovascular Research Center
Providence, Rhode Island, 02903
Wenliang Song, MD, 4014449851, WSong@brownhealth.org
Daria Salamevich, MD, 7343588165, dsalamevich@lifespan.org
About this study
Official title: Lipoprotein Functions in Healthy Individuals and Subjects With Lipid Disorders
This study looks at how lipoproteins, which are particles in the blood that transport cholesterol, influence heart and blood vessel health. Beyond just their levels, the way these particles function plays a key role in preventing or contributing to disease. In some conditions, like high cholesterol or diabetes, lipoproteins may not work properly, increasing the risk of clogged arteries and other complications.
The investigators aim to study these changes in people with lipid disorders to better understand their impact on blood health and to find new ways to prevent and treat heart disease.
Read the detailed description
Traditionally, lipoproteins have been associated with cardiovascular protection, but emerging research indicates that their functionality may be a more critical factor than their levels in evaluating cardiovascular risk. Lipoproteins, such as HDL, LDL, and VLDL, play vital roles in processes like reverse cholesterol transport and demonstrate anti-inflammatory, antioxidative, and antiplatelet properties. However, in conditions like atherosclerosis, diabetes, and dyslipidemia, these lipoproteins often become dysfunctional, and the mechanisms behind this dysfunction remain incompletely understood.
This study aims to thoroughly investigate the pathogenic roles of lipoproteins by examining their structural and functional modifications and their influence on platelet activity in individuals with lipid disorders.
- Conditions
- Lipid Disorders
- Keywords
- lipids, lipoproteins, platelets, high cholesterol
- Medical subject headings
- Lipid Metabolism Disorders, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with lipid disorders | Individuals with lipid disorders (elevated HDL and LDL) | |
| Healthy individuals | Healthy individuals with normal lipid values and without lipid-related diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of platelet aggregation
Platelet aggregation area under the curve will be used as primary endpoint. Specifically, the percentage of platelet aggregation multiple time will be calculated to get area under the curve as a comprehensive marker for platelet aggregation response.
Measured: 5 years
Secondary outcomes (7)
Percentage of Activated Platelets as Assessed by Flow Cytometry
Platelet activation will be assessed as a secondary endpoint. The percentage of activated platelets will be measured using flow cytometry, focusing on markers such as P-selectin expression and fibrinogen binding to the GPIIb/IIIa receptor. Measurements will be taken at multiple time points, and data will be summarized using statistical measures such as mean ± standard deviation.
Measured: 5 years
Plasma levels of CRP in mg/L
Inflammatory markers will be measured as secondary endpoints to evaluate systemic inflammation. Plasma levels of C-reactive protein (CRP) will be reported in milligrams per liter (mg/L) using enzyme-linked immunosorbent assay (ELISA) or similar validated methods. Data will be summarized using statistical measures such as mean ± standard deviation, and comparisons will be made across study groups and time points.
Measured: 5 years
Plasma levels of resolvins in pg/mL
Specialized pro-resolving mediators (SPMs) will be measured as secondary endpoints to assess their role in inflammation resolution. Plasma levels of resolvins will be quantified using liquid chromatography-tandem mass spectrometry (LC-MS/MS) and reported in picograms per milliliter (pg/mL). Data will be summarized using statistical measures such as mean ± standard deviation, and comparisons will be made across study groups and time points.
Measured: 5 years
Plasma Levels of IL-6 in pg/mL
Inflammatory markers will be measured as secondary endpoints to evaluate systemic inflammation. Plasma levels of interleukin-6 (IL-6) will be quantified in picograms per milliliter (pg/mL) using enzyme-linked immunosorbent assay (ELISA) or similar validated methods. Data will be summarized using statistical measures such as mean ± standard deviation, and comparisons will be made across study groups and time points.
Measured: 5 years
Plasma Levels of TNF-α in pg/mL
Inflammatory markers will be measured as secondary endpoints to evaluate systemic inflammation. Plasma levels of tumor necrosis factor-alpha (TNF-α) will be quantified in picograms per milliliter (pg/mL) using enzyme-linked immunosorbent assay (ELISA) or similar validated methods. Data will be summarized using statistical measures such as mean ± standard deviation, and comparisons will be made across study groups and time points.
Measured: 5 years
Plasma levels of protectins in pg/mL
Specialized pro-resolving mediators (SPMs) will be measured as secondary endpoints to assess their role in inflammation resolution. Plasma levels of protectins will be quantified using liquid chromatography-tandem mass spectrometry (LC-MS/MS) and reported in picograms per milliliter (pg/mL). Data will be summarized using statistical measures such as mean ± standard deviation, and comparisons will be made across study groups and time points.
Measured: 5 years
Plasma levels of maresins in pg/mL
Specialized pro-resolving mediators (SPMs) will be measured as secondary endpoints to assess their role in inflammation resolution. Plasma levels of maresins, will be quantified using liquid chromatography-tandem mass spectrometry (LC-MS/MS) and reported in picograms per milliliter (pg/mL). Data will be summarized using statistical measures such as mean ± standard deviation, and comparisons will be made across study groups and time points.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start18 Jul 2024
- Primary completion18 Jul 2028 (estimated)
- Study completion18 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid DisordersStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747000
- Sponsor's protocol ID
- 2195890
- Other IDs
- 710-7149062
- Status last verified
- Sep 2025
- First submitted
- 18 Dec 2024
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Currently, the decision regarding sharing IPD has not been finalized. While we recognize the value of data sharing for scientific collaboration, data sharing policies must align with participant confidentiality, regulatory requirements, and institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipoprotein Functions in Healthy Individuals and Subjects With Lipid Disorders
- ClinicalTrials.gov ID
- NCT06747000
- Acronym / sponsor ID
- 2195890
- Conditions
- Lipid Disorders
- Keywords
- lipids, lipoproteins, platelets, high cholesterol
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 18 Jul 2028 (estimated)
- Study completion
- 18 Jul 2029 (estimated)
- First posted
- 24 Dec 2024 (actual)
- 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.
This study looks at how lipoproteins, which are particles in the blood that transport cholesterol, influence heart and blood vessel health. Beyond just their levels, the way these particles function plays a key role in preventing or contributing to disease. In some conditions, like high cholesterol or diabetes, lipoproteins may not work properly, increasing the risk of clogged arteries and other complications.
The investigators aim to study these changes in people with lipid disorders to better understand their impact on blood health and to find new ways to prevent and treat heart disease.
Detailed description
Traditionally, lipoproteins have been associated with cardiovascular protection, but emerging research indicates that their functionality may be a more critical factor than their levels in evaluating cardiovascular risk. Lipoproteins, such as HDL, LDL, and VLDL, play vital roles in processes like reverse cholesterol transport and demonstrate anti-inflammatory, antioxidative, and antiplatelet properties. However, in conditions like atherosclerosis, diabetes, and dyslipidemia, these lipoproteins often become dysfunctional, and the mechanisms behind this dysfunction remain incompletely understood.
This study aims to thoroughly investigate the pathogenic roles of lipoproteins by examining their structural and functional modifications and their influence on platelet activity in individuals with lipid disorders.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with lipid disorders | – | –Individuals with lipid disorders (elevated HDL and LDL) |
| Healthy individuals | – | –Healthy individuals with normal lipid values and without lipid-related diseases |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We Planning to start recruiting process in July 2024. We will identify potential subjects who are seen in the lipid clinic of Lifespan hospitals by EMR review. We will contact potential subjects at a routine care lipid clinic visit or by phone independent of their routine care visits. Recruitment will take place at the Lipid Clinic at Lifespan Hospital, the Brown campus, and our research lab.
Key inclusion criteria (4 listed)
- Healthy volunteers
- Abnormalities in lipid panels
- Able to provide informed consent
- Between the age of 18 and 69
Key exclusion criteria (5 listed)
- Drug or alcohol abuse within 6 months or significant mental/psychological impairment
- Current smokers
- Subjects with known bleeding disorders (for example, hemophilia)
- Subjects requiring regular transfusions for any reason
- No ethnic/racial groups will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of platelet aggregation
Time frame: 5 years
Platelet aggregation area under the curve will be used as primary endpoint. Specifically, the percentage of platelet aggregation multiple time will be calculated to get area under the curve as a comprehensive marker for platelet aggregation response.
7 secondary outcomes
Percentage of Activated Platelets as Assessed by Flow Cytometry
Time frame: 5 years
Plasma levels of CRP in mg/L
Time frame: 5 years
Plasma levels of resolvins in pg/mL
Time frame: 5 years
Plasma Levels of IL-6 in pg/mL
Time frame: 5 years
Plasma Levels of TNF-α in pg/mL
Time frame: 5 years
Plasma levels of protectins in pg/mL
Time frame: 5 years
Plasma levels of maresins in pg/mL
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: Undecided. Currently, the decision regarding sharing IPD has not been finalized. While we recognize the value of data sharing for scientific collaboration, data sharing policies must align with participant confidentiality, regulatory requirements, and institutional policies.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipid Disorders, run by The Miriam Hospital at 2 sites in United States.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenliang Song, MD (4014449851, WSong@brownhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of platelet aggregation (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2025.