Lipoprotein Interactions and Platelet Function in Healthy Individuals and Those With Lipid Disorders

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.

Study Overview

• Status: Recruiting
• Conditions: Lipid Disorders

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 Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Wenliang Song, MD; Phone Number: 4014449851; Email: WSong@brownhealth.org
• Study Contact Backup: Name: Daria Salamevich; Phone Number: 7343588165; Email: DSalamevich@brownhealth.org

Study Locations

• United States
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Recruiting
      • Brown University Health Lipid Clinic
      • Contact: Wenliang Song, MD; Phone Number: 4014449851; Email: WSong@brownhealth.org
      • Contact: Daria Salamevich; Phone Number: 7343588165; Email: DSalamevich@brownhealth.org
      • Principal Investigator: Wenliang, MD
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Cardiovascular Research Center
      • Contact: Wenliang Song, MD; Phone Number: 4014449851; Email: WSong@brownhealth.org
      • Contact: Daria Salamevich, MD; Phone Number: 7343588165; Email: dsalamevich@lifespan.org
      • Principal Investigator: Wenliang Song, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• Healthy volunteers
• Abnormalities in lipid panels
• Able to provide informed consent
• Between the age of 18 and 69

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	5 years

Collaborators and Investigators

• Sponsor: The Miriam Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2024
• Primary Completion (Estimated): July 18, 2028
• Study Completion (Estimated): July 18, 2029

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): December 24, 2024

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 25, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: platelets; lipids; lipoproteins; high cholesterol
• Additional Relevant MeSH Terms: Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Nutritional and Metabolic Diseases; Hypercholesterolemia; Lipid Metabolism Disorders
• Other Study ID Numbers: 2195890; 710-7149062 (Other Grant/Funding Number: Departmental)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No