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NCT Number: NCT06747000

Lipoprotein Interactions and Platelet Function in Healthy Individuals and Those 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.

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Key information

Conditions

Lipid Disorders Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Brown University Health Lipid Clinic, East Providence, Rhode Island, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Percentage of Activated Platelets as Assessed by Flow Cytometry

    Time frame: 5 years

    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.

  2. Plasma levels of CRP in mg/L

    Time frame: 5 years

    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.

  3. Plasma levels of resolvins in pg/mL

    Time frame: 5 years

    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.

  4. Plasma Levels of IL-6 in pg/mL

    Time frame: 5 years

    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. Plasma Levels of TNF-α in pg/mL

    Time frame: 5 years

    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.

  6. Plasma levels of protectins in pg/mL

    Time frame: 5 years

    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.

  7. Plasma levels of maresins in pg/mL

    Time frame: 5 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Daria Salamevich

CONTACT

[email protected]

7343588165

Wenliang Song, MD

CONTACT

[email protected]

4014449851

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Registry information

Official study title

Lipoprotein Functions in Healthy Individuals and Subjects With Lipid Disorders

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Dec 24, 2024
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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