Lipid Disorders
Conditions
Keywords
lipids, lipoproteins, platelets, high cholesterol
Brief 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. 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.
Interventions
None listed
Sponsors
The Miriam Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of platelet aggregation | 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
| Measure | Time frame | Description |
|---|---|---|
| Plasma levels of CRP in mg/L | 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. |
| Plasma levels of resolvins in pg/mL | 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. |
| Plasma Levels of IL-6 in pg/mL | 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. |
| Percentage of Activated Platelets as Assessed by Flow Cytometry | 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. |
| Plasma levels of protectins in pg/mL | 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. |
| Plasma levels of maresins in pg/mL | 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. |
| Plasma Levels of TNF-α in pg/mL | 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. |
Countries
United States
Contacts
Primary ContactWenliang Song, MD
Backup ContactDaria Salamevich
Outcome results
None listed