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Recruiting NCT06747000

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

Observational Lipid Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Lipid Disorders. Basic parameters: 18 years — 69 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Lipoprotein Functions in Healthy Individuals and Subjects With Lipid Disorders

Overview

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.

Primary outcome measures

  • Percentage of platelet aggregation [Time frame: 5 years]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 2 centers
  • Brown University Health Lipid Clinic — East Providence
  • Cardiovascular Research Center — Providence

Identifiers

NCT: NCT06747000 · 2195890 · 710-7149062

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗