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Clinical Trials/NCT06747000
NCT06747000
Recruiting
Not Applicable

Lipoprotein Functions in Healthy Individuals and Subjects With Lipid Disorders

The Miriam Hospital2 sites in 1 country80 target enrollmentJuly 18, 2024
ConditionsLipid Disorders

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lipid Disorders
Sponsor
The Miriam Hospital
Enrollment
80
Locations
2
Primary Endpoint
Percentage of platelet aggregation
Status
Recruiting
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 18, 2024
End Date
July 18, 2029
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

  • Percentage of Activated Platelets as Assessed by Flow Cytometry(5 years)
  • Plasma levels of CRP in mg/L(5 years)
  • Plasma levels of resolvins in pg/mL(5 years)
  • Plasma Levels of IL-6 in pg/mL(5 years)
  • Plasma Levels of TNF-α in pg/mL(5 years)
  • Plasma levels of protectins in pg/mL(5 years)
  • Plasma levels of maresins in pg/mL(5 years)

Study Sites (2)

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