Clinical trial NCT06747000: Lipoprotein Interactions and Platelet Function in Healthy Individuals and Those with Lipid Disorders
Official title: Lipoprotein Functions in Healthy Individuals and Subjects with Lipid Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lipid Disorders
Keywords: lipids
lipoproteins
platelets
high cholesterol
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Percentage of platelet aggregation
timeFrame: 5 years
Secondary outcomes:
measure: Percentage of Activated Platelets as Assessed by Flow Cytometry
timeFrame: 5 years
measure: Plasma levels of CRP in mg/L
timeFrame: 5 years
measure: Plasma levels of resolvins in pg/mL
timeFrame: 5 years
measure: Plasma Levels of IL-6 in pg/mL
timeFrame: 5 years
measure: Plasma Levels of TNF-α in pg/mL
timeFrame: 5 years
measure: Plasma levels of protectins in pg/mL
timeFrame: 5 years
measure: Plasma levels of maresins in pg/mL
timeFrame: 5 years
Other outcomes:
Locations:
city: East Providence
country: United States
facility: Brown University Health Lipid Clinic
state: Rhode Island
city: Providence
country: United States
facility: Cardiovascular Research Center
state: Rhode Island
Study officials:
References: