Lipid Characterisation of Plasma Microparticles in a Large Population of Healthy Donors (MicroLipids)

Extracellular vesicles (EVs) are membrane structures containing numerous mediators categorised according to their size and mode of production. Among them, microparticles (MPs) are EVs between 100 nm and 1 μm in size that are produced by budding at the plasma membrane of different cell types following different mechanisms of cell activation or death. MPs include a large pool of bioactive molecules, such as lipids, proteins or nucleic acids. This makes them important mediators of intercellular communication, increasingly recognised for their role in various biological processes such as inflammation, coagulation, immune response and tumour progression. Their ability to transmit molecular signals between cells may have implications for disease pathogenesis and cellular interactions in pathological microenvironments. These MPs therefore appear to be an innovative biomarker, potentially useful in the early management of disease, both in terms of diagnosis and as a therapeutic target.

The main techniques used to analyse these MPs include flow cytometry, which enables surface markers to be quantified and determined, and electron microscopy, which provides a direct view of their morphology and structure. Molecular biology, such as the quantitative PCR technique, is also an approach used by several teams, notably to search for RNA or DNA fragments involved in various biological processes. However, few studies have focused on the lipid composition of these MPs. Since MPs are membrane vesicles, they are a major lipid reservoir. In addition, lipids represent a significant population of molecules with extensive properties, whether in inflammation, cell proliferation, energy metabolism, etc.

The aim of this project is to develop a reliable and robust method for analysing plasma MP concentration, phenotype and lipid composition in a population of healthy volunteers. These parameters will subsequently provide a comparator for studying MPs in populations of patients suffering from cardiovascular and/or inflammatory diseases.

Study Overview

• Status: Recruiting
• Conditions: Healthy Donor
• Intervention / Treatment: Biological: blood sampling

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Damien LELEU; Phone Number: +33 0380669248; Email: Damien.leleu@chu-dijon.fr

Study Locations

• France
  • Dijon, France, 21000
    • Recruiting
    • CHU Dijon Bourgogne
    • Contact: Damien LELEU; Phone Number: +33 0380669248; Email: Damien.leleu@chu-dijon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Eligible patients will be identified by EFS staff at the time of their appointment for a platelet donation at the EFS - Maison du Don, Dijon.

Description

Inclusion Criteria:

• Person who has given his/her non-opposition
• All healthy volunteers are eligible to donate according to EFS criteria.

Exclusion Criteria:

• Person subject to a legal protection measure (curatorship, guardianship, etc)
• Pregnant, parturient or breast-feeding women
• Adults who are incapable or unable to give their consent
• Minors
• Person not eligible to donate according to EFS criteria.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy donor; All healthy volunteers are eligible to donate according to EFS criteria.	Biological: blood sampling; 3 x 7mL EDTA blood tubes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
microparticle concentration, phenotyping and lipid composition in a population of healthy subjects.	Through study completion, an average of 60 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: December 14, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 27, 2023

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: LELEU 2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No