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NCT Number: NCT06183632

Lipid Characterisation of Plasma Microparticles in a Large Population of Healthy Donors

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon Bourgogne

Dijon, 21000, France

Location status: Recruiting

Location contact

Damien LELEU

CONTACT

[email protected]

0380669248 ext. +33

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sampling

Biological

3 x 7mL EDTA blood tubes

Primary outcomes

  1. microparticle concentration, phenotyping and lipid composition in a population of healthy subjects.

    Time frame: Through study completion, an average of 60 months

Study contacts

Contact information is provided by the study sponsor or research team.

Damien LELEU

CONTACT

[email protected]

0380669248 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: MicroLipids

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Dec 27, 2023
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.