Biomonitoring of Internal Exposure to MNPLs, and Its Effects, in Blood of Patients With Chronic Kidney Disease (CKD)

Recruiting

• Conditions: Microplastics; Chronic Kidney Diseases; Nanoplastics; Genotoxic Damage
• Interventions: Other: Biomonitoring study to detect MNPLs in biological samples and study of their health effects

• Registration Number: NCT05155267
• Lead Sponsor: Ricard Marcos

Brief Summary

Micro and nanoplastics (MNPLs) effects on human heath is still preliminary. Chronic kidney disease (CKD) participants, specially does patients submitted to hemodialysis, are a population high exposed to plastics. The objective of our research is to be able to detect MNPLs on biological fluids of hemodialysis patients as well as their potential genotoxic and immunological damage.

Detailed Description

The exponential increase in the production/use of plastic translates into a parallel increase of environmental plastic-waste that is continuously degraded into micro and nanoplastics (MNPLs). Information on the MNPLs' effects on human health is still preliminary and, furthermore, the limitations in current methodologies prevent accurate human exposure/risk assessment.

The study aims to analyse specific biomarkers of exposure to MNPLs in humans, as well as biomarkers of genetic damage, which will allow an association between exposure to these plastic materials and the optimisation of different techniques for the detection and characterisation of MNPLs.

The study will evaluate the effect of exposure to MNPLs, analysing the genotoxic damage, different biomarkers of exposure and the effects on microbiota, in different body samples (urine, blood and feces).

Study Timeline

• Study First Submitted: 2021-11-30
• Study First Submitted QC: 2021-11-30
• Study First Posted: 2021-12-13
• Study Start: 2024-02-27
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-18
• Primary Completion: 2024-12
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic Kidney disease participants (CKD)_HD	Biomonitoring study to detect MNPLs in biological samples and study of their health effects	CKD submitted to hemodialysis (HD)
Chronic Kidney disease participants (CKD)_PD	Biomonitoring study to detect MNPLs in biological samples and study of their health effects	CKD non-submitted to hemodialysis (pre-dialysis:PD)
Controls	Biomonitoring study to detect MNPLs in biological samples and study of their health effects	Healthy participants

Primary Outcome Measures

Name	Time	Method
Biomonitoring study to detect the presence of MNPLs in biological fluids	Up to 1 year	Micro and nanoplastic and/or derivatives, would be evaluated. Characterization of possible biomarkers of early biological effects on human health
Study of the effects of MNPLs on immune system	Up to 1 year	Impact evaluation of MNPLs on transcriptome, secretome and inflammatory signalling and inflammasome activation. Investigating the effect of MNPLs on the function of the immune system in vivo and in high-risk individuals
Genotoxicity effects of exposure to MNPLs	Up to 1 year	Genotoxic, chromosome damage evaluation and oxidative DNA damage will be analysed by the Comet assay and the micronucleus assay

Trial Locations

Locations (1)

Servicio Murciano de Salud; 🇪🇸 Murcia, Spain