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

Study Overview
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Brief Summary
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Micro and nanoplastics (MNPLs) effects on human heath is still preliminary. Chronic kidney disease (CKD) participants, specially does patients submitted to hemodialysis, is 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
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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. This observational study will obtain biological samples of hemodialysis Chronic Kidney disease (CKD) patients as a reference and vulnerable group of individuals highly exposed to MNPLs and potentially more susceptible. This allows the optimization of specific biomarkers of human MNPLs exposure and the characterization of biomarkers of early effect that allows an association between the exposure to MNPLs and effects on human health.

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

Conditions
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Chronic Kidney Diseases, Microplastics, Nanoplastics, Genotoxic Damage

Intervention / Treatment
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* Other: Biomonitoring study to detect MNPLs in biological samples and study of their health effects


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Chronic Kidney Disease (CKD): Participant submitted to hemodialysis for more than 3 months Between 18 and 70 years old Stable haemoglobin (more than 10 gr/dl) Absence of infectious disease at the date of sample collection and for a period of more than two weeks Absence of active neoplasia Stable vascular access Inclusion Criteria for controls : Between 18 and 70 years old Absence of chronic kidney disease or dialysis treatment Absence of chronic pathology (including neoplasia) Absence of infectious disease at the date of sample collection and for a period of more than two weeks Spanish residence Exclusion Criteria for CKD: Clinical instability Life expectancy of more than 12 months Coagulation system disorders Participation in other clinical study Pregnancy Unsigned informed consent Exclusion criteria for controls: Participation in other clinical study Pregnancy Unsigned informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic Kidney disease participants (CKD)<br>CKD submitted to hemodialysis | Other: Biomonitoring study to detect MNPLs in biological samples and study of their health effects<br>* Determination of MNPLs levels, genotoxic damage and immunological effects<br>|
| Controls<br>Healthy participants | Other: Biomonitoring study to detect MNPLs in biological samples and study of their health effects<br>* Determination of MNPLs levels, genotoxic damage and immunological effects<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomonitoring study to detect the presence of MNPLs in biological fluids | Micro and nanoplastic and/or derivatives, would be evaluated. Characterization of possible biomarkers of early biological effects on human health | Up to 1 year | 
| Study of the effects of MNPLs on immune system | 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 | Up to 1 year | 
| Genotoxicity effects of exposure to MNPLs | Genotoxic, chromosome damage evaluation and oxidative DNA damage will be analysed by the Comet assay and the micronucleus assay | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD, MNPLs