Chronic Kidney Diseases, Genotoxic Damage, Microplastics, Nanoplastics
Conditions
Keywords
CKD, MNPLs
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).
Interventions
OTHERBiomonitoring study to detect MNPLs in biological samples and study of their health effects
Determination of MNPLs levels, genotoxic damage and immunological effects
Sponsors
Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
Hospital Universitario Virgen de la Arrixaca
Ricard Marcos
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
for Chronic Kidney Disease (CKD) submitted to Hemodialysis: * Participant submitted to hemodialysis for more than 3 months * Between 18 and 85 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 Chronic Kidney Disease (CKD) pre-dialysis: * No hemodialysis treatment * Between 18 and 85 years old * Stable haemoglobin (more than 10 gr/dl) * Glomerular filtration ≤ 20 ml/min * Absence of infectious disease at the date of sample collection and for a period of more than two weeks * Absence of active neoplasia Inclusion Criteria for controls : * Between 18 and 85 years old (paired by gender, age and lifestyle to the CKD patients) * 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 both groups of CKD patients: * Clinical instability * Life expectancy of less than 12 months * Coagulation system disorders * Participation in other clinical study * Pregnancy * Unsigned informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Spain
Contacts
Primary ContactRicard Marcos
Outcome results
None listed