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

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Ricard Marcos; Phone Number: +34 93 586 20 52; Email: ricard.marcos@uab.cat

Study Locations

• Spain
  • Murcia, Spain
    • Recruiting
    • Servicio Murciano de Salud
    • Contact: Laura Martinez, Dr.; Email: lma5@um.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This project will study a minimum of 25 adult participants with chronic kidney disease, included and not included in an haemodialysis programme. A control group (at least 25 individuals), matched by gender, age and lifestyle with CKD participants will be also included.

Description

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

Exclusion criteria for controls:

• Participation in other clinical study
• Pregnancy
• Unsigned informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Controls; Healthy participants	Other: Biomonitoring study to detect MNPLs in biological samples and study of their health effects; Determination of MNPLs levels, genotoxic damage and immunological effects
Chronic Kidney disease participants (CKD)_HD; CKD submitted to hemodialysis (HD)	Other: Biomonitoring study to detect MNPLs in biological samples and study of their health effects; Determination of MNPLs levels, genotoxic damage and immunological effects
Chronic Kidney disease participants (CKD)_PD; CKD non-submitted to hemodialysis (pre-dialysis:PD)	Other: Biomonitoring study to detect MNPLs in biological samples and study of their health effects; Determination of MNPLs levels, genotoxic damage and immunological effects

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ricard Marcos
• Collaborators: Hospital Universitario Virgen de la Arrixaca; Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
• Investigators: Principal Investigator: Pablo Pelegrín, Instituto Murciano de Investigación Biosanitaria (IMIB); Study Chair: Juan Bernardo Cabezuelo, Hospital Clínico Universitario Virgen Arrixaca (Murcia); Study Chair: Laura Martínez, Hospital Clínico Universitario Virgen Arrixaca (Murcia)

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: November 30, 2021
• First Posted (Actual): December 13, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: CKD; MNPLs
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 1-1

Drug and device information, study documents

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