Clinical trial NCT05155267: Biomonitoring of Internal Exposure to MNPLs, and Its Effects, in Blood of Patients With Chronic Kidney Disease (CKD)
Official title: Biomonitoring of Internal Exposure to MNPLs (Micro and NanoPlastics), and Its Effects, in Blood of Patients With Chronic Kidney Disease (CKD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Diseases
Microplastics
Nanoplastics
Genotoxic Damage
Keywords: CKD
MNPLs
Lead sponsor: Universitat Autonoma de Barcelona
Sponsor class: OTHER
Collaborators: name: Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
name: Hospital Universitario Virgen de la Arrixaca
First posted: 2021-12-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Biomonitoring study to detect the presence of MNPLs in biological fluids
timeFrame: Up to 1 year
measure: Study of the effects of MNPLs on immune system
timeFrame: Up to 1 year
measure: Genotoxicity effects of exposure to MNPLs
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Servicio Murciano de Salud
Study officials:
affiliation: Instituto Murciano de Investigación Biosanitaria (IMIB)
name: Pablo Pelegrín
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico Universitario Virgen Arrixaca (Murcia)
name: Juan Bernardo Cabezuelo
role: STUDY_CHAIR
affiliation: Hospital Clínico Universitario Virgen Arrixaca (Murcia)
name: Laura Martínez
role: STUDY_CHAIR
References: