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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-27

Study Completion Date

2025-01-31

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, 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.

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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.

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).

Conditions

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Chronic Kidney Diseases Microplastics Nanoplastics Genotoxic Damage

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Chronic Kidney disease participants (CKD)_HD

CKD submitted to hemodialysis (HD)

Biomonitoring study to detect MNPLs in biological samples and study of their health effects

Intervention Type OTHER

Determination of MNPLs levels, genotoxic damage and immunological effects

Chronic Kidney disease participants (CKD)_PD

CKD non-submitted to hemodialysis (pre-dialysis:PD)

Biomonitoring study to detect MNPLs in biological samples and study of their health effects

Intervention Type OTHER

Determination of MNPLs levels, genotoxic damage and immunological effects

Controls

Healthy participants

Biomonitoring study to detect MNPLs in biological samples and study of their health effects

Intervention Type OTHER

Determination of MNPLs levels, genotoxic damage and immunological effects

Interventions

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Biomonitoring study to detect MNPLs in biological samples and study of their health effects

Determination of MNPLs levels, genotoxic damage and immunological effects

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

* 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

* Clinical instability
* Life expectancy of less than 12 months
* Coagulation system disorders
* Participation in other clinical study
* Pregnancy
* Unsigned informed consent

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes