Biomonitoring of Internal Exposure to MNPLs (Micro and NanoPlastics), and Its Effects, in Blood of Patients With Chronic Kidney Disease (CKD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Biomonitoring study to detect the presence of MNPLs in biological fluids
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Biomonitoring study to detect the presence of MNPLs in biological fluids
时间窗: 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
时间窗: 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
时间窗: Up to 1 year
Genotoxic, chromosome damage evaluation and oxidative DNA damage will be analysed by the Comet assay and the micronucleus assay
次要结局
未报告次要终点
研究者
Ricard Marcos
Professor
Universitat Autonoma de Barcelona