Study on the Relationship Between Environmental and Occupational Exposure to Metals and Parkinson's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Enrollment
研究概览
简要总结
The Department of Experimental Medicine - Section of Hygiene, Occupational Medicine, Forensic Medicine of the Second University of Naples, the Section of Neurology of the Second University of Naples and the Mediterranean Neurological Institute NEUROMED, IRCCS are involved in the realization of a research project aimed at studying the correlation between environmental and occupational exposure to metals (copper, iron and manganese) and Parkinson disease in order to increase the knowledge of these possible risk factors and highlight an eventual predictive-diagnostic meaning of possible discrepancies in the content of these elements; secondly the collected data could be used for assessing the association (odd ratio-OR) between pathologies and different risk factors (for example smoking habits, professional exposure and so on).
详细描述
During the selection of the sample it is essential to consider all the variables that could provoke an alteration in the levels of the indicators examined in the biological fluids investigated.
The adoption of strict criteria for inclusion and exclusion, which differ from metal to metal, is therefore necessary to establish the presence / absence of possible confounding factors that could affect the analysis or interpretation of the data.
It is to be noted also that the number of required participants in a study of MB must be sufficiently large to allow an adequate statistical analysis: the more limited the group of subjects included in the study is, the broader the variability of the data due to inter-individual and methodological differences.
In light of this, some variables, such as age and sex, will be firstly neglected and other potential confounding factors will be considered such as, for example, smoking habits.
Based on the purpose of the research project, the following criteria for exclusion will be considered:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 28 Years 至 70 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
Enrollment
时间窗: two-year
Enrollment: In order to verify if some factors might be connected with a metals exposure for the disease onset, a questionnaire investigating the patients' residence area, the field of work and the specific activities carried out, as well as lifestyle habits has been prepared. Sample Collection: Patients and controls will be subject to blood sampling for manganese, copper and iron quantitative analysis
Sample Collection
时间窗: two-year
We sample 5 ml of blood in tube serum (at least 2 ml of serum) then we label the test tube with an identifying code which is: S-PRK(for cases affected by Parkinson followed by a progressive number es. S-PRK 1,2,3.....), and S-CRL (for controls followed by a progressive number es. S-CRL 1,2,3....) This samples will be centrifugated at 4000 rpm for 10 min. Than we divide the serum in 5 eppendorf of 1.5 mL for cases and 5 for controls: * Eppendorf 1: 300 µl of serum labeled AMN-X (X indicating the progressive number both for cases and controls) * Eppendorf 2: 300 µl of serum labeled BMN-X * Eppendorf 3: 300 µl of serum labeled ACU-X * Eppendorf 4: 300 µl of serum labeled BCU-X * Eppendorf 5: the remaining serum put in Fe-X The aliquots will be stored in a refrigerator at 4-6 ° C (no longer than 7 days) in appropriate Eppendorf box, in order to avoid the inclination of the sample with consequent loss of serum.
次要结局
- determination by atomic absorption spectroscopy of the concentration of manganese, copper and iron(two-year)
研究者
PAOLA PEDATA
Universitary researcher of Second University of Naples
University of Campania "Luigi Vanvitelli"