Study on the Relationship Between Environmental and Occupational Exposure to Metals and Parkinson's Disease

• Conditions: Parkinson Disease, Secondary

• Registration Number: NCT02588924
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

Brief Summary

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).

Detailed Description

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:

* diseases that may interfere with toxicokinetics of the analyzed metals;

* pharmacological therapy;

* habit-forming additives consumption (excessive alcohol consumption);

* altered physiological states (pregnancy, strenuous physical exercise, recent meal, stress, psychological disorders);

On the contrary, the basic criteria for inclusion in the study are:

* age: subjects of working age, between 18 and 65 years;

* diagnosis of Parkinson's disease (using the criteria of the "London Brain Bank")

Regarding the criteria of partition or stratification of the subjects, the type and number of the possible partitions are conditioned by the sample size; indeed it is essential to ensure a sufficient number of cases (and if possible a similar number of cases) in the various layers to have correct statistical results. It was recommended that the minimum number of subjects per layer must be equal to 80.

In order to collect all the necessary information for the inclusion of subjects in the study and the subsequent stratification of the data, an anonymous questionnaire was realized and administered to each recruited subject.

The questionnaire deals with the environment and the lifestyle and work habits of every participant and it consists of multiple choice questions and free response questions and is divided into macro areas: identification data for data processing; place of residence; professional activity; extraprofessional activities; eating habits; habit-forming additives consumption; medical history.

Each question will be transformed into a "continue" or "categorical" variable in order to be able to build and constantly update a database summarizing the collected data and allowing the statistical analysis of the results.

Each subject enrolled will be also asked to sign a consent form, which states that he or she voluntarily take part to the study, after being informed about the purpose of the study and the analysis of both biological samples and personal data.

The guarantee of anonymity for people recruited for this study is provided by an anonymous questionnaire which do not contain personal data, which are collected only in the consent form, separately from the questionnaire.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-28
• Status Verified: 2015-10
• Study First Submitted QC: 2015-10-26
• Last Update Submitted: 2015-10-26
• Study First Posted: 2015-10-28
• Last Update Posted: 2015-10-28
• Primary Completion: 2016-09
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Enrollment	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	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.

Secondary Outcome Measures

Name	Time	Method
determination by atomic absorption spectroscopy of the concentration of manganese, copper and iron	two-year	the determination by atomic absorption spectroscopy of the concentration of manganese, copper and iron on the eppendorf sampled will be carried out at the Laboratory of Industrial Toxicology of Occupational Medicine Area - Section of Hygiene, Occupational Medicine, Forensic Medicine of the Second University of Naples

Trial Locations

Locations (2)

Neuromed IRCCS; 🇮🇹 Pozzilli, Isernia, Italy

Second University of Naples; 🇮🇹 Naples, Napoli, Italy