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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational

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

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 Summary:

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 a
    Sponsor: Second University of Naples

    Current Primary Outcome:

    • Enrollment [ Time Frame: 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 [ Time Frame: 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

      Original Primary Outcome: Same as current

      Current Secondary Outcome: determination by atomic absorption spectroscopy of the concentration of manganese, copper and iron [ Time Frame: 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


      Original Secondary Outcome: Same as current

      Information By: Second University of Naples

      Dates:
      Date Received: September 28, 2015
      Date Started: September 2015
      Date Completion: September 2017
      Last Updated: October 26, 2015
      Last Verified: October 2015