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Trial record 46 of 2452 for:    parkinson's

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

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ClinicalTrials.gov Identifier: NCT02588924
Recruitment Status : Unknown
Verified October 2015 by PAOLA PEDATA, University of Campania "Luigi Vanvitelli".
Recruitment status was:  Enrolling by invitation
First Posted : October 28, 2015
Last Update Posted : October 28, 2015
Sponsor:
Collaborator:
Neuromed IRCCS
Information provided by (Responsible Party):
PAOLA PEDATA, 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).

Condition or disease Intervention/treatment
Parkinson Disease, Secondary Other: Second University of Naples Other: Neuromed IRCCS

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Study on the Relationship Between Environmental and Occupational Exposure to Metals and Parkinson's Disease
Study Start Date : September 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Manganese

Group/Cohort Intervention/treatment
Second University of Naples
the present research project is aimed at measuring out the concentrations of copper, iron and manganese in biological fluids (blood, serum) of patients with Parkinson's disease and of subjects of the control group and assess possible correlations between changes in the content of metals and the pathology.
Other: Second University of Naples
enrollment of patients with Parkinson's disease; collection of blood samples; measuring out the concentrations of copper, iron and manganese in biological fluids (blood, serum) of patients with Parkinson's disease and of subjects of the control group and assess possible correlations between changes in the content of metals and the pathology.

Neuromed IRCCS
the present research project is aimed at measuring out the concentrations of copper, iron and manganese in biological fluids (blood, serum) of patients with Parkinson's disease and of subjects of the control group and assess possible correlations between changes in the content of metals and the pathology.
Other: Neuromed IRCCS
enrollment of patients with Parkinson's disease; collection of blood samples;




Primary Outcome Measures :
  1. 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


  2. 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 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 :
  1. 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


Other Outcome Measures:
  1. The statistical data analysis using the SPSS software [ Time Frame: two-year ]
    Statistical analysis will be carry out by using the SPSS software, version 14.0.1 for Windows (SPSS ITALIA s.r.l Bologna, Italy)


Biospecimen Retention:   Samples Without DNA
Serum


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Ages Eligible for Study:   28 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Cases: subjects of both sexes with at least 10 years of work seniority with diagnosis of Parkinson's disease, coming from Neuromed IRCCS and Second University of Naples Controls: healthy subjects matched by age, sex, lifestyle habits and areas of residence, work seniority.
Criteria

EXCLUSION CRITERIA:

  • diseases that may interfere with toxicokinetics of the analyzed metals;
  • taking medication;
  • taking discretionary agents (excessive alcohol consumption);
  • altered physiological states (pregnancy, strenuous physical exercise, recent meal, stress, psychological disorders);

INCLUSION CRITERIA:

  • age: subjects of working age, between 28 and 70 years;
  • diagnosis of Parkinson's disease (using the criteria of the "London Brain Bank")

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02588924


Locations
Italy
Neuromed IRCCS
Pozzilli, Isernia, Italy, 86077
Second University of Naples
Naples, Napoli, Italy, 80138
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
Neuromed IRCCS
Investigators
Principal Investigator: Paola Pedata, researcher University of Campania "Luigi Vanvitelli"

Responsible Party: PAOLA PEDATA, Universitary researcher of Second University of Naples, University of Campania "Luigi Vanvitelli"
ClinicalTrials.gov Identifier: NCT02588924     History of Changes
Other Study ID Numbers: 961
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015

Keywords provided by PAOLA PEDATA, University of Campania "Luigi Vanvitelli":
Parkinson Disease
ENVIRONMENTAL AND OCCUPATIONAL EXPOSURE TO METALS

Additional relevant MeSH terms:
Parkinson Disease
Parkinson Disease, Secondary
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Manganese
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs