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

NCT02588924 | Unknown DMC

• 1 other identifier: 961
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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).

Conditions

Parkinson Disease, Secondary

Keywords

Parkinson Disease; ENVIRONMENTAL AND OCCUPATIONAL EXPOSURE TO METALS

Outcome Measures

Primary Outcomes (2)

• Enrollment

  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

  two-year

• Sample Collection

  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.

  two-year

Secondary Outcomes (1)

• determination by atomic absorption spectroscopy of the concentration of manganese, copper and iron

  two-year

Other Outcomes (1)

• The statistical data analysis using the SPSS software

  two-year

Study Arms (2)

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

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

Interventions

Second University of Naples OTHER

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.

Second University of Naples

Neuromed IRCCS OTHER

enrollment of patients with Parkinson's disease; collection of blood samples;

Neuromed IRCCS

Eligibility Criteria

• Age: 28 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead
• Neuromed IRCCS: collaborator

Study Sites (2)

Neuromed IRCCS

Pozzilli, Isernia, 86077, Italy

Location

Second University of Naples

Naples, Napoli, 80138, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Parkinson Disease, Secondary; Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Paola Pedata, researcher

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Universitary researcher of Second University of Naples

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: October 28, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2017
• Last Updated: October 28, 2015

Record last verified: 2015-10

Locations

IT (2)