Pesticides and Parkinson´s Disease (Pest-PD)

May 14, 2024 updated by: Esther Cubo, Hospital Universitario de Burgos

Prevalence of Preclinical and Prodromal Parkinson´s Disease in Subjects Exposed to Pesticides

The aim of this project is to study whether people exposed to pesticides have a higher risk of developing PD. We will perform an epidemiological study determining the presence of pesticides in urine and comparing signs traditionally associated with PD in early forms.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Within different risk factors, pesticide exposure increases the risk of developing Parkinson's disease (PD) through epigenetic mechanisms by modifying the expression of genes related to PD and secondary mitochondrial dysfunction.We will conduct a cross-sectional prevalence study with cases (exposed to pesticides) and controls (not exposed to pesticides), randomly selecting 130 individuals in each group. Pesticide exposure will be determined through questionnaires.We will study the prevalence of preclinical and prodromal PD based on pesticide exposure, stratified by age and gender in the exposed, and non-exposed groups. Preclinical and prodromal PD will be assessed using: biological biomarkers and prodromal PD signs. Multivariate analyses will be employed to determine the risk of presenting early PD, adjusting for different clinical covariates. The results of this study will allow us to understand the early mechanisms associated with neurodegeneration and pesticides exposure.

Study Type

Observational

Enrollment (Estimated)

260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Subjects not diagnosed with PD living in Burgos region

Description

Inclusion Criteria:

  • Farmers exposed to pesticides for cases
  • No work exposure to pesticides for controls

Exclusion Criteria:

  • Subjects without signed consent form
  • Neurological significant conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cases
Subjects exposed to pesticides
Other: exposure to pesticides
based on work exposures to pesticides
Controls
Subjects without any exposure to pesticides
Other: exposure to pesticides
based on work exposures to pesticides

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prodromal PD
Time Frame: over the last year
Early non motor symptoms
over the last year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario de Burgos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

December 30, 2028

Study Registration Dates

First Submitted

May 14, 2024

First Submitted That Met QC Criteria

May 14, 2024

First Posted (Actual)

May 20, 2024

Study Record Updates

Last Update Posted (Actual)

May 20, 2024

Last Update Submitted That Met QC Criteria

May 14, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRS 2682/A1/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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