- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07341997
Environmental Factors Associated With Peripheral Neuropathies in French Guiana (YANANER)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Peripheral neuropathies (PN) affect 1% of the global population, with higher prevalence in the elderly. They lead to gait disorders and chronic pain, severely impacting quality of life. Despite thorough investigations, 20-30% of cases have no identified cause. In French Guiana, unique factors may contribute to these neuropathies, including the use of potentially neurotoxic traditional plant remedies and outbreaks of arboviral diseases, which can complicate conditions like Guillain-Barré syndrome. Additionally, illegal gold mining exposes residents to mercury, both directly and through environmental contamination. We hypothesize that these local factors might explain the unidentified cases of PN and exacerbate neuropathies in patients with pre-existing nerve vulnerability, such as diabetic neuropathy.
This is a prospective multicenter case-control study being conducted in hospitals in Cayenne and Saint-Laurent du Maroni. At the inclusion visit, blood samples will be taken to assess arbovirus serology, particularly for Zika, Chikungunya and Dengue, as well as to measure levels of heavy metals, including mercury and lead. In addition, urine and hair samples will be taken to analyze these heavy metals. Participants will also fill in a questionnaire about their plant consumption.
They will not be followed as part of the research.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nathalie DESCHAMPS, Principal Investigator
- Phone Number: +594 594 397 317
- Email: nathalie.deschamps@ch-cayenne.fr
Study Contact Backup
- Name: Vincent De Paul SENEKIAN, Principal Investigator
- Email: v.senekian@ch-ouestguyane.fr
Study Locations
-
-
-
Cayenne, French Guiana, 97300
- Recruiting
- Centre Hospitalier de Cayenne
-
Contact:
- Nathalie DESCHAMPS, Principal Investigator
- Phone Number: +594 594 397 317
- Email: nathalie.deschamps@ch-cayenne.fr
-
Contact:
- Mathieu NACHER
- Email: mathieu.nacher@ch-cayenne.fr
-
Sub-Investigator:
- Doriane SELLIN
-
Sub-Investigator:
- Clémentine MONTAGNAC
-
Saint-Laurent-du-Maroni, French Guiana, 97320
- Recruiting
- Centre Hospitalier de l'Ouest Guyanais
-
Contact:
- Vincent De Paul SENEKIAN, Principal Investigator
- Email: v.senekian@ch-ouestguyane.fr
-
Contact:
- Nathalie DESCHAMPS, Principal Investigator
- Email: nathalie.deschamps@ch-cayenne.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- For the Case group: patients diagnosed with diabetic peripheral neuropathy or chronic idiopathic axonal polyneuropathy
- For the Control group: patients hospitalized or consulting at the hospitals in Cayenne and Saint-Laurent du Maroni, without peripheral neuropathy.
Exclusion Criteria:
- For the Case and Control groups: patients under the age of 18, those who object to participation and those who are unable to complete the questionnaire.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control group
Patients hospitalised or consulting at hospitals in Cayenne and Saint-Laurent du Maroni who do not have peripheral neuropathy.
|
Patients diagnosed with diabetic peripheral neuropathy or chronic idiopathic axonal polyneuropathy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of exposure rates among cases and controls
Time Frame: At inclusion
|
The primary endpoint will be the comparison of rates of exposure to arboviruses, heavy metals and consumption of potentially neurotoxic plants in cases and controls. The heavy metals assay and the questionnaire will be carried out at the inclusion visit. |
At inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Genetic mutations indentification
Time Frame: At inclusion
|
Secondary endpoint will be identification of genetic mutations responsible for peripheral neuropathy
|
At inclusion
|
|
Peripheral Nerve Disability (PND) determination
Time Frame: At inclusion
|
Secondary endpoint will be determination of Peripheral Nerve Disability (PND)
|
At inclusion
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Mathieu NACHER, Centre Hospitalier de Cayenne
Publications and helpful links
General Publications
- Nacher M, Ouedraogo E, Succo T, Guarmit B, Djossou F, Stettler L, Alvarez F, Elenga N, Adenis A, Couppié P. L'infection VIH en Guyane: revue historique et tendances actuelles. Bull Epidemiol Hebd. 2020;2-3:43-51. http://beh. santepubliquefrance.fr/beh/2020/2-3/pdf/2020_2-3_2.pdf.
- Cardoso * T. BA. Le mercure en Guyane française : synthèse des études d'imprégnation et d'impact sanitaires menées de 1994 à 2005. Bulletin Epidémiologique Hebdomadaire - BEH. 2010 Apr;13:118-20.
- Lernould B. Intoxications à la Bita dans le bassin du Maroni en 2011, série de 4 cas, aspects cliniques et paracliniques, botaniques et de santé publique. Th Doc Méd. Université du Droit et de la Santé - Lille 2, Lille, France. 2013. https://pepite- depot.univ-lille.fr/LIBRE/Th_Medecine/2013/2013LIL2M304. pdf.
- Graille J, Blaizot R, Darrigade AS, Sainte-Marie D, Nacher M, Schaub R, Couppie P. Leprosy in French Guiana 2007-2014: a re-emerging public health problem. Br J Dermatol. 2020 Jan;182(1):237-239. doi: 10.1111/bjd.18334. Epub 2019 Sep 8. No abstract available.
- Sabbah N, Carles G, Demar M, Nacher M. Diabetes in French Guiana, adapting national standards of therapeutic education and care to the amazonian challenge. World J Diabetes. 2021 Feb 15;12(2):98-107. doi: 10.4239/wjd.v12.i2.98.
- Maurice L, Barraza F, Blondet I, Ho-A-Chuck M, Tablon J, Brousse P, Demar M, Schreck E. Childhood lead exposure of Amerindian communities in French Guiana: an isotopic approach to tracing sources. Environ Geochem Health. 2021 Nov;43(11):4741-4757. doi: 10.1007/s10653-021-00944-9. Epub 2021 May 11.
- Matos LM, Borges AT, Palmeira AB, Lima VM, Maciel EP, Fernandez RNM, Mendes JPL, Romero GAS. Frequency of exposure to arboviruses and characterization of Guillain Barre syndrome in a clinical cohort of patients treated at a tertiary referral center in Brasilia, Federal District. Rev Soc Bras Med Trop. 2022 Apr 8;55:e03062021. doi: 10.1590/0037-8682-0306-2021. eCollection 2022.
- Maury-Brachet R, Gentes S, Dassie EP, Feurtet-Mazel A, Vigouroux R, Laperche V, Gonzalez P, Hanquiez V, Mesmer-Dudons N, Durrieu G, Legeay A. Mercury contamination levels in the bioindicator piscivorous fish Hoplias aimara in French Guiana rivers: mapping for risk assessment. Environ Sci Pollut Res Int. 2020 Feb;27(4):3624-3636. doi: 10.1007/s11356-018-3983-x. Epub 2019 Jan 4.
- Laperche V, Hellal J, Maury-Brachet R, Joseph B, Laporte P, Breeze D, Blanchard F. Regional distribution of mercury in sediments of the main rivers of French Guiana (Amazonian basin). Springerplus. 2014 Jun 26;3:322. doi: 10.1186/2193-1801-3-322. eCollection 2014.
- Schmidt HH, Waddington-Cruz M, Botteman MF, Carter JA, Chopra AS, Hopps M, Stewart M, Fallet S, Amass L. Estimating the global prevalence of transthyretin familial amyloid polyneuropathy. Muscle Nerve. 2018 May;57(5):829-837. doi: 10.1002/mus.26034. Epub 2018 Feb 1.
- Pasnoor M, Nascimento OJ, Trivedi J, Wolfe GI, Nations S, Herbelin L, de Freitas MG, Quintanilha G, Khan S, Dimachkie M, Barohn R. North America and South America (NA-SA) neuropathy project. Int J Neurosci. 2013 Aug;123(8):563-7. doi: 10.3109/00207454.2013.782026. Epub 2013 Apr 17.
- Hanewinckel R, van Oijen M, Ikram MA, van Doorn PA. The epidemiology and risk factors of chronic polyneuropathy. Eur J Epidemiol. 2016 Jan;31(1):5-20. doi: 10.1007/s10654-015-0094-6. Epub 2015 Dec 23.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YANANER
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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