Mapping the Health Status of the Population of French Polynesia: the MATAEA Project

Microbiome Clinical Trial

— MATAEA  

Official title:

Mapping the Health Status of the Population of French Polynesia: the MATAEA Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06133400
• Other study ID #: 2019-ILM-001
• Secondary ID: 2019-A01793-5420
• Status: Completed
• Phase: N/A
• Start date: November 4, 2019
• Est. completion date: December 8, 2021

Study information

• Verified date: November 2023
• Source: Institut Louis Malardé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a cross-sectional study carried out on a sample of the adult population aged 18 to 69, distributed over the five archipelagos of French Polynesia.

Participation in the study involves: agreement to answer a questionnaire to collect information on socio-demographic characteristics, lifestyle habits and medical history; physical measurements (height, weight, waist circumference, blood pressure and skin pigmentation); and agreement to take biological samples (blood, saliva and stool) for biological, genetic and microbiological analyses.

The aim of the study is to assess the current health status of the population of French Polynesia and to evaluate the influence of contextual risk factors (lifestyle, place of residence, history of infection) and intrinsic susceptibility factors (genetics, age, gender, microbiota) in relation to non-communicable and infectious diseases.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1942
• Est. completion date: December 8, 2021
• Est. primary completion date: December 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

• be aged 18 or over and under 70 on the date of recruitment

• having signed the consent form

Exclusion Criteria:

• Minors

• Pregnant or parturient women, and nursing mothers

• Persons deprived of their liberty by a judicial or administrative decision

• Adults who are the subject of a legal protection measure or who are unable to express their consent

• People undergoing psychiatric care

• Individuals who are not affiliated to a social security scheme or beneficiaries of such a scheme

• Homeless people

• Disabled people (unable to move)

• People unable to answer the questionnaire

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Metal Poison
• Microbiome
• Non Communicable Diseases
• Noncommunicable Diseases
• Pesticide Exposure

Intervention

Other:
• Questionnaire
Questionnaire about socio-demographical status, health status and lifestyle habits
• Physical measurements
Measurement of height, weight, waist circumference, blood pressure and skin pigmentation
• Biological samples
Collect venous blood, saliva and stool samples

Locations

Country	Name	City	State
French Polynesia	Institut Louis Malardé	Papeete	Tahiti

Sponsors (6)

Lead Sponsor	Collaborator
Institut Louis Malardé	Centre Hospitalier de la Polynésie française, Institut de la Statistique de la Polynésie française, Institut National en Santé Publique du Québec, Institut Pasteur, Université de la Polynésie française

Country where clinical trial is conducted

French Polynesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of obesity	Proportion of participants with indicators of obesity based on physical measurements (BMI, waist circumference) and quantification of lipid levels from blood samples.	2 years
Primary	Prevalence of diabetes	Proportion of participants with indicators of diabetes based on self-reported data on diabetes history (previous diagnosis, antidiabetic treatment) and quantification of glycated haemoglobin from blood samples.	2 years
Primary	Prevalence of cardiovascular diseases	Proportion of participants with indicators of cardiovascular diseases based on self-reported data on history of hypertension (previous diagnosis, treatment for hypertension), blood pressure measurement, and quantification of lipid levels from blood samples.	2 years
Primary	Association between non-communicable diseases and behavioral factors	Calculation of odd ratios to investigate association between non-communicable diseases (obesity, diabetes, cardiovascular diseases) and behavioral factors such as tobacco smoking, alcohol consumption, diet or physical activity data self-reported by the participants in the questionnaire.	2 years
Primary	Association between non-communicable diseases and physical measurements	Calculation of odd ratios to investigate association between non-communicable diseases (obesity, diabetes, cardiovascular diseases) and physical measurements such as BMI (based on the BMI formula i.e., weight in kilograms divided by height in meters squared).	2 years
Primary	Association between non-communicable diseases and blood analyses	Calculation of odd ratios to investigate association between non-communicable diseases (obesity, diabetes, cardiovascular diseases) and blood analyses (such as glycated haemoglobin and lipid levels).	2 years
Primary	Seroprevalence of communicable diseases	Proportion of participants with IgG antibodies, detected in blood samples, specific for different pathogens : arboviruses (four dengue serotypes, Zika, chikungunya), hepatitis B and C viruses, hantaviruses, SARS-CoV-2 and other pathogens known to regularly cause infections in French Polynesia (including influenza viruses, human immunodeficiency virus…). Proportion of participants with positive filarial antigenemia to assess the prevalence of Bancroftian lymphatic filariasis.	2 years
Primary	Composition of microbiome	Bacterial DNA sequencing from stool and saliva samples to assess the gut and oral microbiota profiles and association with lifestyle behavior, diet and susceptibility to communicable and non-communicable diseases.	2 years
Primary	Level of exposure to heavy metals	Quantification of levels of heavy metals (including mercury and lead) from blood samples and association with lifestyle behavior and diet.	2 years
Primary	Level of exposure to pesticides	Quantification of levels of pesticides (including chlordane and toxaphene) from blood samples and association with lifestyle behavior and diet.	2 years
Primary	Level of exposure to mosquito bites	Proportion of participants with IgG antibodies targeting mosquito salivary proteins in blood samples to assess the risk of infection by mosquito-borne viruses	2 years
Primary	Prevalence of ciguatera poisoning	Estimation of the rate of ciguatera poisoning in the population based on data self-reported by the participants in the questionnaire e.g. the occurrence of symptoms suggestive for ciguatera poisoning at least once in their lifetime	2 years
Primary	Demographic and adaptive history of French Polynesians using genomics	Human Whole Genome Sequencing from saliva samples to reconstruct the genetic history of the population of French Polynesia, in terms of both demographic and adaptive history.	2 years
Primary	Genetic susceptibility to obesity	Genome-wide association studies to identify human genetic factors that are associated with BMI or lipids levels.	2 years
Primary	Genetic susceptibility to diabetes	Genome-wide association studies to identify human genetic factors that are associated with HbA1c.	2 years
Primary	Genetic susceptibility to communicable diseases	Genome-wide association studies to identify human genetic factors that are associated with the detection of IgG antibodies specific for different pathogens: arboviruses, hepatitis B and C viruses, hantaviruses, SARS-CoV-2 and other pathogens known to regularly cause infections in French Polynesia (including influenza viruses, human immunodeficiency virus…).	2 years