- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06133400
Mapping the Health Status of the Population of French Polynesia: the MATAEA Project (MATAEA)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tahiti
-
Papeete, Tahiti, French Polynesia, 98713
- Institut Louis Malardé
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Subjects representative of the adult population (18-69 y) of French Polynesia
Population sample composed of people aged 18 to 69.
These people must have been living in French Polynesia for more than two years at the time of the 2017 census
|
Questionnaire about socio-demographical status, health status and lifestyle habits
Measurement of height, weight, waist circumference, blood pressure and skin pigmentation
Collect venous blood, saliva and stool samples
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of obesity
Time Frame: 2 years
|
Proportion of participants with indicators of obesity based on physical measurements (BMI, waist circumference) and quantification of lipid levels from blood samples.
|
2 years
|
|
Prevalence of diabetes
Time Frame: 2 years
|
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
|
|
Prevalence of cardiovascular diseases
Time Frame: 2 years
|
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
|
|
Seroprevalence of communicable diseases
Time Frame: 2 years
|
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
|
|
Composition of microbiome
Time Frame: 2 years
|
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
|
|
Level of exposure to mosquito bites
Time Frame: 2 years
|
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
|
|
Prevalence of ciguatera poisoning
Time Frame: 2 years
|
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
|
|
Demographic and adaptive history of French Polynesians using genomics
Time Frame: 2 years
|
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
|
|
Association between non-communicable diseases and behavioral factors
Time Frame: 2 years
|
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
|
|
Association between non-communicable diseases and physical measurements
Time Frame: 2 years
|
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
|
|
Association between non-communicable diseases and blood analyses
Time Frame: 2 years
|
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
|
|
Level of exposure to heavy metals
Time Frame: 2 years
|
Quantification of levels of heavy metals (including mercury and lead) from blood samples and association with lifestyle behavior and diet.
|
2 years
|
|
Level of exposure to pesticides
Time Frame: 2 years
|
Quantification of levels of pesticides (including chlordane and toxaphene) from blood samples and association with lifestyle behavior and diet.
|
2 years
|
|
Genetic susceptibility to obesity
Time Frame: 2 years
|
Genome-wide association studies to identify human genetic factors that are associated with BMI or lipids levels.
|
2 years
|
|
Genetic susceptibility to diabetes
Time Frame: 2 years
|
Genome-wide association studies to identify human genetic factors that are associated with HbA1c.
|
2 years
|
|
Genetic susceptibility to communicable diseases
Time Frame: 2 years
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Van-Mai CAO-LORMEAU, PhD, Institut Louis Malardé
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-ILM-001
- 2019-A01793-54 (Other Identifier: ANSM)
- 2017-069 (Other Identifier: Institut Pasteur)
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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