Non Communicable DiseasesMATAEANCT06133400
Mapping the Health Status of the Population of French Polynesia: the MATAEA Project
A study testing Questionnaire, Physical measurements and Biological samples in people with Non Communicable Diseases and Microbiome, run by Institut Louis Malardé at 1 site in French Polynesia.
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… Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Non Communicable Diseases, Microbiome, Communicable Diseases
- What is being tested?
- Questionnaire, Physical measurements and Biological samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,942 participants
- Where
- 1 siteFrench Polynesia
- Study dates
- 4 Nov 2019to 8 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be aged 18 or over and under 70 on the date of recruitment
- having signed the consent form
Who cannot join
- 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
Show all 9Show fewer
- Homeless people
- Disabled people (unable to move)
- People unable to answer the questionnaire
Trial locations and contacts
1 site in 1 country.
French Polynesia1 site
Institut Louis Malardé
Papeete, Îles du Vent, 98713
About this study
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.
- Conditions
- Non Communicable Diseases, Microbiome, Communicable Diseases, Pesticide Exposure, Metal Poison, Genetics Population
- Being tested
- Questionnaire, Physical measurements, Biological samples
- Keywords
- cross-sectional survey, non-communicable disease, communicable disease, French Polynesia, population genetics
- Medical subject headings
- Noncommunicable Diseases, Communicable Diseases, Heavy Metal Poisoning, Ciguatera Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaire about socio-demographical status, health status and lifestyle habits
Physical measurementsOther
Measurement of height, weight, waist circumference, blood pressure and skin pigmentation
Biological samplesOther
Collect venous blood, saliva and stool samples
| Study group | Role | What they receive |
|---|---|---|
| Subjects representative of the adult population (18-69 y) of French Polynesia | Experimental | 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 Receives: Other: Questionnaire; Other: Physical measurements; Other: Biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
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).
Measured: 2 years
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).
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
Level of exposure to pesticides
Quantification of levels of pesticides (including chlordane and toxaphene) from blood samples and association with lifestyle behavior and diet.
Measured: 2 years
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
Measured: 2 years
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
Measured: 2 years
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.
Measured: 2 years
Genetic susceptibility to obesity
Genome-wide association studies to identify human genetic factors that are associated with BMI or lipids levels.
Measured: 2 years
Genetic susceptibility to diabetes
Genome-wide association studies to identify human genetic factors that are associated with HbA1c.
Measured: 2 years
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…).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start4 Nov 2019
- Primary completion8 Dec 2021
- Study completion8 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Communicable DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,942 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Louis Malardé
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pasteur, Institut de la Statistique de la Polynésie française, Centre Hospitalier de la Polynésie française, Université de la Polynésie française, Institut National en Santé Publique du Québec
- Responsible party
- Sponsor
- Investigators
- Van-Mai CAO-LORMEAU, PhD, Study director, Institut Louis Malardé
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133400
- Sponsor's protocol ID
- 2019-ILM-001
- Other IDs
- 2019-A01793-54, 2017-069
- Acronym
- MATAEA
- Status last verified
- Nov 2023
- First submitted
- 30 Oct 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Teiti I, Aubry M, Fernandes-Pellerin S, Patin E, Madec Y, Boucheron P, Vanhomwegen J, Torterat J, Lastere S, Olivier S, Jaquaniello A, Roux M, Mendiboure V, Harmant C, Bisiaux A, Rijo de Leon G, Liu D, Bossin H, Mathieu-Daude F, Gatti C, Suhas E, Chung K, Condat B, Ayotte P, Conte E, Jolly N, Manuguerra JC, Sakuntabhai A, Fontanet A, Quintana-Murci L, Cao-Lormeau VM. Unravelling the determinants of human health in French Polynesia: the MATAEA project. Front Epidemiol. 2023 Nov 27;3:1201038. doi: 10.3389/fepid.2023.1201038. eCollection 2023.
PubMed 38455935
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping the Health Status of the Population of French Polynesia: the MATAEA Project
- ClinicalTrials.gov ID
- NCT06133400
- Acronym / sponsor ID
- MATAEA / 2019-ILM-001
- Conditions
- Non Communicable Diseases, Microbiome, Communicable Diseases, Pesticide Exposure, Metal Poison, Genetics Population
- Keywords
- cross-sectional survey, non-communicable disease, communicable disease, French Polynesia, population genetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,942 participants (actual)
- Lead sponsor
- Institut Louis MalardéUniversity, hospital or other
- Collaborators
- Institut Pasteur, Institut de la Statistique de la Polynésie française, Centre Hospitalier de la Polynésie française, Université de la Polynésie française, Institut National en Santé Publique du Québec
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 8 Dec 2021 (actual)
- Study completion
- 8 Dec 2021 (actual)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects representative of the adult population (18-69 y) of French Polynesia | Experimental | Other: Questionnaire, Other: Physical measurements, Other: Biological samplesPopulation 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 |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- be aged 18 or over and under 70 on the date of recruitment
- having signed the consent form
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireQuestionnaire about socio-demographical status, health status and lifestyle habits | Other | Subjects representative of the adult population (18-69 y) of French Polynesia |
| Physical measurementsMeasurement of height, weight, waist circumference, blood pressure and skin pigmentation | Other | Subjects representative of the adult population (18-69 y) of French Polynesia |
| Biological samplesCollect venous blood, saliva and stool samples | Other | Subjects representative of the adult population (18-69 y) of French Polynesia |
Primary outcome
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.
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.
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.
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.
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).
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).
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.
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.
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.
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.
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
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
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.
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.
Genetic susceptibility to diabetes
Time frame: 2 years
Genome-wide association studies to identify human genetic factors that are associated with HbA1c.
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…).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 38455935Teiti I, Aubry M, Fernandes-Pellerin S, Patin E, Madec Y, Boucheron P, Vanhomwegen J, Torterat J, Lastere S, Olivier S, Jaquaniello A, Roux M, Mendiboure V, Harmant C, Bisiaux A, Rijo de Leon G, Liu D, Bossin H, Mathieu-Daude F, Gatti C, Suhas E, Chung K, Condat B, Ayotte P, Conte E, Jolly N, Manuguerra JC, Sakuntabhai A, Fontanet A, Quintana-Murci L, Cao-Lormeau VM. Unravelling the determinants of human health in French Polynesia: the MATAEA project. Front Epidemiol. 2023 Nov 27;3:1201038. doi: 10.3389/fepid.2023.1201038. eCollection 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Van-Mai CAO-LORMEAU, PhD study director
Institut Louis Malardé
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire, Physical measurements and Biological samples in people with Non Communicable Diseases and Microbiome, run by Institut Louis Malardé at 1 site in French Polynesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in French Polynesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of obesity (time frame: 2 years). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06133400, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.