Health TrialsbyHealthPanel

Landscape of Gout in French Polynesia.

ConditionsGout DiseaseMetabolic DiseasesInflammation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorLille Catholic University

About this trial

The aim of this research is to characterise the genetic and molecular landscape of gout, inflammation and metabolic diseases, as well as the associated molecular, anthropomorphic and pathological characteristics.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age between 18 and 75 years old inclusive

Signature of informed consent

Fasting for the collection of biological samples

Declared Polynesian ancestry

Disqualifiers

Refusal or inability to understand or give consent

Physical inability to follow and respect the protocol

1st degree relative*,

Person under guardianship or trusteeship

Trial population

General population group: Participants will be recruited by general practitioners or study nurses during consultations in community-based practices. The objective is to include a representative general population sample, with no specific reason for consultation required or excluded. Gout group: Patients will be recruited at the Rheumatology Clinic of the Taaone Hospital Center (CHT) in Papeete when presenting with gout symptoms, either tophaceous gout or an acute flare within the previous 48 hours. 2021 follow-up group: Participants from the TOPATA study conducted in 2021 will be recontacted by telephone to assess willingness to participate, followed by an in-person inclusion visit. Only individuals currently living in Tahiti will be contacted. Nurses will be responsible for recruitment, biological sample collection, physical measurements, and questionnaire administration.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Epidemiological study

    Other intervention

    Collection of sociodemographic data, collection of treatment data, standard and clinical ophthalmological examination, physical and biological measurements, clinical characteristics specific to chronic and metabolic diseases, questionnaires (gout questionnaire, health assessment questionnaire (HAQ-II), EuroQol (EQ)-5D-5L, joint pain, state of health, diet and physical activity, access to care, addictions, sleep quality, pain scale (EVA), personal and family history) will be performed.

  • Blood and urine tests

    Diagnostic test

    Collection of blood and urine samples for genetic, biochemical, omics, and biobank analyses, in order to characterize cardiometabolic health markers will be performed.

Treatment groups

2,750 Participants
are divided into 3 treatment groups
Group A: General Population Group2 interventions
Group B: Gout Group2 interventions
Group C: Follow-up group 20212 interventions

Trial outcomes

Primary outcomes

1

GWAS-identified associations between population-enriched genetic variants and health-related traits

Effect estimates (odds ratios or beta coefficients) for statistically significant associations between population-enriched genetic variants and predefined health-related traits identified through GWAS.

Time frame
12 month

Secondary outcomes

1

Multiple correlation between gout, hyperuricemia, type 2 diabetes and obesity

Anthropometric and biological characteristics of gout, hyperuricemia, type 2 diabetes, and obesity will be assessed, and comorbidity associations analyzed using multivariate logistic regression. Measurements will include waist and hip circumferences, blood pressure, muscle properties by myotonometry, lower-limb strength via chair stand test, and handgrip strength. Blood analyses will assess lipid profile, liver function, inflammation, renal function and metabolism, glucose metabolism, and complete blood count. Urine analyses will also be performed.

Time frame
12 month
2

Incidence rate of gout or HU in French Polynesia between 2021 and 2025

Incidence rate of gout or HU in French Polynesia between 2021 and 2025 in a sample of participants in the 2021 cohort with asymptomatic HU and no gout.

Time frame
4 years
3

Proportion of each type of urate-lowering therapy prescribed annually between 2019 and 2025

Breakdown of types of THU prescribed between 2019 and 2025 based on the database of healthcare claims submitted to the Caisse de Prévoyance Sociale (CPS)

Time frame
4 years
4

Incidence of major adverse cardiovascular events (MACE) in patients with gout, diabetes, or obesity

Occurrence of MACE related to gout, diabetes or obesity on the Healthcare Claims Database (HCD).

Time frame
12 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lille Catholic University

Lead sponsor

Variant Bio, Inc.

Collaborator

Source ClinicalTrials.gov
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