NCT04812886

Brief Summary

Gout is a chronic disease caused by the deposit of monosodium urate (MSU) crystals in body tissues secondary to hyperuricemia. Patients with gout suffer severe attacks of acute joint pain. As the disease progresses, the joint pain becomes chronic and associated with disabling and deformative manifestations called tophi. Gout is strongly associated with various comorbidities including cardiovascular disease and chronic kidney failure. Gout is a very common disease, affecting 0.9% of the adult population in France and nearly 4% of the North-American population. Data from New Zealand show a particularly high prevalence of gout among Polynesians (minority populations in New Zealand and other islands of the South Pacific) that would be explained by genetic susceptibility and frequently intertwined with metabolic diseases. Recent findings obtained from the Polynesian population in New Caledonia disclose high prevalence figures close to 7%, a level expected to be confirmed by an epidemiology study that will be conducted in parallel with the present study and designed to determine the precise prevalence of gout in French Polynesia and the most frequently associated genetic variants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,088

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

April 29, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2021

Completed
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

March 17, 2021

Last Update Submit

April 16, 2026

Conditions

Gout

Keywords

Gout, French Polynesia, Epidemiology

Outcome Measures

Primary Outcomes (1)

  • Gout Prevalence

    Measure of gout prevalence

    6 months

Secondary Outcomes (5)

  • Diagnosis of Hyperuricemia

    6 months

  • Genome wide analysis for identification of genetic variants linked to gout

    6 months

  • HLA B58:01 allele prevalence

    6 months

  • Multiple correlation between renal failure, diabetes, gout and cardiovascular comorbidities

    6 months

  • Multiple correlation between renal failure, diabetes, hyperuricemia and cardiovascular comorbidities

    6 months

Study Arms (1)

Epidemiological study

EXPERIMENTAL
Other: Epidemiological study

Interventions

Epidemiological studyOTHER

Questionnaires (quality of life, gout, life habit, comorbidities) anthropometrics and health measures DNA analysis RNA analysis Metabolomic analysis

Epidemiological study

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Living in Tahiti, Moorea, Tahaa-Raiatea, Tikehau, Nuku Hiva, Mangareva, Rurutu
  • Agreeing to participate in the study

You may not qualify if:

  • Homeless
  • Living in communities (military camp, hospices, university residence, ...)
  • Unable to answer questionnaires
  • Under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de la Polynésie Française

Pirae, 98713, French Polynesia

Location

Related Publications (1)

  • Pascart T, Wasik KA, Preda C, Chune V, Torterat J, Prud'homme N, Nassih M, Martin A, Le Masson J, Rodiere V, Frogier S, Canova G, Pescheux JP, Shan Sei Fan C, Jauffret C, Claeys P, von Baeyer SL, Castel SE, Emde AK, Yerges-Armstrong L, Fox K, Leask M, Vitagliano JJ, Graf S, Norberciak L, Raynal J, Dalbeth N, Merriman T, Bardin T, Oehler E. The gout epidemic in French Polynesia: a modelling study of data from the Ma'i u'u epidemiological survey. Lancet Glob Health. 2024 Apr;12(4):e685-e696. doi: 10.1016/S2214-109X(24)00012-3.

    PMID: 38485432RESULT

MeSH Terms

Conditions

Gout

Interventions

Epidemiologic Studies

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Tristan Pascart, MD, PhD

    GHICL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2021

First Posted

March 24, 2021

Study Start

April 29, 2021

Primary Completion

August 16, 2021

Study Completion

August 16, 2021

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)