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GoutTahitiNCT04900090

Tahiti-families: Polynesian Families of Gout Patients

A study testing Epidemiological study in people with Gout, run by Lille Catholic University at 1 site in French Polynesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Gout
What is being tested?
Epidemiological study
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteFrench Polynesia
Study dates
25 May 2021to 31 Aug 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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Case group :
  • Gout patients
  • Polynesian origin
  • Aged 18 to 80 years
  • Agreeing to participate in the study
  • Having a 1st or 2nd degree relative who is also gouty and a 1st degree relative of the same generation and sex who is not gouty
Show all 10Show fewer
  • Control group :
  • Non-gouty individuals who are 1st degree relatives of a gouty patient of the same generation and sex
  • Aged 18 to 80 years
  • Agreeing to participate in the study

Who cannot join

  • Pregnant women
  • Persons under guardianship, curatorship or other legal incapacity
  • Persons with a contraindication to Magnetic resonance imaging (MRI) examination
  • For non-gouty controls : current hyperuricemic treatment (Allopurinol, Febuxostat, Probenecid or Benzbromarone)
  • For gouty case : not participating in the TOPATA study (NCT04812886)

Trial locations and contacts

1 site in 1 country.

French Polynesia1 site

  • Centre Hospitalier de Polynésie Française

    Papeete, Ville de Pirae, 98713

About this study

Official title: Tahiti-families: From Genetic to Phenotype Study of Polynesian Families of Gout Patients

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 tophus. This disease is strongly associated with several comorbidities such as cardiovascular disease and chronic kidney failure. Gout is a very common disease, which is 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 interrelated metabolic diseases. Data on the Polynesian population in New Caledonia suggest prevalence figures close to 7% and prevalence in French Polynesia is assumed to be higher. International genomic studies of gout and hyperuricaemia have identified alleles associated with the occurrence of gout.

The aim is to focus on families with several gouty members (numerous in French Polynesia, and geographically clustered) in order to enable the study of individuals with monogenic gout or with a low number of variants (= cases) determining in the occurrence of gout, as well as a non-gouty family member (= controls).

Dual-energy CT scan (DECT) allows identification and quantification of UMS crystal deposits in the tissue. The volume of crystals correlates not only with the inflammatory activity of the disease but also with the comorbidities that complicate it. Dual-energy scanning has shown the presence of UMS crystals in some hyperuricemic individuals, which could help to identify those individuals most at risk of developing the disease as they already have the stigma of sub-clinical inflammatory activity.

Conditions
Gout
Being tested
Epidemiological study
Keywords
Gout, French Polynesia, Epidemiology, Family
Medical subject headings
Gout

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epidemiological studyOther

    • Clinical phenotypic assessment and neurosensory measures
    • Biological, genetic and metabolomic evaluation
    • Questionnaires (quality of life, gout, life habit, comorbidities)
    • Morphological evaluation by Dual-energy CT scan
Study groups in NCT04900090
Study groupRoleWhat they receive
Case group : gout patientsExperimentalEpidemiological study
Receives: Other: Epidemiological study
Control groupExperimentalEpidemiological study
Receives: Other: Epidemiological study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Multiple correlation between genetic variants and clinical presentation

    Genome-wide association study (GWAS) aims at identifying genetic variants (genotype) that associated with specific traits (phenotype).

    The link between the genetic variants and the stage of the disease will be sought using a bivariate analysis: Chi-2 tests or Fisher's exact tests in case of small numbers will be implemented

    Measured: 4 months

Secondary outcomes (3)

  1. Multiple correlation between disease stage, comorbidities, environmental and metabolomics data

    The link between variants will be stablish using a multivariate logistic regression model.- The comorbidities analysed are the following: initial uraemia, glomerular filtration rate (GFR), hypertension, chronic heart failure, diabetes, obesity (BMI > 30), obliterative arterial disease of the lower limbs, history of myocardial infarction, history of cerebrovascular accident

    • The environmental data analysed were as follows: habitus data (alcohol consumption, soft drinks, physical activity)

    Measured: 4 months

  2. Multiple correlation between severity of gout, its impact (pain, disease impact, and quality of life), presence of certain genetic variants, metabolomic changes and comorbidities

    The link between variants will be stablish using a multivariate logistic regression model. Quality of life will be assessed by the EuroQol questionnaire; perception of hyperuricemia-related illness by the Brief Hyperuricemia Perceptions Questionnaire (BIPQ); body and foot pain in the previous week by a VAS out of 100; activity limitations by the Health Assessment Questionnaire (HAQ-II); foot pain and disability by the Manchester Foot Pain and Disability Index (MFPDI).

    Measured: 4 months

  3. Multiple correlation between genetic variants, comorbidities, environmental factors, presence of gout

    The link between variants will be stablish using a multivariate logistic regression model. Health status will be assessed by the following elements:

    • Perceived health status: good (modalities "very good" and "good") / bad ("average", "bad" and "very bad")
    • Total number of visits to a health professional in the last 12 monthsThe presence of gout will be determined using a calculation combining and weighting different responses to the questionnaires.

    The diagnosis of gout is retained if the patient meets the 2015 ACR/EULAR criteria for diagnostic classification of gout.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2021
  2. Study start25 May 2021
  3. Primary completion31 Aug 2021
  4. Study completion31 Aug 2021

Resources

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
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04900090
Sponsor's protocol ID
RC-P00106
Acronym
Tahiti
Status last verified
Apr 2026
First submitted
12 May 2021
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38485432

Questions about this trial

What is this clinical trial studying?

A study testing Epidemiological study in people with Gout, run by Lille Catholic University 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 10 inclusion and 5 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 1 May 2026. 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?

Multiple correlation between genetic variants and clinical presentation (time frame: 4 months). 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 NCT04900090, 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 1 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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