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Epidemiology of Gout in French Polynesia (TOPATA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04812886
Recruitment Status : Completed
First Posted : March 24, 2021
Last Update Posted : September 30, 2021
Sponsor:
Collaborators:
Variant Bio, Inc.
University of Birmingham
University of San Diego
Ministry of Health, French Polynesia
Information provided by (Responsible Party):
Lille Catholic University

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.

Condition or disease Intervention/treatment Phase
Gout Other: Epidemiological study Not Applicable

Detailed Description:

International genomic studies conducted in populations with hyperuricemia and gout have identified a number of associated alleles. The strength of the association between a given allele and gout (or hyperuricemia) provides an indication of the importance of the encoded protein in disease pathogenesis. It was in this way that the development of gout was found to depend on renal urate transporters that were subsequently targeted by new uricosuric therapies.

Overall, the search for gout-associated genes has mostly been done in the general European population and revealed a small number of candidate loci. Most of these only contribute a small amount to the heritability for gout susceptibility, suggesting that additional genes and mechanisms of genetic influence are yet to be discovered. A common feature of Genome-Wide Association studies done so far is that usually large sample sizes are required in order to detect differences in allele frequencies and their contribution to different traits between test groups. The Polynesian population of French Polynesia possesses characteristics that make it particularly attractive to carry out population-based genetic research. Historical records indicate that the Polynesians of Tahiti and surrounding islands originate from a small founder population that has undergone a number of bottlenecks, eventually becoming a genetically homogenous population with a fairly high degree of consanguinity. The combination of a historic founder event, continued isolation and recent expansion are all ideal properties for a Genome Wide Association Study, as they ensure that 1) population stratification will be easy to correct when performing association tests and 2) there are likely high-effect variants that were kept at low frequency in mainland Europe due to negative selection but rose to high frequencies in the Polynesians via the increase in genetic drift or selection through adaptation to a specific environment and diet. Therefore, it is plausible that rare variants with large effect on health-related quantitative traits may be more easily detectable in Polynesians, even with much smaller sample sizes.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1088 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Gout in French Polynesia: Epidemiology and Comorbidities, Genetic Causes and Prevalence of HLA B58:01
Actual Study Start Date : April 29, 2021
Actual Primary Completion Date : August 16, 2021
Actual Study Completion Date : August 16, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Gout

Arm Intervention/treatment
Experimental: Epidemiological study Other: Epidemiological study
Questionnaires (quality of life, gout, life habit, comorbidities) anthropometrics and health measures DNA analysis RNA analysis Metabolomic analysis




Primary Outcome Measures :
  1. Gout Prevalence [ Time Frame: 6 months ]
    Measure of gout prevalence


Secondary Outcome Measures :
  1. Diagnosis of Hyperuricemia [ Time Frame: 6 months ]
    Diagnosed when uricemia is higher than 360 µmol/l

  2. Genome wide analysis for identification of genetic variants linked to gout [ Time Frame: 6 months ]
    Analysis of the genetic determinants of gout and hyperuricemia in French Polynesia via a pan-genomic analysis using complete and then rapid sequencing techniques

  3. HLA B58:01 allele prevalence [ Time Frame: 6 months ]
  4. Multiple correlation between renal failure, diabetes, gout and cardiovascular comorbidities [ Time Frame: 6 months ]
    The association between cardiovascular comorbidities/renal failure/diabetes and gout will be investigated using a multivariate logistic regression model.

  5. Multiple correlation between renal failure, diabetes, hyperuricemia and cardiovascular comorbidities [ Time Frame: 6 months ]
    The association between cardiovascular comorbidities/renal failure/diabetes and hyperuricemia will be investigated using a multivariate logistic regression model.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04812886


Locations
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French Polynesia
Centre Hospitalier de la Polynésie Française
Pirae, French Polynesia, 98713
Sponsors and Collaborators
Lille Catholic University
Variant Bio, Inc.
University of Birmingham
University of San Diego
Ministry of Health, French Polynesia
Investigators
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Principal Investigator: Tristan Pascart, MD, PhD GHICL
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Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT04812886    
Other Study ID Numbers: RC-P00104
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: September 30, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lille Catholic University:
Gout, French Polynesia, Epidemiology
Additional relevant MeSH terms:
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Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases