- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04812886
Epidemiology of Gout in French Polynesia (TOPATA)
Gout in French Polynesia: Epidemiology and Comorbidities, Genetic Causes and Prevalence of HLA B58:01
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Pirae, French Polynesia, 98713
- Centre Hospitalier de la Polynésie Française
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Epidemiological study
|
Questionnaires (quality of life, gout, life habit, comorbidities) anthropometrics and health measures DNA analysis RNA analysis Metabolomic analysis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gout Prevalence
Time Frame: 6 months
|
Measure of gout prevalence
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnosis of Hyperuricemia
Time Frame: 6 months
|
Diagnosed when uricemia is higher than 360 µmol/l
|
6 months
|
|
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
|
6 months
|
|
HLA B58:01 allele prevalence
Time Frame: 6 months
|
6 months
|
|
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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.
|
6 months
|
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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.
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tristan Pascart, MD, PhD, GHICL
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Crystal Arthropathies
- Musculoskeletal Diseases
- Arthritis
- Joint Diseases
- Rheumatic Diseases
- Purine-Pyrimidine Metabolism, Inborn Errors
- Metabolism, Inborn Errors
- Genetic Diseases, Inborn
- Metabolic Diseases
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Nutritional and Metabolic Diseases
- Gout
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Epidemiologic Study Characteristics
- Epidemiologic Studies
Other Study ID Numbers
- RC-P00104
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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