{"doc_desc":{"title":"Cohorte en population g\u00e9n\u00e9rale : relation entre sensibilit\u00e9 \u00e0 l'insuline et maladies cardiovasculaires","idno":"FRESH-PEF3301-fr","producers":[{"name":"Beverley BALKAU","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3301-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"3301"},{"agency":"FReSH","code":"FRESH-PEF3301"}]},"title":"Cohorte en population g\u00e9n\u00e9rale : relation entre sensibilit\u00e9 \u00e0 l'insuline et maladies cardiovasculaires","alternate_title":"EGIR-RISC"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"ANSM"},{"name":"CPP"}]},"authoring_entity":[{"type":"investigator","name":"Beverley;BALKAU","PILabo":"Inserm","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ORCID","uri":"0000-0003-2021-413X","role":"pi id"},{"title":"IdRef","uri":"122895401","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"Non"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CTRE RECHERCHE NUTRITION HUMAINE RHONE-ALPES (CRNH RHONE-ALPES)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02dgk8j41","role":"sponsor id"},{"title":"SIREN","uri":"180089526","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"EUROPEAN COMMISSION RESEARCH","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00k4n6c32"}]},{"name":"ASTRAZENECA (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/016qv5070"},{"title":"SIREN","uri":"558201075"}]},{"name":"MERCK SANTE","extlink":[{"title":"SIREN","uri":"572028033"}]}]},"distribution_statement":{"contact":[{"name":"","type":"contact"}]},"study_info":{"keywords":[{"keyword":"insulo-r\u00e9sistance"},{"keyword":"ath\u00e9roscl\u00e9rose"},{"keyword":"maladies cardiovasculaires"},{"keyword":"d\u00e9c\u00e8s pr\u00e9coce"},{"keyword":"d\u00e9terminants"},{"keyword":"cons\u00e9quences"},{"keyword":"diab\u00e8te"}],"topics":[{"topic":"Endocrinologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d1dd1bac-5313-4ab3-837f-4acd3ec521a7"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D004704"}]},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux : Addictions","vocab":"health determinant"}],"purpose":"Objectif principal : Etude de l'insulo-r\u00e9sistance et l'ath\u00e9roscl\u00e9rose, les d\u00e9terminants de l'insulino-r\u00e9sistance, mesure par la m\u00e9thode de r\u00e9f\u00e9rence, son \u00e9volution sur 9 ans et les cons\u00e9quences, le diab\u00e8te, les maladies cardiovasculaires et le d\u00e9c\u00e8s pr\u00e9coce. Objectifs secondaires : 1. L'\u00e9valuation de l'insulino-r\u00e9sistance et son association avec les maladies cardiovasculaires 2. L'identification des facteurs g\u00e9n\u00e9tiques et environnementaux li\u00e9s \u00e0 l'insulino-r\u00e9sistance 3. La proposition d'un mod\u00e8le pour identifier l'insulino-r\u00e9sistance","abstract":"","coll_dates":[{"start":"2002-01-01","end":"2007-01-01"}],"nation":[{"name":"Autriche","abbreviation":"at","extLink":{"vocab":"ISO","vocabURI":"at"}},{"name":"Danemark","abbreviation":"dk","extLink":{"vocab":"ISO","vocabURI":"dk"}},{"name":"Finlande","abbreviation":"fi","extLink":{"vocab":"ISO","vocabURI":"fi"}},{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}},{"name":"Allemagne","abbreviation":"de","extLink":{"vocab":"ISO","vocabURI":"de"}},{"name":"Gr\u00e8ce","abbreviation":"gr","extLink":{"vocab":"ISO","vocabURI":"gr"}},{"name":"Pays-Bas","abbreviation":"nl","extLink":{"vocab":"ISO","vocabURI":"nl"}},{"name":"Irlande","abbreviation":"ie","extLink":{"vocab":"ISO","vocabURI":"ie"}},{"name":"Italie","abbreviation":"it","extLink":{"vocab":"ISO","vocabURI":"it"}},{"name":"Su\u00e8de","abbreviation":"se","extLink":{"vocab":"ISO","vocabURI":"se"}},{"name":"Espagne","abbreviation":"es","extLink":{"vocab":"ISO","vocabURI":"es"}},{"name":"Suisse","abbreviation":"ch","extLink":{"vocab":"ISO","vocabURI":"ch"}},{"name":"Royaume-Uni","abbreviation":"gb","extLink":{"vocab":"ISO","vocabURI":"gb"}},{"name":"Serbie","abbreviation":"rs","extLink":{"vocab":"ISO","vocabURI":"rs"}},{"name":"Montenegro","abbreviation":"me","extLink":{"vocab":"ISO","vocabURI":"me"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" \u00e2ge compris entre 30 et 60 ans, - en bon \u00e9tat de sant\u00e9 g\u00e9n\u00e9ral, - pas de sympt\u00f4mes de maladies cardiovasculaires, - tension art\u00e9rielle inf\u00e9rieure \u00e0 170\\\/90 mm Hg, - cholest\u00e9rol total inf\u00e9rieur \u00e0 7,8 mmol\\\/l, - triglyc\u00e9rides sanguin inf\u00e9rieurs \u00e0 4,6 mmol\\\/l, - glucose plasmatique (\u00e0 jeun et 2h apr\u00e8s une prise de glucose orale) inf\u00e9rieur \u00e0 7,0\\\/11,1 mmol\\\/l, - pas de traitement en relation avec le diab\u00e8te, l'hypertension ou les troubles lipidiques.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es paracliniques (hors biologiques) : Imagerie']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"1500"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Pour un acc\u00e8s aux donn\u00e9es, formuler une demande \u00e9crite au "project management board"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"29-03-2012","lastUpdatedAuto":null,"lastUpdatedManual":"05-09-2017","isContributorPI":"Non","contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["","",""]},"relatedDocument":[{"type":"","title":"Liste des publications dans HAL","link":"http:\/\/www.hal.inserm.fr\/RISC_STUDY"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (Europe)","Industrie","Industrie"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"- Questionnaire par entretien : (1) habitudes de vie, ant\u00e9c\u00e9dents familiaux, (2) maladies survenues. 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