{"doc_desc":{"title":"Cohorte de patients atteints de type diab\u00e8te type 2: polymorphisme g\u00e9n\u00e9tique et analyse longitudinale de la fonction r\u00e9nale","idno":"FRESH-PEF4071-fr","producers":[{"name":"Pierre-Jean SAULNIER","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE POITIERS"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF4071-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"4071"},{"agency":"FReSH","code":"FRESH-PEF4071"}]},"title":"Cohorte de patients atteints de type diab\u00e8te type 2: polymorphisme g\u00e9n\u00e9tique et analyse longitudinale de la fonction r\u00e9nale","alternate_title":"SURDIAGENE: SUivi R\u00e9nal , DIAb\u00e8te de type 2 et GENEtique"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"}]},"authoring_entity":[{"type":"investigator","name":"Mich\u00e8le;GROSDENIER","PILabo":"CHU Poitiers \/ Biobank","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE POITIERS","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"200055358","role":"organisation id"},{"title":"RNSR","uri":"200919261B","role":"labo id"}],"email":"michele.grosdenier.bruneau@chu-poitiers.fr","isContact":"Oui"}],"oth_id":[{"name":"Implication dans un r\u00e9seau de cohorte : collaboration aux cohortes D2NG et DIABHCAR (cf article Hadjadj S et al Diabetes Care 2008)","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE POITIERS","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/029s6hd13","role":"sponsor id"},{"title":"SIREN","uri":"200055358","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"GROUPT ETUDE MALADIES METABOLIQUES SYST. (GEMMS)","extlink":[{"title":"SIREN","uri":"441699105"}]},{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]}]},"distribution_statement":{"contact":[{"name":"Samy;HADJADJ","email":"samy.hadjadj@gmail.com","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE POITIERS","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/029s6hd13","role":"organisation id","title":"ROR"},{"uri":"200055358","role":"organisation id","title":"SIREN"}]},{"name":"Mich\u00e8le;GROSDENIER","email":"michele.grosdenier.bruneau@chu-poitiers.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE POITIERS","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/029s6hd13","role":"organisation id","title":"ROR"},{"uri":"200055358","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"\u00e9v\u00e9nements de sant\u00e9"},{"keyword":"fonction r\u00e9nale"},{"keyword":"cardio-vasculaire"},{"keyword":"d\u00e9c\u00e8s"},{"keyword":"population"},{"keyword":"syst\u00e8me de sant\u00e9"}],"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":"N\u00e9phrologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/3961e9d2-ab3b-451b-b246-20fc0ec3b0c4"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009398"}]},{"topic":"Diab\u00e8te sucr\u00e9 de type 2","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/119724091","title":"CIM-11"}]},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux : Alimentation","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"}],"purpose":"PRINCIPAL : \u00e9tudier les d\u00e9terminants g\u00e9n\u00e9tiques associ\u00e9s \u00e0 la modification de la fonction r\u00e9nale (modification de la clairance de la cr\u00e9atinine) SECONDAIRES : 1- \u00e9tudier les d\u00e9terminants g\u00e9n\u00e9tiques associ\u00e9s \u00e0 la modification de l\u2019excr\u00e9tion urinaire d\u2019albumine 2- \u00e9tudier les d\u00e9terminants g\u00e9n\u00e9tiques associ\u00e9s aux autres complications d\u00e9g\u00e9n\u00e9ratives du diab\u00e8te (r\u00e9tinopathie, \u00e9v\u00e9nement cardiovasculaire)","abstract":"","coll_dates":[{"start":"2003-01-01","end":"2020-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"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            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"B1. Diab\u00e8te de type 2 (DT2): Les sujets de l\u2019\u00e9tude SURDIAGENE pr\u00e9sentent un DT2. La distinction entre diab\u00e8te de type 1 (DT1) et DT2 est parfois d\u00e9licate. Nous retenons comme crit\u00e8re de diagnostic du DT2 : - \u00e2ge au diagnostic sup\u00e9rieur ou \u00e9gal \u00e0 35 ans - insulino-requ\u00e9rance apparue plus de 2 ans apr\u00e8s le diagnostic de diab\u00e8te - absence de diab\u00e8te secondaire - absence de c\u00e9tonurie au diagnostic  B2. Suivi longitudinal : Les sujets de l\u2019\u00e9tude SURDIAGENE  pr\u00e9sentent un DT2 dont le suivi du diab\u00e8te sur au moins 1 an comprend un recueil de donn\u00e9es cliniques (pression art\u00e9rielle, poids) et biologiques (h\u00e9moglobine glyqu\u00e9e, cr\u00e9atinin\u00e9mie, excr\u00e9tion urinaire d\u2019albumine) permettant d\u2019analyser l\u2019\u00e9volution de la n\u00e9phropathie et des autres complications d\u00e9g\u00e9n\u00e9ratives (r\u00e9tiniennes et cardiovasculaires)  \",\n    \"clusion_E\": \"Les sujets ne pouvant pas participer \u00e0 l\u2019\u00e9tude SURDIAGENE sont les sujets qui pr\u00e9sentent  a) des crit\u00e8res m\u00e9dicaux de   - ne pr\u00e9sentant pas un diab\u00e8te ou pr\u00e9sentant un DT1 ou un diab\u00e8te secondaire \"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence au moment de la saisie des donn\u00e9es informatiques et apr\u00e8s la saisie des donn\u00e9es informatiques Gestion des donn\u00e9es manquantes par retour vers un tiers Relance des m\u00e9decins pour r\u00e9aliser les visites de suivi Relance des sujets pour r\u00e9aliser les visites de suivi Autre(s) proc\u00e9dure(s) qualit\u00e9 : proc\u00e9dure interne INSERM CIC 802 en cours de d\u00e9veloppement Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es']"}},"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":"1200"},"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":"Demande \u00e0 faire aupr\u00e8s du responsable scientifique","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":"13-08-2012","lastUpdatedAuto":null,"lastUpdatedManual":"07-08-2019","isContributorPI":"Non","contributorName":"Pierre-Jean SAULNIER","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE POITIERS","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[{"type":"","title":"List of publications in Pubmed","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=SURDIAGENE"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Priv\u00e9 \u00e0 but non lucratif","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":"Oui"},"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":"Entretiens : saisie \u00e0 partir d\u2019un questionnaire papier (saisie manuelle) avec double saisie Examens cliniques : \u00e9tape manuscrite (saisie manuelle) avec double saisie Examens biologiques : saisie directe","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Poitiers (Vienne)"},"dataTypes":{"clinicalDataDetails":"Examen clinique : Au cours du suivi P\u00e9riodicit\u00e9 de l'examen : 2 ansInformations recueillies lors de l'examen clinique : Poids, pression art\u00e9rielle, donn\u00e9es biologiques : cr\u00e9atinin\u00e9mie, albumine urinaire, HBA1C","biologicalDataDetails":"Fonction r\u00e9nale et \u00e9quilibre glyc\u00e9mique :La fonction r\u00e9nale est bas\u00e9e sur une mesure de la cr\u00e9atinine plasmatique et une estimation du d\u00e9bit de filtration glom\u00e9rulaire (DFG estim\u00e9 par les formules MDRD et CKD-EPI).L\u2019atteinte r\u00e9nale du diab\u00e9te (initiale et dans le suivi) est \u00e9galement caract\u00e9ris\u00e9e via l\u2019excr\u00e9tion urinaire d\u2019albumine et le ratio Albumine urinaire\/cr\u00e9atinine urinaire. Cela permet se stader le niveau d\u2019atteinte r\u00e9nale en plus du DFG.L\u2019\u00e9quilibre glyc\u00e9mique est estim\u00e9 via la mesure de l\u2019h\u00e9moglobine glyqu\u00e9e (HbA1c).","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}