{"doc_desc":{"title":"Etude cas-t\u00e9moins sur le polymorphisme g\u00e9n\u00e9tique chez des sujets diab\u00e9tiques de type 2 et atteints de n\u00e9phropathie diab\u00e9tique","idno":"FRESH-PEF3956-fr","producers":[{"name":"Pierre-Jean SAULNIER","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE POITIERS"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3956-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"3956"},{"agency":"FReSH","code":"FRESH-PEF3956"}]},"title":"Etude cas-t\u00e9moins sur le polymorphisme g\u00e9n\u00e9tique chez des sujets diab\u00e9tiques de type 2 et atteints de n\u00e9phropathie diab\u00e9tique","alternate_title":"D2NG: DIAB\u00e8te de type 2, NEPHROpathie et GENEtique"},"study_authorization":{"agency":[{"name":"Autre"}]},"authoring_entity":[{"name":"Mich\u00e8le;GROSDENIER","firstname":"Mich\u00e8le","lastname":"GROSDENIER","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/029s6hd13","role":"organisation id"},{"title":"SIREN","uri":"200055358","role":"organisation id"}],"email":"michele.grosdenier.bruneau@chu-poitiers.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE POITIERS","PILabo":"CHU Poitiers \/ Biobank","isContact":true}],"oth_id":[{"name":""}],"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":"AGENCE FRANCAISE DE DEVELOPPEMENT (AFD)","extlink":[{"title":"SIREN","uri":"775665599"}]},{"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"}]},{"name":"SOCIETE FRANCOPHONE DU DIABETE","extlink":[{"title":"SIREN","uri":"404995110"}]}]},"distribution_statement":{"contact":[{"name":"Samy;HADJADJ","lastname":"HADJADJ","firstname":"Samy","type":"contact","email":"samy.hadjadj@gmail.com","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","lastname":"GROSDENIER","firstname":"Mich\u00e8le","type":"contact","email":"michele.grosdenier.bruneau@chu-poitiers.fr","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":"d\u00e9terminants g\u00e9n\u00e9tiques"},{"keyword":"complications r\u00e9nales"},{"keyword":"\u00e9tude transpopulationnelle"},{"keyword":"\u00e9tude de liaison"},{"keyword":"ph\u00e9notypes sp\u00e9cifiques"},{"keyword":"crit\u00e8res anatomo-pathologiques"},{"keyword":"association"}],"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 aux complications r\u00e9nales du diab\u00e8te de type 2 par une triple approche int\u00e9gr\u00e9e : * Etude d\u2019association * Etude transpopulationnelle * Etude de liaison SECONDAIRES : 1- \u00e9tudier des ph\u00e9notypes sp\u00e9cifiques de la n\u00e9phropathie diab\u00e9tique (crit\u00e8res anatomo-pathologiques) 2- compl\u00e9ter l\u2019analyse cas t\u00e9moin par une \u00e9tude de suivi longitudinal (projet SURDIAGENE)","abstract":"","coll_dates":[{"start":"2001-01-01","end":"2012-01-01"}],"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 (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\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\": \"Les sujets pouvant \u00eatre inclus dans l'\u00e9tude sont des sujets majeurs, ayant donn\u00e9 leur consentement \u00e9clair\u00e9, sign\u00e9 apr\u00e8s information, affili\u00e9s \u00e0 un r\u00e9gime de S\u00e9curit\u00e9 Sociale ou b\u00e9n\u00e9ficiaire d'un tel r\u00e9gime. Nous souhaitons inclure dans l'\u00e9tude DIAB2-NEPHRO-GENE diff\u00e9rents sujets pr\u00e9sentant tous un diab\u00e8te de type 2 qui peuvent \u00eatre class\u00e9s en trois groupes:  1- Sujets t\u00e9moins (indemnes de n\u00e9phropathie diab\u00e9tique) :  - sujets pr\u00e9sentant une r\u00e9tinopathie diab\u00e9tique quelqu'en soit le stade. - diab\u00e8te de type 2 connu depuis plus de 5 ans. - excr\u00e9tion urinaire d'albumine (EUA) normale (d\u00e9finie comme une concentration d'albumine urinaire strictement inf\u00e9rieure \u00e0 20 mg\\\/l ou 30 mg\\\/24h), 2 fois sur 3 pr\u00e9l\u00e8vements cons\u00e9cutifs, au cours des 5 derni\u00e8res ann\u00e9es. - EUA normale en l'absence de traitement par inhibiteur de l'enzyme de conversion ou par antagoniste des r\u00e9cepteurs de l'angiotensine II. - cr\u00e9atinin\u00e9mie strictement inf\u00e9rieure \u00e0 150 \uf06dM.  2- Sujets cas (atteints de n\u00e9phropathie diab\u00e9tique) :  - sujet pr\u00e9sentant une glom\u00e9rulopathie diab\u00e9tique, m\u00eame en l'absence de r\u00e9tinopathie, affirm\u00e9e par la biopsie r\u00e9nale. - ou sujet pr\u00e9sentant les caract\u00e9ristiques suivantes :  - r\u00e9tinopathie diab\u00e9tique quelqu'en soit le stade.  - diab\u00e8te de type 2 connu depuis plus de 5 ans  - anomalie de l'excr\u00e9tion urinaire d'albumine (EUA) (d\u00e9finie comme une concentration d'albumine urinaire sup\u00e9rieure ou \u00e9gale \u00e0 20mg\\\/l ou 30 mg\\\/24h), 2 fois sur 3 pr\u00e9l\u00e8vements cons\u00e9cutifs, au cours des 5 derni\u00e8res ann\u00e9es   - avec ou sans alt\u00e9ration de la fonction r\u00e9nale (d\u00e9finie par une cr\u00e9atinin\u00e9mie sup\u00e9rieure \u00e0 150 \u00b5mol\\\/l, ou recours \u00e0 une \u00e9puration extra-r\u00e9nale ou \u00e0 une transplantation r\u00e9nale).  - absence de maladie r\u00e9nale autre que la n\u00e9phropathie diab\u00e9tique  3- diab\u00e8te de type 2 connu depuis moins de 5 ans (diab\u00e8te r\u00e9cent) quelque soit l\u2019excr\u00e9tion urinaire d\u2019albumine et la cr\u00e9atin\u00e9mie\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es biologiques']","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"}]},"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\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"- 1100 cas\/cases- 660 t\u00e9moins\/controls"},"method_notes":"Etude observationnelle","study_class":"\u00c9tude compl\u00e9t\u00e9e","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Etude cas-t\u00e9moins"]}]},"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":"02-07-2012","lastUpdatedAuto":null,"lastUpdatedManual":"07-08-2019","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Priv\u00e9 \u00e0 but non lucratif","Public (France)","Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":["","","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":false,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Fiche d\u2019observation, remplie par les m\u00e9decins investigateurs, adress\u00e9e avec le consentement et les \u00e9chantillons biologiques par courrier express.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"fonction r\u00e9nale et \u00e9quilibre glyc\u00e9mique","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}