{"doc_desc":{"title":"Genetic Polymorphism in Subjects with Type 2 Diabetes and Diabetic Nephropathy: Study \u201cDIAB\u20192-NEPHRO-GENE\u201d (DIAB\u00e8te de type 2, NEPHROpathie et GENEtique)","idno":"FRESH-PEF3956-en","producers":[{"name":"Pierre-Jean SAULNIER","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE POITIERS"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3956-en","IDno":{"metadata_no":[{"agency":"PEF","code":"3956"},{"agency":"FReSH","code":"FRESH-PEF3956"}]},"title":"Genetic Polymorphism in Subjects with Type 2 Diabetes and Diabetic Nephropathy: Study \u201cDIAB\u20192-NEPHRO-GENE\u201d (DIAB\u00e8te de type 2, NEPHROpathie et GENEtique)","alternate_title":"D2NG"},"study_authorization":{"agency":[]},"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":"Epidemiology France Portal (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":[],"topics":[{"topic":"Endocrinology","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":"Nephrology","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":"Type 2 diabetes mellitus","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/119724091","title":"CIM-11"}]},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Behavioral determinants: Eating habits","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"}],"purpose":"MAIN: to study the genetic determinants associated with renal complications from Type 2 diabetes using a triple-integrated approach: *Association Study *Cross-population Study *Liaison Study SECONDARY: 1 - to investigate diabetic nephropathy specific phenotypes (anatomopathological criteria) 2 - to complete case-control analysis with a longitudinal follow-up study (SURDIAGENE project)","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":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Individuals included in the study are adult subjects who have given their signed informed consent and covered by a social security scheme or registered with a likewise scheme. We wish to include different subjects with type 2 diabetes in the DIAB2-NEPHRO-GENE study that can be divided into three groups: 1 - Case-control subjects (with no diabetic nephropathy) - subjects with diabetic retinopathy, regardless of stage - known type 2 diabetes for more than 5 years - normal urinary albumin excretion (UAE) (defined as urinary albumin concentration strictly below 20 mg\\\/l or 30 mg\\\/24h), twice occurring out of 3 consecutive samples over the last 5 years. - Normal UAE in the absence of conversion enzyme inhibitor or angiotensin II antagonist receptors - creatinine strictly less than 150\uf06dM.2 - Case subjects (with diabetic nephropathy): - subjects with diabetic glomerulopathy confirmed by renal biopsy, even with absence of retinopathy - or subjects with the following characteristics: - diabetic retinopathy regardless of stage. - known type 2 diabetes for more than 5 years - abnormal urinary albumin excretion (UAE)(defined as urinary albumin concentration higher or equal to 20 mg\\\/l or 30 mg\\\/24h), twice occurring out of 3 consecutive samples over the last 5 years - with or without change to renal function (defined by creatinine higher than 150 \u00b5mol\\\/l, or need for extra-renal purification or renal transplantation). - absence of kidney disease other than diabetic nephropathy 3 - known type 2 diabetes for at least 5 years (recent diabetes) regardless of urinary albumin excretion or creatinine\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Biological data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"- 1100 cas\/cases- 660 t\u00e9moins\/controls"},"method_notes":"Observational Study","study_class":"Completed study","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Case-control study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Send request to the scientist in charge","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","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)","Private non-profit","Public (France)","Private non-profit"],"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":"Observation file, completed by the investigating physician, sent with consent and biological samples by express post.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Renal function and glycaemic control","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}