{"doc_desc":{"title":"Genetic Polymorphism in Subjects with Type 2 Diabetes and Longitudinal Analysis of Renal Function: \u201cSURDIAGENE\u201d Study (SUivi R\u00e9nal , DIAb\u00e8te de type 2 et GENEtique)","idno":"FRESH-PEF4071-en","producers":[{"name":"Pierre-Jean SAULNIER","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE POITIERS"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF4071-en","IDno":{"metadata_no":[{"agency":"PEF","code":"4071"},{"agency":"FReSH","code":"FRESH-PEF4071"}]},"title":"Genetic Polymorphism in Subjects with Type 2 Diabetes and Longitudinal Analysis of Renal Function: \u201cSURDIAGENE\u201d Study (SUivi R\u00e9nal , DIAb\u00e8te de type 2 et GENEtique)","alternate_title":"SURDIAGENE"},"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":"","type":"collaboration"}],"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":"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","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":"Health episodes"},{"keyword":"renal function"},{"keyword":"cardiovascular"},{"keyword":"death"},{"keyword":"population"},{"keyword":"health system"}],"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 investigate the genetic determinants associated with changes in renal function (changes in creatinine clearance) SECONDARY: 1. - to investigate the genetic determinants associated with changes in urinary albumin excretion 2 - to investigate the genetic determinants associated with other degenerative complications of diabetes (retinopathy, cardiovascular events)","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":"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\": \"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            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"B1. Type 2 diabetes (T2D): Subjects from the SURDIAGENE study with T2D. The distinction between type 1 (TD1) and type 2 (T2D) diabetes is sometimes difficult. We define criteria for T2D diagnosis as: - age at diagnosis is 35 years old or over - apparent insulin-dependence after more than 2 years following diabetes diagnosis - absence of secondary diabetes - absence of ketonuria at diagnosis B2: Longitudinal follow-up: Subjects in the SURDIAGENE study with T2D who are being monitored for diabetes for at least one year, which includes a collection of clinical (blood pressure, weight) and biological data (glycated haemoglobin, serum creatinine, urinary albumin excretion) to analyse the progression of renal disease and other degenerative (retinal and cardiovascular) complications B3. Exclusion criteria is defined as: Subjects who are not permitted to participate in the SURDIAGENE study are subjects who a) fulfil medical criteria for exclusion - do not have diabetes or have T1D or secondary diabetes - are presenting renal disease caused by non-diabetic renal insufficiency (arterial hypertension is not considered as part of the exclusion criteria, except if hypertensive nephropathy precedes discovery of diabetes). - proteinuria at time of diabetes diagnosis - non-diabetic glomerular nephropathy confirmed by renal biopsy - pure vascular nephropathy - confirmed glomerular haematuria or malformed uropathy - chronic interstitial nephritis with history of pyelonephritis or persistent urinary tract infections - follow-up is less than 1 year b) fulfilling legal\",\n    \"clusion_E\": \" (amended law dated 20th December 1988) - minors - adults protected by law - deprived of liberty - brain-dead - who have not given their written participation consent - women who are pregnant, parturient or breastfeeding - not affiliated to social security\"\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\r\nHealth event\/mortality"}]},"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\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"1200"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort 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 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":"13-08-2012","lastUpdatedAuto":null,"lastUpdatedManual":"07-08-2019","isContributorPI":false,"contributorName":"","contributorAffiliation":"","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":["Private non-profit","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Interview: input from a paper questionnaire (manual input) with double entry Clinical examinations: handwritten (manual input) with double data entry Biological analysis: direct input","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Poitiers (Vienne)"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Renal function and glycaemic control: Renal function is based on a measurement of plasma creatinine and estimated glomerular filtration rate (GFR estimated by MDRD and CKD-EPI equations). Diabetic renal insufficiency (initial and during follow-up) is equally characterised by urinary albumin excretion and urinary albumin\/urinary creatinine ratio. The level of renal impairment as well as GFR can be established as such. Glycaemic control rate is calculated by measuring glycated haemoglobin (HbA1c).","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}