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<docDscr>
  <citation>
    <titlStmt>
      <titl>Genetic Polymorphism in Subjects with Type 2 Diabetes and Longitudinal Analysis of Renal Function: “SURDIAGENE” Study (SUivi Rénal , DIAbète de type 2 et GENEtique)</titl>
      <IDNo>FRESH-PEF4071-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE POITIERS" role="">Pierre-Jean SAULNIER</producer>
    </prodStmt>
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      <version></version>
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<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Genetic Polymorphism in Subjects with Type 2 Diabetes and Longitudinal Analysis of Renal Function: “SURDIAGENE” Study (SUivi Rénal , DIAbète de type 2 et GENEtique)            </titl>
      <altTitl>
                    SURDIAGENE                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF4071-en            </IDNo>
      <IDNo agency="PEF">
                    4071                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF4071                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Michèle GROSDENIER                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE POITIERS">
        <ExtLink title="ROR" URI="https://ror.org/029s6hd13" role="organisation id"/>
        <ExtLink title="SIREN" URI="200055358" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="collaboration">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            CENTRE HOSPITALIER UNIVERSITAIRE DE POITIERS                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            GROUPT ETUDE MALADIES METABOLIQUES SYST. (GEMMS)                    
                                    </fundAg>
      <fundAg>
                                            MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE POITIERS" email="samy.hadjadj@gmail.com">
                    Samy;HADJADJ
                                            <ExtLink title="ROR" URI="https://ror.org/029s6hd13" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="200055358" role="organisation id"/>
                                    </contact>
      <contact affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE POITIERS" email="michele.grosdenier.bruneau@chu-poitiers.fr">
                    Michèle;GROSDENIER
                                            <ExtLink title="ROR" URI="https://ror.org/029s6hd13" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="200055358" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-17"/>
      <distDate date="2026-06-17"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    Health episodes</keyword>
      <keyword vocab="" vocabURI="">
                    renal function</keyword>
      <keyword vocab="" vocabURI="">
                    cardiovascular</keyword>
      <keyword vocab="" vocabURI="">
                    death</keyword>
      <keyword vocab="" vocabURI="">
                    population</keyword>
      <keyword vocab="" vocabURI="">
                    health system</keyword>
      <topcClas vocab="health theme">
                        Endocrinology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/d1dd1bac-5313-4ab3-837f-4acd3ec521a7"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D004704"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Nephrology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/3961e9d2-ab3b-451b-b246-20fc0ec3b0c4"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D009398"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Type 2 diabetes mellitus                                            </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants: Genetic predisposition                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants: Eating habits                    </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants                    </topcClas>
    </subject>
    <abstract contentType="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>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2003-01-01"/>
      <collDate event="end" date="2020-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe 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                    </universe>
      <universe 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                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Biological data</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through organizations (health services or institutions</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>schools</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>businesses</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.)</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>[1000-10000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Interview with the participant (including clinical)                                                            <concept vocab="CESSDA" vocabURI="Interview"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>1200</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <conditions>Send request to scientist in charge</conditions>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
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