<?xml version="1.0" encoding="UTF-8"?>
<codeBook version="2.5" ID="FRESH-PEF3956-en" xml-lang="en" xmlns="ddi:codebook:2_5" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="ddi:codebook:2_5 https://ddialliance.org/Specification/DDI-Codebook/2.5/XMLSchema/codebook.xsd">
<docDscr>
  <citation>
    <titlStmt>
      <titl>Genetic Polymorphism in Subjects with Type 2 Diabetes and Diabetic Nephropathy: Study “DIAB’2-NEPHRO-GENE” (DIABète de type 2, NEPHROpathie et GENEtique)</titl>
      <IDNo>FRESH-PEF3956-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE POITIERS" role="">Pierre-Jean SAULNIER</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Genetic Polymorphism in Subjects with Type 2 Diabetes and Diabetic Nephropathy: Study “DIAB’2-NEPHRO-GENE” (DIABète de type 2, NEPHROpathie et GENEtique)            </titl>
      <altTitl>
                    D2NG                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF3956-en            </IDNo>
      <IDNo agency="PEF">
                    3956                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF3956                </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="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            CENTRE HOSPITALIER UNIVERSITAIRE DE POITIERS                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            AGENCE FRANCAISE DE DEVELOPPEMENT (AFD)                    
                                    </fundAg>
      <fundAg>
                                            GROUPT ETUDE MALADIES METABOLIQUES SYST. (GEMMS)                    
                                    </fundAg>
      <fundAg>
                                            MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES                    
                                    </fundAg>
      <fundAg>
                                            SOCIETE FRANCOPHONE DU DIABETE                    
                                    </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>
      <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 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>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2001-01-01"/>
      <collDate event="end" date="2012-01-01"/>
      <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">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D055815"/>
                                                    </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 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M.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 µmol/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                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Biological data</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity</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>Converting or copying information into a structured record                                                            <concept vocab="CESSDA" vocabURI="Transcription"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Case-control study                    </notes>
    <anlyInfo>
      <respRate>- 1100 cas/cases- 660 témoins/controls</respRate>
    </anlyInfo>
    <stdyClas>Completed study</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <conditions>Send request to the scientist in charge</conditions>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
