<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03814915</url>
  </required_header>
  <id_info>
    <org_study_id>IMIDIRECT_2012</org_study_id>
    <nct_id>NCT03814915</nct_id>
  </id_info>
  <brief_title>Diabetes Research on Patient Stratification</brief_title>
  <acronym>DIRECT</acronym>
  <official_title>DIabetes REsearCh on Patient straTification</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lund University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lund University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overarching goal of the IMI DIRECT (Innovative Medicines Initiative Diabetes Research on&#xD;
      Patient Stratification) Consortium is the identification of biomarkers that aid therapeutic&#xD;
      targeting in prediabetes (Study 1) or early onset type 2 diabetes (Study 2).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are two multicentre prospective cohort studies within the glycaemic deterioration work&#xD;
      package of IMI DIRECT (WP2). These two cohorts are designed to address the area of glycaemic&#xD;
      deterioration by amassing data and biomaterials that will be used to discover novel&#xD;
      biomarkers for glycaemic deterioration in people at high risk of developing type 2 diabetes&#xD;
      (Study 1) and in those who have recently been diagnosed with the disease (Study 2).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2012</start_date>
  <completion_date type="Actual">July 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Glycemic deterioration</measure>
    <time_frame>Up to 10 years follow-up</time_frame>
    <description>Change in glucose (or HbA1c) over time and/or progression to anti diabetic medications/insulin</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">3049</enrollment>
  <condition>Type2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Study 1 - Prediabetes</arm_group_label>
    <description>The primary objective of Study 1 is to collect biosamples and information that might yield novel, predictive biomarkers for glycaemic deterioration in non-diabetic high-risk participants.&#xD;
Participants in Study 1 were recruited from existing prospective cohort studies in or around each of the following European cities: Malmö, Sweden (Malmö Diet and Cancer Study); Amsterdam, The Netherlands (Hoorn Study); Copenhagen, Denmark (Inter99); and Kuopio, Finland (METSIM). A clinically practicable screening tool (DIRECT-DETECT) was used to identify at-risk participants from existing cohort studies, who were then recruited into this new prospective cohort study (Study 1).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study 2- Diabetic</arm_group_label>
    <description>The primary objective of Study 2 is to collect biosamples and information that might yield novel, predictive biomarkers for glycaemic deterioration in people who have recently been diagnosed with type 2 diabetes. Participants in Study 2 of DIRECT are recruited from or nearby each of the following European cities: Malmö, Sweden; Amsterdam, the Netherlands; Copenhagen, Denmark; Exeter, UK; Newcastle, UK; Dundee, UK. Potential participants are recruited through targeted searches of existing databases and research registers combined with person-to-person contact at educational clinics and through routine retinal screening programmes.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood Omics: Fasting blood samples taken for genomic, transcriptomic, proteomic and&#xD;
      metabolomic assessments.&#xD;
&#xD;
      Microbiome Urine Toenail clippings&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        White European (self-report of parental ethnicity), Age ≥35 and &lt;75 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Study 1&#xD;
&#xD;
        Inclusion criteria&#xD;
&#xD;
          -  No treatment with insulin-sensitising, glucose-lowering or other antidiabetic drugs&#xD;
&#xD;
          -  Fasting capillary blood glucose &lt;10 mmol/l at baseline&#xD;
&#xD;
          -  White European (self-report of parental ethnicity)&#xD;
&#xD;
          -  Age ≥35 and &lt;75 years&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Diagnosed diabetes of any type, HbA1c ≥6.5% (48 mmol/mol) or fasting plasma glucose&#xD;
             ≥7.0 mmol/l or 2 h plasma glucose &gt;11.0 mmol/l previously&#xD;
&#xD;
          -  For women, pregnancy, lactation or plans to conceive within the study period&#xD;
&#xD;
          -  Use of a pacemaker&#xD;
&#xD;
          -  Any other significant medical reason for exclusion as determined by the investigator&#xD;
&#xD;
        Study 2&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with type 2 diabetes not less than 6 months and not more than 24&#xD;
             months before baseline examination&#xD;
&#xD;
          -  Management by lifestyle with or without metformin therapy&#xD;
&#xD;
          -  All HbA1c &lt;7.6% (&lt;60 mmol/mol) within previous 3 months&#xD;
&#xD;
          -  White European&#xD;
&#xD;
          -  Age ≥35 and &lt;75&#xD;
&#xD;
          -  Estimated GFR &gt;50 ml/min'&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Type 1 diabetes&#xD;
&#xD;
               -  A previous HbA1c &gt;9.0% (&gt;75 mmol/mol)&#xD;
&#xD;
               -  Prior treatment with insulin or an oral hypoglycaemic agent other than metformin&#xD;
&#xD;
               -  BMI &lt;20 or &gt;50 kg/m2&#xD;
&#xD;
               -  Pregnancy, lactation or plans to conceive within the study period&#xD;
&#xD;
               -  Any other significant medical reason for exclusion as determined by the&#xD;
                  investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ewan Pearson, FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Dundee</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Paul W Franks, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lund University</affiliation>
  </overall_official>
  <reference>
    <citation>Koivula RW, Heggie A, Barnett A, Cederberg H, Hansen TH, Koopman AD, Ridderstrale M, Rutters F, Vestergaard H, Gupta R, Herrgard S, Heymans MW, Perry MH, Rauh S, Siloaho M, Teare HJ, Thorand B, Bell J, Brunak S, Frost G, Jablonka B, Mari A, McDonald TJ, Dekker JM, Hansen T, Hattersley A, Laakso M, Pedersen O, Koivisto V, Ruetten H, Walker M, Pearson E, Franks PW; DIRECT Consortium. Discovery of biomarkers for glycaemic deterioration before and after the onset of type 2 diabetes: rationale and design of the epidemiological studies within the IMI DIRECT Consortium. Diabetologia. 2014 Jun;57(6):1132-42. doi: 10.1007/s00125-014-3216-x. Epub 2014 Apr 4.</citation>
    <PMID>24695864</PMID>
  </reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>January 14, 2020</last_update_submitted>
  <last_update_submitted_qc>January 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gene-environment interaction</keyword>
  <keyword>Genome</keyword>
  <keyword>Glycaemic control</keyword>
  <keyword>Lifestyle</keyword>
  <keyword>Microbiome</keyword>
  <keyword>Prediabetes</keyword>
  <keyword>Proteome</keyword>
  <keyword>Type 2 diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03814915
org study id: IMIDIRECT_2012
nct id: NCT03814915
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overarching goal of the IMI DIRECT (Innovative Medicines Initiative Diabetes Research on
      Patient Stratification) Consortium is the identification of biomarkers that aid therapeutic
      targeting in prediabetes (Study 1) or early onset type 2 diabetes (Study 2).
There are two multicentre prospective cohort studies within the glycaemic deterioration work
      package of IMI DIRECT (WP2). These two cohorts are designed to address the area of glycaemic
      deterioration by amassing data and biomaterials that will be used to discover novel
      biomarkers for glycaemic deterioration in people at high risk of developing type 2 diabetes
      (Study 1) and in those who have recently been diagnosed with the disease (Study 2).
observational model: Cohort
time perspective: Prospective
measure: Glycemic deterioration
time frame: Up to 10 years follow-up
description: Change in glucose (or HbA1c) over time and/or progression to anti diabetic medications/insulin
arm group label: Study 1 - Prediabetes
description: The primary objective of Study 1 is to collect biosamples and information that might yield novel, predictive biomarkers for glycaemic deterioration in non-diabetic high-risk participants.
Participants in Study 1 were recruited from existing prospective cohort studies in or around each of the following European cities: Malmö, Sweden (Malmö Diet and Cancer Study); Amsterdam, The Netherlands (Hoorn Study); Copenhagen, Denmark (Inter99); and Kuopio, Finland (METSIM). A clinically practicable screening tool (DIRECT-DETECT) was used to identify at-risk participants from existing cohort studies, who were then recruited into this new prospective cohort study (Study 1).
arm group label: Study 2- Diabetic
description: The primary objective of Study 2 is to collect biosamples and information that might yield novel, predictive biomarkers for glycaemic deterioration in people who have recently been diagnosed with type 2 diabetes. Participants in Study 2 of DIRECT are recruited from or nearby each of the following European cities: Malmö, Sweden; Amsterdam, the Netherlands; Copenhagen, Denmark; Exeter, UK; Newcastle, UK; Dundee, UK. Potential participants are recruited through targeted searches of existing databases and research registers combined with person-to-person contact at educational clinics and through routine retinal screening programmes.
Blood Omics: Fasting blood samples taken for genomic, transcriptomic, proteomic and
      metabolomic assessments.

      Microbiome Urine Toenail clippings
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: 74 Years
healthy volunteers: No
last name: Ewan Pearson, FRCP
role: Principal Investigator
affiliation: University of Dundee
last name: Paul W Franks, PhD
role: Principal Investigator
affiliation: Lund University
citation: Koivula RW, Heggie A, Barnett A, Cederberg H, Hansen TH, Koopman AD, Ridderstrale M, Rutters F, Vestergaard H, Gupta R, Herrgard S, Heymans MW, Perry MH, Rauh S, Siloaho M, Teare HJ, Thorand B, Bell J, Brunak S, Frost G, Jablonka B, Mari A, McDonald TJ, Dekker JM, Hansen T, Hattersley A, Laakso M, Pedersen O, Koivisto V, Ruetten H, Walker M, Pearson E, Franks PW; DIRECT Consortium. Discovery of biomarkers for glycaemic deterioration before and after the onset of type 2 diabetes: rationale and design of the epidemiological studies within the IMI DIRECT Consortium. Diabetologia. 2014 Jun;57(6):1132-42. doi: 10.1007/s00125-014-3216-x. Epub 2014 Apr 4.
PMID: 24695864
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No