<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/NCT02231736</url>
  </required_header>
  <id_info>
    <org_study_id>UNIVIE-549-1</org_study_id>
    <nct_id>NCT02231736</nct_id>
  </id_info>
  <brief_title>Chromosomal Damage in Type 2 Diabetes Patients (MIKRODIAB)</brief_title>
  <acronym>MIKRODIAB</acronym>
  <official_title>Incidence of Chromosomal Damage in Type 2 Diabetes Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Vienna</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine whether glycemic control (HbA1c) is linked to&#xD;
      chromosomal damage in type 2 Diabetes patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2014</start_date>
  <primary_completion_date type="Anticipated">February 2015</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The quality of HbA1c influences micronuclei formation in binucleated cells</measure>
    <time_frame>Baseline</time_frame>
    <description>In this cross-sectional study the micronuclei formation in binucleated lymphocytes (Number of micronuclei/1000 binucleated cells) is compared between a low (HbA1c&lt;7.5%) and a high (HbA1c&gt;7.5%) glycemic group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Type 2 diabetes duration of the subjects influences chromosomal damage</measure>
    <time_frame>Baseline</time_frame>
    <description>The micronuclei formation in binucleated lymphocytes (Number of micronuclei/1000 binucleated cells) is associated with the duration of the Typ 2 diabetes disease.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Type 2 Diabetes</condition>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Type 2 diabetes, HbA1c&gt;7.5</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Type 2 diabetes, HbA1c&lt;7.5</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Type 2 Diabetes patients, female,&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 Diabetes (T2DM)&#xD;
&#xD;
          -  Sex: female&#xD;
&#xD;
          -  Age: &gt; 30years&#xD;
&#xD;
          -  Medication: oral anti-diabetics and/or Insulin therapy&#xD;
&#xD;
          -  Constant nutritional behavior, constant physical activity, constant weight for the&#xD;
             last 4 weeks&#xD;
&#xD;
          -  Non-smoking for at least 1 year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with type 1 DM&#xD;
&#xD;
          -  Age: &lt; 30years&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Participation in another clinical trial&#xD;
&#xD;
          -  Change of medication in regard to metabolic parameters within the last 4 weeks&#xD;
&#xD;
          -  Significant cardiovascular damage with NYHA &gt; III&#xD;
&#xD;
          -  Liver disease with three-times higher transaminase values&#xD;
&#xD;
          -  Chronic kidney disease with serum creatinine &gt; 2 mg/dl&#xD;
&#xD;
          -  Dialysis&#xD;
&#xD;
          -  HIV positive&#xD;
&#xD;
          -  History of chronic alcohol abuse in the last two years&#xD;
&#xD;
          -  History of cancer, stroke, organ transplantation&#xD;
&#xD;
          -  Male&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karl-Heinz Wagner, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNIVIE</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Karl-Heinz Wagner, PhD</last_name>
    <phone>00431427754930</phone>
    <email>Karl-Heinz.wagner@univie.ac.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Annemarie Grindel</last_name>
    <phone>00431427754901</phone>
    <email>annemarie.grindel@univie.ac.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karl-Heinz Wagner, PhD</last_name>
      <phone>004314277</phone>
      <phone_ext>54930</phone_ext>
      <email>Karl-Heinz.wagner@univie.ac.at</email>
    </contact>
    <contact_backup>
      <last_name>Annemarie Grindel</last_name>
      <phone>004314277</phone>
      <phone_ext>54901</phone_ext>
      <email>annemarie.grindel@univie.ac.at</email>
    </contact_backup>
    <investigator>
      <last_name>Helmuth Brath, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>September 1, 2014</last_update_submitted>
  <last_update_submitted_qc>September 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 4, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Vienna</investigator_affiliation>
    <investigator_full_name>Karl-Heinz Wagner</investigator_full_name>
    <investigator_title>Director Research Platform Active Ageing</investigator_title>
  </responsible_party>
  <keyword>Type 2 Diabetes</keyword>
  <keyword>Chromosomal damage</keyword>
  <keyword>Micronuclei</keyword>
  <keyword>DNA damage</keyword>
  <keyword>HbA1c</keyword>
  <keyword>Comet Assay</keyword>
  <keyword>Glycemic control</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>
  <!-- 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/NCT02231736
org study id: UNIVIE-549-1
nct id: NCT02231736
lead sponsor: 
has dmc: No
The purpose of the study is to determine whether glycemic control (HbA1c) is linked to
      chromosomal damage in type 2 Diabetes patients
observational model: Cohort
time perspective: Cross-Sectional
measure: The quality of HbA1c influences micronuclei formation in binucleated cells
time frame: Baseline
description: In this cross-sectional study the micronuclei formation in binucleated lymphocytes (Number of micronuclei/1000 binucleated cells) is compared between a low (HbA1c<7.5%) and a high (HbA1c>7.5%) glycemic group
measure: Type 2 diabetes duration of the subjects influences chromosomal damage
time frame: Baseline
description: The micronuclei formation in binucleated lymphocytes (Number of micronuclei/1000 binucleated cells) is associated with the duration of the Typ 2 diabetes disease.
arm group label: Type 2 diabetes, HbA1c>7.5
arm group label: Type 2 diabetes, HbA1c<7.5
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
last name: Karl-Heinz Wagner, PhD
role: Principal Investigator
affiliation: UNIVIE
last name: Karl-Heinz Wagner, PhD
phone: 00431427754930
email: Karl-Heinz.wagner@univie.ac.at
last name: Annemarie Grindel
phone: 00431427754901
email: annemarie.grindel@univie.ac.at
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: University of Vienna
investigator full name: Karl-Heinz Wagner
investigator title: Director Research Platform Active Ageing
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2