<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/NCT04474535</url>
  </required_header>
  <id_info>
    <org_study_id>T1DM C-peptide</org_study_id>
    <nct_id>NCT04474535</nct_id>
  </id_info>
  <brief_title>C-peptide Correlation With Microvascular Complications in T1DM</brief_title>
  <official_title>Association of β-cell Secretory Status With Early Microvascular and Macrovascular Complications in Patients With Type 1 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National and Kapodistrian University of Athens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National and Kapodistrian University of Athens</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 purpose of this study is to investigate the presence of residual insulin secretion in&#xD;
      patients with DM1 and its correlation with the possible protection against early&#xD;
      microvascular and macrovascular complications, emphasizing on the functionality of the&#xD;
      myocardium.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will include approximately 200 patients, male and female, with DM1 who are being&#xD;
      followed in the outpatient diabetic clinic of our hospital.&#xD;
&#xD;
      Each patient will visit the Research Laboratory of the Diabetes Centre of our Department. The&#xD;
      visit will take place in the morning in a fasting state of about 12 hours. Demographic data&#xD;
      will be recorded along with the patients' habits, lifestyle, current medication and complete&#xD;
      medical history of concomitant diseases.&#xD;
&#xD;
      This will be followed by anthropometric measurements (weight, height, BMI) and afterwards&#xD;
      blood samples will be taken for the determination of urea, creatinine, glucose, HbA1c and&#xD;
      lipids. Part of each blood sample will be collected in tubes containing EDTA to determine&#xD;
      fasting c-peptide concentrations. The presence of microalbuminuria will be assessed from a&#xD;
      morning urine sample by calculating urinary albumin to creatinine ratio (ACR).&#xD;
&#xD;
      The functionality of the heart's autonomic nervous system will be assessed through the use of&#xD;
      heart rate variability (HRV) measurements, using the standard Ewing's tests panel: deep&#xD;
      inhalation, standing up and Valsalva's manoeuvre. Changes in blood pressure when changing&#xD;
      from the supine to the standing position will also be recorded. Subsequently, the&#xD;
      distensibility of the large vessels will be determined, by calculating the conduction&#xD;
      velocity of the pulse wave between the carotid and the femoral artery (pulse wave velocity&#xD;
      (PWV)).&#xD;
&#xD;
      Finally, a full transthoracic echocardiographic study will be carried out to assess&#xD;
      functionality, systolic and diastolic, of the left ventricle (LV).&#xD;
&#xD;
      All data will be recorded in an electronic database for statistical processing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 3, 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">August 2021</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>C-peptide concentrations</measure>
    <time_frame>1 day</time_frame>
    <description>Concentrations of plasma c-peptide in the fasting condition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Microvascular complications</measure>
    <time_frame>1 day</time_frame>
    <description>Presence of microvascular complications</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Macrovascular complications</measure>
    <time_frame>1 day</time_frame>
    <description>Presence of macrovascular complications</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Association between c-peptide and complications</measure>
    <time_frame>1 day</time_frame>
    <description>Positive or negative association between c-peptide concentrations and presence of microvascular or macrovascular diabetes complications</description>
  </secondary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Type 1 Diabetes</condition>
  <condition>C-peptide</condition>
  <condition>Diabetes Complications</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum, plasma, urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients with type 1 diabetes followed in our Diabetes outpatient clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 1 diabetes&#xD;
&#xD;
          -  Informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known macrovascular complications&#xD;
&#xD;
          -  Known serious microvascular complications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Alexandros Kokkinos</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Department of Propaedeutic Medicine, University of Athens</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alexandros Kokkinos</last_name>
    <phone>+302132061248</phone>
    <email>rjd@otenet.gr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine</name>
      <address>
        <city>Athens</city>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexandros Kokkinos, MD, PhD</last_name>
      <phone>+302132061248</phone>
      <email>akokkinos@med.uoa.gr</email>
    </contact>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National and Kapodistrian University of Athens</investigator_affiliation>
    <investigator_full_name>Alexandros Kokkinos</investigator_full_name>
    <investigator_title>Associate Professor in Internal Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
    <mesh_term>Diabetes Complications</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/NCT04474535
org study id: T1DM C-peptide
nct id: NCT04474535
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the presence of residual insulin secretion in
      patients with DM1 and its correlation with the possible protection against early
      microvascular and macrovascular complications, emphasizing on the functionality of the
      myocardium.
The study will include approximately 200 patients, male and female, with DM1 who are being
      followed in the outpatient diabetic clinic of our hospital.

      Each patient will visit the Research Laboratory of the Diabetes Centre of our Department. The
      visit will take place in the morning in a fasting state of about 12 hours. Demographic data
      will be recorded along with the patients' habits, lifestyle, current medication and complete
      medical history of concomitant diseases.

      This will be followed by anthropometric measurements (weight, height, BMI) and afterwards
      blood samples will be taken for the determination of urea, creatinine, glucose, HbA1c and
      lipids. Part of each blood sample will be collected in tubes containing EDTA to determine
      fasting c-peptide concentrations. The presence of microalbuminuria will be assessed from a
      morning urine sample by calculating urinary albumin to creatinine ratio (ACR).

      The functionality of the heart's autonomic nervous system will be assessed through the use of
      heart rate variability (HRV) measurements, using the standard Ewing's tests panel: deep
      inhalation, standing up and Valsalva's manoeuvre. Changes in blood pressure when changing
      from the supine to the standing position will also be recorded. Subsequently, the
      distensibility of the large vessels will be determined, by calculating the conduction
      velocity of the pulse wave between the carotid and the femoral artery (pulse wave velocity
      (PWV)).

      Finally, a full transthoracic echocardiographic study will be carried out to assess
      functionality, systolic and diastolic, of the left ventricle (LV).

      All data will be recorded in an electronic database for statistical processing.
observational model: Cohort
time perspective: Cross-Sectional
measure: C-peptide concentrations
time frame: 1 day
description: Concentrations of plasma c-peptide in the fasting condition
measure: Microvascular complications
time frame: 1 day
description: Presence of microvascular complications
measure: Macrovascular complications
time frame: 1 day
description: Presence of macrovascular complications
measure: Association between c-peptide and complications
time frame: 1 day
description: Positive or negative association between c-peptide concentrations and presence of microvascular or macrovascular diabetes complications
Serum, plasma, urine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 70 Years
last name: Alexandros Kokkinos
role: Principal Investigator
affiliation: First Department of Propaedeutic Medicine, University of Athens
last name: Alexandros Kokkinos
phone: +302132061248
email: rjd@otenet.gr
facility: 
status: Recruiting
contact: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: National and Kapodistrian University of Athens
investigator full name: Alexandros Kokkinos
investigator title: Associate Professor in Internal Medicine
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Diabetes Complications