<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/NCT03260998</url>
  </required_header>
  <id_info>
    <org_study_id>ECGCCATD</org_study_id>
    <nct_id>NCT03260998</nct_id>
  </id_info>
  <brief_title>ECG Changes in Children and Adolescents With Type 1 Diabetes</brief_title>
  <official_title>ECG Changes in Children and Adolescents With Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      Diabetes Mellitus type 1 is characterized by an absolute insulin deficiency caused by&#xD;
      T-cell-mediated autoimmune destruction of pancreatic β-cells . It is the predominant form of&#xD;
      diabetes mellitus during childhood and adolescence. Hyperglycemia is a major cause of&#xD;
      vascular and neuropathic complications that are seen in patients with diabetes mellitus type&#xD;
      1.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiovascular risk factors remain the most controversial chronic complication in diabetes&#xD;
      mellitus type 1 Neuropathy in diabetes mellitus type 1 can lead to abnormalities in the&#xD;
      response of the coronary vasculature to sympathetic stimulation, which may manifest&#xD;
      clinically as resting tachycardia or bradycardia, exercise intolerance, orthostatic&#xD;
      hypotension, loss of the nocturnal decline in blood pressure, or silent myocardial ischemia&#xD;
      on cardiac testing. These abnormalities can lead to delayed presentation of cardiovascular&#xD;
      disease. An early indicator of cardiac autonomic neuropathy is reduced heart rate&#xD;
      variability, which can be assessed qualitatively in the clinic. Limited data suggest silent&#xD;
      myocardial ischemia is more common in the presence of cardiac autonomic neuropathy .&#xD;
      Cardiovascular mortality is a leading cause of death in Type 1 diabetic patients, in&#xD;
      particular in patients with nephropathy.QT dispersion defined as the difference between&#xD;
      maximal and minimal QT intervals from different electrocardiogram leads ( the QT interval was&#xD;
      defined as the time between the first deflection from the isoelectric PR interval and the&#xD;
      visual return of the T wave to the T-P segment ) ,Because these electrocardiogram&#xD;
      abnormalities may confer an increased risk of ventricular arrhythmias and sudden cardiac&#xD;
      death , early identification may have prognostic value .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2017</start_date>
  <completion_date type="Anticipated">January 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>corrected QT dispersion</measure>
    <time_frame>one day</time_frame>
    <description>difference between maximal and minimal corrected QT intervals from different ECG leads</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Diabetes Mellitus, Type 1</condition>
  <arm_group>
    <arm_group_label>diabetic patients type 1</arm_group_label>
    <description>electrocardiogram will be done for 60 children and adolescents with type 1 diabetes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy persons</arm_group_label>
    <description>electrocardiogram will be done for 60 age and sex matched non diabetic children and adolescents</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>electrocardiogram</intervention_name>
    <description>measurment of QT dispersion and corrected QT and other electrocardiogram changes</description>
    <arm_group_label>diabetic patients type 1</arm_group_label>
    <arm_group_label>healthy persons</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will include 60 children and adolescents with type 1 diabetes attending Assiut&#xD;
        university hospital and 60 sex and age matched control subjects .&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All children and adolescents with type 1 diabetes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Cornary artery disease .&#xD;
&#xD;
          2. Heart failure , congenital heart disease ,&#xD;
&#xD;
          3. Rheumatic valve disease .&#xD;
&#xD;
          4. Primary cardiomyopathy .&#xD;
&#xD;
          5. Thyroid dysfunction .&#xD;
&#xD;
          6. Bundle branch block and atrioventricular conduction abnormalities .&#xD;
&#xD;
          7. Anti arrhythmic drugs .&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mariam Atef, master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohamed Amir, MD</last_name>
    <phone>01005689353</phone>
    <email>Dr.amir63@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ameer Abo Elgheet, MD</last_name>
    <phone>01065742277</phone>
    <email>Dr.amir63@yahoo.com</email>
  </overall_contact_backup>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>August 27, 2017</last_update_submitted>
  <last_update_submitted_qc>August 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mariam Nagieb</investigator_full_name>
    <investigator_title>principal investigator</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03260998
org study id: ECGCCATD
nct id: NCT03260998
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Diabetes Mellitus type 1 is characterized by an absolute insulin deficiency caused by
      T-cell-mediated autoimmune destruction of pancreatic β-cells . It is the predominant form of
      diabetes mellitus during childhood and adolescence. Hyperglycemia is a major cause of
      vascular and neuropathic complications that are seen in patients with diabetes mellitus type
      1.
Cardiovascular risk factors remain the most controversial chronic complication in diabetes
      mellitus type 1 Neuropathy in diabetes mellitus type 1 can lead to abnormalities in the
      response of the coronary vasculature to sympathetic stimulation, which may manifest
      clinically as resting tachycardia or bradycardia, exercise intolerance, orthostatic
      hypotension, loss of the nocturnal decline in blood pressure, or silent myocardial ischemia
      on cardiac testing. These abnormalities can lead to delayed presentation of cardiovascular
      disease. An early indicator of cardiac autonomic neuropathy is reduced heart rate
      variability, which can be assessed qualitatively in the clinic. Limited data suggest silent
      myocardial ischemia is more common in the presence of cardiac autonomic neuropathy .
      Cardiovascular mortality is a leading cause of death in Type 1 diabetic patients, in
      particular in patients with nephropathy.QT dispersion defined as the difference between
      maximal and minimal QT intervals from different electrocardiogram leads ( the QT interval was
      defined as the time between the first deflection from the isoelectric PR interval and the
      visual return of the T wave to the T-P segment ) ,Because these electrocardiogram
      abnormalities may confer an increased risk of ventricular arrhythmias and sudden cardiac
      death , early identification may have prognostic value .
observational model: Case-Control
time perspective: Prospective
measure: corrected QT dispersion
time frame: one day
description: difference between maximal and minimal corrected QT intervals from different ECG leads
arm group label: diabetic patients type 1
description: electrocardiogram will be done for 60 children and adolescents with type 1 diabetes
arm group label: healthy persons
description: electrocardiogram will be done for 60 age and sex matched non diabetic children and adolescents
intervention type: Diagnostic Test
intervention name: electrocardiogram
description: measurment of QT dispersion and corrected QT and other electrocardiogram changes
arm group label: diabetic patients type 1
arm group label: healthy persons
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mariam Atef, master
role: Principal Investigator
affiliation: Assiut University
last name: Mohamed Amir, MD
phone: 01005689353
email: Dr.amir63@yahoo.com
last name: Ameer Abo Elgheet, MD
phone: 01065742277
email: Dr.amir63@yahoo.com
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mariam Nagieb
investigator title: principal investigator
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: Undecided