<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/NCT04410718</url>
  </required_header>
  <id_info>
    <org_study_id>H-20024279</org_study_id>
    <nct_id>NCT04410718</nct_id>
  </id_info>
  <brief_title>Glycaemia and Cardiac Function in Patients With COVID-19</brief_title>
  <acronym>GLYCOVID-19</acronym>
  <official_title>Glycaemia and Cardiac Function in Patients With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Steno Diabetes Center Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Steno Diabetes Center Copenhagen</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 study design is observational, exploratory study consisting of two cohorts of COVID-19&#xD;
      patients admitted to the ICU and the medical ward, respectively. The primary outcome focusing&#xD;
      on the effect of plasma glucose levels on cardiac function will be evaluated by repeated&#xD;
      assessment of cardiac function by echocardiography and measurement of plasma glucose.&#xD;
      Furthermore, blood coagulability will be evaluated to determine the importance of diabetes&#xD;
      status and plasma glucose changes for whole blood coagulability at time of admission to the&#xD;
      ICU and progression in coagulability abnormalities. In the medical ward cohort, two&#xD;
      assessments will be performed separated by no more than 12 hours. In the ICU cohort, three&#xD;
      assessments will be performed separated by no more than 6 hours. Ideally, 60 patients with&#xD;
      COVID-19 will be included in the ICU cohort with a 1:1 distribution between patient with and&#xD;
      without diabetes. Ideally, 40 patients with diabetes will be included in the cohort of&#xD;
      patients admitted to medical ward (hospitalisation cohort).&#xD;
&#xD;
      The primary hypothesis is that levels of plasma glucose have clinically significant impact on&#xD;
      left ventricular systolic function in patients with COVID-19 admitted to the ICU. The&#xD;
      secondary hypothesis is that the impact of plasma glucose on left ventricular systolic&#xD;
      function is associated with glycaemic control prior to admission as measured by HbA1c.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 20, 2020</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma glucose levels and left ventricular ejection fraction</measure>
    <time_frame>The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).</time_frame>
    <description>The within-subject effect of plasma glucose levels on left ventricular systolic function as measured by left ventricular ejection fraction (a pooled analysis of the hospitalisation cohort and ICU cohort)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Key secondary outcome: HbA1c, plasma glucose levels and left ventricular systolic function</measure>
    <time_frame>The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).</time_frame>
    <description>Difference in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by left ventricular ejection fraction between patients with chronic hyperglycaemia prior to admission (HbA1c &gt;53 mmol/mol) and with normoglycaemia prior to admission (HbA1c ≤53 mmol/l) (ICU cohort only)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma glucose levels and strain analysis</measure>
    <time_frame>The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).</time_frame>
    <description>The within-subject effect of plasma glucose levels on left ventricular systolic function as measured by strain analysis (a pooled analysis of the hospitalisation cohort and ICU cohort)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma glucose levels and mitral annular systolic velocity</measure>
    <time_frame>The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).</time_frame>
    <description>The within-subject effect of plasma glucose levels on left ventricular systolic function as measured by mitral annular systolic velocity (a pooled analysis of the hospitalisation cohort and ICU cohort)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma glucose levels and left ventricular ejection fraction (sub-group analysis)</measure>
    <time_frame>The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).</time_frame>
    <description>Differences in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by left ventricular ejection fraction between the hospitalisation cohort, the ICU cohort with diabetes and the ICU cohort without diabetes, respectively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma glucose levels and strain analysis (sub-group analysis)</measure>
    <time_frame>The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).</time_frame>
    <description>Differences in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by strain analysis between the hospitalisation cohort, the ICU cohort with diabetes and the ICU cohort without diabetes, respectively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma glucose levels and mitral annular systolic velocity (sub-group analysis)</measure>
    <time_frame>The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).</time_frame>
    <description>Differences in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by mitral annular systolic velocity between the hospitalisation cohort, the ICU cohort with diabetes and the ICU cohort without diabetes, respectively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c, Plasma glucose levels and strain analysis</measure>
    <time_frame>The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).</time_frame>
    <description>Difference in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by strain analysis between patients with chronic hyperglycaemia prior to admission (HbA1c &gt;53 mmol/mol) and with normoglycaemia prior to admission (HbA1c ≤53 mmol/l) (ICU cohort only)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c, Plasma glucose levels and mitral annular systolic velocity</measure>
    <time_frame>The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).</time_frame>
    <description>Difference in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by mitral annular systolic velocity between patients with chronic hyperglycaemia prior to admission (HbA1c &gt;53 mmol/mol) and with normoglycaemia prior to admission (HbA1c ≤53 mmol/l) (ICU cohort only)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes status and whole blood coagulability and fibrinolysis</measure>
    <time_frame>At time of admission to the ICU (max. 24 hours after admission to the ICU)</time_frame>
    <description>Difference in whole blood coagulability and fibrinolysis as measured by TEG between patients with and without diabetes at time of admission to the ICU (ICU cohort only)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes status and change in whole blood coagulability and fibrinolysis during ICU stay</measure>
    <time_frame>From first until last assessment during ICU stay (max. 24 hours).</time_frame>
    <description>Difference in change in whole blood coagulability and fibrinolysis as measured by TEG between patients with and without diabetes treated at the ICU (ICU cohort only)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prognostic value of TEG analysis</measure>
    <time_frame>From time of admission and until four weeks after admission</time_frame>
    <description>The prognostic value of cardiac function and TEG on the following patient outcomes 1) need for treatment in the ICU (hospitalisation cohort only) 2) need for respirator treatment (hospitalisation cohort only) 3) COVID-19 related death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prognostic value of cardiac function</measure>
    <time_frame>From time of admission and until four weeks after admission</time_frame>
    <description>The prognostic value of cardiac function on the following patient outcomes 1) need for treatment in the ICU (hospitalisation cohort only) 2) need for respirator treatment (hospitalisation cohort only) 3) COVID-19 related death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes status and high-sensitivity troponins</measure>
    <time_frame>At the time of admission to the ICU (max. 24 hours after admission to the ICU)</time_frame>
    <description>Difference in cardiac damage as measured by high-sensitivity troponin (hs-troponin) between patients with and without diabetes admitted to the ICU (ICU cohort only)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes status and change high-sensitivity troponins</measure>
    <time_frame>From first until last assessment during ICU stay (max. 24 hours)</time_frame>
    <description>Difference in change in cardiac damage as measured by high-sensitivity troponin (hs-troponin) between patients with and without diabetes admitted to the ICU (ICU cohort only)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Diabetes Mellitus</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Diabetes Mellitus, Type 1</condition>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>The intensive care unit cohort</arm_group_label>
    <description>Patients (with or without diabetes) with COVID-19 admitted to the intensive care unit</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The hospitalisation cohort</arm_group_label>
    <description>Patients with diabetes and COVID-19 admitted to the medical ward</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Glycaemic levels</intervention_name>
    <description>Glycaemic levels during admission for COVID-19</description>
    <arm_group_label>The hospitalisation cohort</arm_group_label>
    <arm_group_label>The intensive care unit cohort</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The present study aims to evaluate the effect of glycaemia on cardiac function in patients&#xD;
        with COVID-19 by examining cardiac function by echocardiography in two patient groups: 1)&#xD;
        hospitalised COVID-19 patients with diabetes admitted to the medical ward 2) COVID-19&#xD;
        patients with or without diabetes admitted to the ICU.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        The ICU cohort - Inclusion criteria&#xD;
&#xD;
          -  Informed and written consent&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Verified COVID-19&#xD;
&#xD;
          -  Admission to the ICU within the last 24 hours&#xD;
&#xD;
          -  Type 1 or type 2 diabetes prior to admission (the diabetes sub-group only)&#xD;
&#xD;
        The ICU cohort - Exclusion criteria&#xD;
&#xD;
          -  Cardiac arrhythmia at time of inclusion (previously diagnosed paroxysmal atrial&#xD;
             fibrillation will be allowed)&#xD;
&#xD;
          -  Pacemaker rhythm&#xD;
&#xD;
          -  Severe valve disease&#xD;
&#xD;
        The hospitalisation cohort - inclusion criteria&#xD;
&#xD;
          -  Informed and written consent&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Verified COVID-19&#xD;
&#xD;
          -  Admission to medical ward within the last 24 hours&#xD;
&#xD;
          -  Type 1 or type 2 diabetes prior to admission&#xD;
&#xD;
        The hospitalisation cohort - Exclusion criteria&#xD;
&#xD;
          -  Cardiac arrhythmia at time of inclusion (previously diagnosed paroxysmal atrial&#xD;
             fibrillation will be allowed)&#xD;
&#xD;
          -  Pacemaker rhythm&#xD;
&#xD;
          -  Severe valve disease&#xD;
&#xD;
        Withdrawal criteria&#xD;
&#xD;
        - The participants may withdraw at will at any time&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Herlev and Gentofte Hospital</name>
      <address>
        <city>Hellerup</city>
        <state>Please Select</state>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hvidovre Hospital</name>
      <address>
        <city>Hvidovre</city>
        <state>Please Select</state>
        <zip>2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>May 5, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>November 28, 2022</last_update_submitted>
  <last_update_submitted_qc>November 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Steno Diabetes Center Copenhagen</investigator_affiliation>
    <investigator_full_name>Andreas Andersen</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 2</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</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/NCT04410718
org study id: H-20024279
nct id: NCT04410718
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study design is observational, exploratory study consisting of two cohorts of COVID-19
      patients admitted to the ICU and the medical ward, respectively. The primary outcome focusing
      on the effect of plasma glucose levels on cardiac function will be evaluated by repeated
      assessment of cardiac function by echocardiography and measurement of plasma glucose.
      Furthermore, blood coagulability will be evaluated to determine the importance of diabetes
      status and plasma glucose changes for whole blood coagulability at time of admission to the
      ICU and progression in coagulability abnormalities. In the medical ward cohort, two
      assessments will be performed separated by no more than 12 hours. In the ICU cohort, three
      assessments will be performed separated by no more than 6 hours. Ideally, 60 patients with
      COVID-19 will be included in the ICU cohort with a 1:1 distribution between patient with and
      without diabetes. Ideally, 40 patients with diabetes will be included in the cohort of
      patients admitted to medical ward (hospitalisation cohort).

      The primary hypothesis is that levels of plasma glucose have clinically significant impact on
      left ventricular systolic function in patients with COVID-19 admitted to the ICU. The
      secondary hypothesis is that the impact of plasma glucose on left ventricular systolic
      function is associated with glycaemic control prior to admission as measured by HbA1c.
observational model: Cohort
time perspective: Prospective
measure: Plasma glucose levels and left ventricular ejection fraction
time frame: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
description: The within-subject effect of plasma glucose levels on left ventricular systolic function as measured by left ventricular ejection fraction (a pooled analysis of the hospitalisation cohort and ICU cohort)
measure: Key secondary outcome: HbA1c, plasma glucose levels and left ventricular systolic function
time frame: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
description: Difference in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by left ventricular ejection fraction between patients with chronic hyperglycaemia prior to admission (HbA1c >53 mmol/mol) and with normoglycaemia prior to admission (HbA1c ≤53 mmol/l) (ICU cohort only)
measure: Plasma glucose levels and strain analysis
time frame: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
description: The within-subject effect of plasma glucose levels on left ventricular systolic function as measured by strain analysis (a pooled analysis of the hospitalisation cohort and ICU cohort)
measure: Plasma glucose levels and mitral annular systolic velocity
time frame: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
description: The within-subject effect of plasma glucose levels on left ventricular systolic function as measured by mitral annular systolic velocity (a pooled analysis of the hospitalisation cohort and ICU cohort)
measure: Plasma glucose levels and left ventricular ejection fraction (sub-group analysis)
time frame: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
description: Differences in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by left ventricular ejection fraction between the hospitalisation cohort, the ICU cohort with diabetes and the ICU cohort without diabetes, respectively
measure: Plasma glucose levels and strain analysis (sub-group analysis)
time frame: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
description: Differences in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by strain analysis between the hospitalisation cohort, the ICU cohort with diabetes and the ICU cohort without diabetes, respectively
measure: Plasma glucose levels and mitral annular systolic velocity (sub-group analysis)
time frame: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
description: Differences in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by mitral annular systolic velocity between the hospitalisation cohort, the ICU cohort with diabetes and the ICU cohort without diabetes, respectively
measure: HbA1c, Plasma glucose levels and strain analysis
time frame: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
description: Difference in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by strain analysis between patients with chronic hyperglycaemia prior to admission (HbA1c >53 mmol/mol) and with normoglycaemia prior to admission (HbA1c ≤53 mmol/l) (ICU cohort only)
measure: HbA1c, Plasma glucose levels and mitral annular systolic velocity
time frame: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
description: Difference in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by mitral annular systolic velocity between patients with chronic hyperglycaemia prior to admission (HbA1c >53 mmol/mol) and with normoglycaemia prior to admission (HbA1c ≤53 mmol/l) (ICU cohort only)
measure: Diabetes status and whole blood coagulability and fibrinolysis
time frame: At time of admission to the ICU (max. 24 hours after admission to the ICU)
description: Difference in whole blood coagulability and fibrinolysis as measured by TEG between patients with and without diabetes at time of admission to the ICU (ICU cohort only)
measure: Diabetes status and change in whole blood coagulability and fibrinolysis during ICU stay
time frame: From first until last assessment during ICU stay (max. 24 hours).
description: Difference in change in whole blood coagulability and fibrinolysis as measured by TEG between patients with and without diabetes treated at the ICU (ICU cohort only)
measure: Prognostic value of TEG analysis
time frame: From time of admission and until four weeks after admission
description: The prognostic value of cardiac function and TEG on the following patient outcomes 1) need for treatment in the ICU (hospitalisation cohort only) 2) need for respirator treatment (hospitalisation cohort only) 3) COVID-19 related death
measure: Prognostic value of cardiac function
time frame: From time of admission and until four weeks after admission
description: The prognostic value of cardiac function on the following patient outcomes 1) need for treatment in the ICU (hospitalisation cohort only) 2) need for respirator treatment (hospitalisation cohort only) 3) COVID-19 related death
measure: Diabetes status and high-sensitivity troponins
time frame: At the time of admission to the ICU (max. 24 hours after admission to the ICU)
description: Difference in cardiac damage as measured by high-sensitivity troponin (hs-troponin) between patients with and without diabetes admitted to the ICU (ICU cohort only)
measure: Diabetes status and change high-sensitivity troponins
time frame: From first until last assessment during ICU stay (max. 24 hours)
description: Difference in change in cardiac damage as measured by high-sensitivity troponin (hs-troponin) between patients with and without diabetes admitted to the ICU (ICU cohort only)
arm group label: The intensive care unit cohort
description: Patients (with or without diabetes) with COVID-19 admitted to the intensive care unit
arm group label: The hospitalisation cohort
description: Patients with diabetes and COVID-19 admitted to the medical ward
intervention type: Other
intervention name: Glycaemic levels
description: Glycaemic levels during admission for COVID-19
arm group label: The hospitalisation cohort
arm group label: The intensive care unit cohort
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Steno Diabetes Center Copenhagen
investigator full name: Andreas Andersen
investigator title: Principal Investigator
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Diabetes Mellitus, Type 1