<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/NCT04488848</url>
  </required_header>
  <id_info>
    <org_study_id>ERGE</org_study_id>
    <nct_id>NCT04488848</nct_id>
  </id_info>
  <brief_title>Cardiometabolic Effects of Rapid Glucose Excursion</brief_title>
  <acronym>ERGE</acronym>
  <official_title>Effect of Rapid Glucose Excursion Versus Continuous Glucose Infusion on Cardiovascular and Metabolic Parameters in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Barmherzige Brüder Linz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Barmherzige Brüder Linz</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 effects of rapid glucose excursions, induced by intravenous bolus application of glucose&#xD;
      in healthy probands, on cardiometabolic and inflammatory parameters will be investigated&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND: It is well known that people with diabetes have a five times higher risk of dying&#xD;
      of cardiovascular death than non-diabetics. However not only hyperglycaemia per se but also&#xD;
      glycaemic variability is currently particularly regarded as a risk factor for cardiovascular&#xD;
      and microvascular complications. Intermittent blood sugar excursions with pronounced&#xD;
      fluctuations between high and low values instead of constant, even increased blood sugar&#xD;
      exposure, have been shown to be more harmful in several studies.&#xD;
&#xD;
      AIM: The aim of this study is to determine the effect of rapid glucose excursion versus&#xD;
      continuous glucose infusion on cardiovascular and metabolic parameters in healthy volunteers.&#xD;
&#xD;
      METHODS/DESIGN: In this study, ten healthy male subjects will be studied on two occasions. In&#xD;
      a random order the subjects will receive 3 times 20 grams of glucose intravenously as a bolus&#xD;
      or, on the other occasion, 60 grams of glucose continuously over 3 hours. Cardiometabolic&#xD;
      biomarkers will be analysed serially to analyse the effects of glucose excursions.&#xD;
&#xD;
      PROSPECT: Glycaemic variability may be a crucial factor in the development of diabetic&#xD;
      complications, but there is currently a lack of conclusive evidence. The causes and&#xD;
      mechanisms of these negative influences on the cardiovascular system due to high glucose&#xD;
      variability have not been sufficiently investigated and are therefore not fully understood so&#xD;
      far. To date, however, there have been no studies with acutely altered glucose concentrations&#xD;
      in healthy volunteers that have investigated the effects on traditional as well as recently&#xD;
      identified cardiovascular and metabolic biomarkers. Knowledge of such effects may improve the&#xD;
      therapeutic strategy in diabetic patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 11, 2019</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Interleukin-6</measure>
    <time_frame>48 hours</time_frame>
    <description>measurement of the concentration of IL-6 (parameter of inflammation) in the serum over time following infusion</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Diabetes Mellitus, Experimental</condition>
  <arm_group>
    <arm_group_label>continous glucose</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>continous glucose infusion (60 grams over 3 hours)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>bolus (excursion)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 x 20 grams of glucose as a bolus over 6 minutes at t0, 60 minutes and 120 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>bolus glucose</intervention_name>
    <description>bolus Glucose</description>
    <arm_group_label>bolus (excursion)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>continuous clucose</intervention_name>
    <description>continuous clucose</description>
    <arm_group_label>continous glucose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men aged 18 years or older with no disease history&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  receiving any medication&#xD;
&#xD;
          -  probands who suffer from infectious disease&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>homogeneity</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Matthias Heinzl, MD</last_name>
    <phone>+43732789721236</phone>
    <email>matthias.heinzl@gmx.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Martin Clodi, MD, Prof.</last_name>
    <phone>+43732789724305</phone>
    <email>martin.clodi@clodi.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Barmherzige Brüder Linz - Innere Medizin</name>
      <address>
        <city>Linz</city>
        <zip>4021</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthias Heinzl</last_name>
      <phone>+436765206829</phone>
      <email>matthias.heinzl@bblinz.at</email>
    </contact>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 7, 2019</study_first_submitted>
  <study_first_submitted_qc>July 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>January 25, 2021</last_update_submitted>
  <last_update_submitted_qc>January 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Experimental</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/NCT04488848
org study id: ERGE
nct id: NCT04488848
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The effects of rapid glucose excursions, induced by intravenous bolus application of glucose
      in healthy probands, on cardiometabolic and inflammatory parameters will be investigated
BACKGROUND: It is well known that people with diabetes have a five times higher risk of dying
      of cardiovascular death than non-diabetics. However not only hyperglycaemia per se but also
      glycaemic variability is currently particularly regarded as a risk factor for cardiovascular
      and microvascular complications. Intermittent blood sugar excursions with pronounced
      fluctuations between high and low values instead of constant, even increased blood sugar
      exposure, have been shown to be more harmful in several studies.

      AIM: The aim of this study is to determine the effect of rapid glucose excursion versus
      continuous glucose infusion on cardiovascular and metabolic parameters in healthy volunteers.

      METHODS/DESIGN: In this study, ten healthy male subjects will be studied on two occasions. In
      a random order the subjects will receive 3 times 20 grams of glucose intravenously as a bolus
      or, on the other occasion, 60 grams of glucose continuously over 3 hours. Cardiometabolic
      biomarkers will be analysed serially to analyse the effects of glucose excursions.

      PROSPECT: Glycaemic variability may be a crucial factor in the development of diabetic
      complications, but there is currently a lack of conclusive evidence. The causes and
      mechanisms of these negative influences on the cardiovascular system due to high glucose
      variability have not been sufficiently investigated and are therefore not fully understood so
      far. To date, however, there have been no studies with acutely altered glucose concentrations
      in healthy volunteers that have investigated the effects on traditional as well as recently
      identified cardiovascular and metabolic biomarkers. Knowledge of such effects may improve the
      therapeutic strategy in diabetic patients.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Interleukin-6
time frame: 48 hours
description: measurement of the concentration of IL-6 (parameter of inflammation) in the serum over time following infusion
arm group label: continous glucose
arm group type: Placebo Comparator
description: continous glucose infusion (60 grams over 3 hours)
arm group label: bolus (excursion)
arm group type: Experimental
description: 3 x 20 grams of glucose as a bolus over 6 minutes at t0, 60 minutes and 120 minutes
intervention type: Other
intervention name: bolus glucose
description: bolus Glucose
arm group label: bolus (excursion)
intervention type: Other
intervention name: continuous clucose
description: continuous clucose
arm group label: continous glucose
criteria: 
gender: Male
gender based: Yes
gender description: homogeneity
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Matthias Heinzl, MD
phone: +43732789721236
email: matthias.heinzl@gmx.at
last name: Martin Clodi, MD, Prof.
phone: +43732789724305
email: martin.clodi@clodi.at
facility: 
status: Recruiting
contact: 
country: Austria
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Experimental
sharing ipd: Undecided