<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/NCT04430946</url>
  </required_header>
  <id_info>
    <org_study_id>GutT1DM</org_study_id>
    <nct_id>NCT04430946</nct_id>
  </id_info>
  <brief_title>Postprandial Gut Hormone Responses in Patients With Type 1 Diabetes Mellitus</brief_title>
  <official_title>Comparison of Postpradial Gut Hormone and Metabolic Responses Between Patients With Type 1 Diabetes Mellitus and Healthy Controls</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>
    <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 will compare the postprandial responses to a test meal between subjects with type 1&#xD;
      diabetes and healthy control subjects, in terms of gut hormone levels, meal induced&#xD;
      thermogenesis, hunger and satiety perception, as well as futher metabolic parameters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim of the study&#xD;
&#xD;
      To compare the acute effect of the consumption of a test meal on satiety, gastrointestinal&#xD;
      hormones' response, post-meal thermogenesis, and further metabolic parameters in lean&#xD;
      patients with type 1 diabetes mellitus (T1DM), obese patients with T1DM, and healthy lean and&#xD;
      obese controls.&#xD;
&#xD;
      Study subjects:&#xD;
&#xD;
      Four groups of participants will be recruited, consisting of 15 lean healthy subjects (BMI&#xD;
      &lt;25 kg/m2), 15 obese healthy subjects, 15 lean patients with T1DM (BMI &lt;25 kg/m2), and 15&#xD;
      obese patients with T1DM (BMI ≥ 30kg/m2). Groups will be matched for age and sex. Healthy&#xD;
      volunteers will be recruited from the community, and diabetic individuals from our diabetes&#xD;
      clinic. Eligibility criteria will include 18-65 years of age, no use of medications affecting&#xD;
      appetite and stable weight (no fluctuations exceeding 5 kg the last 3 months.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Demographic data and anthropometric measurements will be collected on the day of visit.&#xD;
      Fasting blood samples will be collected for measurement of plasma glucose, insulin,&#xD;
      triglycerides, GIP, GLP-1, PYY (total), ghrelin (total). VAS for hunger and satiety will be&#xD;
      completed in the fasting state. Participants will then consume a test meal of ~700 kcal&#xD;
      consisting of protein and fat (no carbohydrates) within 10 minutes. Blood samples will be&#xD;
      drawn and VAS scales completed postprandially at 30, 60, 90, 120, 150, 180 min. RMR&#xD;
      measurements using indirect calorimetry will be performed in the fasting state, 1 hour and 3&#xD;
      hours postprandially to assess meal induced thermogenesis. Postprandial responses for these&#xD;
      parameters will be assessed as area under the curve (AUC).&#xD;
&#xD;
      Patients with T1DM treated with basal- bolus insulin therapy will receive their regular basal&#xD;
      insulin dose and patients on an insulin pump will be kept on their basal rate of insulin&#xD;
      infusion. In case of fasting hyperglycemia, the session will be canceled.&#xD;
&#xD;
      Postrpandial glucose excursion will be treated with fast acting insulin.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 25, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gut peptide hormone responses</measure>
    <time_frame>3 hours</time_frame>
    <description>Postprandial responses of ghrelin, PYY, GLP-1, Glicentin, Oxyntomodulin measured as area under the curve (AUC)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Meal induced thermogenesis</measure>
    <time_frame>3 hours</time_frame>
    <description>Change in basal metabolic rate after meal consumption as assessed by indirect calorimetry</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>type1diabetes</condition>
  <condition>Hunger</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Lean patients with type 1 diabetes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test meal consumed within 10 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obese patients with type 1 diabetes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test meal consumed within 10 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lean healthy control subjects</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Test meal consumed within 10 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obese healthy control subjects</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Test meal consumed within 10 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Standardized test meal</intervention_name>
    <description>A test meal of ~700 kcal consisting of protein and fat will be consumed within 10 minutes</description>
    <arm_group_label>Lean healthy control subjects</arm_group_label>
    <arm_group_label>Lean patients with type 1 diabetes</arm_group_label>
    <arm_group_label>Obese healthy control subjects</arm_group_label>
    <arm_group_label>Obese patients with type 1 diabetes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 1 diabetes&#xD;
&#xD;
          -  BMI &gt;30 kg/m2 for the obese groups&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetic neuropathy&#xD;
&#xD;
          -  Malignancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexandros Kokkinos</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Department of Propaedeutic Medicine, Laiko General Hospital</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>June 2022</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 6, 2022</last_update_submitted>
  <last_update_submitted_qc>June 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2022</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04430946
org study id: GutT1DM
nct id: NCT04430946
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study will compare the postprandial responses to a test meal between subjects with type 1
      diabetes and healthy control subjects, in terms of gut hormone levels, meal induced
      thermogenesis, hunger and satiety perception, as well as futher metabolic parameters.
Aim of the study

      To compare the acute effect of the consumption of a test meal on satiety, gastrointestinal
      hormones' response, post-meal thermogenesis, and further metabolic parameters in lean
      patients with type 1 diabetes mellitus (T1DM), obese patients with T1DM, and healthy lean and
      obese controls.

      Study subjects:

      Four groups of participants will be recruited, consisting of 15 lean healthy subjects (BMI
      <25 kg/m2), 15 obese healthy subjects, 15 lean patients with T1DM (BMI <25 kg/m2), and 15
      obese patients with T1DM (BMI ≥ 30kg/m2). Groups will be matched for age and sex. Healthy
      volunteers will be recruited from the community, and diabetic individuals from our diabetes
      clinic. Eligibility criteria will include 18-65 years of age, no use of medications affecting
      appetite and stable weight (no fluctuations exceeding 5 kg the last 3 months.

      Methods:

      Demographic data and anthropometric measurements will be collected on the day of visit.
      Fasting blood samples will be collected for measurement of plasma glucose, insulin,
      triglycerides, GIP, GLP-1, PYY (total), ghrelin (total). VAS for hunger and satiety will be
      completed in the fasting state. Participants will then consume a test meal of ~700 kcal
      consisting of protein and fat (no carbohydrates) within 10 minutes. Blood samples will be
      drawn and VAS scales completed postprandially at 30, 60, 90, 120, 150, 180 min. RMR
      measurements using indirect calorimetry will be performed in the fasting state, 1 hour and 3
      hours postprandially to assess meal induced thermogenesis. Postprandial responses for these
      parameters will be assessed as area under the curve (AUC).

      Patients with T1DM treated with basal- bolus insulin therapy will receive their regular basal
      insulin dose and patients on an insulin pump will be kept on their basal rate of insulin
      infusion. In case of fasting hyperglycemia, the session will be canceled.

      Postrpandial glucose excursion will be treated with fast acting insulin.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Gut peptide hormone responses
time frame: 3 hours
description: Postprandial responses of ghrelin, PYY, GLP-1, Glicentin, Oxyntomodulin measured as area under the curve (AUC)
measure: Meal induced thermogenesis
time frame: 3 hours
description: Change in basal metabolic rate after meal consumption as assessed by indirect calorimetry
arm group label: Lean patients with type 1 diabetes
arm group type: Experimental
description: Test meal consumed within 10 minutes
arm group label: Obese patients with type 1 diabetes
arm group type: Experimental
description: Test meal consumed within 10 minutes
arm group label: Lean healthy control subjects
arm group type: Active Comparator
description: Test meal consumed within 10 minutes
arm group label: Obese healthy control subjects
arm group type: Active Comparator
description: Test meal consumed within 10 minutes
intervention type: Diagnostic Test
intervention name: Standardized test meal
description: A test meal of ~700 kcal consisting of protein and fat will be consumed within 10 minutes
arm group label: Lean healthy control subjects
arm group label: Lean patients with type 1 diabetes
arm group label: Obese healthy control subjects
arm group label: Obese patients with type 1 diabetes
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alexandros Kokkinos
role: Principal Investigator
affiliation: First Department of Propaedeutic Medicine, Laiko General Hospital
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
sharing ipd: No