<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/NCT03824002</url>
  </required_header>
  <id_info>
    <org_study_id>21772</org_study_id>
    <nct_id>NCT03824002</nct_id>
  </id_info>
  <brief_title>Dulaglutide in Diabetic Patients, Relationship Between Arterial Stiffness, Endothelial Function, Clinical and Laboratory Variables</brief_title>
  <official_title>Arterial Stiffness and Endothelial Function Indexes, Relationships With Clinical and Laboratory Variables in a Group of Diabetic Patients in Treatment With Dulaglutide: a Case-control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Palermo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Palermo</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to evaluate arterial stiffness and endothelial function indexes and their&#xD;
      relationship with clinic and laboratory varible in a group of diabetic patients in treatment&#xD;
      with dulaglutide&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      46 patients with type 2 diabetes mellitus were recruited at the Internal Medicine with Stroke&#xD;
      care ward of the University hospital of Palermo &quot;P. Giaccone&quot; from April 2017 to April 2018.&#xD;
      For all patients treatment with dulaglutide was undertaken. As control group were recruited&#xD;
      46 patients from the same ward not affected by diabetes mellitus or affected by diabetes&#xD;
      mellitus but not in treatment with dulaglutide.&#xD;
&#xD;
      The study was carried out in accordance with the principles of the Helsinki Declaration&#xD;
      revised in 2001 and all patients gave their written consent to take part in this research.&#xD;
&#xD;
      Each patient treated with dulaglutide was compared for age, sex and cardiovascular risk with&#xD;
      control patients. The diagnosis of type 2 diabetes mellitus was based on the revised criteria&#xD;
      of the American Diabetes Association (ADA), and using a clinical algorithm that considered&#xD;
      the age of onset of the disease, the symptoms and weight present, the family history and the&#xD;
      therapy practiced. Arterial hypertension was defined according to the 2017 ESC-ESH criteria.&#xD;
      Dyslipidemia was defined based on total cholesterol levels&gt; 200 mg/dl, triglycerides&gt; 150&#xD;
      mg/dl and HDL levels &lt;40 mg/dl regardless of the patient's gender.&#xD;
&#xD;
      Among the cases enrolled, 46 (100%) had type 2 diabetes mellitus, 37 (80.43%) had arterial&#xD;
      hypertension and 26 (56.52%) hypercholesterolemia.&#xD;
&#xD;
      Clinical and anthropometric data were collected at the time of recruitment. Blood samples&#xD;
      were taken from each patient (cases and controls) to determine serum glucose, HbA1c, total&#xD;
      cholesterol, HDL and LDL cholesterol, triglycerides, creatinine, and a urine sample to assess&#xD;
      the presence of microalbuminuria. These withdrawals were then repeated three months and nine&#xD;
      months from the time of recruitment.&#xD;
&#xD;
      The digital endothelial function was evaluated through the RHI-pat analysis using&#xD;
      Endo-PAT2000. Pulse Wave Velocity (PWV) Carotid-Femoral Pulse was measured in the supine&#xD;
      position using an automatic device (SphygmoCor version 7.1) that evaluated the propagation&#xD;
      time of the sphygmic wave between the carotid and femoral pulse.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">April 20, 2018</completion_date>
  <primary_completion_date type="Actual">October 1, 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline Reactive Hyperemia Index at 3 and 9 months</measure>
    <time_frame>0 months, 3 months and 9 months</time_frame>
    <description>Endothelial function index RHI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline systolic blood pressure at 3 and 9 months</measure>
    <time_frame>0 months, 3 months and 9 months</time_frame>
    <description>systolic blood pressure in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Body Mass Index at 3 and 9 months</measure>
    <time_frame>0 months, 3 months and 9 months</time_frame>
    <description>weight and height will be combined to report BMI in kg/m^2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline cholesterol at 3 and 9 months</measure>
    <time_frame>0 months, 3 months and 9 months</time_frame>
    <description>blood cholesterol in mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline triglycerides at 3 and 9 months</measure>
    <time_frame>0 months, 3 months and 9 months</time_frame>
    <description>blood triglycerides in mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline glucose at 3 and 9 months</measure>
    <time_frame>0 months, 3 months and 9 months</time_frame>
    <description>fasting blood glucose in mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline diastolic blood pressure at 3 and 9 months</measure>
    <time_frame>0 months, 3 months and 9 months</time_frame>
    <description>diastolic blood pressure in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Pulse Wave Velocity at 3 and 9 months</measure>
    <time_frame>0 months, 3 months and 9 months</time_frame>
    <description>Pulse Wave Velocity in m/s</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">92</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>patients treated with dulaglutide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Diabetes therapy with dulaglutide and various combinations of aspart insulin, glargine, metformin, repaglinide</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patients not treated with dulaglutide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Diabetes therapy with various combinations of aspart insulin, glargine, metformin, repaglinide but without dulaglutide</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dulaglutide</intervention_name>
    <description>Diabetes therapy with dulaglutide and various combinations of insulin, metformin, glinides</description>
    <arm_group_label>patients treated with dulaglutide</arm_group_label>
    <other_name>aspart insulin</other_name>
    <other_name>glargine insulin</other_name>
    <other_name>metformin</other_name>
    <other_name>repaglinide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspart insulin</intervention_name>
    <description>Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide</description>
    <arm_group_label>patients not treated with dulaglutide</arm_group_label>
    <arm_group_label>patients treated with dulaglutide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glargine</intervention_name>
    <description>Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide</description>
    <arm_group_label>patients not treated with dulaglutide</arm_group_label>
    <arm_group_label>patients treated with dulaglutide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin</intervention_name>
    <description>Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide</description>
    <arm_group_label>patients not treated with dulaglutide</arm_group_label>
    <arm_group_label>patients treated with dulaglutide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Repaglinide</intervention_name>
    <description>Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide</description>
    <arm_group_label>patients not treated with dulaglutide</arm_group_label>
    <arm_group_label>patients treated with dulaglutide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diabetes mellitus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cancer, severe ckd, end stage liver disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Internal Medicine Ward, University of Palermo</name>
      <address>
        <city>Palermo</city>
        <zip>90127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Palermo</investigator_affiliation>
    <investigator_full_name>Antonino Tuttolomondo</investigator_full_name>
    <investigator_title>University professor</investigator_title>
  </responsible_party>
  <keyword>diabetes mellitus</keyword>
  <keyword>dulaglutide</keyword>
  <keyword>endothelial function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
    <mesh_term>Insulin, Globin Zinc</mesh_term>
    <mesh_term>Metformin</mesh_term>
    <mesh_term>Insulin Glargine</mesh_term>
    <mesh_term>Insulin Aspart</mesh_term>
    <mesh_term>Dulaglutide</mesh_term>
    <mesh_term>Repaglinide</mesh_term>
    <mesh_term>Insulin, Long-Acting</mesh_term>
    <mesh_term>Insulin degludec, insulin aspart drug combination</mesh_term>
  </intervention_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/NCT03824002
org study id: 21772
nct id: NCT03824002
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The study aims to evaluate arterial stiffness and endothelial function indexes and their
      relationship with clinic and laboratory varible in a group of diabetic patients in treatment
      with dulaglutide
46 patients with type 2 diabetes mellitus were recruited at the Internal Medicine with Stroke
      care ward of the University hospital of Palermo "P. Giaccone" from April 2017 to April 2018.
      For all patients treatment with dulaglutide was undertaken. As control group were recruited
      46 patients from the same ward not affected by diabetes mellitus or affected by diabetes
      mellitus but not in treatment with dulaglutide.

      The study was carried out in accordance with the principles of the Helsinki Declaration
      revised in 2001 and all patients gave their written consent to take part in this research.

      Each patient treated with dulaglutide was compared for age, sex and cardiovascular risk with
      control patients. The diagnosis of type 2 diabetes mellitus was based on the revised criteria
      of the American Diabetes Association (ADA), and using a clinical algorithm that considered
      the age of onset of the disease, the symptoms and weight present, the family history and the
      therapy practiced. Arterial hypertension was defined according to the 2017 ESC-ESH criteria.
      Dyslipidemia was defined based on total cholesterol levels> 200 mg/dl, triglycerides> 150
      mg/dl and HDL levels <40 mg/dl regardless of the patient's gender.

      Among the cases enrolled, 46 (100%) had type 2 diabetes mellitus, 37 (80.43%) had arterial
      hypertension and 26 (56.52%) hypercholesterolemia.

      Clinical and anthropometric data were collected at the time of recruitment. Blood samples
      were taken from each patient (cases and controls) to determine serum glucose, HbA1c, total
      cholesterol, HDL and LDL cholesterol, triglycerides, creatinine, and a urine sample to assess
      the presence of microalbuminuria. These withdrawals were then repeated three months and nine
      months from the time of recruitment.

      The digital endothelial function was evaluated through the RHI-pat analysis using
      Endo-PAT2000. Pulse Wave Velocity (PWV) Carotid-Femoral Pulse was measured in the supine
      position using an automatic device (SphygmoCor version 7.1) that evaluated the propagation
      time of the sphygmic wave between the carotid and femoral pulse.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Change from Baseline Reactive Hyperemia Index at 3 and 9 months
time frame: 0 months, 3 months and 9 months
description: Endothelial function index RHI
measure: Change from Baseline systolic blood pressure at 3 and 9 months
time frame: 0 months, 3 months and 9 months
description: systolic blood pressure in mmHg
measure: Change from Baseline Body Mass Index at 3 and 9 months
time frame: 0 months, 3 months and 9 months
description: weight and height will be combined to report BMI in kg/m^2
measure: Change from Baseline cholesterol at 3 and 9 months
time frame: 0 months, 3 months and 9 months
description: blood cholesterol in mg/dl
measure: Change from Baseline triglycerides at 3 and 9 months
time frame: 0 months, 3 months and 9 months
description: blood triglycerides in mg/dl
measure: Change from Baseline glucose at 3 and 9 months
time frame: 0 months, 3 months and 9 months
description: fasting blood glucose in mg/dl
measure: Change from Baseline diastolic blood pressure at 3 and 9 months
time frame: 0 months, 3 months and 9 months
description: diastolic blood pressure in mmHg
measure: Change from Baseline Pulse Wave Velocity at 3 and 9 months
time frame: 0 months, 3 months and 9 months
description: Pulse Wave Velocity in m/s
arm group label: patients treated with dulaglutide
arm group type: Experimental
description: Diabetes therapy with dulaglutide and various combinations of aspart insulin, glargine, metformin, repaglinide
arm group label: patients not treated with dulaglutide
arm group type: Active Comparator
description: Diabetes therapy with various combinations of aspart insulin, glargine, metformin, repaglinide but without dulaglutide
intervention type: Drug
intervention name: Dulaglutide
description: Diabetes therapy with dulaglutide and various combinations of insulin, metformin, glinides
arm group label: patients treated with dulaglutide
other name: aspart insulin
other name: glargine insulin
other name: metformin
other name: repaglinide
intervention type: Drug
intervention name: Aspart insulin
description: Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
arm group label: patients not treated with dulaglutide
arm group label: patients treated with dulaglutide
intervention type: Drug
intervention name: Glargine
description: Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
arm group label: patients not treated with dulaglutide
arm group label: patients treated with dulaglutide
intervention type: Drug
intervention name: Metformin
description: Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
arm group label: patients not treated with dulaglutide
arm group label: patients treated with dulaglutide
intervention type: Drug
intervention name: Repaglinide
description: Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
arm group label: patients not treated with dulaglutide
arm group label: patients treated with dulaglutide
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Palermo
investigator full name: Antonino Tuttolomondo
investigator title: University professor
mesh term: Diabetes Mellitus
mesh term: Insulin
mesh term: Insulin, Globin Zinc
mesh term: Metformin
mesh term: Insulin Glargine
mesh term: Insulin Aspart
mesh term: Dulaglutide
mesh term: Repaglinide
mesh term: Insulin, Long-Acting
mesh term: Insulin degludec, insulin aspart drug combination