<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/NCT01715428</url>
  </required_header>
  <id_info>
    <org_study_id>LIRAGLUTIDE UNIPA</org_study_id>
    <nct_id>NCT01715428</nct_id>
  </id_info>
  <brief_title>Liraglutide and Cardio-Metabolic Risk Markers</brief_title>
  <official_title>Effects of Liraglutide on Cardio-Metabolic Risk Markers</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>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Incretin-based therapies have shown significant effects beyond those on glucose metabolism.&#xD;
      We aim in the present study to evaluate the effects of liraglutide on several&#xD;
      cardio-metabolic risk markers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In details, we will evaluate the effects of liraglutide on carotid-intima media thickness,&#xD;
      oxidative stress, ghrelin, heat shock proteins and lipoproteins.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>carotid intima-media thickness</measure>
    <time_frame>every four months for a total period of 2 years</time_frame>
    <description>carotid intima-media thickness will be assessed by doppler ultrasonography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in oxidative stress markers</measure>
    <time_frame>after 2 months of therapy</time_frame>
    <description>Serum LOOH levels were evaluated following the oxidation of Fe2+ to Fe3+ in the presence of xylenol orange at 560 nm. Levels of GSH were measured in serum using a spectrophotometric assay based on the reaction of thiol groups with 2,2-dithio-bis-nitrobenzoic acid, while the production of ROS was assessed using fluorescent probe dihydroethidium staining (Sigma).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in plasma ghrelin concentrations and heat-shock proteins</measure>
    <time_frame>after 2 months of therapy</time_frame>
    <description>plasma ghrelin concentrations and heat shock protein 60 were measured by ELISA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in atherogenic lipoproteins</measure>
    <time_frame>after 2 and after 4 months of therapy</time_frame>
    <description>the full LDL subclass profile (from larger and less atherogenic LDL-1 and LDL-2, to smaller denser LDL-3 to LDL-7) was assessed by gel electrophoresis (Lipoprint, Quantimetrix, USA)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>Type-2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Liraglutide</arm_group_label>
    <description>administration of liraglutide at 1.2 mg/daily</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum and plasma samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        adult subjects with type-2 diabetes&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - patients with a diagnosis of type-2 diabetes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - severe hepatic or renal diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Giuseppe Montalto, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Palermo, Italy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital 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>November 2017</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>November 20, 2017</last_update_submitted>
  <last_update_submitted_qc>November 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Palermo</investigator_affiliation>
    <investigator_full_name>Manfredi Rizzo</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>diabetes, cardiovascular risk</keyword>
  <!-- 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/NCT01715428
org study id: LIRAGLUTIDE UNIPA
nct id: NCT01715428
lead sponsor: 
has dmc: No
Incretin-based therapies have shown significant effects beyond those on glucose metabolism.
      We aim in the present study to evaluate the effects of liraglutide on several
      cardio-metabolic risk markers.
In details, we will evaluate the effects of liraglutide on carotid-intima media thickness,
      oxidative stress, ghrelin, heat shock proteins and lipoproteins.
observational model: Case-Only
time perspective: Prospective
measure: carotid intima-media thickness
time frame: every four months for a total period of 2 years
description: carotid intima-media thickness will be assessed by doppler ultrasonography
measure: changes in oxidative stress markers
time frame: after 2 months of therapy
description: Serum LOOH levels were evaluated following the oxidation of Fe2+ to Fe3+ in the presence of xylenol orange at 560 nm. Levels of GSH were measured in serum using a spectrophotometric assay based on the reaction of thiol groups with 2,2-dithio-bis-nitrobenzoic acid, while the production of ROS was assessed using fluorescent probe dihydroethidium staining (Sigma).
measure: changes in plasma ghrelin concentrations and heat-shock proteins
time frame: after 2 months of therapy
description: plasma ghrelin concentrations and heat shock protein 60 were measured by ELISA
measure: changes in atherogenic lipoproteins
time frame: after 2 and after 4 months of therapy
description: the full LDL subclass profile (from larger and less atherogenic LDL-1 and LDL-2, to smaller denser LDL-3 to LDL-7) was assessed by gel electrophoresis (Lipoprint, Quantimetrix, USA)
arm group label: Liraglutide
description: administration of liraglutide at 1.2 mg/daily
serum and plasma samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Giuseppe Montalto, MD
role: Study Director
affiliation: University of Palermo, Italy
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Palermo
investigator full name: Manfredi Rizzo
investigator title: Assistant Professor