xml: <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/NCT05988346</url>
    </required_header>
    <id_info>
      <org_study_id>0408052023</org_study_id>
      <nct_id>NCT05988346</nct_id>
    </id_info>
    <brief_title>Ghrelin and Diastolic Heart Function</brief_title>
    <official_title>Ghrelin Expression Could Regulate Diastolic Heart Function in Obese Patients With Diabetes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Campania &quot;Luigi Vanvitelli&quot;</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Campania &quot;Luigi Vanvitelli&quot;</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>
        In type 2 diabetes mellitus (T2DM) and obese patients the adipose tissue could over-express&#xD;
        cytokines, sirtuin-1 (SIRT1), and microRNAs (miRs) implied in the regulation of left&#xD;
        ventricle (LV) diastolic function (LV-DF). Ghrelin could modulate these pathways. Thus, in&#xD;
        the current study authors will investigate ghrelin expression in T2DM obese patients after&#xD;
        abdominal fat excision, and particularly in those with normalization of LV-DF at 1 year of&#xD;
        follow-up.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2016</start_date>
    <completion_date type="Actual">March 1, 2022</completion_date>
    <primary_completion_date type="Actual">January 1, 2022</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>normalization of LV diastolic dysfunction</measure>
      <time_frame>12 months</time_frame>
      <description>At 1 year of follow-up authors evaluated the patients (those with first and second degree of LV diastolic dysfunction) that will experience the normalization of LV diastolic function.</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Actual">60</enrollment>
    <condition>Diabetes Mellitus, Type 2</condition>
    <condition>Obesity, Abdominal</condition>
    <condition>Diastolic Dysfunction</condition>
    <arm_group>
      <arm_group_label>type 2 diabetes mellitus (T2DM) obese patients without left ventricle (LV) diastolic dysfunction.</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>T2DM obese patients with first degree of left ventricle (LV) diastolic dysfunction.</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>T2DM obese patients with second degree of left ventricle (LV) diastolic dysfunction.</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>abdominal plastic intervention</intervention_name>
      <description>According to international guidelines, authors will remove the superficial abdominal fat from the patients enrolled in the study.</description>
      <arm_group_label>T2DM obese patients with first degree of left ventricle (LV) diastolic dysfunction.</arm_group_label>
      <arm_group_label>T2DM obese patients with second degree of left ventricle (LV) diastolic dysfunction.</arm_group_label>
      <arm_group_label>type 2 diabetes mellitus (T2DM) obese patients without left ventricle (LV) diastolic dysfunction.</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Authors will analyze biospecimen from the removed abdominal adipose tissue.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          The authors will enroll T2DM obese patients, according to the evidence or not of LV&#xD;
          diastolic dysfunction, and then divided in three groups. The LV diastolic dysfunction was&#xD;
          characterized as indicated by international recommendations, by the values of E/E' ratio&#xD;
          (18). Thus, the patients without LV diastolic dysfunction (E/E'&lt;9) were characterized as&#xD;
          group 1. Those with LV diastolic dysfunction (E/E'&gt;9), were divided in two groups, in&#xD;
          accordance with the E/E' values: group 2 (the patients with 9&lt;E/E'&lt;13), and group 3 (the&#xD;
          patients with E/E'&gt;13).&#xD;
  &#xD;
          Obesity will be diagnosed as body mass index (BMI) &gt; 30 (15). All enrolled patients will&#xD;
          have T2DM according to international guidelines diagnostic criteria: evidence of fasting&#xD;
          plasma glucose of ≥7.0 mmol/L (126 mg/dL; impaired fasting glucose [IFG]), a 2-hour glucose&#xD;
          of ≥11.1 mmol/L during a 75 g oral glucose tolerance test (GTT) (&gt;200 mg/dL; impaired&#xD;
          glucose tolerance [IGT]), or a plasma hemoglobin (Hb) A1c of ≥48 mmol/mol (≥6.5%), (16).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Clinical diagnosis of T2DM obese patients;&#xD;
  &#xD;
            -  T2DM obese patients under anti-diabetic full medical therapy and glycemic control.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  clinical diagnosis of type 1 diabetes;&#xD;
  &#xD;
            -  T2DM patients in poor glycemic control (HbA1c values of &gt;7%);&#xD;
  &#xD;
            -  chronic neurological disorders;&#xD;
  &#xD;
            -  heart failure and coronary heart disease or depression of left ventricular ejection&#xD;
               fraction (LVEF &lt;55%);&#xD;
  &#xD;
            -  severe anemia;&#xD;
  &#xD;
            -  thyroid dysfunction;&#xD;
  &#xD;
            -  kidney failure;&#xD;
  &#xD;
            -  uncontrolled blood pressure (blood pressure &gt; 140/90 mmHg on two occasions 2 weeks&#xD;
               apart);&#xD;
  &#xD;
            -  inflammatory chronic disease;&#xD;
  &#xD;
            -  neoplastic disease.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Celestino Sardu</name>
        <address>
          <city>Naples</city>
          <zip>80138</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Campania &quot;Luigi Vanvitelli&quot;</investigator_affiliation>
      <investigator_full_name>Celestino Sardu</investigator_full_name>
      <investigator_title>Professor of Medicine</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
      <mesh_term>Obesity, Abdominal</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05988346
  org study id: 0408052023
  nct id: NCT05988346
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  In type 2 diabetes mellitus (T2DM) and obese patients the adipose tissue could over-express
        cytokines, sirtuin-1 (SIRT1), and microRNAs (miRs) implied in the regulation of left
        ventricle (LV) diastolic function (LV-DF). Ghrelin could modulate these pathways. Thus, in
        the current study authors will investigate ghrelin expression in T2DM obese patients after
        abdominal fat excision, and particularly in those with normalization of LV-DF at 1 year of
        follow-up.
  observational model: Cohort
  time perspective: Prospective
  measure: normalization of LV diastolic dysfunction
  time frame: 12 months
  description: At 1 year of follow-up authors evaluated the patients (those with first and second degree of LV diastolic dysfunction) that will experience the normalization of LV diastolic function.
  arm group label: type 2 diabetes mellitus (T2DM) obese patients without left ventricle (LV) diastolic dysfunction.
  arm group label: T2DM obese patients with first degree of left ventricle (LV) diastolic dysfunction.
  arm group label: T2DM obese patients with second degree of left ventricle (LV) diastolic dysfunction.
  intervention type: Procedure
  intervention name: abdominal plastic intervention
  description: According to international guidelines, authors will remove the superficial abdominal fat from the patients enrolled in the study.
  arm group label: T2DM obese patients with first degree of left ventricle (LV) diastolic dysfunction.
  arm group label: T2DM obese patients with second degree of left ventricle (LV) diastolic dysfunction.
  arm group label: type 2 diabetes mellitus (T2DM) obese patients without left ventricle (LV) diastolic dysfunction.
  Authors will analyze biospecimen from the removed abdominal adipose tissue.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  facility: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: University of Campania "Luigi Vanvitelli"
  investigator full name: Celestino Sardu
  investigator title: Professor of Medicine
  mesh term: Diabetes Mellitus, Type 2
  mesh term: Obesity, Abdominal
  sharing ipd: Undecided