<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/NCT03792607</url>
  </required_header>
  <id_info>
    <org_study_id>RRC-2015-2360454</org_study_id>
    <nct_id>NCT03792607</nct_id>
  </id_info>
  <brief_title>Network-based Approach in Type 2 Diabetes and Its Cardiovascular Risk</brief_title>
  <acronym>PIRAMIDE</acronym>
  <official_title>Perturbation of Interactome Through Micro-RNA And Methylome Analyses In Diabetes Endophenotypes: the PIRAMIDE Study Design</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Giuditta Benincasa</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>
      PIRAMIDE study design will test the hypothesis that simultaneous interactions between DNA&#xD;
      methylation and microRNAs may hit T2D candidate genes and predict the development of&#xD;
      T2D-related cardiovascular complications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 14, 2019</start_date>
  <completion_date type="Anticipated">June 14, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 14, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>DNA methylation status both of CD4+ and CD8+ cells</measure>
    <time_frame>3 Months</time_frame>
    <description>Using Methylation 27K BeadChip platform based on Bisulfite conversion technology, DNA methylation profile of 35 preselected T2D patients will be measured both in CD4+ and CD8+ cells collected from peripheral blood respect with controls.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bioinformatics analysis to predict putative novel T2D candidate genes</measure>
    <time_frame>6 Months</time_frame>
    <description>The network-based algorithm &quot;Weighted Human DNA methylation PPI network (WMPN)&quot; will be applied to methylome data in order to obtain a disease module containing the crucial differentially methylated genes both in CD4+ and CD8+ cells from T2D patients and controls.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RNA sequencing analysis both in CD4+ and CD8+ cells</measure>
    <time_frame>3 Months</time_frame>
    <description>RNA sequencing analysis by using Illumina HiSeq2000 Next Generatin Sequencing (NGS) platform will be performed for identifying differentially expressed micro-RNA and mRNA target both in CD4+ and CD8+ cells isolated from T2D patients and controls .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ROC curves to evaluate putative DNA methylation/microRNA interactions as prognostic biomarkers of cardiovascular dysfunction in T2D patients</measure>
    <time_frame>12 Months</time_frame>
    <description>The ROC curves will be used to correlation putative epigenetics interactions (DNA methylation and microRNA) with the presence or absence of T2D-related cardiovascular dysfunction.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">35</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <condition>Cardiovascular Diseases</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Peripheral blood CD4+ T cells and CD8+ T cells&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        We will enroll 35 men and women 50 years or older with diagnosis of T2D and 35 sex and&#xD;
        age-matched controls. Population study will be recruited at the Department of Medical,&#xD;
        Surgical, Neurological, Metabolic and Geriatric Sciences of University della Campania&#xD;
        &quot;Luigi Vanvitelli&quot;.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical Diagnosis of Type 2 Diabetes. In according to current guidelines, diabetes is&#xD;
             diagnosed by evidence of impairing fast glucose (IFG) &gt; 7.0 mmol/L (&gt;125 mg/dl), post&#xD;
             prandial glycemia &gt; 11.1 mmol/L (&gt;200 mg/dl), and evidence of glycated hemoglobin&#xD;
             (HbA1c) &gt; 6.6%. Clinical and demographic characteristics of study population will be&#xD;
             avaiable from datasets generated by physicians.&#xD;
&#xD;
          -  Clinical Diagnosis of macrovascular dysfunction.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Patients with known history of cancer, malignancy disorders, active infections, and&#xD;
        chronic or immune-mediated diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Giuditta Benincasa, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Department of Internal Medicine and Specialistics</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Giuditta Benincasa, MSc</last_name>
    <phone>+390815667916</phone>
    <email>giuditta.benincasa@unicampania.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Claudio Napoli, Professor</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Università della Campania Luigi Vanvitelli</name>
      <address>
        <city>Naples</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giuditta Benincasa, MSc</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 31, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>September 17, 2019</last_update_submitted>
  <last_update_submitted_qc>September 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Campania &quot;Luigi Vanvitelli&quot;</investigator_affiliation>
    <investigator_full_name>Giuditta Benincasa</investigator_full_name>
    <investigator_title>Principal Investigator GIUDITTA BENINCASA</investigator_title>
  </responsible_party>
  <keyword>Network medicine</keyword>
  <keyword>Epigenetics</keyword>
  <keyword>Diabetes</keyword>
  <keyword>Cardiovascular risk</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_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/NCT03792607
org study id: RRC-2015-2360454
nct id: NCT03792607
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
PIRAMIDE study design will test the hypothesis that simultaneous interactions between DNA
      methylation and microRNAs may hit T2D candidate genes and predict the development of
      T2D-related cardiovascular complications.
observational model: Case-Control
time perspective: Prospective
measure: DNA methylation status both of CD4+ and CD8+ cells
time frame: 3 Months
description: Using Methylation 27K BeadChip platform based on Bisulfite conversion technology, DNA methylation profile of 35 preselected T2D patients will be measured both in CD4+ and CD8+ cells collected from peripheral blood respect with controls.
measure: Bioinformatics analysis to predict putative novel T2D candidate genes
time frame: 6 Months
description: The network-based algorithm "Weighted Human DNA methylation PPI network (WMPN)" will be applied to methylome data in order to obtain a disease module containing the crucial differentially methylated genes both in CD4+ and CD8+ cells from T2D patients and controls.
measure: RNA sequencing analysis both in CD4+ and CD8+ cells
time frame: 3 Months
description: RNA sequencing analysis by using Illumina HiSeq2000 Next Generatin Sequencing (NGS) platform will be performed for identifying differentially expressed micro-RNA and mRNA target both in CD4+ and CD8+ cells isolated from T2D patients and controls .
measure: ROC curves to evaluate putative DNA methylation/microRNA interactions as prognostic biomarkers of cardiovascular dysfunction in T2D patients
time frame: 12 Months
description: The ROC curves will be used to correlation putative epigenetics interactions (DNA methylation and microRNA) with the presence or absence of T2D-related cardiovascular dysfunction.
Peripheral blood CD4+ T cells and CD8+ T cells
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Giuditta Benincasa, MSc
role: Principal Investigator
affiliation: Clinical Department of Internal Medicine and Specialistics
last name: Giuditta Benincasa, MSc
phone: +390815667916
email: giuditta.benincasa@unicampania.it
last name: Claudio Napoli, Professor
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Sponsor-Investigator
investigator affiliation: University of Campania "Luigi Vanvitelli"
investigator full name: Giuditta Benincasa
investigator title: Principal Investigator GIUDITTA BENINCASA
mesh term: Cardiovascular Diseases
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2