<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/NCT03297749</url>
  </required_header>
  <id_info>
    <org_study_id>4242/01</org_study_id>
    <nct_id>NCT03297749</nct_id>
  </id_info>
  <brief_title>Genetic Variants and Oxidative Stress as Links Between Periodontitis and Metabolic Syndrome</brief_title>
  <official_title>Genetic Variants and Oxidative Stress as Links Between Periodontitis and Metabolic Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Catania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University College, London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate the systemic impact of periodontitis in patients with&#xD;
      Metabolic Syndrome, by assessing measures of sub-clinical atherosclerosis and cardiovascular&#xD;
      risk, microbial factors and host genetic variants, and to study the possible effect of&#xD;
      mediators of inflammation and oxidative stress as links between the two conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a cross-sectional study. 102 patients with metabolic syndrome will be recruited and&#xD;
      will have periodontal and dental examination for diagnosis of caries and periodontal&#xD;
      diseases. They will undergo blood, saliva, GCF and subgingival plaque sampling and a series&#xD;
      of tests on cardiovascular disease, including measures of pulse-wave velocity,carotid&#xD;
      intima-media thickness and echocardiography assessment. Statistical analysis will assess&#xD;
      associations between dental diagnoses and metabolic, cardiovascular, inflammatory, genetic,&#xD;
      microbial and cardiovascular risk outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 1, 2015</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2017</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>pulse wave velocity</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>oxidative stress</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>carotid intima-media thickness</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>genetic variants</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>left ventricular mass</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>inflammatory markers</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>subgingival microbes</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">102</enrollment>
  <condition>Periodontitis, Adult</condition>
  <condition>Metabolic Syndrome</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational study (no intervention)</intervention_name>
    <description>No interventions</description>
    <other_name>No interventions</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with metabolic syndrome will be recruited from outpatients attending the Internal&#xD;
        Medicine Unity at the University of Catania.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Caucasian ethnicity&#xD;
&#xD;
          -  Age 18- 75&#xD;
&#xD;
          -  Diagnosis of metabolic syndrome&#xD;
&#xD;
          -  Presence of at least 12 teeth&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Presence of infectious diseases such as hepatitis and HIV&#xD;
&#xD;
          -  Use of non-steroidal anti-inflammatory drugs (excluding low-dose aspirin) within one&#xD;
             month prior to the baseline visit&#xD;
&#xD;
          -  Use of systemic antibiotics within three months prior to the baseline visit&#xD;
&#xD;
          -  Antibiotic pre-medication required for the performance of periodontal examination&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>University of Catania</name>
      <address>
        <city>Catania</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCL</name>
      <address>
        <city>London</city>
        <zip>EN54LU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>October 25, 2017</last_update_submitted>
  <last_update_submitted_qc>October 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Chronic Periodontitis</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT03297749
org study id: 4242/01
nct id: NCT03297749
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate the systemic impact of periodontitis in patients with
      Metabolic Syndrome, by assessing measures of sub-clinical atherosclerosis and cardiovascular
      risk, microbial factors and host genetic variants, and to study the possible effect of
      mediators of inflammation and oxidative stress as links between the two conditions.
This is a cross-sectional study. 102 patients with metabolic syndrome will be recruited and
      will have periodontal and dental examination for diagnosis of caries and periodontal
      diseases. They will undergo blood, saliva, GCF and subgingival plaque sampling and a series
      of tests on cardiovascular disease, including measures of pulse-wave velocity,carotid
      intima-media thickness and echocardiography assessment. Statistical analysis will assess
      associations between dental diagnoses and metabolic, cardiovascular, inflammatory, genetic,
      microbial and cardiovascular risk outcomes.
observational model: Case-Control
time perspective: Cross-Sectional
measure: pulse wave velocity
time frame: baseline
measure: oxidative stress
time frame: baseline
measure: carotid intima-media thickness
time frame: baseline
measure: genetic variants
time frame: baseline
measure: left ventricular mass
time frame: baseline
measure: inflammatory markers
time frame: baseline
measure: subgingival microbes
time frame: baseline
intervention type: Other
intervention name: Observational study (no intervention)
description: No interventions
other name: No interventions
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
facility: 
facility: 
country: Italy
country: United Kingdom
responsible party type: Sponsor
mesh term: Periodontitis
mesh term: Chronic Periodontitis
mesh term: Metabolic Syndrome
mesh term: Syndrome
sharing ipd: No