<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/NCT02205021</url>
  </required_header>
  <id_info>
    <org_study_id>2012P001603</org_study_id>
    <nct_id>NCT02205021</nct_id>
  </id_info>
  <brief_title>Neck Fat Accumulation and Its Relationship to Cardiovascular Risk and Metabolic Syndrome</brief_title>
  <official_title>Compartmental Neck Fat Accumulation and Its Relationship to Cardiovascular Risk and Metabolic Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Accumulation of fat in the neck using tape measures has been linked to increased&#xD;
      cardiovascular risk. The investigators' hypothesis is that detailed measures of neck fat&#xD;
      using computed tomography will show that specific fat compartments in the neck contribute&#xD;
      differently to cardiovascular risk.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <primary_completion_date type="Actual">March 2014</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Relationship of specific neck compartments to cardiovascular risk</measure>
    <time_frame>1 year between PET/CT and cardiometabolic marker measures</time_frame>
    <description>Cardiovascular risk measures were obtained within one year of CT imaging of the neck.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">303</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>All subjects</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <arm_group_label>All subjects</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Retrospective search of whole-body PET/CT examinations and consecutively selected imaging&#xD;
        studies.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  no history of malignancy at the time of image acquisition&#xD;
&#xD;
          -  fasting glucose measured immediately prior to PET/CT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of neck cancer, radiation therapy, and/or surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>91 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Torriani, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>July 30, 2014</last_update_submitted>
  <last_update_submitted_qc>July 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 31, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Torriani, Martin,M.D.</investigator_full_name>
    <investigator_title>Assistant Professor of Radiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</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/NCT02205021
org study id: 2012P001603
nct id: NCT02205021
lead sponsor: 
has dmc: No
Accumulation of fat in the neck using tape measures has been linked to increased
      cardiovascular risk. The investigators' hypothesis is that detailed measures of neck fat
      using computed tomography will show that specific fat compartments in the neck contribute
      differently to cardiovascular risk.
observational model: Cohort
time perspective: Retrospective
measure: Relationship of specific neck compartments to cardiovascular risk
time frame: 1 year between PET/CT and cardiometabolic marker measures
description: Cardiovascular risk measures were obtained within one year of CT imaging of the neck.
arm group label: All subjects
intervention type: Other
intervention name: No intervention
arm group label: All subjects
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 91 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Martin Torriani, M.D.
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Torriani, Martin,M.D.
investigator title: Assistant Professor of Radiology
mesh term: Metabolic Syndrome