<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/NCT03035526</url>
  </required_header>
  <id_info>
    <org_study_id>AA1972</org_study_id>
    <nct_id>NCT03035526</nct_id>
  </id_info>
  <brief_title>Sex Hormones and Pericardial Adipose Tissue</brief_title>
  <official_title>Do Endogenous Sex Hormones Affect Pericardial Adipose Tissue Volume of Males in The Multi-Ethnic Study of Atherosclerosis (MESA)?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gulhane School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gulhane School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</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>
      In this study, our aim is to show the relation between sex hormones and PAT and to confirm&#xD;
      whether PAT is associated with coronary artery calcification (CAC) in different testosterone&#xD;
      levels in the males.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2000</start_date>
  <completion_date type="Actual">January 2002</completion_date>
  <primary_completion_date type="Actual">January 2002</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Relation ship between pericardial adipose tissue and sex hormones in males</measure>
    <time_frame>years</time_frame>
    <description>Total testosterone and sex hormone binding globulin levels were related with pericardial adipose tissue</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">3213</enrollment>
  <condition>Pericardial Adipose Tissue and Sex Hormones</condition>
  <arm_group>
    <arm_group_label>3161 men (45-84 years old)</arm_group_label>
    <description>3161 men without known coronary artery disease</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        3161 men (45-84 years old; white, black, Hispanic, or Chinese) at 6 centers in the United&#xD;
        States&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  3213 males&#xD;
&#xD;
          -  African American&#xD;
&#xD;
          -  Caucasian&#xD;
&#xD;
          -  Asian (largely Chinese) and Hispanic adults aged 45-84 years and free of known&#xD;
             cardiovascular disease at baseline (2000-2002)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with known coronary artery disease&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>84 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>January 25, 2017</last_update_submitted>
  <last_update_submitted_qc>January 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gulhane School of Medicine</investigator_affiliation>
    <investigator_full_name>Aydogan Aydogdu</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <!-- 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/NCT03035526
org study id: AA1972
nct id: NCT03035526
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this study, our aim is to show the relation between sex hormones and PAT and to confirm
      whether PAT is associated with coronary artery calcification (CAC) in different testosterone
      levels in the males.
observational model: Cohort
time perspective: Cross-Sectional
measure: Relation ship between pericardial adipose tissue and sex hormones in males
time frame: years
description: Total testosterone and sex hormone binding globulin levels were related with pericardial adipose tissue
arm group label: 3161 men (45-84 years old)
description: 3161 men without known coronary artery disease
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
minimum age: 45 Years
maximum age: 84 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Gulhane School of Medicine
investigator full name: Aydogan Aydogdu
investigator title: MD