<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/NCT03009279</url>
  </required_header>
  <id_info>
    <org_study_id>qfsnfm-004</org_study_id>
    <nct_id>NCT03009279</nct_id>
  </id_info>
  <brief_title>Relationship of Metabolic Syndrome and Its Components With Thyroid Nodule(s)</brief_title>
  <official_title>Relationship of Metabolic Syndrome and Its Components With Thyroid Nodule(s)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lin Liao</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Qianfoshan Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the association between metabolic syndrome (MS) and thyroid nodule(s).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To investigate the association between metabolic syndrome (MS), body mass index (BMI),&#xD;
      hyperglycemia, dyslipidemia, hypertension and thyroid nodule(s) or thyroid functions in&#xD;
      euthyroid subjects. Screen for the risk factors that affect the incidence of thyroid&#xD;
      nodule(s).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">November 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>The laboratory examinations</measure>
    <time_frame>In 2013-2015</time_frame>
    <description>Lipids,glucose,thyroid functions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood pressure of patients in each group</measure>
    <time_frame>In 2013-2015</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>BMI of patients in each group</measure>
    <time_frame>In 2013-2015</time_frame>
    <description>body mass index（BMI）</description>
  </other_outcome>
  <other_outcome>
    <measure>Age of patients in each group</measure>
    <time_frame>In 2013-2015</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Gender of patients in each group</measure>
    <time_frame>In 2013-2015</time_frame>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Metabolic Syndrome</condition>
  <condition>Thyroid Nodule</condition>
  <arm_group>
    <arm_group_label>The MS group</arm_group_label>
    <description>Patients with metabolic syndrome(MS).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The non-MS group</arm_group_label>
    <description>Patients without metabolic syndrome(MS).</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        People who received routain physical and laboratory examinations in the Health Management&#xD;
        Cenre of QianFoShan Hospital from Jan. 2013 to Dec. 2015.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. People who received routain physical and laboratory examinations in the Health&#xD;
             Management Cenre of QianFoShan Hospital from Jan. 2013 to Dec. 2015.&#xD;
&#xD;
          2. signed the informed consent.&#xD;
&#xD;
          3. Have complete clinical data.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with previous history of thyroid disease other than thyroid nodules.&#xD;
&#xD;
          2. People with abnormal thyroid function.&#xD;
&#xD;
          3. Thyroid ultrasound revealed patients with other lesions other than normal thyroid and&#xD;
             thyroid nodules.&#xD;
&#xD;
          4. Pregnant or lactating women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lin Liao</last_name>
    <role>Study Chair</role>
    <affiliation>Qianfoshan Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lin Liao, MD</last_name>
    <phone>8615168888260</phone>
    <email>liaolin@medmail.com.cn</email>
  </overall_contact>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 26, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>January 5, 2017</last_update_submitted>
  <last_update_submitted_qc>January 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Qianfoshan Hospital</investigator_affiliation>
    <investigator_full_name>Lin Liao</investigator_full_name>
    <investigator_title>chief of endocrinology department at Qianfoshan Hospital</investigator_title>
  </responsible_party>
  <keyword>blood pressure</keyword>
  <keyword>fasting plasma glucose</keyword>
  <keyword>thyroid stimulating hormone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Nodule</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03009279
org study id: qfsnfm-004
nct id: NCT03009279
lead sponsor: 
has dmc: Yes
To investigate the association between metabolic syndrome (MS) and thyroid nodule(s).
To investigate the association between metabolic syndrome (MS), body mass index (BMI),
      hyperglycemia, dyslipidemia, hypertension and thyroid nodule(s) or thyroid functions in
      euthyroid subjects. Screen for the risk factors that affect the incidence of thyroid
      nodule(s).
measure: The laboratory examinations
time frame: In 2013-2015
description: Lipids,glucose,thyroid functions
measure: Blood pressure of patients in each group
time frame: In 2013-2015
measure: BMI of patients in each group
time frame: In 2013-2015
description: body mass index（BMI）
measure: Age of patients in each group
time frame: In 2013-2015
measure: Gender of patients in each group
time frame: In 2013-2015
arm group label: The MS group
description: Patients with metabolic syndrome(MS).
arm group label: The non-MS group
description: Patients without metabolic syndrome(MS).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lin Liao
role: Study Chair
affiliation: Qianfoshan Hospital
last name: Lin Liao, MD
phone: 8615168888260
email: liaolin@medmail.com.cn
responsible party type: Sponsor-Investigator
investigator affiliation: Qianfoshan Hospital
investigator full name: Lin Liao
investigator title: chief of endocrinology department at Qianfoshan Hospital
mesh term: Thyroid Nodule
mesh term: Metabolic Syndrome
mesh term: Thyroid Diseases
mesh term: Syndrome
sharing ipd: Yes