<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/NCT03025919</url>
  </required_header>
  <id_info>
    <org_study_id>2016YFC1305700s</org_study_id>
    <nct_id>NCT03025919</nct_id>
  </id_info>
  <brief_title>Evaluation of Innovated Screening Tools for Type 2 Diabetes Among Chinese Population(SENSIBLE STUDY I)</brief_title>
  <official_title>Using 2h-glycosuria Combined With Fasting Plasma Glucose , Advanced Glycation End-product Alone or in Combination With Fasting Plasma Glucose in Diabetes Screening in Chinese Natural Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhongda Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhongda Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of using 2h-UG combined with FPG, AGEsP alone or in combination with FPG in&#xD;
      diabetes screening in Chinese natural population&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using the WHO criteria as the golden standard，drawing the ROC curve of 2h-UG combined with&#xD;
      FPG, AGEsP alone or in combination with FPG，calculating the area under the ROC curve.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date>December 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>area under the ROC curve</measure>
    <time_frame>6 months</time_frame>
    <description>area under the ROC curve of different method of using 2h-UG combined with FPG, AGEsP alone or in combination with FPG in diabetes screening in Chinese natural population</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>sensitivity and specificity of screening</measure>
    <time_frame>6 months</time_frame>
    <description>Using WHO criteria as golden standard,sensitivity and specificity of using 2h-UG combined with FPG, AGEsP alone or in combination with FPG in diabetes screening in Chinese natural population</description>
  </secondary_outcome>
  <enrollment type="Anticipated">20000</enrollment>
  <condition>Type II Diabetes Mellitus</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Natural Chinese population&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  20~70 year old urban and rural residents;&#xD;
&#xD;
          -  Volunteer to participate in this study and sign informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Endocrinology, Zhongda Hospital, Institute of Diabetes, Southeast University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zilin Sun</last_name>
      <phone>+82-025-83262818</phone>
      <email>sunzilin1963@126.com</email>
    </contact>
    <investigator>
      <last_name>Zilin Sun</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yang Yuan</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>May 3, 2017</last_update_submitted>
  <last_update_submitted_qc>May 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zhongda Hospital</investigator_affiliation>
    <investigator_full_name>Zilin Sun</investigator_full_name>
    <investigator_title>director physician</investigator_title>
  </responsible_party>
  <keyword>Advanced glycation end-product</keyword>
  <keyword>Glycosuria</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03025919
org study id: 2016YFC1305700s
nct id: NCT03025919
lead sponsor: 
has dmc: Yes
Evaluation of using 2h-UG combined with FPG, AGEsP alone or in combination with FPG in
      diabetes screening in Chinese natural population
Using the WHO criteria as the golden standard，drawing the ROC curve of 2h-UG combined with
      FPG, AGEsP alone or in combination with FPG，calculating the area under the ROC curve.
observational model: Other
time perspective: Cross-Sectional
measure: area under the ROC curve
time frame: 6 months
description: area under the ROC curve of different method of using 2h-UG combined with FPG, AGEsP alone or in combination with FPG in diabetes screening in Chinese natural population
measure: sensitivity and specificity of screening
time frame: 6 months
description: Using WHO criteria as golden standard,sensitivity and specificity of using 2h-UG combined with FPG, AGEsP alone or in combination with FPG in diabetes screening in Chinese natural population
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Zhongda Hospital
investigator full name: Zilin Sun
investigator title: director physician
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2