<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/NCT03024788</url>
  </required_header>
  <id_info>
    <org_study_id>2016YFC1305700d</org_study_id>
    <nct_id>NCT03024788</nct_id>
  </id_info>
  <brief_title>Determination of the Optimum Cut-off Value of Type 2 Diabetes Diagnosis Among Chinese Population(SENSIBLE STUDY II)</brief_title>
  <official_title>Determination of Cut-off Value of Advanced Glycation End-product and Glycosylated Haemoglobin in Type 2 Diabetes Diagnosis in China</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>
      Study of the correlation between AGEsP and HbA1c and diabetic retinopathy prevalence:&#xD;
      determination of cut-off value of AGEsP and HbA1c in type 2 diabetes diagnosis in China&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To find the cut-off point of AGEsP and HbA1c for diagnosis of diabetes by drawing the&#xD;
      logistic regression model between prevalence of retinopathy and AGEsP level and HbA1c&#xD;
      level,and find the point where the prevalence of retinopathy changes most rapidly.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date>December 2020</completion_date>
  <primary_completion_date type="Anticipated">June 2020</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>prevalence of retinopathy</measure>
    <time_frame>3 years</time_frame>
    <description>the prevalence of retinopathy in different AGEsP and HbA1c levels</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>incidence of retinopathy</measure>
    <time_frame>3 years</time_frame>
    <description>incidence of retinopathy in different AGEsP and HbA1c levels</description>
  </secondary_outcome>
  <enrollment type="Actual">6000</enrollment>
  <condition>Type II Diabetes</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>syringe, fundus camera etc</intervention_name>
    <description>Physical examination, fundus examination, blood and urine samples collection</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Chinese natural population&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  20~70 years old;&#xD;
&#xD;
          -  Volunteer to participate in this study and signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 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>Glycosylated haemoglobin</keyword>
  <keyword>advanced glycation end products</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>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03024788
org study id: 2016YFC1305700d
nct id: NCT03024788
lead sponsor: 
has dmc: Yes
Study of the correlation between AGEsP and HbA1c and diabetic retinopathy prevalence:
      determination of cut-off value of AGEsP and HbA1c in type 2 diabetes diagnosis in China
To find the cut-off point of AGEsP and HbA1c for diagnosis of diabetes by drawing the
      logistic regression model between prevalence of retinopathy and AGEsP level and HbA1c
      level,and find the point where the prevalence of retinopathy changes most rapidly.
observational model: Cohort
time perspective: Prospective
measure: prevalence of retinopathy
time frame: 3 years
description: the prevalence of retinopathy in different AGEsP and HbA1c levels
measure: incidence of retinopathy
time frame: 3 years
description: incidence of retinopathy in different AGEsP and HbA1c levels
intervention type: Device
intervention name: syringe, fundus camera etc
description: Physical examination, fundus examination, blood and urine samples collection
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
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
sharing ipd: Undecided