<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/NCT03299010</url>
  </required_header>
  <id_info>
    <org_study_id>HKUCTR-2232</org_study_id>
    <nct_id>NCT03299010</nct_id>
  </id_info>
  <brief_title>10-year Risk Prediction Models of Complications and Mortality of DM in Hong Kong</brief_title>
  <official_title>10-year Risk Prediction Models of Complications and Mortality of Diabetes Mellitus in Chinese Patients in Primary Care in Hong Kong</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</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>
      Diabetes Mellitus (DM) is a well-recognized public health issue worldwide. DM can lead to&#xD;
      many complications resulting in morbidity and mortality, approximately 70% of DM related&#xD;
      deaths were attributed to cardiovascular diseases (CVD).&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      To develop 10-year risk prediction models for CVD, end stage renal disease (ESRD) and&#xD;
      all-cause mortality among Chinese patients with DM in primary care.&#xD;
&#xD;
      Hypotheses:&#xD;
&#xD;
        1. Patient socio-demographic, clinical parameters, disease characteristics and treatment&#xD;
           modalities are predictive of 10-year risk of CVD, ESRD and all-cause mortality.&#xD;
&#xD;
        2. Risk prediction models developed from this study should have over 70% of discriminating&#xD;
           power.&#xD;
&#xD;
      Design and Subjects:&#xD;
&#xD;
      10-year retrospective cohort study. All Chinese patients who were clinically diagnosed to&#xD;
      have DM and were receiving care in the public (Hospital Authority) primary care clinics on or&#xD;
      before 1 July 2006 will be followed up until 31 December 2016.&#xD;
&#xD;
      Main outcomes measures:&#xD;
&#xD;
      For total CVD, CHD, stroke, heart failure, ESRD, all-cause mortality&#xD;
&#xD;
        1. 10-year incidence;&#xD;
&#xD;
        2. Predictive factors&#xD;
&#xD;
      Data analysis:&#xD;
&#xD;
      Two thirds of subjects will be randomly selected as the training sample for model&#xD;
      development. Cox regressions will be used to develop sex-specific 10-year risk prediction&#xD;
      models for each outcome. The validity of models will be tested on the remaining one third of&#xD;
      subjects by Harrell C statistics and ROC&#xD;
&#xD;
      Expected results:&#xD;
&#xD;
      Risk prediction models will enable accurate risk stratification and cost-effective&#xD;
      interventions for Chinese DM patients in primary care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to develop 10-year risk prediction models for total CVD and all-cause&#xD;
      mortality among Chinese diabetic patients in primary care. Risk prediction models for&#xD;
      individual DM complications including CHD, heart failure, stroke and ESRD will also be&#xD;
      developed.&#xD;
&#xD;
      The objectives are to:&#xD;
&#xD;
        1. Calculate the 10 years incidence of total CVD, all-cause mortality and each major DM&#xD;
           complication in Chinese DM patients in primary care.&#xD;
&#xD;
        2. Determine the risk factors that significantly predict total CVD, all-cause mortality and&#xD;
           each major DM complication for Chinese DM patients in primary care.&#xD;
&#xD;
        3. Develop and validate risk prediction models for total CVD, all-cause mortality and each&#xD;
           major DM complication for Chinese DM patients in primary care.&#xD;
&#xD;
        4. Develop a risk prediction nomogram and chart for the risk of total CVD, all-cause&#xD;
           mortality for Chinese DM patients in primary care&#xD;
&#xD;
      Hypotheses:&#xD;
&#xD;
        1. Patient socio-demographic, clinical parameters, disease characteristics, and treatment&#xD;
           modalities are predictive of 10-year risk of total CVD, all-cause mortality and&#xD;
           individual DM complication as a dependent variable.&#xD;
&#xD;
        2. The risk prediction models for total CVD, all-cause mortality and individual DM&#xD;
           complication developed in this study can have over 70% of discriminating power.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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>The incidence of total CVD, all-cause mortality and each of 4 major DM complications (CHD, stroke, heart failure and ESRD) over 10 years</measure>
    <time_frame>10 years</time_frame>
    <description>Calculate the 10 years incidence of total CVD, all-cause mortality and each major DM complication in Chinese DM patients in primary care.&#xD;
CVD is defined as the presence of any of CHD, heart failure and stroke. CHD includes all ischaemic heart disease, myocardial infarction, coronary death or sudden death as indicated by the ICPC-2 K74 to K76 or ICD-9-CM 410.x, 411.x to 414.x, 798.x codes. Heart failure is defined by the ICPC-2 K77 or ICD-9-CM 428.x. Stoke (fatal and non-fatal stroke) is defined by the ICPC-2 K89 to K91 or ICD-9-CM 430.x to 438.x codes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Factors predictive of total CVD, all-cause mortality and each of 4 major DM complications (CHD, stroke, heart failure and ESRD) over 10 years</measure>
    <time_frame>10 years</time_frame>
    <description>Determine the risk factors that significantly predict total CVD, all-cause mortality and each major DM complication for Chinese DM patients in primary care.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>10-year risk prediction models for total CVD, all-cause mortality and each of 4 major DM complications (CHD, stroke, heart failure and ESRD)</measure>
    <time_frame>10 years</time_frame>
    <description>Develop and validate risk prediction models for total CVD, all-cause mortality and each major DM complication for Chinese DM patients in primary care.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Factors that have sufficient power to classify Chinese DM patients in primary care into risk group in terms of total CVD and all-cause mortality</measure>
    <time_frame>10 years</time_frame>
    <description>Develop a risk prediction nomogram and chart for the risk of total CVD, all-cause mortality for Chinese DM patients in primary care</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">141516</enrollment>
  <condition>Diabetes Mellitus</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Mortality</condition>
  <condition>Primary Health Care</condition>
  <arm_group>
    <arm_group_label>DM patient</arm_group_label>
    <description>Patients with a documented clinical diagnosis of DM and were receiving care in the Hospital Authority (HA) primary care General Out-Patient Clinics (GOPC) and Family Medicine Clinics (FMC) on or before 1 July 2006 identified from the HA clinical management system (CMS) database.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The cohort will include all patients with a documented clinical diagnosis of DM and were&#xD;
        receiving care in the Hospital Authority (HA) primary care General Out-Patient Clinics&#xD;
        (GOPC) and Family Medicine Clinics (FMC) on or before 1 July 2006 identified from the HA&#xD;
        clinical management system (CMS) database.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. At least 1 GOPC/FMC attendance on or within 1 year before 1 July 2006&#xD;
&#xD;
          2. Had a CMS (Clinical Management System) record in the Hospital Authority (HA) of the&#xD;
             coding of ICPC-2 of T89 (Diabetes insulin dependent) or T90 (Diabetes non-insulin&#xD;
             dependent) on or before 1 July 2006&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who had a diagnosis of any DM complications defined by the relevant ICPC-2 or&#xD;
             ICD-9-CM on or before 1 July 2006&#xD;
&#xD;
          2. Patients exclusively managed by Specialist Out-Patient Clinic (SOPC) on or before 1&#xD;
             July 2006.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cindy L.K. Lam</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Family Medicine and Primary Care, University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Family Medicine &amp; Primary Care, University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <state>Hong Kong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>March 24, 2020</last_update_submitted>
  <last_update_submitted_qc>March 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Professor Cindy L.K. Lam</investigator_full_name>
    <investigator_title>Head of Department</investigator_title>
  </responsible_party>
  <keyword>Diabetes Mellitus</keyword>
  <keyword>Risk</keyword>
  <keyword>Complications</keyword>
  <keyword>Mortality</keyword>
  <keyword>Cardiovascular Diseases</keyword>
  <keyword>Chinese</keyword>
  <keyword>Prediction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 4, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT03299010/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03299010
org study id: HKUCTR-2232
nct id: NCT03299010
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Diabetes Mellitus (DM) is a well-recognized public health issue worldwide. DM can lead to
      many complications resulting in morbidity and mortality, approximately 70% of DM related
      deaths were attributed to cardiovascular diseases (CVD).

      Objectives:

      To develop 10-year risk prediction models for CVD, end stage renal disease (ESRD) and
      all-cause mortality among Chinese patients with DM in primary care.

      Hypotheses:

        1. Patient socio-demographic, clinical parameters, disease characteristics and treatment
           modalities are predictive of 10-year risk of CVD, ESRD and all-cause mortality.

        2. Risk prediction models developed from this study should have over 70% of discriminating
           power.

      Design and Subjects:

      10-year retrospective cohort study. All Chinese patients who were clinically diagnosed to
      have DM and were receiving care in the public (Hospital Authority) primary care clinics on or
      before 1 July 2006 will be followed up until 31 December 2016.

      Main outcomes measures:

      For total CVD, CHD, stroke, heart failure, ESRD, all-cause mortality

        1. 10-year incidence;

        2. Predictive factors

      Data analysis:

      Two thirds of subjects will be randomly selected as the training sample for model
      development. Cox regressions will be used to develop sex-specific 10-year risk prediction
      models for each outcome. The validity of models will be tested on the remaining one third of
      subjects by Harrell C statistics and ROC

      Expected results:

      Risk prediction models will enable accurate risk stratification and cost-effective
      interventions for Chinese DM patients in primary care.
This study aims to develop 10-year risk prediction models for total CVD and all-cause
      mortality among Chinese diabetic patients in primary care. Risk prediction models for
      individual DM complications including CHD, heart failure, stroke and ESRD will also be
      developed.

      The objectives are to:

        1. Calculate the 10 years incidence of total CVD, all-cause mortality and each major DM
           complication in Chinese DM patients in primary care.

        2. Determine the risk factors that significantly predict total CVD, all-cause mortality and
           each major DM complication for Chinese DM patients in primary care.

        3. Develop and validate risk prediction models for total CVD, all-cause mortality and each
           major DM complication for Chinese DM patients in primary care.

        4. Develop a risk prediction nomogram and chart for the risk of total CVD, all-cause
           mortality for Chinese DM patients in primary care

      Hypotheses:

        1. Patient socio-demographic, clinical parameters, disease characteristics, and treatment
           modalities are predictive of 10-year risk of total CVD, all-cause mortality and
           individual DM complication as a dependent variable.

        2. The risk prediction models for total CVD, all-cause mortality and individual DM
           complication developed in this study can have over 70% of discriminating power.
observational model: Cohort
time perspective: Retrospective
measure: The incidence of total CVD, all-cause mortality and each of 4 major DM complications (CHD, stroke, heart failure and ESRD) over 10 years
time frame: 10 years
description: Calculate the 10 years incidence of total CVD, all-cause mortality and each major DM complication in Chinese DM patients in primary care.
CVD is defined as the presence of any of CHD, heart failure and stroke. CHD includes all ischaemic heart disease, myocardial infarction, coronary death or sudden death as indicated by the ICPC-2 K74 to K76 or ICD-9-CM 410.x, 411.x to 414.x, 798.x codes. Heart failure is defined by the ICPC-2 K77 or ICD-9-CM 428.x. Stoke (fatal and non-fatal stroke) is defined by the ICPC-2 K89 to K91 or ICD-9-CM 430.x to 438.x codes.
measure: Factors predictive of total CVD, all-cause mortality and each of 4 major DM complications (CHD, stroke, heart failure and ESRD) over 10 years
time frame: 10 years
description: Determine the risk factors that significantly predict total CVD, all-cause mortality and each major DM complication for Chinese DM patients in primary care.
measure: 10-year risk prediction models for total CVD, all-cause mortality and each of 4 major DM complications (CHD, stroke, heart failure and ESRD)
time frame: 10 years
description: Develop and validate risk prediction models for total CVD, all-cause mortality and each major DM complication for Chinese DM patients in primary care.
measure: Factors that have sufficient power to classify Chinese DM patients in primary care into risk group in terms of total CVD and all-cause mortality
time frame: 10 years
description: Develop a risk prediction nomogram and chart for the risk of total CVD, all-cause mortality for Chinese DM patients in primary care
arm group label: DM patient
description: Patients with a documented clinical diagnosis of DM and were receiving care in the Hospital Authority (HA) primary care General Out-Patient Clinics (GOPC) and Family Medicine Clinics (FMC) on or before 1 July 2006 identified from the HA clinical management system (CMS) database.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Cindy L.K. Lam
role: Principal Investigator
affiliation: Department of Family Medicine and Primary Care, University of Hong Kong
facility: 
facility: 
country: China
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Professor Cindy L.K. Lam
investigator title: Head of Department
mesh term: Cardiovascular Diseases
mesh term: Diabetes Mellitus
provided document: 