<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/NCT02981121</url>
  </required_header>
  <id_info>
    <org_study_id>KDPS</org_study_id>
    <nct_id>NCT02981121</nct_id>
  </id_info>
  <brief_title>Hospital-based Diabetes Prevention Study in Korea</brief_title>
  <official_title>Hospital-based Diabetes Prevention Study in Korea: A Prospective, Multi-center, Randomized, Open-label Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jeong-taek Woo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Evidence-Based Healthcare Collaborating Agency</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kyungpook National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Korea University Guro Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pusan National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ajou University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Severance Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chonbuk National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kyunghee University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will study prevention effect of Life style modification on diabetes&#xD;
      mellitus comparing with conventional management and Metformin administration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">November 2020</completion_date>
  <primary_completion_date type="Anticipated">November 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cumulative incidence of Diabetes Mellitus after randomization</measure>
    <time_frame>36 months from the baseline</time_frame>
    <description>Definition of &quot;incidence of Diabetes Mellitus&quot;&#xD;
Fasting Glucose ≥126 mg/dL or&#xD;
75g Oral glucose tolerance test 2 hours after the Blood glucose ≥ 200 mg / dL or&#xD;
HbA1c≥6.5%</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change on HbA1c</measure>
    <time_frame>12, 24, 36 months from the baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on Fasting Glucose</measure>
    <time_frame>12, 24, 36 months from the baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on HOMA2%S</measure>
    <time_frame>12, 24, 36 months from the baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on HOMA2%B</measure>
    <time_frame>12, 24, 36 months from the baseline</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">744</enrollment>
  <condition>PreDiabetes</condition>
  <arm_group>
    <arm_group_label>Conventional Management</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>A patient will receive 30 minutes of individual education from the investigator, based on the standard guidelines of the Korean Diabetes Association. And will be followed up every 6 months for 36 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Life style modification</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Proceed according to the Intervention Protocol developed by the Nutrition Committee of the Korean Diabetes Association. Aim to lose more than 5% of weight within 6 months, and then aim to keep weight loss constantly. After randomization, the diabetes educator team (physician / nurse / dietician) applies the intervention program for exercise therapy and diet therapy, and manages it through online education (telephone visit) and offline education (institution visit).&#xD;
Exercise: Moderate or abnormal exercise for more than 150 minutes per week (moderate or abnormal exercise for 30 minutes or more per day)&#xD;
Diet remedies: Train Calorie intake, nutrient intake and Monitoring.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Metformin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After randomization, take 250 mg once a day for 2 weeks. If there is no side effect, take 500 mg once a day for 2 weeks. If there are no side effects, the maximum dose can be increased to 1000mg.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise and Diet remedies</intervention_name>
    <arm_group_label>Life style modification</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin</intervention_name>
    <arm_group_label>Metformin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 30&lt;Age&lt;71&#xD;
&#xD;
          2. BMI≥23 kg/m2&#xD;
&#xD;
          3. '75g Oral glucose tolerance 2 hours after the test Blood glucose140~199mg/dL' or&#xD;
             'Fasting Blood Sugar 110~125 mg/dL' or 'HbA1c 5.7%~6.4%'&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Who diagnosed with Diabetes Mellitus or Who having Drugs for Diabetes Mellitus.&#xD;
&#xD;
          2. Type 2 Diabetes Mellitus&#xD;
&#xD;
               -  Who diagnosed with Diabetes Mellitus except for maternity period.&#xD;
&#xD;
               -  Who have had drugs for Diabetes Mellitus(hypoglycemic agent or insulin) except&#xD;
                  for maternity period.&#xD;
&#xD;
               -  Fasting Glucose≥ 126 mg/dL&#xD;
&#xD;
               -  75g Oral glucose tolerance 2 hours after the Blood glucose ≥ 200 mg/dL&#xD;
&#xD;
               -  HbA1c ≥ 6.5%&#xD;
&#xD;
          3. Who life expectancy is short.&#xD;
&#xD;
               -  Cardiac history&#xD;
&#xD;
                    -  History of severe cardiovascular disease within the last 6 months (cerebral&#xD;
                       hemorrhage, stroke, myocardial infarction, angina pectoris, heart failure,&#xD;
                       etc.)&#xD;
&#xD;
                    -  Systolic blood pressure &gt;180 mmHg or Diastolic blood pressure &gt;105 mmHg&#xD;
&#xD;
                    -  aortic stenosis&#xD;
&#xD;
                    -  Left bundle branch block or Third degree AV block&#xD;
&#xD;
               -  Who had been diagnosed and treated for malignant tumors including leukemia and&#xD;
                  lymphoma within the last 5 years&#xD;
&#xD;
               -  Abnormal renal function (Creatinine ≥ 1.4 mg/dL (male) or ≥ 1.3 mg/dL (female) or&#xD;
                  Urine Protein ≥ 2 +)&#xD;
&#xD;
               -  Anemia(Hematocrit &lt;36%((male) or&gt;&lt;33%(female)) ⑤ Cirrhosis or chronic active&#xD;
                  hepatitis (AST/ALT&gt;３UNL)&#xD;
&#xD;
               -  Acute gastrointestinal disease (pancreatitis, infectious intestinal disease)&#xD;
&#xD;
               -  Who is scheduled major surgery within the last 3 to 6 months or just after the&#xD;
                  surgery.&#xD;
&#xD;
               -  Chronic infection (HIV, active tuberculosis, etc.)&#xD;
&#xD;
               -  Pulmonary patients who rely on oxygen or daily bronchodilators&#xD;
&#xD;
          4. Who is judged to be able to influence the clinical trial by investigator.&#xD;
&#xD;
               -  Who can not communicate&#xD;
&#xD;
               -  Those with psychiatric or cognitive impairment that may affect the compliance of&#xD;
                  the clinical trial&#xD;
&#xD;
               -  Those who do not agree to the treatment group allocation by random assignment&#xD;
&#xD;
               -  Those who participate in other studies that may interfere with the clinical trial&#xD;
&#xD;
               -  Those who lost weight by more than 10% during the past 6 months, excluding weight&#xD;
                  loss after giving birth&#xD;
&#xD;
               -  Those who can not have normal walking or exercise&#xD;
&#xD;
               -  Women who are pregnant&#xD;
&#xD;
               -  Those who are currently pregnant or who are within the last 3 months after giving&#xD;
                  birth&#xD;
&#xD;
               -  Those planning pregnancy during the clinical trial period&#xD;
&#xD;
               -  Those who have a history of drug and alcohol abuse (acute, chronic) within the&#xD;
                  last 2 years&#xD;
&#xD;
               -  Those who are not appropriate or unreliable for clinical trials at the discretion&#xD;
                  of the tester&#xD;
&#xD;
          5. Who taking medication or medical condition that may affect the diagnosis of diabetes&#xD;
&#xD;
               -  Thiazide diuretics&#xD;
&#xD;
               -  Systemic beta blockers&#xD;
&#xD;
               -  Taking Niacin for the treatment of neutropenic depression&#xD;
&#xD;
               -  Possibility of taking or injecting a systemic steroid preparation&#xD;
&#xD;
               -  Taking a serotonin reuptake inhibitor (SSRI) for weight loss purpose.&#xD;
&#xD;
               -  Taking medicine for weight loss&#xD;
&#xD;
               -  Hormone status is not appropriate during thyroid hormone replacement therapy (TSH&#xD;
                  abnormal range) (If thyroid hormone therapy is stable for more than 3 months and&#xD;
                  TSH is normal, the patient can participate in)&#xD;
&#xD;
               -  Others with other endocrine diseases (eg Cushing's syndrome, acromegaly)&#xD;
&#xD;
               -  During treatment, fasting plasma triglyceride&gt; 600 mg / dL&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>31 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jeong-Taek Woo</last_name>
    <phone>822-958-8220</phone>
    <email>jtwoomd@khmc.or.kr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sang Youl Rhee</last_name>
    <phone>822-958-8220</phone>
    <email>bard95@hanmail.net</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kyunghee University Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>02447</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jeong-taek Woo, MD, PhD</last_name>
      <phone>+82-2-958-8128</phone>
      <email>jtwoomd@khmc.or.kr</email>
    </contact>
    <contact_backup>
      <last_name>Sang Youl Rhee, MD, PhD</last_name>
      <phone>+82-2-958-8220</phone>
      <email>bard95@hanmail.net</email>
    </contact_backup>
    <investigator>
      <last_name>Jeong-taek Woo, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Suk Chon, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sang Youl Rhee, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>July 21, 2017</last_update_submitted>
  <last_update_submitted_qc>July 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Kyunghee University Medical Center</investigator_affiliation>
    <investigator_full_name>Jeong-taek Woo</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Diabetes Prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prediabetic State</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02981121
org study id: KDPS
nct id: NCT02981121
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The investigators will study prevention effect of Life style modification on diabetes
      mellitus comparing with conventional management and Metformin administration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Cumulative incidence of Diabetes Mellitus after randomization
time frame: 36 months from the baseline
description: Definition of "incidence of Diabetes Mellitus"
Fasting Glucose ≥126 mg/dL or
75g Oral glucose tolerance test 2 hours after the Blood glucose ≥ 200 mg / dL or
HbA1c≥6.5%
measure: Change on HbA1c
time frame: 12, 24, 36 months from the baseline
measure: Change on Fasting Glucose
time frame: 12, 24, 36 months from the baseline
measure: Change on HOMA2%S
time frame: 12, 24, 36 months from the baseline
measure: Change on HOMA2%B
time frame: 12, 24, 36 months from the baseline
arm group label: Conventional Management
arm group type: No Intervention
description: A patient will receive 30 minutes of individual education from the investigator, based on the standard guidelines of the Korean Diabetes Association. And will be followed up every 6 months for 36 months.
arm group label: Life style modification
arm group type: Experimental
description: Proceed according to the Intervention Protocol developed by the Nutrition Committee of the Korean Diabetes Association. Aim to lose more than 5% of weight within 6 months, and then aim to keep weight loss constantly. After randomization, the diabetes educator team (physician / nurse / dietician) applies the intervention program for exercise therapy and diet therapy, and manages it through online education (telephone visit) and offline education (institution visit).
Exercise: Moderate or abnormal exercise for more than 150 minutes per week (moderate or abnormal exercise for 30 minutes or more per day)
Diet remedies: Train Calorie intake, nutrient intake and Monitoring.
arm group label: Metformin
arm group type: Active Comparator
description: After randomization, take 250 mg once a day for 2 weeks. If there is no side effect, take 500 mg once a day for 2 weeks. If there are no side effects, the maximum dose can be increased to 1000mg.
intervention type: Behavioral
intervention name: Exercise and Diet remedies
arm group label: Life style modification
intervention type: Drug
intervention name: Metformin
arm group label: Metformin
criteria: 
gender: All
minimum age: 31 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jeong-Taek Woo
phone: 822-958-8220
email: jtwoomd@khmc.or.kr
last name: Sang Youl Rhee
phone: 822-958-8220
email: bard95@hanmail.net
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: Korea, Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Kyunghee University Medical Center
investigator full name: Jeong-taek Woo
investigator title: Professor
mesh term: Prediabetic State
mesh term: Metformin
sharing ipd: No