<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/NCT03252080</url>
  </required_header>
  <id_info>
    <org_study_id>HMD2017</org_study_id>
    <nct_id>NCT03252080</nct_id>
  </id_info>
  <brief_title>Effect of Holistic Management on the Patients With Type 2 Diabetes</brief_title>
  <official_title>Effect of Holistic Management on the Patients With Type 2 Diabetes Who Received or Did Not Receive a Short-term Intensive Education</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cheng Qing-feng</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chongqing Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Two hundreds patients with T2DM from the outpatient clinic of The First Affiliated Hospital&#xD;
      of Chongqing Medical University will be enrolled in this study. Participating subjects will&#xD;
      be randomly assigned into one of the 2 groups: Group A (n=100) will be placed on the&#xD;
      short-term intensive education program alone while Group B (n=100) will be placed on the&#xD;
      short-term intensive education as well as a holistic management for 6 months.&#xD;
&#xD;
      Diabetes education: The patients of each group will undergo designated education programs in&#xD;
      4 subgroups. Group A and B will be given the same education classes once a week in the first&#xD;
      month (total 4 times), 5 hours per class. The education classes will be taught by a dedicated&#xD;
      team of diabetes specialist doctors and nurses, with the contents including a basic&#xD;
      understanding of diabetes, diabetic diet, exercise, drug treatments and blood glucose&#xD;
      monitoring. At the conclusion of the education classes, the patients in Group B then will&#xD;
      undergo a weekly telephone interview with specialist nurses for 6 months to help patients&#xD;
      resolve self-management problems while patients in Group A will not. The specialist nurses&#xD;
      will talk individually with the patients in Group B for 10-15 min per week. The nurses will&#xD;
      ask the patients about their results of self-blood glucose monitoring, help them find the&#xD;
      reasons of poor blood glucose control as well as answer the patient's questions.&#xD;
&#xD;
      Clinical examination: All subjects will complete Audit of Diabetes Dependent Quality of Life&#xD;
      (ADDQoL) before education classes commence (baseline), at 3 months and 6 months (endpoint)&#xD;
      after education classes to evaluate their quality of life. All patients will be examined for&#xD;
      height, weight, blood pressure, FPG, PPG and HbA1c at baseline, 3 months after education&#xD;
      classes and endpoint. A diabetes specialist nurse will measure the height, weight and blood&#xD;
      pressure, and assist the subjects to fill the questionnaire. FPG and PPG will be determined&#xD;
      by the hexokinase method, while HbA1c by high performance liquid chromatography.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2017</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">March 2018</primary_completion_date>
  <phase>N/A</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ADDQoL score at endpoint</measure>
    <time_frame>6 months</time_frame>
    <description>All subjects complete Audit of Diabetes Dependent Quality of Life (ADDQoL) at endpoint to evaluate their quality of life. There are 13 items including Employment/career, Social life, Family relationships, Friends, Sex life, Sport/leisure, Travel, Future (own), Future of family, Motivation, Physical activities, Others fussing and Enjoyment of food. Each item is scored -3 to +3 (-3 = would be a great deal better if I did not have diabetes; +3 = would be a great deal worse if I did not have diabetes), yielding total between -39 to +39.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of ADDQoL score between baseline and endpoint</measure>
    <time_frame>6 months</time_frame>
    <description>All subjects complete Audit of Diabetes Dependent Quality of Life (ADDQoL) at baseline and endpoint to evaluate their quality of life. There are 13 items including Employment/career, Social life, Family relationships, Friends, Sex life, Sport/leisure, Travel, Future (own), Future of family, Motivation, Physical activities, Others fussing and Enjoyment of food. Each item is scored -3 to +3 (-3 = would be a great deal better if I did not have diabetes; +3 = would be a great deal worse if I did not have diabetes), yielding total between -39 to +39. The change of ADDQoL score between baseline and endpoint = the total score of ADDQoL at endpoint - the total score of ADDQoL at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FPG at endpoint</measure>
    <time_frame>6 months</time_frame>
    <description>All patients are examined for FPG at endpoint. FPG are determined by the hexokinase method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PPG at endpoint</measure>
    <time_frame>6 months</time_frame>
    <description>All patients are examined for PPG at endpoint. PPG are determined by the hexokinase method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c at endpoint</measure>
    <time_frame>6 months</time_frame>
    <description>All patients are examined for HbA1c at endpoint. HbA1c are determined by high performance liquid chromatography.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Education (Group A)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>short-intensive education for one month</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Education &amp; holistic management(Group B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>short-intensive education for one month followed with holistic management for 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>short-term intensive education</intervention_name>
    <description>The patients of both groups are given the education classes once a week in the first month (total 4 times), 5 hours per class. The education classes are taught by a dedicated team of diabetes specialist doctors and nurses, with the contents including a basic understanding of diabetes, diabetic diet, exercise, drug treatments and blood glucose monitoring.</description>
    <arm_group_label>Education &amp; holistic management(Group B)</arm_group_label>
    <arm_group_label>Education (Group A)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Holistic management</intervention_name>
    <description>The specialist nurses talk individually with the patients for 10-15 min per week. The nurses ask the patients about their results of self-blood glucose monitoring, help them find the reasons of poor blood glucose control as well as answer the patient's questions.</description>
    <arm_group_label>Education &amp; holistic management(Group B)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with T2DM for more than 1 year,&#xD;
&#xD;
          -  Age from 18 to 75 years old,&#xD;
&#xD;
          -  Have fasting plasma glucose (FPG) ≥ 7.2mmol/L or 2 hours postprandial plasma glucose&#xD;
             (2hPPG) ≥ 10.0mmol/L,&#xD;
&#xD;
          -  Glycosylated hemoglobin (HbA1c) ≥ 7.0%,&#xD;
&#xD;
          -  Have the ability to self-care.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with severe liver or kidney dysfunction, severe heart failure, cognitive&#xD;
             dysfunction or pregnancy will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 14, 2017</last_update_submitted>
  <last_update_submitted_qc>August 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Chongqing Medical University</investigator_affiliation>
    <investigator_full_name>Cheng Qing-feng</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>type 2 diabetes</keyword>
  <keyword>holistic management</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/NCT03252080
org study id: HMD2017
nct id: NCT03252080
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Two hundreds patients with T2DM from the outpatient clinic of The First Affiliated Hospital
      of Chongqing Medical University will be enrolled in this study. Participating subjects will
      be randomly assigned into one of the 2 groups: Group A (n=100) will be placed on the
      short-term intensive education program alone while Group B (n=100) will be placed on the
      short-term intensive education as well as a holistic management for 6 months.

      Diabetes education: The patients of each group will undergo designated education programs in
      4 subgroups. Group A and B will be given the same education classes once a week in the first
      month (total 4 times), 5 hours per class. The education classes will be taught by a dedicated
      team of diabetes specialist doctors and nurses, with the contents including a basic
      understanding of diabetes, diabetic diet, exercise, drug treatments and blood glucose
      monitoring. At the conclusion of the education classes, the patients in Group B then will
      undergo a weekly telephone interview with specialist nurses for 6 months to help patients
      resolve self-management problems while patients in Group A will not. The specialist nurses
      will talk individually with the patients in Group B for 10-15 min per week. The nurses will
      ask the patients about their results of self-blood glucose monitoring, help them find the
      reasons of poor blood glucose control as well as answer the patient's questions.

      Clinical examination: All subjects will complete Audit of Diabetes Dependent Quality of Life
      (ADDQoL) before education classes commence (baseline), at 3 months and 6 months (endpoint)
      after education classes to evaluate their quality of life. All patients will be examined for
      height, weight, blood pressure, FPG, PPG and HbA1c at baseline, 3 months after education
      classes and endpoint. A diabetes specialist nurse will measure the height, weight and blood
      pressure, and assist the subjects to fill the questionnaire. FPG and PPG will be determined
      by the hexokinase method, while HbA1c by high performance liquid chromatography.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: ADDQoL score at endpoint
time frame: 6 months
description: All subjects complete Audit of Diabetes Dependent Quality of Life (ADDQoL) at endpoint to evaluate their quality of life. There are 13 items including Employment/career, Social life, Family relationships, Friends, Sex life, Sport/leisure, Travel, Future (own), Future of family, Motivation, Physical activities, Others fussing and Enjoyment of food. Each item is scored -3 to +3 (-3 = would be a great deal better if I did not have diabetes; +3 = would be a great deal worse if I did not have diabetes), yielding total between -39 to +39.
measure: Change of ADDQoL score between baseline and endpoint
time frame: 6 months
description: All subjects complete Audit of Diabetes Dependent Quality of Life (ADDQoL) at baseline and endpoint to evaluate their quality of life. There are 13 items including Employment/career, Social life, Family relationships, Friends, Sex life, Sport/leisure, Travel, Future (own), Future of family, Motivation, Physical activities, Others fussing and Enjoyment of food. Each item is scored -3 to +3 (-3 = would be a great deal better if I did not have diabetes; +3 = would be a great deal worse if I did not have diabetes), yielding total between -39 to +39. The change of ADDQoL score between baseline and endpoint = the total score of ADDQoL at endpoint - the total score of ADDQoL at baseline.
measure: FPG at endpoint
time frame: 6 months
description: All patients are examined for FPG at endpoint. FPG are determined by the hexokinase method.
measure: PPG at endpoint
time frame: 6 months
description: All patients are examined for PPG at endpoint. PPG are determined by the hexokinase method.
measure: HbA1c at endpoint
time frame: 6 months
description: All patients are examined for HbA1c at endpoint. HbA1c are determined by high performance liquid chromatography.
arm group label: Education (Group A)
arm group type: Active Comparator
description: short-intensive education for one month
arm group label: Education & holistic management(Group B)
arm group type: Experimental
description: short-intensive education for one month followed with holistic management for 6 months
intervention type: Behavioral
intervention name: short-term intensive education
description: The patients of both groups are given the education classes once a week in the first month (total 4 times), 5 hours per class. The education classes are taught by a dedicated team of diabetes specialist doctors and nurses, with the contents including a basic understanding of diabetes, diabetic diet, exercise, drug treatments and blood glucose monitoring.
arm group label: Education & holistic management(Group B)
arm group label: Education (Group A)
intervention type: Behavioral
intervention name: Holistic management
description: The specialist nurses talk individually with the patients for 10-15 min per week. The nurses ask the patients about their results of self-blood glucose monitoring, help them find the reasons of poor blood glucose control as well as answer the patient's questions.
arm group label: Education & holistic management(Group B)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
responsible party type: Sponsor-Investigator
investigator affiliation: Chongqing Medical University
investigator full name: Cheng Qing-feng
investigator title: Associate professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2