<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/NCT02984605</url>
  </required_header>
  <id_info>
    <org_study_id>XH-16-046</org_study_id>
    <nct_id>NCT02984605</nct_id>
  </id_info>
  <brief_title>Effects of Nutrition Meal Replacement and Individualized Exercise Prescription on Type 2 Diabetes</brief_title>
  <official_title>Effects of Nutrition Meal Replacement and Individualized Exercise Prescription on Metabolism in Overweight and Obese Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai University of Sports National Science Park</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yinhang Community Health Service Center of Yangpu District</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dinghai Community Health Service Center of Yangpu District</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kongjiang Community Health Service Center of Yangpu District</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Daqiao Community Health Service Center of Yangpu District</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the nutritional meal replacement and individualized exercise&#xD;
      prescription intervention on overweight and obese type 2 diabetes mellitus. Half of&#xD;
      participants will receive nutritional meal replacement and individualized exercise&#xD;
      prescription on the basis of conventional glucose-lowering treatment, while the other half&#xD;
      will only receive conventional glucose-lowering treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diabetes mellitus is a chronic metabolic disease which seriously threatens people's health at&#xD;
      present. Although new drugs for the treatment of diabetes continue to emerge, but the effect&#xD;
      of diabetes treatment is still not satisfactory. Medical nutrition therapy (nutrition therapy&#xD;
      medical, MNT) and exercise therapy are essential measures for prevention and control of&#xD;
      diabetes at any stage of the natural course of the disease, especially for the overweight and&#xD;
      obese patients with type 2 diabetes. However, at present, the majority of patients could not&#xD;
      get the guide from nutrition specialist and sports specialist. In addition, the existing diet&#xD;
      programs are often more complex, difficult to implement and adhere to in daily life, and&#xD;
      exercise programs are often lack of targeted. In view of this, the Shanghai peak Sports&#xD;
      Management Co., Ltd. developed a kind of nutritional meal replacement for weight loss. The&#xD;
      nutritional powder has the characteristics of high nutrition, low calorie, low glycemic and&#xD;
      strong satiety, and the heat is only 126kcal, and have a good sense of satiety. Studies have&#xD;
      shown that 1 times a day with bags of nutritional meal replacement instead of 1 meals for&#xD;
      obese people have a role in weight loss. In theory, the meal is also suitable for diabetes&#xD;
      patients, especially overweight and obese type 2 diabetes, such as the combination of&#xD;
      individual exercise prescription may be better, but there is still a lack of relevant&#xD;
      research. In view of this, we proposed a joint sports workers, explore nutritional and&#xD;
      individualized exercise prescription intervention on overweight and obese type 2 diabetes&#xD;
      mellitus, to explore suitable for China's diabetes lifestyle intervention measures, improve&#xD;
      the level of prevention and treatment of diabetes in China.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>glycated hemoglobin</measure>
    <time_frame>24 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Overweight</condition>
  <condition>Obesity</condition>
  <condition>Type2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Interventional group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm：Hypoglycemic agents + Nutrition meal replacement &amp; exercise prescription&#xD;
Hypoglycemic agents in combined with 1 times a day with bags of nutritional meal replacement and exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Arm：Hypoglycemic agents&#xD;
without take nutrition meal replacement &amp; exercise prescription</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>nutritional meal replacement</intervention_name>
    <description>1 times a day with bags of nutritional meal replacement + individualized exercise prescription</description>
    <arm_group_label>Interventional group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of overweight and obesity type 2 diabetes&#xD;
&#xD;
          -  Must be able to swallow tablets&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Insulin dependent diabetes&#xD;
&#xD;
          -  Thyroid disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ming Cui, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>YinXing Community Health Service Center of Yangpu District</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wenbin Liu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dinghai Community Health Service Center of Yangpu District</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xiaoyi Che, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kongjiang Community Health Service Center of Yangpu District</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hui Liu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Daqiao Community Health Service Center of Yangpu District</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Qing Su, MD</last_name>
    <phone>86(21)25077536</phone>
    <email>suqingxinhua@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xiaoyong Li, MD</last_name>
    <phone>86(21)25077538</phone>
    <email>lixiaoyong0055@126.com</email>
  </overall_contact_backup>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>December 4, 2016</study_first_submitted>
  <study_first_submitted_qc>December 4, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 4, 2016</last_update_submitted>
  <last_update_submitted_qc>December 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
    <mesh_term>Overweight</mesh_term>
  </condition_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/NCT02984605
org study id: XH-16-046
nct id: NCT02984605
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
This study evaluates the nutritional meal replacement and individualized exercise
      prescription intervention on overweight and obese type 2 diabetes mellitus. Half of
      participants will receive nutritional meal replacement and individualized exercise
      prescription on the basis of conventional glucose-lowering treatment, while the other half
      will only receive conventional glucose-lowering treatment.
Diabetes mellitus is a chronic metabolic disease which seriously threatens people's health at
      present. Although new drugs for the treatment of diabetes continue to emerge, but the effect
      of diabetes treatment is still not satisfactory. Medical nutrition therapy (nutrition therapy
      medical, MNT) and exercise therapy are essential measures for prevention and control of
      diabetes at any stage of the natural course of the disease, especially for the overweight and
      obese patients with type 2 diabetes. However, at present, the majority of patients could not
      get the guide from nutrition specialist and sports specialist. In addition, the existing diet
      programs are often more complex, difficult to implement and adhere to in daily life, and
      exercise programs are often lack of targeted. In view of this, the Shanghai peak Sports
      Management Co., Ltd. developed a kind of nutritional meal replacement for weight loss. The
      nutritional powder has the characteristics of high nutrition, low calorie, low glycemic and
      strong satiety, and the heat is only 126kcal, and have a good sense of satiety. Studies have
      shown that 1 times a day with bags of nutritional meal replacement instead of 1 meals for
      obese people have a role in weight loss. In theory, the meal is also suitable for diabetes
      patients, especially overweight and obese type 2 diabetes, such as the combination of
      individual exercise prescription may be better, but there is still a lack of relevant
      research. In view of this, we proposed a joint sports workers, explore nutritional and
      individualized exercise prescription intervention on overweight and obese type 2 diabetes
      mellitus, to explore suitable for China's diabetes lifestyle intervention measures, improve
      the level of prevention and treatment of diabetes in China.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: glycated hemoglobin
time frame: 24 weeks
arm group label: Interventional group
arm group type: Experimental
description: Arm：Hypoglycemic agents + Nutrition meal replacement & exercise prescription
Hypoglycemic agents in combined with 1 times a day with bags of nutritional meal replacement and exercise
arm group label: Control group
arm group type: No Intervention
description: Arm：Hypoglycemic agents
without take nutrition meal replacement & exercise prescription
intervention type: Dietary Supplement
intervention name: nutritional meal replacement
description: 1 times a day with bags of nutritional meal replacement + individualized exercise prescription
arm group label: Interventional group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ming Cui, MD
role: Principal Investigator
affiliation: YinXing Community Health Service Center of Yangpu District
last name: Wenbin Liu, MD
role: Principal Investigator
affiliation: Dinghai Community Health Service Center of Yangpu District
last name: Xiaoyi Che, MD
role: Principal Investigator
affiliation: Kongjiang Community Health Service Center of Yangpu District
last name: Hui Liu, MD
role: Principal Investigator
affiliation: Daqiao Community Health Service Center of Yangpu District
last name: Qing Su, MD
phone: 86(21)25077536
email: suqingxinhua@163.com
last name: Xiaoyong Li, MD
phone: 86(21)25077538
email: lixiaoyong0055@126.com
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Overweight
sharing ipd: No