<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/NCT04469400</url>
  </required_header>
  <id_info>
    <org_study_id>2019-317</org_study_id>
    <nct_id>NCT04469400</nct_id>
  </id_info>
  <brief_title>Lifestyle Intervention for Patients With Impaired Glucose Regulation</brief_title>
  <official_title>Study on Lifestyle Intervention for Patients With Impaired Glucose Regulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang 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>
      Impaired glucose regulation (IGR) is closely related to overweight/obesity. By studying&#xD;
      different dietary patterns (energy-limited diet vs. low-carbohydrate diet) and intensive&#xD;
      lifestyle interventions combined with blood glucose monitoring, glucose regulation of&#xD;
      overweight/obesity is affected. To improve the blood glucose and related metabolic indexes of&#xD;
      patients with impaired (IGR), establish 1-2 clinical intervention programs for impaired&#xD;
      glucose regulation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2022</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fasting blood glucose</measure>
    <time_frame>ten weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood glucose 2 hours after meal</measure>
    <time_frame>ten weeks</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>Group1</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Researchers conduct health education on patients, including dietary guidance, physical activity guidance, psychological behavior counseling, etc.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to education, the subjects will consume 2 composite protein solid drinks per day, in conjunction with the three-meal diet to increase satiety and intake of sufficient nutrients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to education, the subjects will consume 2 nutrition bars daily to replace the staple food of daily lunch and dinner to help reduce carbohydrate intake and intake of sufficient nutrients</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Low fat diet intensive intervention</intervention_name>
    <description>education and Compound protein solid beverage</description>
    <arm_group_label>Group2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low-Carbon Water Diet Intensive Intervention</intervention_name>
    <description>education and Nutrition bar</description>
    <arm_group_label>Group3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-65 years old ② Fasting blood glucose is between 5.6-6.9 mmol/L (100-125mg/dL)&#xD;
             or oral glucose tolerance test (OGTT) 2h plasma glucose (2h-PG) is 7.8-11.1 mmol/L&#xD;
             (140-200 mg/dL)&#xD;
&#xD;
               -  24 kg/m2 ≤ BMI ≤ 35 kg/m2&#xD;
&#xD;
                    -  Those who are willing to accept assessment and sign informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with diabetes or undergoing diabetes treatment;&#xD;
&#xD;
               -  Receiving drugs or surgery for weight loss at present or in the past 3 months;&#xD;
&#xD;
                    -  Receiving corticosteroid or thyroid hormone treatment;&#xD;
&#xD;
                         -  Secondary obesity caused by endocrine, genetic, metabolic and central&#xD;
                            nervous system diseases;&#xD;
&#xD;
                              -  Patients with abnormal liver function (alanine aminotransferase&#xD;
                                 or/and aspartate aminotransferase exceeding the upper limit of&#xD;
                                 normal value 3 times); patients with abnormal renal function&#xD;
                                 (serum creatinine exceeding the upper limit of normal value);&#xD;
                                 suffering from kidney disease and other diseases that need to&#xD;
                                 control protein intake;&#xD;
&#xD;
                                   -  Diseases affecting the digestion and absorption of food (such&#xD;
                                      as chronic diarrhea, constipation, severe gastrointestinal&#xD;
                                      inflammation, active gastrointestinal ulcer, gastrointestinal&#xD;
                                      resection, cholecystitis/cholecystectomy, etc.); ⑦ Suffering&#xD;
                                      from cardiovascular and cerebrovascular diseases, grade 3&#xD;
                                      hypertension, chronic hepatitis, malignant tumors, anemia,&#xD;
                                      mental illness and memory disorders, epilepsy and other&#xD;
                                      diseases; ⑧ Suffering from infectious diseases such as active&#xD;
                                      tuberculosis and AIDS; ⑨ During pregnancy or lactation;&#xD;
                                      ⑩Patients with physical disabilities and clinicians think it&#xD;
                                      is not suitable to participate in the study (for example,&#xD;
                                      have a serious disease not included in the discharge&#xD;
                                      criteria) or are unwilling to participate in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pianhong Zhang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Second Affiliated Hospital, School of Medicine, Zhejiang University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pianhong zhang</last_name>
    <phone>057187783851</phone>
    <email>zrlcyyzx@zju.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cixi People's Hospital</name>
      <address>
        <city>Cixi</city>
        <state>Zhejiang</state>
        <zip>315300</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianping Shao</last_name>
      <phone>057463911999</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Second Affiliated Hospital of Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>leilei wang</last_name>
      <phone>057187783851</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jinhua municipal central hospital</name>
      <address>
        <city>Jinhua</city>
        <state>Zhejiang</state>
        <zip>321000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guifen Hu</last_name>
      <phone>057982338512</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lishui People's Hospital</name>
      <address>
        <city>Lishui</city>
        <state>Zhejiang</state>
        <zip>323020</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shiwei Ye</last_name>
      <phone>05782780222</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ningbo Huamei Hospital, University of Chinese Academy of Sciences</name>
      <address>
        <city>Ningbo</city>
        <state>Zhejiang</state>
        <zip>315010</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Binbin Xu</last_name>
      <phone>05748387099</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shaoxing People's Hospital</name>
      <address>
        <city>Shaoxing</city>
        <state>Zhejiang</state>
        <zip>312000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sue Chen</last_name>
      <phone>057588228888</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>The first affiliated hospital of Wenzhou medical university</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <zip>325000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Binbin Gu</last_name>
      <phone>057755578033</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Yuyao People's Hospital</name>
      <address>
        <city>Yuyao</city>
        <state>Zhejiang</state>
        <zip>315400</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jinjian Pan</last_name>
      <phone>057462629999</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 14, 2021</last_update_submitted>
  <last_update_submitted_qc>July 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2021</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>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/NCT04469400
org study id: 2019-317
nct id: NCT04469400
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Impaired glucose regulation (IGR) is closely related to overweight/obesity. By studying
      different dietary patterns (energy-limited diet vs. low-carbohydrate diet) and intensive
      lifestyle interventions combined with blood glucose monitoring, glucose regulation of
      overweight/obesity is affected. To improve the blood glucose and related metabolic indexes of
      patients with impaired (IGR), establish 1-2 clinical intervention programs for impaired
      glucose regulation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Fasting blood glucose
time frame: ten weeks
measure: Blood glucose 2 hours after meal
time frame: ten weeks
arm group label: Group1
arm group type: No Intervention
description: Researchers conduct health education on patients, including dietary guidance, physical activity guidance, psychological behavior counseling, etc.
arm group label: Group2
arm group type: Experimental
description: In addition to education, the subjects will consume 2 composite protein solid drinks per day, in conjunction with the three-meal diet to increase satiety and intake of sufficient nutrients
arm group label: Group3
arm group type: Experimental
description: In addition to education, the subjects will consume 2 nutrition bars daily to replace the staple food of daily lunch and dinner to help reduce carbohydrate intake and intake of sufficient nutrients
intervention type: Dietary Supplement
intervention name: Low fat diet intensive intervention
description: education and Compound protein solid beverage
arm group label: Group2
intervention type: Other
intervention name: Low-Carbon Water Diet Intensive Intervention
description: education and Nutrition bar
arm group label: Group3
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pianhong Zhang
role: Principal Investigator
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
last name: Pianhong zhang
phone: 057187783851
email: zrlcyyzx@zju.edu.cn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Overweight
sharing ipd: No