<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/NCT03766334</url>
  </required_header>
  <id_info>
    <org_study_id>TJ-T1DM-CGM-001</org_study_id>
    <nct_id>NCT03766334</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Highland Barley Diet on Glucose Variability in Patients With Type 1 Diabetes Mellitus</brief_title>
  <official_title>Efficacy and Safety of Highland Barley Diet on Glucose Variability in Patients With Type 1 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huazhong University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Huazhong University of Science and Technology</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>
      Approximately 80 patients will be enrolled in the study from China and randomized in a 1:1&#xD;
      ratio to one of the 2 treatment arms:diabetes diet+highland barley diet; or diabetes diet.&#xD;
&#xD;
      Study treatment will continue for 12 weeks. The primary efficacy measure is the change in&#xD;
      MAGE from continuous glucose monitoring system at 12 weeks. The study consists of 3 periods:&#xD;
      a 1-week screening (period A), a 8-day run-in period (period B) and a 12-week treatment&#xD;
      period (period C). Continuous glucose monitoring system will be used in baseline and&#xD;
      endpoint.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized, open-label comparison of the effects and safety of barley&#xD;
      meal plus diabetes diet on blood glucose fluctuations in patients with type 1 diabetes (T1DM)&#xD;
      using multiple daily insulin injections (MDI). , parallel test. About 80 patients with T1DM&#xD;
      were enrolled in the preliminary trial. During the lead-in period, no interventions were&#xD;
      given to the patient's diet from day 1 to day 4, and diabetes diet education and guidance&#xD;
      were given from day 5 to day 8, depending on the patient's blood glucose and diet.&#xD;
      Personalization of habits, weights, and activities, etc., establish a diabetes diet. At the&#xD;
      end of the lead-in period, patients were randomly divided into two treatment groups according&#xD;
      to the ratio of 1:1: Observation group: Diabetes diet + barley diet. (The barley meal group&#xD;
      diet was formulated according to the diabetes diet, but each meal was replaced with 20g&#xD;
      barley nutrition powder and other calories instead of part of the diet. In the control group:&#xD;
      Diabetes diet; dietary treatment after randomization will continue for 12 weeks. From the&#xD;
      induction period to the treatment period 6 days, treatment period 10-12 weeks&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 5, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">October 31, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average blood glucose fluctuations at endpoint and baseline</measure>
    <time_frame>from baseline to 12-week endpoint</time_frame>
    <description>Objective to investigate the effect of combination diabetes diet and highland barley diet on glucose variability in insufficient control patients with type 1 diabetes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glycated hemoglobin(endpoint)-Glycated hemoglobin(baseline)</measure>
    <time_frame>from baseline to 12-week endpoint</time_frame>
    <description>Objective to investigate the effect of combination diabetes diet and highland barley diet on glucose control in patients with type 1 diabetes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>insulin dose(endpoint)-insulin dose(baseline)</measure>
    <time_frame>from baseline to 12-week endpoint</time_frame>
    <description>Objective to investigate the effect of combination diabetes diet and highland barley diet on insulin dose in patients with type 1 diabetes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessment scale SF-36(endpoint)-Quality of life assessment scale SF-36(baseline)</measure>
    <time_frame>from baseline to 12-week endpoint</time_frame>
    <description>Objective to investigate the effect of combination diabetes diet and highland barley diet on life quality in patients with type 1 diabetes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass index(endpoint)-Body mass index(baseline)</measure>
    <time_frame>from baseline to 12-week endpoint</time_frame>
    <description>Objective to investigate the effect of combination diabetes diet and highland barley diet on BMI in patients with type 1 diabetes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>beta-cell function at endpoint and baseline</measure>
    <time_frame>from baseline to 12-week endpoint</time_frame>
    <description>Objective to investigate the effect of combination diabetes diet and highland barley diet on beta-cell function in patients with type 1 diabetes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference(endpoint)-Waist circumference(baseline)</measure>
    <time_frame>from baseline to 12-week endpoint</time_frame>
    <description>Objective to investigate the effect of combination diabetes diet and highland barley diet on waist circumference in patients with type 1 diabetes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Type1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Diabetes Diet+Highland Barley Diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Diabetes Diet+Highland Barley Diet(20g, thrice-daily)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diabetes Diet</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>only Diabetes Diet</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Highland Barley Diet</intervention_name>
    <description>Highland Barley Diet(20g, thrice-daily)</description>
    <arm_group_label>Diabetes Diet+Highland Barley Diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. type 1 diabetes patients with disease duration more than one year&#xD;
&#xD;
          2. HbA1c ≥7.0 % and &lt; 11.0 %&#xD;
&#xD;
          3. Men and women (non-pregnant and using a medically approved birthcontrol method) aged ≥&#xD;
             18 and ≤ 65 years&#xD;
&#xD;
          4. BMI ≥ 18 and ≤ 26 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Type 2 diabetes or other specific types of diabetes&#xD;
&#xD;
          2. Pregnancy, preparation for pregnancy, lactation and women of childbearing age&#xD;
             incapable of effective contraception methods&#xD;
&#xD;
          3. Uncooperative subject because of various reasons&#xD;
&#xD;
          4. Abnormal liver function, glutamic-pyruvic transaminase (ALT) and glutamic-oxaloacetic&#xD;
             transaminase (AST) &gt; twice the upper limits of normal&#xD;
&#xD;
          5. Impairment of renal function, serum creatinine: ≥ 133mmol/L for female，≥ 135mmol/L for&#xD;
             male&#xD;
&#xD;
          6. Serious chronic gastrointestinal diseases&#xD;
&#xD;
          7. Edema&#xD;
&#xD;
          8. Serious heart diseases, such as cardiac insufficiency (level III or more according to&#xD;
             NYHA), acute coronary syndrome and old myocardial infraction&#xD;
&#xD;
          9. Blood pressure: Systolic blood pressure (SBP) ≥ 180mmHg and/or diastolic blood&#xD;
             pressure (DBP) ≥ 110mmHg&#xD;
&#xD;
         10. White blood count (WBC) &lt; 4.0×109/L or platelet count (PLT) &lt; 90×109/L，or definite&#xD;
             anemia (Hb：&lt; 120g/L for male, &lt; 110g/L for female), or other hematological diseases&#xD;
&#xD;
         11. Endocrine system diseases, such as hyperthyroidism and hypercortisolism&#xD;
&#xD;
         12. Experimental drug allergy or frequent hypoglycemia&#xD;
&#xD;
         13. Psychiatric disorders, drug or other substance abuse&#xD;
&#xD;
         14. Diabetic ketoacidosis and hyperosmolar nonketotic coma requiring insulin therapy&#xD;
&#xD;
         15. Stressful situations such as surgery, serious trauma and so on&#xD;
&#xD;
         16. Chronic hypoxic diseases such as pulmonary emphysema and pulmonary heart disease&#xD;
&#xD;
         17. Combined use of drugs effecting glucose metabolism such as glucocorticoid Tumor,&#xD;
             especially bladder tumor and/or family history of bladder tumor and/or long-term&#xD;
             hematuria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>xuefeng Yu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tongji Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xuefeng Yu, doctor</last_name>
    <phone>+86-13986070673</phone>
    <email>xfyu188@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>LI Liu</last_name>
    <phone>+86-18202755862</phone>
    <email>287715963@qq.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Tongji Hospital, Tongji Medical College, Huazhong University of Science and technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xi Chen, doctor</last_name>
      <phone>86+13667217301</phone>
      <email>amazingamycx@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 2, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>August 30, 2021</last_update_submitted>
  <last_update_submitted_qc>August 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Huazhong University of Science and Technology</investigator_affiliation>
    <investigator_full_name>Xuefeng Yu</investigator_full_name>
    <investigator_title>Chief of Department of Endocrinology</investigator_title>
  </responsible_party>
  <keyword>Highland Barley Diet</keyword>
  <keyword>Glucose variability</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 1</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/NCT03766334
org study id: TJ-T1DM-CGM-001
nct id: NCT03766334
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Approximately 80 patients will be enrolled in the study from China and randomized in a 1:1
      ratio to one of the 2 treatment arms:diabetes diet+highland barley diet; or diabetes diet.

      Study treatment will continue for 12 weeks. The primary efficacy measure is the change in
      MAGE from continuous glucose monitoring system at 12 weeks. The study consists of 3 periods:
      a 1-week screening (period A), a 8-day run-in period (period B) and a 12-week treatment
      period (period C). Continuous glucose monitoring system will be used in baseline and
      endpoint.
This is a prospective, randomized, open-label comparison of the effects and safety of barley
      meal plus diabetes diet on blood glucose fluctuations in patients with type 1 diabetes (T1DM)
      using multiple daily insulin injections (MDI). , parallel test. About 80 patients with T1DM
      were enrolled in the preliminary trial. During the lead-in period, no interventions were
      given to the patient's diet from day 1 to day 4, and diabetes diet education and guidance
      were given from day 5 to day 8, depending on the patient's blood glucose and diet.
      Personalization of habits, weights, and activities, etc., establish a diabetes diet. At the
      end of the lead-in period, patients were randomly divided into two treatment groups according
      to the ratio of 1:1: Observation group: Diabetes diet + barley diet. (The barley meal group
      diet was formulated according to the diabetes diet, but each meal was replaced with 20g
      barley nutrition powder and other calories instead of part of the diet. In the control group:
      Diabetes diet; dietary treatment after randomization will continue for 12 weeks. From the
      induction period to the treatment period 6 days, treatment period 10-12 weeks
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Average blood glucose fluctuations at endpoint and baseline
time frame: from baseline to 12-week endpoint
description: Objective to investigate the effect of combination diabetes diet and highland barley diet on glucose variability in insufficient control patients with type 1 diabetes.
measure: Glycated hemoglobin(endpoint)-Glycated hemoglobin(baseline)
time frame: from baseline to 12-week endpoint
description: Objective to investigate the effect of combination diabetes diet and highland barley diet on glucose control in patients with type 1 diabetes.
measure: insulin dose(endpoint)-insulin dose(baseline)
time frame: from baseline to 12-week endpoint
description: Objective to investigate the effect of combination diabetes diet and highland barley diet on insulin dose in patients with type 1 diabetes.
measure: Quality of life assessment scale SF-36(endpoint)-Quality of life assessment scale SF-36(baseline)
time frame: from baseline to 12-week endpoint
description: Objective to investigate the effect of combination diabetes diet and highland barley diet on life quality in patients with type 1 diabetes.
measure: Body mass index(endpoint)-Body mass index(baseline)
time frame: from baseline to 12-week endpoint
description: Objective to investigate the effect of combination diabetes diet and highland barley diet on BMI in patients with type 1 diabetes.
measure: beta-cell function at endpoint and baseline
time frame: from baseline to 12-week endpoint
description: Objective to investigate the effect of combination diabetes diet and highland barley diet on beta-cell function in patients with type 1 diabetes.
measure: Waist circumference(endpoint)-Waist circumference(baseline)
time frame: from baseline to 12-week endpoint
description: Objective to investigate the effect of combination diabetes diet and highland barley diet on waist circumference in patients with type 1 diabetes.
arm group label: Diabetes Diet+Highland Barley Diet
arm group type: Experimental
description: Diabetes Diet+Highland Barley Diet(20g, thrice-daily)
arm group label: Diabetes Diet
arm group type: No Intervention
description: only Diabetes Diet
intervention type: Dietary Supplement
intervention name: Highland Barley Diet
description: Highland Barley Diet(20g, thrice-daily)
arm group label: Diabetes Diet+Highland Barley Diet
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: xuefeng Yu
role: Principal Investigator
affiliation: Tongji Hospital
last name: Xuefeng Yu, doctor
phone: +86-13986070673
email: xfyu188@163.com
last name: LI Liu
phone: +86-18202755862
email: 287715963@qq.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Huazhong University of Science and Technology
investigator full name: Xuefeng Yu
investigator title: Chief of Department of Endocrinology
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No