<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/NCT03766308</url>
  </required_header>
  <id_info>
    <org_study_id>TJ-NFM-0001</org_study_id>
    <nct_id>NCT03766308</nct_id>
  </id_info>
  <brief_title>The Clinical Study of the Effect of Highland Barley Diet on Blood Glucose in Patients With Type 2 Diabetes Mellitus</brief_title>
  <official_title>The Clinical Study of the Effect of Highland Barley Diet on Blood Glucose in Patients With Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xuefeng Yu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Huazhong University of Science and Technology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The clinical study of the effect of highland barley diet on blood glucose in patients with&#xD;
      type 2 diabetes mellitus&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The clinical study of the effect of highland barley diet on blood glucose in patients with&#xD;
      type 2 diabetes mellitus.&#xD;
&#xD;
      Approximately 40 patients will be enrolled in the study from China and randomized in a 1:1&#xD;
      ratio to one of the 2 treatment arms: highland barley diet + metformin; or +common diet&#xD;
      metformin.&#xD;
&#xD;
      Study treatment will continue for 12 weeks. The primary efficacy measure is the change in&#xD;
      HbA1c at 12 weeks. The study consists of 3 periods: a 1-week screening (period A), a 4-week&#xD;
      run-in period (period B) and a 12-week treatment period (period C).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">October 30, 2020</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HbA1c</measure>
    <time_frame>from baseline to 12-week endpoint</time_frame>
    <description>In the newly diagnosed type 2 diabetic patients, the absolute value of glycosylated hemoglobin from baseline to 12-week endpoints was compared between groups in the qingke diet group and the normal diet group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The percentage of participants who achieved HbA1c ≤ 6.5% and &lt; 7%</measure>
    <time_frame>12 weeks</time_frame>
    <description>The percentage of participants who achieved HbA1c ≤ 6.5% and &lt; 7%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood glucose</measure>
    <time_frame>6 weeks and 12weeks</time_frame>
    <description>Fasting blood glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial Blood Glucose</measure>
    <time_frame>6 weeks and 12weeks</time_frame>
    <description>Postprandial blood glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>7 point self-monitoring blood sugar</measure>
    <time_frame>from baseline to 6 and 12 weeks</time_frame>
    <description>7 point self-monitoring blood sugar</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood lipid</measure>
    <time_frame>from baseline to 6 and 12 weeks</time_frame>
    <description>blood lipid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>uric acid</measure>
    <time_frame>from baseline to 6 and 12 weeks</time_frame>
    <description>uric acid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin resistance index</measure>
    <time_frame>0weeks and 12weeks</time_frame>
    <description>Insulin resistance index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beta cell function index of islet</measure>
    <time_frame>0weeks and 12weeks</time_frame>
    <description>Beta cell function index of islet</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>from baseline to 12 weeks</time_frame>
    <description>Change in body weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Waist circumference</measure>
    <time_frame>from baseline to 12 weeks</time_frame>
    <description>Change in Waist circumference</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Highland barley diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>highland barley diet(20g, thrice-daily) +Metformin sustained-release tablets(500mg, thrice-daily)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ADA diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ADA diet + Metformin sustained-release tablets(500mg, thrice-daily)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Highland Barley Diet</intervention_name>
    <description>Highland Barley Diet</description>
    <arm_group_label>Highland barley diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>ADA diet</intervention_name>
    <description>ADA diet</description>
    <arm_group_label>ADA diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provision of informed consent&#xD;
&#xD;
          2. Type 2 diabetic patients （new diagnose ）&#xD;
&#xD;
          3. HbA1c ≥7.0 % and &lt; 9.0 % (HbA1c &gt; 7.0 % and ≤ 8.0% at randomization)&#xD;
&#xD;
          4. Men and women (non-pregnant and using a medically approved birth-control method) aged&#xD;
             ≥ 18 and ≤ 70 years&#xD;
&#xD;
          5. BMI ≥ 23 and ≤ 35 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Type 1 diabetes or other specific types of diabetes&#xD;
&#xD;
          2. Pregnancy, preparation for pregnancy, lactation and women of child-bearing 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>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <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>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>October 29, 2017</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>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Huazhong University of Science and Technology</investigator_affiliation>
    <investigator_full_name>Xuefeng Yu</investigator_full_name>
    <investigator_title>Director of Department of Endocrinology</investigator_title>
  </responsible_party>
  <keyword>highland barley diet</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/NCT03766308
org study id: TJ-NFM-0001
nct id: NCT03766308
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The clinical study of the effect of highland barley diet on blood glucose in patients with
      type 2 diabetes mellitus
The clinical study of the effect of highland barley diet on blood glucose in patients with
      type 2 diabetes mellitus.

      Approximately 40 patients will be enrolled in the study from China and randomized in a 1:1
      ratio to one of the 2 treatment arms: highland barley diet + metformin; or +common diet
      metformin.

      Study treatment will continue for 12 weeks. The primary efficacy measure is the change in
      HbA1c at 12 weeks. The study consists of 3 periods: a 1-week screening (period A), a 4-week
      run-in period (period B) and a 12-week treatment period (period C).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: HbA1c
time frame: from baseline to 12-week endpoint
description: In the newly diagnosed type 2 diabetic patients, the absolute value of glycosylated hemoglobin from baseline to 12-week endpoints was compared between groups in the qingke diet group and the normal diet group.
measure: The percentage of participants who achieved HbA1c ≤ 6.5% and < 7%
time frame: 12 weeks
description: The percentage of participants who achieved HbA1c ≤ 6.5% and < 7%
measure: blood glucose
time frame: 6 weeks and 12weeks
description: Fasting blood glucose
measure: Postprandial Blood Glucose
time frame: 6 weeks and 12weeks
description: Postprandial blood glucose
measure: 7 point self-monitoring blood sugar
time frame: from baseline to 6 and 12 weeks
description: 7 point self-monitoring blood sugar
measure: blood lipid
time frame: from baseline to 6 and 12 weeks
description: blood lipid
measure: uric acid
time frame: from baseline to 6 and 12 weeks
description: uric acid
measure: Insulin resistance index
time frame: 0weeks and 12weeks
description: Insulin resistance index
measure: Beta cell function index of islet
time frame: 0weeks and 12weeks
description: Beta cell function index of islet
measure: Change in body weight
time frame: from baseline to 12 weeks
description: Change in body weight
measure: Change in Waist circumference
time frame: from baseline to 12 weeks
description: Change in Waist circumference
arm group label: Highland barley diet
arm group type: Experimental
description: highland barley diet(20g, thrice-daily) +Metformin sustained-release tablets(500mg, thrice-daily)
arm group label: ADA diet
arm group type: Active Comparator
description: ADA diet + Metformin sustained-release tablets(500mg, thrice-daily)
intervention type: Dietary Supplement
intervention name: Highland Barley Diet
description: Highland Barley Diet
arm group label: Highland barley diet
intervention type: Dietary Supplement
intervention name: ADA diet
description: ADA diet
arm group label: ADA diet
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Huazhong University of Science and Technology
investigator full name: Xuefeng Yu
investigator title: Director of Department of Endocrinology
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2