xml: <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/NCT05994586</url>
    </required_header>
    <id_info>
      <org_study_id>07-AP-MET</org_study_id>
      <nct_id>NCT05994586</nct_id>
    </id_info>
    <brief_title>The Efficacy of AP029 Mix in Patients With Impaired Carbohydrate Metabolism</brief_title>
    <official_title>The Effect of Mix AP029 on the Efficacy of Metformin Therapy and Its Side Effects in Patients With Type II Diabetes and on Mechanisms Related to Prediabetes in Patients With Impaired Carbohydrate-lipid Metabolism</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AronPharma Sp. z o. o.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>AronPharma Sp. z o. o.</source>
    <oversight_info>
      <has_dmc>No</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 aim of the study is to demonstrate that a daily supplementation of AP029 Mix: I) has a&#xD;
        positive effect on reducing side effects of metformin, while enhancing the therapeutic effect&#xD;
        of metformin; II) normalizes prediabetes biomarkers in order to prevent further progression&#xD;
        into diabetes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Randomized, double-blind, cross over study conducted under medical supervision on 1) group of&#xD;
        20 patients with type II diabetes and 2) group of 10 patients with prediabetes.&#xD;
  &#xD;
        Study design: 2 months of AP029 supplementation, 1 month wash-out, 2 months of placebo&#xD;
        intake. Patients will attend 4 visits. On each visit, the following parameters are analyzed:&#xD;
        level of glucose, insulin, HbA1c, hsCRP lipid panel (total cholesterol (TC), triglycerides&#xD;
        (TG), low density lipoprotein (LDL), HDL) and inflammatory and oxidative stress markers. In&#xD;
        addition, a questionnaire of symptoms associated with metformin intake will be conducted&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 25, 2023</start_date>
    <completion_date type="Anticipated">November 26, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 26, 2023</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>Crossover Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Glucose level</measure>
      <time_frame>Baseline, 2 months, 3 months, 5 months</time_frame>
      <description>Comparison of glucose level</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Insulin level</measure>
      <time_frame>Baseline, 2 months, 3 months, 5 months</time_frame>
      <description>Comparison of insulin level</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Discomfort related to metformin side effects</measure>
      <time_frame>Baseline, 2 months, 3 months, 5 months</time_frame>
      <description>Based on questionnaire</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Lipid panel (total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), HDL)</measure>
      <time_frame>Baseline, 2 months, 3 months, 5 months</time_frame>
      <description>Comparison of lipid panel markers</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>hsCRP level</measure>
      <time_frame>Baseline, 2 months, 3 months, 5 months</time_frame>
      <description>Comparison of hsCRP level</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>HbA1c level</measure>
      <time_frame>Baseline, 2 months, 3 months, 5 months</time_frame>
      <description>Comparison of hbA1c level</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Diabetes in Adolescence</condition>
    <condition>PreDiabetes</condition>
    <arm_group>
      <arm_group_label>AP029 mix - type II diabetes</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with type II diabetes receiving metformin for up to 5 months</description>
    </arm_group>
    <arm_group>
      <arm_group_label>AP029 mix - prediabetes</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with pre-diabetic</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo - type II diabetes</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Patients with type II diabetes receiving metformin for up to 5 months</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo - prediabetes</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Patients with pre-diabetic</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>AP029 mix</intervention_name>
      <description>Polyphenol-rich plant extracts Twice a day</description>
      <arm_group_label>AP029 mix - prediabetes</arm_group_label>
      <arm_group_label>AP029 mix - type II diabetes</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Twice a day</description>
      <arm_group_label>Placebo - prediabetes</arm_group_label>
      <arm_group_label>Placebo - type II diabetes</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria for type II diabetes:&#xD;
  &#xD;
            -  Women and men, 18-75 years old&#xD;
  &#xD;
            -  Patients diagnosed with type II diabetes mellitus&#xD;
  &#xD;
            -  Patients on metformin treatment up to 5 months&#xD;
  &#xD;
            -  BMI 20-35 kg/m2&#xD;
  &#xD;
            -  Signed informed consent&#xD;
  &#xD;
          Inclusion Criteria for prediabetes:&#xD;
  &#xD;
            -  Women and men, 18-75 years old&#xD;
  &#xD;
            -  BMI 20-35 kg/m2&#xD;
  &#xD;
            -  Fasting blood glucose levels between 100 mg/dl and 125 mg/dl (5.6-6.9 mmol/l)&#xD;
  &#xD;
            -  Signed informed consent&#xD;
  &#xD;
          Exclusion Criteria for type II diabetes:&#xD;
  &#xD;
            -  Patients diagnosed with type I diabetes&#xD;
  &#xD;
            -  Patients receiving insulin or other anti-diabetic medications&#xD;
  &#xD;
            -  Women who are pregnant, planning to become pregnant during the study, or breastfeeding&#xD;
  &#xD;
            -  Surgery within the last 6 months&#xD;
  &#xD;
            -  Intake of dietary supplements containing plant extracts rich in polyphenols and&#xD;
               anthocyanins&#xD;
  &#xD;
            -  Intake of supplements containing: white mulberry, chromium, berberine&#xD;
  &#xD;
            -  Patients receiving glucocorticosteroids, immunosuppressants&#xD;
  &#xD;
            -  Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis,&#xD;
               leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant&#xD;
  &#xD;
            -  Acute inflammation (C-reactive protein &gt;20mg/dl)&#xD;
  &#xD;
          Exclusion Criteria for prediabetes:&#xD;
  &#xD;
            -  Patients diagnosed with type I, II, LADA diabetes&#xD;
  &#xD;
            -  Patients receiving insulin or other anti-diabetic medications&#xD;
  &#xD;
            -  Women who are pregnant, planning to become pregnant during the study, or breastfeeding&#xD;
  &#xD;
            -  Surgery within the last 6 months&#xD;
  &#xD;
            -  Intake of dietary supplements containing plant extracts rich in polyphenols and&#xD;
               anthocyanins&#xD;
  &#xD;
            -  Intake of supplements containing: white mulberry, chromium, berberine&#xD;
  &#xD;
            -  Patients receiving glucocorticosteroids, immunosuppressants&#xD;
  &#xD;
            -  Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis,&#xD;
               leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant&#xD;
  &#xD;
            -  Acute inflammation (C-reactive protein &gt;20mg/dl)&#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>Pomorskie Centrum Reumatologiczne im. dr Jadwigi Titz-Kosko</name>
        <address>
          <city>Sopot</city>
          <zip>81-820</zip>
          <country>Poland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Barbara Khaidakov, PhD</last_name>
        <phone>798 210 651</phone>
        <phone_ext>+48</phone_ext>
        <email>barbara.khaidakov@aronpharma.pl</email>
      </contact>
      <investigator>
        <last_name>Dagmara Wiewiórkowska-Garczewska</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Poland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Type II diabetes</keyword>
    <keyword>Prediabetes</keyword>
    <keyword>Disorders of Carbohydrate Metabolism</keyword>
    <keyword>Chokeberry</keyword>
    <keyword>Elderberry</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prediabetic State</mesh_term>
      <mesh_term>Glucose Intolerance</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05994586
  org study id: 07-AP-MET
  nct id: NCT05994586
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to demonstrate that a daily supplementation of AP029 Mix: I) has a
        positive effect on reducing side effects of metformin, while enhancing the therapeutic effect
        of metformin; II) normalizes prediabetes biomarkers in order to prevent further progression
        into diabetes.
  Randomized, double-blind, cross over study conducted under medical supervision on 1) group of
        20 patients with type II diabetes and 2) group of 10 patients with prediabetes.
  
        Study design: 2 months of AP029 supplementation, 1 month wash-out, 2 months of placebo
        intake. Patients will attend 4 visits. On each visit, the following parameters are analyzed:
        level of glucose, insulin, HbA1c, hsCRP lipid panel (total cholesterol (TC), triglycerides
        (TG), low density lipoprotein (LDL), HDL) and inflammatory and oxidative stress markers. In
        addition, a questionnaire of symptoms associated with metformin intake will be conducted
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Supportive Care
  masking: Double (Participant, Investigator)
  measure: Glucose level
  time frame: Baseline, 2 months, 3 months, 5 months
  description: Comparison of glucose level
  measure: Insulin level
  time frame: Baseline, 2 months, 3 months, 5 months
  description: Comparison of insulin level
  measure: Discomfort related to metformin side effects
  time frame: Baseline, 2 months, 3 months, 5 months
  description: Based on questionnaire
  measure: Lipid panel (total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), HDL)
  time frame: Baseline, 2 months, 3 months, 5 months
  description: Comparison of lipid panel markers
  measure: hsCRP level
  time frame: Baseline, 2 months, 3 months, 5 months
  description: Comparison of hsCRP level
  measure: HbA1c level
  time frame: Baseline, 2 months, 3 months, 5 months
  description: Comparison of hbA1c level
  arm group label: AP029 mix - type II diabetes
  arm group type: Experimental
  description: Patients with type II diabetes receiving metformin for up to 5 months
  arm group label: AP029 mix - prediabetes
  arm group type: Experimental
  description: Patients with pre-diabetic
  arm group label: Placebo - type II diabetes
  arm group type: Placebo Comparator
  description: Patients with type II diabetes receiving metformin for up to 5 months
  arm group label: Placebo - prediabetes
  arm group type: Placebo Comparator
  description: Patients with pre-diabetic
  intervention type: Dietary Supplement
  intervention name: AP029 mix
  description: Polyphenol-rich plant extracts Twice a day
  arm group label: AP029 mix - prediabetes
  arm group label: AP029 mix - type II diabetes
  intervention type: Other
  intervention name: Placebo
  description: Twice a day
  arm group label: Placebo - prediabetes
  arm group label: Placebo - type II diabetes
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Poland
  responsible party type: Sponsor
  mesh term: Prediabetic State
  mesh term: Glucose Intolerance
  sharing ipd: No