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/NCT06010992</url>
    </required_header>
    <id_info>
      <org_study_id>36264MD53/3/23</org_study_id>
      <nct_id>NCT06010992</nct_id>
    </id_info>
    <brief_title>Nitazoxanide as Adjuvant Therapy in Type 2 Diabetes Mellitus</brief_title>
    <official_title>A Clinical Study Evaluating the Potential Benefit of Nitazoxanide in Patients With Type 2 Diabetes Mellitus</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tanta University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Menoufia University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Tanta 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>
        Diabetes mellitus (DM) is a complex metabolic disorder characterized by hyperglycemia and&#xD;
        abnormalities in carbohydrate, fat, and protein metabolism. Despite the advancement in&#xD;
        anti-diabetic drug therapy, most patients fail to achieve optimal glycemic control. This&#xD;
        highlights the need for more effective strategies to control type 2 diabetes mellitus.&#xD;
  &#xD;
        Nitazoxanide (NTZ), a broad-spectrum anti-infective drug with activity against various&#xD;
        protozoa, helminthes, bacteria, and viruses, was identified as peroxisome proliferative&#xD;
        activated receptor gamma (PPARγ) agonist using one dimensional drug profile matching.&#xD;
        Additionally, it improved insulin sensitivity in insulin-resistant type 2 diabetic rats.&#xD;
        Therefore, this study is designed to evaluate the efficacy of nitazoxanide as adjunctive&#xD;
        therapy in patients with type 2 diabetes mellitus.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2024</primary_completion_date>
    <phase>Phase 2</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>Glycemic control</measure>
      <time_frame>12 weeks</time_frame>
      <description>Fasting blood glucose and glycated hemoglobin</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Insulin resistance</measure>
      <time_frame>12 weeks</time_frame>
      <description>fasting insulin level with HOMA-IR calculation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lipid profile</measure>
      <time_frame>12 weeks</time_frame>
      <description>Serum levels of total cholesterol, LDL, HDL, and triglycerides</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum levels of A-kinase anchoring protein 1</measure>
      <time_frame>12 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum levels of asprosin</measure>
      <time_frame>12 weeks</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Diabetes Mellitus, Type 2</condition>
    <arm_group>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>35 Patients with type 2 diabetes receiving treatment with metformin and dipeptidyl peptidase-4 (DPP-4) inhibitors (such as vildagliptin).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>35 Patients with type 2 diabetes receiving nitazoxanide 500 mg orally twice daily in addition to metformin and dipeptidyl peptidase-4 (DPP-4) inhibitors (such as vildagliptin).</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Nitazoxanide</intervention_name>
      <description>Nitazoxanide oral capsules 500 mg twice daily</description>
      <arm_group_label>Group 2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Glycated hemoglobin (HbA1c) between 7% and 9%.&#xD;
  &#xD;
            -  Body mass index ≥ 25 kg/m2&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant or nursing women.&#xD;
  &#xD;
            -  Type 1 diabetes mellitus.&#xD;
  &#xD;
            -  Liver disease (alanine aminotransferase &gt; 3 upper normal limit).&#xD;
  &#xD;
            -  Kidney disease (estimated glomerular filtration rate &lt; 60 ml/min/1.73 m2).&#xD;
  &#xD;
            -  Inflammatory bowel diseases.&#xD;
  &#xD;
            -  History of allergy and/or adverse reactions to the drugs used in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Eman Ghonaim</last_name>
      <role>Principal Investigator</role>
      <affiliation>Assistant Lecturer, Faculty of Pharmacy, Tanta University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Eman Ghonaim, Assistant lecturer</last_name>
      <phone>+20-010-970-821-57</phone>
      <email>eman.ghonim@pharm.tanta.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Faculty of medicine, Tanta University</name>
        <address>
          <city>Tanta</city>
          <state>El-Gharbia</state>
          <zip>31527</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Eman Ghonaim</last_name>
        <phone>+20-010-970-821-57</phone>
        <email>eman.ghonim@pharm.tanta.edu.eg</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Faculty of Medicine, Menoufia University</name>
        <address>
          <city>Shibīn Al Kawm</city>
          <state>Menoufia</state>
          <zip>32511</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Eman Ghonaim</last_name>
        <phone>+20-010-970-812-57</phone>
        <email>eman.ghonim@pharm.tanta.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tanta University</investigator_affiliation>
      <investigator_full_name>Eman Ghonaim</investigator_full_name>
      <investigator_title>Assistant lecturer</investigator_title>
    </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>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Nitazoxanide</mesh_term>
    </intervention_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/NCT06010992
  org study id: 36264MD53/3/23
  nct id: NCT06010992
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Diabetes mellitus (DM) is a complex metabolic disorder characterized by hyperglycemia and
        abnormalities in carbohydrate, fat, and protein metabolism. Despite the advancement in
        anti-diabetic drug therapy, most patients fail to achieve optimal glycemic control. This
        highlights the need for more effective strategies to control type 2 diabetes mellitus.
  
        Nitazoxanide (NTZ), a broad-spectrum anti-infective drug with activity against various
        protozoa, helminthes, bacteria, and viruses, was identified as peroxisome proliferative
        activated receptor gamma (PPARγ) agonist using one dimensional drug profile matching.
        Additionally, it improved insulin sensitivity in insulin-resistant type 2 diabetic rats.
        Therefore, this study is designed to evaluate the efficacy of nitazoxanide as adjunctive
        therapy in patients with type 2 diabetes mellitus.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Glycemic control
  time frame: 12 weeks
  description: Fasting blood glucose and glycated hemoglobin
  measure: Insulin resistance
  time frame: 12 weeks
  description: fasting insulin level with HOMA-IR calculation
  measure: Lipid profile
  time frame: 12 weeks
  description: Serum levels of total cholesterol, LDL, HDL, and triglycerides
  measure: Serum levels of A-kinase anchoring protein 1
  time frame: 12 weeks
  measure: Serum levels of asprosin
  time frame: 12 weeks
  arm group label: Group 1
  arm group type: No Intervention
  description: 35 Patients with type 2 diabetes receiving treatment with metformin and dipeptidyl peptidase-4 (DPP-4) inhibitors (such as vildagliptin).
  arm group label: Group 2
  arm group type: Experimental
  description: 35 Patients with type 2 diabetes receiving nitazoxanide 500 mg orally twice daily in addition to metformin and dipeptidyl peptidase-4 (DPP-4) inhibitors (such as vildagliptin).
  intervention type: Drug
  intervention name: Nitazoxanide
  description: Nitazoxanide oral capsules 500 mg twice daily
  arm group label: Group 2
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Eman Ghonaim
  role: Principal Investigator
  affiliation: Assistant Lecturer, Faculty of Pharmacy, Tanta University
  last name: Eman Ghonaim, Assistant lecturer
  phone: +20-010-970-821-57
  email: eman.ghonim@pharm.tanta.edu.eg
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Tanta University
  investigator full name: Eman Ghonaim
  investigator title: Assistant lecturer
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2
  mesh term: Nitazoxanide
  sharing ipd: No