<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/NCT01712711</url>
  </required_header>
  <id_info>
    <org_study_id>1391/7/24-579</org_study_id>
    <nct_id>NCT01712711</nct_id>
  </id_info>
  <brief_title>Helicobacter Pylori Eradication in Diabetic Subjects With Non-alcoholic Fatty Liver Disease</brief_title>
  <official_title>The Effect of Helicobacter Pylori Eradication on Liver Fat Content in Diabetic Subjects With Non-alcoholic Fatty Liver Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tehran University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tehran University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of study was to evaluate the effect of helicobacter pylori eradication on liver fat&#xD;
      content, liver function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR)&#xD;
      index, and anthropometric measurements (body mass index and waist circumference)in diabetic&#xD;
      subjects with non-alcoholic fatty liver disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Helicobacter pylori (HP) antigens have been found in the liver of individuals with benign and&#xD;
      malignant liver diseases. The role of HP in the pathogenesis of non-alcoholic fatty liver&#xD;
      disease (NAFLD) is controversial.&#xD;
&#xD;
      This randomized double blind clinical trial was performed in diabetic dyspeptic patients with&#xD;
      positive antibody to HP and the evidence of fatty liver in ultrasonography. After excluding&#xD;
      other causes, participants with persistent elevated serum aminotransferase levels were&#xD;
      presumed to have NAFLD. Those with NAFLD liver fat score greater than (-0.64) and positive&#xD;
      urea breath test (UBT) were enrolled. They were randomly assigned to lifestyle modification&#xD;
      alone or lifestyle modification plus HP eradication groups. Quadruple therapy (omeprazole,&#xD;
      amoxicillin, bismuth subcitrate, and clarithromycin) for HP eradication was performed in two&#xD;
      weeks. HP eradication was documented by UBT. Liver fat content, fasting serum glucose,&#xD;
      alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, triglyceride,&#xD;
      cholesterol, high and low-density lipoprotein, HOMA-IR, and anthropometric measurements (body&#xD;
      mass index and waist circumference) were checked at baseline and six weeks post-treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</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>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Liver Fat Content Change From Baseline to Six Weeks Post H.Pylori Treatment</measure>
    <time_frame>baseline and 6 weeks</time_frame>
    <description>Liver fat content was calculated by a valid formula. The formula is as the followings:Liver fat content (%) = 10 (-0.805 + 0.282 * metabolic syndrome (yes = 11 no = 0) + 0.078 * type 2 diabetes (yes =2 / no =0) + 0.525 * log fasting serum insulin (mU/L) + 0.521 * log fasting serum AST (U/L) - 0.454 * log (AST/ALT)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Non-alcoholic Fatty Liver Disease</condition>
  <arm_group>
    <arm_group_label>Lifestyle modification</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Obtaining ideal body weight by calorie restriction diet and programmed physical activity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>H.pylori eradication</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>H.pylori eradication</intervention_name>
    <description>The regimen consists of Omeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD)for two weeks</description>
    <arm_group_label>H.pylori eradication</arm_group_label>
    <other_name>Helicobacter pylori treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diabetic dyspeptic patients with positive antibody to H.pylori and persistent elevated&#xD;
             aminotransferase levels with the evidence of fatty liver in ultrasonography, who were&#xD;
             referred to a gastroenterology clinic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Alcohol use (more than 20 gram per day in men and 10 gram per day in women per day),&#xD;
             heart disease (ischemic or congestive), hepatic disease (viral hepatitis, autoimmune&#xD;
             hepatitis, wilson disease, hemochromatosis, liver mass lesion), renal disease (serum&#xD;
             creatinine concentration of &gt; 1.5 mg/dl), any severe systemic co-morbidities,&#xD;
             neoplasm, using any hepatotoxic medication during the past 3 months, previous history&#xD;
             of peptic ulcer, previous history of H.pylori eradication, existence of alarm signs&#xD;
             (weight loss, dysphagia, anemia, vomiting, positive family history of gastrointestinal&#xD;
             cancers), and pregnant or lactating women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raika Jamali, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tehran University of Medical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gastroenterology clinic, Sina Hospital</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <results_first_submitted>March 21, 2013</results_first_submitted>
  <results_first_submitted_qc>March 21, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 6, 2013</results_first_posted>
  <last_update_submitted>April 26, 2018</last_update_submitted>
  <last_update_submitted_qc>April 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tehran University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Raika Jamali, MD</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Steatohepatitis,</keyword>
  <keyword>Helicobacter pylori,</keyword>
  <keyword>Insulin resistance,</keyword>
  <keyword>Alanine aminotransferase,</keyword>
  <keyword>Aspartate aminotransferase,</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Lifestyle Modification</title>
          <description>Obtaining ideal body weight by calorie restriction diet and programmed physical activity</description>
        </group>
        <group group_id="P2">
          <title>H.Pylori Eradication</title>
          <description>H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Lifestyle Modification</title>
          <description>Obtaining ideal body weight by calorie restriction diet and programmed physical activity</description>
        </group>
        <group group_id="B2">
          <title>H.Pylori Eradication</title>
          <description>H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.95" spread="9.53"/>
                    <measurement group_id="B2" value="45.73" spread="12.54"/>
                    <measurement group_id="B3" value="42.84" spread="11.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Iran, Islamic Republic of</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Liver Fat Content Change From Baseline to Six Weeks Post H.Pylori Treatment</title>
        <description>Liver fat content was calculated by a valid formula. The formula is as the followings:Liver fat content (%) = 10 (-0.805 + 0.282 * metabolic syndrome (yes = 11 no = 0) + 0.078 * type 2 diabetes (yes =2 / no =0) + 0.525 * log fasting serum insulin (mU/L) + 0.521 * log fasting serum AST (U/L) - 0.454 * log (AST/ALT)</description>
        <time_frame>baseline and 6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lifestyle Modification</title>
            <description>Obtaining ideal body weight by calorie restriction diet and programmed physical activity</description>
          </group>
          <group group_id="O2">
            <title>H.Pylori Eradication</title>
            <description>H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity</description>
          </group>
        </group_list>
        <measure>
          <title>Liver Fat Content Change From Baseline to Six Weeks Post H.Pylori Treatment</title>
          <description>Liver fat content was calculated by a valid formula. The formula is as the followings:Liver fat content (%) = 10 (-0.805 + 0.282 * metabolic syndrome (yes = 11 no = 0) + 0.078 * type 2 diabetes (yes =2 / no =0) + 0.525 * log fasting serum insulin (mU/L) + 0.521 * log fasting serum AST (U/L) - 0.454 * log (AST/ALT)</description>
          <units>percentage of liver fat content</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.46" spread="2.23"/>
                    <measurement group_id="O2" value="3.61" spread="3.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <desc>self-reporting by participants</desc>
      <group_list>
        <group group_id="E1">
          <title>Lifestyle Modification</title>
          <description>Obtaining ideal body weight by calorie restriction diet and programmed physical activity</description>
        </group>
        <group group_id="E2">
          <title>H.Pylori Eradication</title>
          <description>H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>No limitation existed.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Professor Raika Jamali</name_or_title>
      <organization>Tehran University of Medical Sciences</organization>
      <phone>00982163120000 ext 411</phone>
      <email>jamalira@tums.ac.ir</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01712711
org study id: 1391/7/24-579
nct id: NCT01712711
lead sponsor: 
has dmc: No
The aim of study was to evaluate the effect of helicobacter pylori eradication on liver fat
      content, liver function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR)
      index, and anthropometric measurements (body mass index and waist circumference)in diabetic
      subjects with non-alcoholic fatty liver disease.
Helicobacter pylori (HP) antigens have been found in the liver of individuals with benign and
      malignant liver diseases. The role of HP in the pathogenesis of non-alcoholic fatty liver
      disease (NAFLD) is controversial.

      This randomized double blind clinical trial was performed in diabetic dyspeptic patients with
      positive antibody to HP and the evidence of fatty liver in ultrasonography. After excluding
      other causes, participants with persistent elevated serum aminotransferase levels were
      presumed to have NAFLD. Those with NAFLD liver fat score greater than (-0.64) and positive
      urea breath test (UBT) were enrolled. They were randomly assigned to lifestyle modification
      alone or lifestyle modification plus HP eradication groups. Quadruple therapy (omeprazole,
      amoxicillin, bismuth subcitrate, and clarithromycin) for HP eradication was performed in two
      weeks. HP eradication was documented by UBT. Liver fat content, fasting serum glucose,
      alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, triglyceride,
      cholesterol, high and low-density lipoprotein, HOMA-IR, and anthropometric measurements (body
      mass index and waist circumference) were checked at baseline and six weeks post-treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
measure: Liver Fat Content Change From Baseline to Six Weeks Post H.Pylori Treatment
time frame: baseline and 6 weeks
description: Liver fat content was calculated by a valid formula. The formula is as the followings:Liver fat content (%) = 10 (-0.805 + 0.282 * metabolic syndrome (yes = 11 no = 0) + 0.078 * type 2 diabetes (yes =2 / no =0) + 0.525 * log fasting serum insulin (mU/L) + 0.521 * log fasting serum AST (U/L) - 0.454 * log (AST/ALT)
arm group label: Lifestyle modification
arm group type: No Intervention
description: Obtaining ideal body weight by calorie restriction diet and programmed physical activity
arm group label: H.pylori eradication
arm group type: Experimental
description: H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
intervention type: Drug
intervention name: H.pylori eradication
description: The regimen consists of Omeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD)for two weeks
arm group label: H.pylori eradication
other name: Helicobacter pylori treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Raika Jamali, M.D.
role: Principal Investigator
affiliation: Tehran University of Medical Sciences
facility: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Tehran University of Medical Sciences
investigator full name: Raika Jamali, MD
investigator title: Assistant Professor of Medicine
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: No limitation existed.
point of contact: 