<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/NCT02234440</url>
  </required_header>
  <id_info>
    <org_study_id>ILBS-NASH-Cirrhosis-01</org_study_id>
    <nct_id>NCT02234440</nct_id>
  </id_info>
  <brief_title>Effect of Metformin on Disease Progression in Patients With Cryptogenic Cirrhosis (NASH-related Cirrhosis) With Diabetes or Impaired Glucose Tolerance or Insulin Resistance</brief_title>
  <official_title>Effect of Metformin on Disease Progression in Patients With Cryptogenic Cirrhosis (NASH-related Cirrhosis) With Diabetes or Impaired Glucose Tolerance or Insulin Resistance: a Prospective Randomized, Open Labeled, Clinical Trial&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Liver and Biliary Sciences, India</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute of Liver and Biliary Sciences, India</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, consecutive patients with cryptogenic cirrhosis (NASH-related cirrhosis),&#xD;
      coming to ILBS (Institute of Liver &amp; Biliary Sciences) OPD (Out patient Department) or&#xD;
      getting admitted in the ward will be enrolled on fulfillment of inclusion/exclusion criteria&#xD;
      and consent of the patient. These patients will be randomised to either metformin arm or&#xD;
      conventional treatment arm. After enrollment these subjects will be monitored every three&#xD;
      monthly for total of 12 months or till the primary endpoint is achieved. At the end of the&#xD;
      study, outcome will be measured appropriately.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2014</start_date>
  <completion_date type="Actual">December 31, 2015</completion_date>
  <primary_completion_date type="Actual">December 31, 2015</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>Reduction of portal pressure</measure>
    <time_frame>1 Year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in fibrosis(assessed by noninvasive methods like Fibroscan and Fib 4 index)</measure>
    <time_frame>1 Year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety profile of the drugs like Random Blood Sugar (RBS) and serum lactate monitoring regularly.</measure>
    <time_frame>1.5 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">86</enrollment>
  <condition>NASH Related Cirrhosis</condition>
  <arm_group>
    <arm_group_label>Metformin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Metformin- 500 mg once daily as a starting dose, can be escalated to 2 g/day to control diabetes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Insulin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin</intervention_name>
    <arm_group_label>Metformin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin</intervention_name>
    <arm_group_label>Insulin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 years and above&#xD;
&#xD;
          2. Patients with cryptogenic cirrhosis {NASH (Nash Alcoholic Steatohepatitis)-related&#xD;
             cirrhosis}&#xD;
&#xD;
          3. Presence of diabetes mellitus or insulin resistance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with heart failure&#xD;
&#xD;
          2. Patients with acute kidney injury at the time of enrollment&#xD;
&#xD;
          3. Patients with CKD (Chronic Kidney Disease) or with S. Creatinine &gt; 1 mg/dL&#xD;
&#xD;
          4. Patient with active upper GI bleeding- not settled&#xD;
&#xD;
          5. Patient with SIRS/sepsis/shock&#xD;
&#xD;
          6. Patient in ICU (Intensive Care Unit)&#xD;
&#xD;
          7. Pregnancy&#xD;
&#xD;
          8. Patients with hepatocellular carcinoma&#xD;
&#xD;
          9. Patients who are not willing to participate in the study&#xD;
&#xD;
         10. Patients with any form of decompensation at the time of enrollment in the study&#xD;
&#xD;
         11. Patient with large esophageal varices/ patients who are on beta blocker other than&#xD;
             those patients with HVPG (Hepatic Venous Pressure Gradient) non responder to&#xD;
             betablocker&#xD;
&#xD;
         12. Patient who has already been receiving Metformin prior to enrollment 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>Dr Tanmay S Vyas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Liver and Biliary Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Liver &amp; Biliary Sciences</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110070</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>August 31, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>February 7, 2018</last_update_submitted>
  <last_update_submitted_qc>February 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Insulin Resistance</mesh_term>
    <mesh_term>Glucose Intolerance</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
    <mesh_term>Disease Progression</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
  </intervention_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/NCT02234440
org study id: ILBS-NASH-Cirrhosis-01
nct id: NCT02234440
lead sponsor: 
has dmc: No
In this study, consecutive patients with cryptogenic cirrhosis (NASH-related cirrhosis),
      coming to ILBS (Institute of Liver & Biliary Sciences) OPD (Out patient Department) or
      getting admitted in the ward will be enrolled on fulfillment of inclusion/exclusion criteria
      and consent of the patient. These patients will be randomised to either metformin arm or
      conventional treatment arm. After enrollment these subjects will be monitored every three
      monthly for total of 12 months or till the primary endpoint is achieved. At the end of the
      study, outcome will be measured appropriately.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Reduction of portal pressure
time frame: 1 Year
measure: Improvement in fibrosis(assessed by noninvasive methods like Fibroscan and Fib 4 index)
time frame: 1 Year
measure: Safety profile of the drugs like Random Blood Sugar (RBS) and serum lactate monitoring regularly.
time frame: 1.5 year
arm group label: Metformin
arm group type: Experimental
description: Metformin- 500 mg once daily as a starting dose, can be escalated to 2 g/day to control diabetes
arm group label: Insulin
arm group type: Active Comparator
intervention type: Drug
intervention name: Metformin
arm group label: Metformin
intervention type: Drug
intervention name: Insulin
arm group label: Insulin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dr Tanmay S Vyas, MD
role: Principal Investigator
affiliation: Institute of Liver and Biliary Sciences
facility: 
country: India
responsible party type: Sponsor
mesh term: Liver Cirrhosis
mesh term: Insulin Resistance
mesh term: Glucose Intolerance
mesh term: Fibrosis
mesh term: Disease Progression
mesh term: Metformin