<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/NCT03753438</url>
  </required_header>
  <id_info>
    <org_study_id>ILBS-NASH-04</org_study_id>
    <nct_id>NCT03753438</nct_id>
  </id_info>
  <brief_title>Intragastric Balloon in Compensated NASH(Non Alcoholic Steato Hepatitis) Cirrhotics</brief_title>
  <official_title>Intragastric Balloon in Compensated NASH(Non Alcoholic Steato Hepatitis) Cirrhotics-An Observational Study</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will be conducted in department of Hepatology at ILBS, the patients will be&#xD;
      recruited from the OPD or IPD . The obese cirrhotic patients with NASH will be observed for&#xD;
      standard of care and also patients who undergo IGB placement as part of weight reduction&#xD;
      policy in these group of patients and will undergo an UGI endoscopy followed by placement of&#xD;
      intragastric balloon. Then the patients will be admitted for 2-3 days and followed up till 6&#xD;
      months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2, 2016</start_date>
  <completion_date type="Actual">May 31, 2020</completion_date>
  <primary_completion_date type="Actual">May 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in weight from baseline</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in weight reduction from baseline</measure>
    <time_frame>6 Months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in development of liver related complications</measure>
    <time_frame>3 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in development of liver related complications</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of insulin resistance in both groups.</measure>
    <time_frame>3 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of insulin resistance in both groups.</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decreased usage of medications for diabetes mellitus in both groups.</measure>
    <time_frame>3 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decreased usage of medications for diabetes mellitus in both groups.</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decreased usage of medications for HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) in both groups.</measure>
    <time_frame>3 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decreased usage of medications for HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) in both groups.</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of insulin resistance and decreased usage of medications for TNF-α (Tumor Necrosis Factor-Alpha).</measure>
    <time_frame>3 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of insulin resistance and decreased usage of medications for TNF-α (Tumor Necrosis Factor-Alpha).</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in liver parameters such as serum albumin in both groups.</measure>
    <time_frame>3 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in liver parameters such as serum albumin in both groups.</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement liver parameters such as INR in both groups</measure>
    <time_frame>3 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in liver parameters such as INR in both groups.</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in liver parameters such as bilirubin in both groups</measure>
    <time_frame>3 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in liver parameters such as bilirubin in both groups.</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disappearance of esophageal varices in both groups.</measure>
    <time_frame>3 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disappearance of esophageal varices in both groups.</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in LSM (liver stiffness on fibroscan) in both groups</measure>
    <time_frame>3 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in LSM (liver stiffness on fibroscan) in both groups.</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in CAP (Controlled Attenuation Index) in both groups.</measure>
    <time_frame>3 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in CAP (Controlled Attenuation Index) in both groups.</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in HVPG (Hepatic venous Pressure Gradient) in both groups.</measure>
    <time_frame>3 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in HVPG (Hepatic venous Pressure Gradient) in both groups.</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in liver histology post completion of study in both groups.</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hormonal levels such as Adiponectin level in both groups..</measure>
    <time_frame>3 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hormonal levels such as Adiponectin level in both groups.</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hormonal levels such as leptin level in both groups.</measure>
    <time_frame>3 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hormonal levels such as Ghrelin level in both groups..</measure>
    <time_frame>3 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hormonal levels such as Ghrelin level in both groups..</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hormonal levels such as Endothelin level in both groups..</measure>
    <time_frame>3 Month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hormonal levels such as Endothelin level in both groups..</measure>
    <time_frame>6 Month</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">56</enrollment>
  <condition>Liver Cirrhosis</condition>
  <arm_group>
    <arm_group_label>Intragastric Balloon</arm_group_label>
    <description>Intragastric Balloon will be placed for 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intragstric Ballooning</intervention_name>
    <description>Intragstric Ballooning will be put.</description>
    <arm_group_label>Intragastric Balloon</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        NASH (Non Alcoholic SteatoHepatitis) cirrhosis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients between 18 and 65 years&#xD;
&#xD;
          -  NASH (Non Alcoholic SteatoHepatitis) cirrhosis&#xD;
&#xD;
          -  BMI &gt; 30 and failure to control weight despite full dietary and life style&#xD;
             modifications.&#xD;
&#xD;
          -  Compensated : CTP 6 &amp; 7 without any evidence of decompensation in form of Hepatic&#xD;
             encephalopathy, ascites, GI bleed or prolonged jaundice.&#xD;
&#xD;
          -  Small varices: Grade I varices&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Alcoholic liver disease&#xD;
&#xD;
          -  Advanced liver disease with ascites, hepatic encephalopathy&#xD;
&#xD;
          -  Other liver diseases such as chronic hepatitis B, chronic hepatitis C, Wilsons'&#xD;
             disease, Hemochromatosis, glycogen storage diseases etc.&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Unwilling patients&#xD;
&#xD;
          -  Large varices&#xD;
&#xD;
          -  Past h/o GI bleed&#xD;
&#xD;
          -  Hiatus hernia&#xD;
&#xD;
          -  Gastric ulcer&#xD;
&#xD;
          -  Severe esophagitis (Grade B and above)&#xD;
&#xD;
          -  Severe PHG or gastric erythema&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shiv Kumar Sarin, DM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Liver &amp; 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>June 2021</verification_date>
  <study_first_submitted>October 17, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>June 17, 2021</last_update_submitted>
  <last_update_submitted_qc>June 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2021</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>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03753438
org study id: ILBS-NASH-04
nct id: NCT03753438
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will be conducted in department of Hepatology at ILBS, the patients will be
      recruited from the OPD or IPD . The obese cirrhotic patients with NASH will be observed for
      standard of care and also patients who undergo IGB placement as part of weight reduction
      policy in these group of patients and will undergo an UGI endoscopy followed by placement of
      intragastric balloon. Then the patients will be admitted for 2-3 days and followed up till 6
      months.
observational model: Cohort
time perspective: Prospective
measure: Change in weight from baseline
time frame: 3 months
measure: Change in weight reduction from baseline
time frame: 6 Months
measure: Change in development of liver related complications
time frame: 3 Months
measure: Change in development of liver related complications
time frame: 6 Months
measure: Improvement of insulin resistance in both groups.
time frame: 3 Months
measure: Improvement of insulin resistance in both groups.
time frame: 6 Months
measure: Decreased usage of medications for diabetes mellitus in both groups.
time frame: 3 Months
measure: Decreased usage of medications for diabetes mellitus in both groups.
time frame: 6 Months
measure: Decreased usage of medications for HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) in both groups.
time frame: 3 Months
measure: Decreased usage of medications for HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) in both groups.
time frame: 6 Months
measure: Improvement of insulin resistance and decreased usage of medications for TNF-α (Tumor Necrosis Factor-Alpha).
time frame: 3 Months
measure: Improvement of insulin resistance and decreased usage of medications for TNF-α (Tumor Necrosis Factor-Alpha).
time frame: 6 Months
measure: Improvement in liver parameters such as serum albumin in both groups.
time frame: 3 Months
measure: Improvement in liver parameters such as serum albumin in both groups.
time frame: 6 Months
measure: Improvement liver parameters such as INR in both groups
time frame: 3 Months
measure: Improvement in liver parameters such as INR in both groups.
time frame: 6 Months
measure: Improvement in liver parameters such as bilirubin in both groups
time frame: 3 Months
measure: Improvement in liver parameters such as bilirubin in both groups.
time frame: 6 Months
measure: Disappearance of esophageal varices in both groups.
time frame: 3 Months
measure: Disappearance of esophageal varices in both groups.
time frame: 6 Months
measure: Improvement in LSM (liver stiffness on fibroscan) in both groups
time frame: 3 Months
measure: Improvement in LSM (liver stiffness on fibroscan) in both groups.
time frame: 6 Months
measure: Improvement in CAP (Controlled Attenuation Index) in both groups.
time frame: 3 Months
measure: Improvement in CAP (Controlled Attenuation Index) in both groups.
time frame: 6 Months
measure: Improvement in HVPG (Hepatic venous Pressure Gradient) in both groups.
time frame: 3 Months
measure: Improvement in HVPG (Hepatic venous Pressure Gradient) in both groups.
time frame: 6 Months
measure: Improvement in liver histology post completion of study in both groups.
time frame: 6 Months
measure: Change in hormonal levels such as Adiponectin level in both groups..
time frame: 3 Months
measure: Change in hormonal levels such as Adiponectin level in both groups.
time frame: 6 months
measure: Change in hormonal levels such as leptin level in both groups.
time frame: 3 Months
measure: Change in hormonal levels such as Ghrelin level in both groups..
time frame: 3 Months
measure: Change in hormonal levels such as Ghrelin level in both groups..
time frame: 6 Months
measure: Change in hormonal levels such as Endothelin level in both groups..
time frame: 3 Month
measure: Change in hormonal levels such as Endothelin level in both groups..
time frame: 6 Month
arm group label: Intragastric Balloon
description: Intragastric Balloon will be placed for 6 months
intervention type: Procedure
intervention name: Intragstric Ballooning
description: Intragstric Ballooning will be put.
arm group label: Intragastric Balloon
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Shiv Kumar Sarin, DM
role: Principal Investigator
affiliation: Institute of Liver & Biliary Sciences
facility: 
country: India
responsible party type: Sponsor
mesh term: Liver Cirrhosis
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
sharing ipd: Undecided