<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/NCT04463667</url>
  </required_header>
  <id_info>
    <org_study_id>202002056RIND</org_study_id>
    <nct_id>NCT04463667</nct_id>
  </id_info>
  <brief_title>Impact of Exercise Intervention for Patients With Non-alcoholic Fatty Liver Disease</brief_title>
  <acronym>NAFLD</acronym>
  <official_title>Impact of Exercise Intervention for Patients With Non-alcoholic Fatty Liver Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</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>
      In Taiwan, with the westernization of eating habit and lifestyle, metabolic syndrome and&#xD;
      non-alcoholic fatty liver (NAFLD) have become very important health issues. This project will&#xD;
      therefore study the histological and clinical data of patients with non-alcoholic fatty liver&#xD;
      disease and explore the impact of exercise intervention on the hepatic fatty infiltration of&#xD;
      the patients. The research strategy will include (1) combining modern artificial big data&#xD;
      collection technology to fully monitor the daily life, sleep and exercise patterns of the&#xD;
      participants; (2) improving fatty liver and metabolic syndrome through trial-based exercise&#xD;
      intervention; and (3) exploring the changes of sleep patterns and intestinal microflora in&#xD;
      patients with metabolic liver disease after exercise intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background &amp; aims: In Taiwan, with the investigators sternization of eating habit and&#xD;
      lifestyle, metabolic syndrome and non-alcoholic fatty liver (NAFLD) have become very&#xD;
      important health issues. This project will therefore study the histological and clinical data&#xD;
      of patients with non-alcoholic fatty liver disease and explore the impact of exercise&#xD;
      intervention on the hepatic fatty infiltration of the patients. The research strategy will&#xD;
      include (1) combining modern artificial big data collection technology to fully monitor the&#xD;
      daily life, sleep and exercise patterns of the participants; (2) improving fatty liver and&#xD;
      metabolic syndrome through trial-based exercise intervention; and (3) exploring the changes&#xD;
      of sleep patterns and intestinal microflora in patients with metabolic liver disease after&#xD;
      exercise intervention.&#xD;
&#xD;
      Materials &amp; methods: The investigators will first retrospective collect clinical and&#xD;
      histologic data of patients with biopsy proven NAFLD. Second, the investigators will&#xD;
      establish a non-invasive fatty liver detection and staging platform at National Taiwan&#xD;
      University Hospital. The investigators then plan to enroll 100 patients with non-alcoholic&#xD;
      fatty liver from NTUH employees. The investigators will collect all basic information&#xD;
      including intrahepatic fat and fibrosis severity, and assign them to the exercise&#xD;
      intervention group (n = 80) and the observation group (n = 20) after conditional screening.&#xD;
      After one year of exercise intervention, the investigators will analyze the effect of&#xD;
      exercise on intrahepatic fat (main parameter: 20% reduction in intrahepatic fat; 30% achieved&#xD;
      in the exercise intervention group; 5% achieved in the control group) and related metabolic&#xD;
      syndrome indicators, and analyze different types of exercise Whether the intervention has&#xD;
      different effects, and analyze the improvement of sleep pattern and intestinal microflora&#xD;
      after exercise intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 25, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>The investigators will collect all basic information including intrahepatic fat and fibrosis severity, and assign them to the exercise intervention group (n = 80) and the observation group (n = 20) after conditional screening.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>20% reduction in intrahepatic fat</measure>
    <time_frame>24 weeks.</time_frame>
    <description>We aim to evaluate whether active exercise can help reduce the fat content of the liver. After 24-week exercise intervention, the effect of exercise on the reduction of intrahepatic fat content in cases (active exercise) versus controls (no exercise) will be assessed by MRS/PDFF</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement of intrahepatic fibrosis</measure>
    <time_frame>24 weeks</time_frame>
    <description>We also aim to evaluate whether active exercise can help reduce the fibrosis of the liver. After 24-week exercise intervention, the effect of exercise on the reduction of intrahepatic fat content in cases (active exercise) versus controls (no exercise) will be assessed by Fibroscan examination.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Fatty Liver</condition>
  <condition>NAFLD</condition>
  <arm_group>
    <arm_group_label>The effects of exercise intervention on fatty liver</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The effects of exercise intervention on fatty liver and the improvement of the above-mentioned various metabolic indicators, including improvement of sleep patterns and changes of intestinal microflora.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>exercise</intervention_name>
    <description>Collect all basic information including intrahepatic fat and fibrosis severity, and assign them to the exercise intervention group (n = 80) and the observation group (n = 20) after conditional screening.</description>
    <arm_group_label>The effects of exercise intervention on fatty liver</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  non-alcoholic fatty liver from NTUH employees&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not suitable for exercise (severe cardiovascular disease or severe limb and joint&#xD;
             disease), patients with inherited hyperlipidemia (diabetes&gt; 300 mg / dL or low-density&#xD;
             lipoprotein cholesterol&gt; 190 mg / dL or cardiovascular disease has occurred before the&#xD;
             age of 60 )event).&#xD;
&#xD;
          -  women exclude pregnancy and breastfeeding.&#xD;
&#xD;
          -  liver cancer, AFP&gt; 20 ng/ml.&#xD;
&#xD;
          -  alcohol and drug abusers.&#xD;
&#xD;
          -  the use of steroids, sex hormones, immunosuppressants, radiation exposure and&#xD;
             chemotherapy within 3 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chun-Jen Liu, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Internal Medicine, NTUH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei City</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 26, 2023</last_update_submitted>
  <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Taiwan University Hospital</investigator_affiliation>
    <investigator_full_name>Statistical Center, NTUHCTC</investigator_full_name>
    <investigator_title>Professor Chun-Jen Liu</investigator_title>
  </responsible_party>
  <keyword>NAFLED</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>
  <patient_data>
    <sharing_ipd>No</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/NCT04463667
org study id: 202002056RIND
nct id: NCT04463667
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In Taiwan, with the westernization of eating habit and lifestyle, metabolic syndrome and
      non-alcoholic fatty liver (NAFLD) have become very important health issues. This project will
      therefore study the histological and clinical data of patients with non-alcoholic fatty liver
      disease and explore the impact of exercise intervention on the hepatic fatty infiltration of
      the patients. The research strategy will include (1) combining modern artificial big data
      collection technology to fully monitor the daily life, sleep and exercise patterns of the
      participants; (2) improving fatty liver and metabolic syndrome through trial-based exercise
      intervention; and (3) exploring the changes of sleep patterns and intestinal microflora in
      patients with metabolic liver disease after exercise intervention.
Background & aims: In Taiwan, with the investigators sternization of eating habit and
      lifestyle, metabolic syndrome and non-alcoholic fatty liver (NAFLD) have become very
      important health issues. This project will therefore study the histological and clinical data
      of patients with non-alcoholic fatty liver disease and explore the impact of exercise
      intervention on the hepatic fatty infiltration of the patients. The research strategy will
      include (1) combining modern artificial big data collection technology to fully monitor the
      daily life, sleep and exercise patterns of the participants; (2) improving fatty liver and
      metabolic syndrome through trial-based exercise intervention; and (3) exploring the changes
      of sleep patterns and intestinal microflora in patients with metabolic liver disease after
      exercise intervention.

      Materials & methods: The investigators will first retrospective collect clinical and
      histologic data of patients with biopsy proven NAFLD. Second, the investigators will
      establish a non-invasive fatty liver detection and staging platform at National Taiwan
      University Hospital. The investigators then plan to enroll 100 patients with non-alcoholic
      fatty liver from NTUH employees. The investigators will collect all basic information
      including intrahepatic fat and fibrosis severity, and assign them to the exercise
      intervention group (n = 80) and the observation group (n = 20) after conditional screening.
      After one year of exercise intervention, the investigators will analyze the effect of
      exercise on intrahepatic fat (main parameter: 20% reduction in intrahepatic fat; 30% achieved
      in the exercise intervention group; 5% achieved in the control group) and related metabolic
      syndrome indicators, and analyze different types of exercise Whether the intervention has
      different effects, and analyze the improvement of sleep pattern and intestinal microflora
      after exercise intervention.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The investigators will collect all basic information including intrahepatic fat and fibrosis severity, and assign them to the exercise intervention group (n = 80) and the observation group (n = 20) after conditional screening.
primary purpose: Other
masking: None (Open Label)
measure: 20% reduction in intrahepatic fat
time frame: 24 weeks.
description: We aim to evaluate whether active exercise can help reduce the fat content of the liver. After 24-week exercise intervention, the effect of exercise on the reduction of intrahepatic fat content in cases (active exercise) versus controls (no exercise) will be assessed by MRS/PDFF
measure: Improvement of intrahepatic fibrosis
time frame: 24 weeks
description: We also aim to evaluate whether active exercise can help reduce the fibrosis of the liver. After 24-week exercise intervention, the effect of exercise on the reduction of intrahepatic fat content in cases (active exercise) versus controls (no exercise) will be assessed by Fibroscan examination.
arm group label: The effects of exercise intervention on fatty liver
arm group type: Experimental
description: The effects of exercise intervention on fatty liver and the improvement of the above-mentioned various metabolic indicators, including improvement of sleep patterns and changes of intestinal microflora.
intervention type: Other
intervention name: exercise
description: Collect all basic information including intrahepatic fat and fibrosis severity, and assign them to the exercise intervention group (n = 80) and the observation group (n = 20) after conditional screening.
arm group label: The effects of exercise intervention on fatty liver
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Chun-Jen Liu, Doctor
role: Principal Investigator
affiliation: Department of Internal Medicine, NTUH
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Taiwan University Hospital
investigator full name: Statistical Center, NTUHCTC
investigator title: Professor Chun-Jen Liu
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
sharing ipd: No