<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/NCT03811236</url>
  </required_header>
  <id_info>
    <org_study_id>1911/2017</org_study_id>
    <nct_id>NCT03811236</nct_id>
  </id_info>
  <brief_title>Cold-induced Brown Fat Activation and Hepatic Steatosis</brief_title>
  <official_title>Cold-induced Brown Fat Activation and Hepatic Steatosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</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 the recent years, research on brown adipose tissue (BAT) revealed that larger amounts as&#xD;
      well as higher activity thereof are associated with a favourable metabolic phenotype.&#xD;
      Longitudinal studies which applied recurrent cooling sessions demonstrated a high plasticity&#xD;
      of BAT which significantly increased in size and activity during these studies. These changes&#xD;
      were accompanied by improvements in body fat mass as well as insulin sensitivity.&#xD;
      Non-alcoholic fatty liver disease (NAFLD) is estimated to advance to the primary cause of&#xD;
      liver cirrhosis and hepatocellular carcinoma in the following years. Besides predisposing&#xD;
      genetic and possibly nutritional factors, the insulin resistance syndrome and obesity are the&#xD;
      main factors contributing to this excessive hepatic lipid accumulation.&#xD;
&#xD;
      The aim of this study is to investigate whether BAT recruitment via cold-acclimation results&#xD;
      in decreased hepatic lipid content in overweight/obese patients with NAFLD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    due to the COVID pandemic&#xD;
  </why_stopped>
  <start_date type="Actual">January 21, 2019</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">August 2024</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>Basic Science</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hepatic lipid content (%)</measure>
    <time_frame>Six weeks</time_frame>
    <description>Magnetic resonance imaging-proton density fat fraction</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brown adipose tissue volume (ml) / activity (SUVmean)</measure>
    <time_frame>Six weeks</time_frame>
    <description>18-fluorodeoxyglucose positron emission tomography/ magnetic resonance imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Basal metabolic rate (kcal/day/kg fat-free body mass)</measure>
    <time_frame>Six weeks</time_frame>
    <description>Indirect calorimetry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cold-induced non-shivering thermogenesis (%)</measure>
    <time_frame>Six weeks</time_frame>
    <description>Indirect calorimetry: percentage increase in basal metabolic rate before and after cold exposure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body fat mass (kg)</measure>
    <time_frame>Six weeks</time_frame>
    <description>Air displacement plethysmography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin sensitivity</measure>
    <time_frame>Six weeks</time_frame>
    <description>&quot;Matsuda Index&quot; for 2 hour standard oral glucose tolerance test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">26</enrollment>
  <condition>Non-Alcoholic Fatty Liver Disease</condition>
  <arm_group>
    <arm_group_label>Cold exposure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Room temperature</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cold exposure</intervention_name>
    <description>Two hours of mild cold exposure using a water-perfused vest</description>
    <arm_group_label>Cold exposure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  body mass index 28 - 40 kg/m^2&#xD;
&#xD;
          -  hepatic lipid content &gt; 10 %&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  endocrine disease, except treated hypo-/hyperthyroidism and hypertriglyceridemia (&lt;500&#xD;
             mg/dl) and untreated type II diabetes mellitus (fasting glucose &lt; 140 mg/dl)&#xD;
&#xD;
          -  use of beta-blockers, alpha-blockers and rilmenidine&#xD;
&#xD;
          -  chronic kidney disease&#xD;
&#xD;
          -  inflammatory bowel disease&#xD;
&#xD;
          -  active malignant disease&#xD;
&#xD;
          -  autoimmune disease&#xD;
&#xD;
          -  chronic alcohol abuse or alcohol consumption greater than 30g/d for men or 20 g/d for&#xD;
             women&#xD;
&#xD;
          -  transferrin saturation &gt; 40%&#xD;
&#xD;
          -  serum alpha-1 antitrypsin &lt; 90 mg/dl&#xD;
&#xD;
          -  serum ceruloplasmin &lt; 20 mg/dl&#xD;
&#xD;
          -  positive serology for autoimmune hepatitis&#xD;
&#xD;
          -  positive hepatitis serology&#xD;
&#xD;
          -  liver cirrhosis&#xD;
&#xD;
          -  portal hypertension&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  contraindications for magnetic resonance imaging&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Florian Kiefer, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Vienna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>April 5, 2022</last_update_submitted>
  <last_update_submitted_qc>April 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Dr. Florian Kiefer</investigator_full_name>
    <investigator_title>Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <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/NCT03811236
org study id: 1911/2017
nct id: NCT03811236
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In the recent years, research on brown adipose tissue (BAT) revealed that larger amounts as
      well as higher activity thereof are associated with a favourable metabolic phenotype.
      Longitudinal studies which applied recurrent cooling sessions demonstrated a high plasticity
      of BAT which significantly increased in size and activity during these studies. These changes
      were accompanied by improvements in body fat mass as well as insulin sensitivity.
      Non-alcoholic fatty liver disease (NAFLD) is estimated to advance to the primary cause of
      liver cirrhosis and hepatocellular carcinoma in the following years. Besides predisposing
      genetic and possibly nutritional factors, the insulin resistance syndrome and obesity are the
      main factors contributing to this excessive hepatic lipid accumulation.

      The aim of this study is to investigate whether BAT recruitment via cold-acclimation results
      in decreased hepatic lipid content in overweight/obese patients with NAFLD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
measure: Hepatic lipid content (%)
time frame: Six weeks
description: Magnetic resonance imaging-proton density fat fraction
measure: Brown adipose tissue volume (ml) / activity (SUVmean)
time frame: Six weeks
description: 18-fluorodeoxyglucose positron emission tomography/ magnetic resonance imaging
measure: Basal metabolic rate (kcal/day/kg fat-free body mass)
time frame: Six weeks
description: Indirect calorimetry
measure: Cold-induced non-shivering thermogenesis (%)
time frame: Six weeks
description: Indirect calorimetry: percentage increase in basal metabolic rate before and after cold exposure
measure: Body fat mass (kg)
time frame: Six weeks
description: Air displacement plethysmography
measure: Insulin sensitivity
time frame: Six weeks
description: "Matsuda Index" for 2 hour standard oral glucose tolerance test
arm group label: Cold exposure
arm group type: Experimental
arm group label: Room temperature
arm group type: No Intervention
intervention type: Other
intervention name: Cold exposure
description: Two hours of mild cold exposure using a water-perfused vest
arm group label: Cold exposure
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Florian Kiefer, MD, PhD
role: Principal Investigator
affiliation: Medical University of Vienna
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Dr. Florian Kiefer
investigator title: Associate Professor of Medicine
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
sharing ipd: No