<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/NCT03787108</url>
  </required_header>
  <id_info>
    <org_study_id>NL64534.068.18</org_study_id>
    <nct_id>NCT03787108</nct_id>
  </id_info>
  <brief_title>Measuring Fatty Liver With Ultrasound and MRS in Children With Overweight or Obesity</brief_title>
  <official_title>Measuring Fatty Liver With Ultrasound and MRS in Children With Overweight or Obesity (Dutch Title: Het Meten Van Leververvetting Met Echo en MRS in Kinderen Met Overgewicht of Obesitas)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maastricht University Medical Center</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>
      Obesity is associated with a variety of comorbidities, amongst which non-alcoholic fatty&#xD;
      liver disease (NAFLD). A recent meta-analysis has shown that the prevalence of NAFLD in obese&#xD;
      pediatric populations is around 35%, compared to approximately 8% in general pediatric&#xD;
      populations, making it a very important health threat in these populations. The golden&#xD;
      standard for diagnosis of NAFLD is liver biopsy. However, since liver biopsy is associated&#xD;
      with a certain risk of morbidity and mortality, this method is inappropriate for screening&#xD;
      large populations at-risk for developing NAFLD. Magnetic resonance spectroscopy has&#xD;
      demonstrated excellent correlation with liver biopsy and the is the most accuratete&#xD;
      non-invasive method to measure liver fat content in children. However, MRS is expensive and&#xD;
      not available in all centres. A novel ultrasonographic measurement to quantitatively assess&#xD;
      liver steatosis is the hepatorenal index (HRI). Previous studies have shown high sensitivity&#xD;
      and specificity of the HRI, as compared to MRS and liver biopsy. However, this measurement&#xD;
      has never been validated in children. In this study, the HRI will be compared to MRS in&#xD;
      children with obesity, to validate the HRI and to determine cut-off points.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale: Obesity is associated with a variety of co-morbidities. Children with obesity are&#xD;
      more likely to have risk factors associated with cardiovascular disease (eg, hypertension,&#xD;
      high cholesterol, and type 2 diabetes mellitus), but also non-alcoholic fatty liver disease&#xD;
      (NAFLD). A recent meta-analysis has shown that the prevalence of NAFLD in obese pediatric&#xD;
      populations is approximately 35%, compared to approximately 8% in general pediatric&#xD;
      populations [6], making it a very important health threat in these populations. The golden&#xD;
      standard for the diagnosis of NAFLD is liver biopsy. However, since liver biopsy is&#xD;
      associated with a certain risk of morbidity and mortality, this method is inappropriate for&#xD;
      screening large populations at-risk for developing NAFLD. Magnetic resonance spectroscopy has&#xD;
      demonstrated excellent correlation with liver biopsy and the most accurate non-invasive&#xD;
      method to measure liver fat content in children. However, MRS is an expensive method that is&#xD;
      not available in all centers. A novel ultrasonographic measurement to quantitatively assess&#xD;
      liver steatosis is the hepatorenal index (HRI), which is calculated as the ratio of hepatic&#xD;
      and renal ultrasonographic brightness. Previous studies in adults have shown a high&#xD;
      sensitivity and specificity of the HRI, as compared to liver biopsy as well as H-MRS.&#xD;
      However, the measurement of the HRI has never been validated in children. The validation of&#xD;
      this simple, non-invasive method to quantitatively assess fat accumulation in the liver,&#xD;
      could improve the screening for, and follow-up of, NAFLD in at-risk populations.&#xD;
&#xD;
      Objective: The aim of this study is to validate the ultrasonographic hepatorenal index in&#xD;
      children with overweight, obesity and morbid obesity, by using MRS, and to determine cut-off&#xD;
      points for the HRI according to liver fat percentages measured with MRS.&#xD;
&#xD;
      Study design: cross-sectional study&#xD;
&#xD;
      Study population: Overweight and obese children from the Centre for Overweight Adolescent and&#xD;
      Childrens Healthcare (COACH) program.&#xD;
&#xD;
      Main study parameters/endpoints: Ultrasonographic hepato-renal index and liver fat percentage&#xD;
      as determined by magnetic resonance spectroscopy.&#xD;
&#xD;
      Secondary study parameters/endpoints: correlate liver fat percentage as measured with MRS,&#xD;
      and HRI, with anthropometric, metabolic and cardiovascular parameters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">March 31, 2019</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>Ultrasonographic hepato-renal index</measure>
    <time_frame>Until december 2019</time_frame>
    <description>Ratio of hepatic and renal echogenicity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Liver fat percentage</measure>
    <time_frame>Until december 2019</time_frame>
    <description>Liver fat percentage will be measured withmagnetic resonance spectroscopy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BMI z-score</measure>
    <time_frame>Until december 2019</time_frame>
    <description>Secondary outcomes will be correlated with liver fat percentage as measured with MRS and with the ultrasonographic hepato-renal index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liver enzyme levels</measure>
    <time_frame>Until december 2019</time_frame>
    <description>Secondary outcomes will be correlated with liver fat percentage as measured with MRS and with the ultrasonographic hepato-renal index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fibrosan values</measure>
    <time_frame>Until december 2019</time_frame>
    <description>Secondary outcomes will be correlated with liver fat percentage as measured with MRS and with the ultrasonographic hepato-renal index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid spectrum</measure>
    <time_frame>Until december 2019</time_frame>
    <description>Secondary outcomes will be correlated with liver fat percentage as measured with MRS and with the ultrasonographic hepato-renal index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose metabolism</measure>
    <time_frame>Until december 2019</time_frame>
    <description>Secondary outcomes will be correlated with liver fat percentage as measured with MRS and with the ultrasonographic hepato-renal index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Until december 2019</time_frame>
    <description>Secondary outcomes will be correlated with liver fat percentage as measured with MRS and with the ultrasonographic hepato-renal index</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">53</enrollment>
  <condition>Non-Alcoholic Fatty Liver Disease</condition>
  <arm_group>
    <arm_group_label>Children with suspected NAFLD</arm_group_label>
    <description>Children with overweight or obesity. Both children that are and children that are not suspected of having NAFLD (based on ultrasound and laboratory findings) are included.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Magnetic resonance spectroscopy measurement</intervention_name>
    <description>Magnetic resonance spectroscopy measurement will be performed to measure liver fat content.</description>
    <arm_group_label>Children with suspected NAFLD</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All consecutive participants in the COACH program (children with overweight or obesity),&#xD;
        that meet the inclusion criteria, will be invited to participate in this study, until the&#xD;
        calculated sample size is reached.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participation in the COACH program&#xD;
&#xD;
          -  Aged below 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  · Implanted medical devices such as pacemakers or neurostimulators&#xD;
&#xD;
               -  Metal objects in the body (for instances prosthetics, piercings, metal parts in&#xD;
                  the eye, permanent eyeliner)&#xD;
&#xD;
               -  Previous brain surgery&#xD;
&#xD;
               -  Cardiac arrhythmia&#xD;
&#xD;
               -  Epilepsy&#xD;
&#xD;
               -  Claustrofobia&#xD;
&#xD;
               -  Not wanting to be informed about accidental findings on MRS&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Anita Vreugdenhil</last_name>
    <phone>0031 43 3875284</phone>
    <email>a.vreugdenhil@mumc.nl</email>
  </overall_contact>
  <location>
    <facility>
      <name>Maastricht University Medical Center</name>
      <address>
        <city>Maastricht</city>
        <state>Limburg</state>
        <zip>6202AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anita Vreugdenhil, Dr.</last_name>
      <phone>0031 (0)43 387 5284</phone>
    </contact>
    <contact_backup>
      <last_name>Kylie Karnebeek, Drs.</last_name>
      <phone>0031 (0)43 387 4402</phone>
    </contact_backup>
    <investigator>
      <last_name>Anita Vreugdenhil, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kylie Karnebeek, Drs.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jogchum Plat, Prof. dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Vera Schrauwen - Hinderling, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Simon Robben, Prof. dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>October 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>March 20, 2019</last_update_submitted>
  <last_update_submitted_qc>March 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Non-Alcoholic Fatty Liver Disease</keyword>
  <keyword>Magnetic Resonance Spectroscopy</keyword>
  <keyword>Ultrasonographic hepatorenal index</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>
    <mesh_term>Overweight</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/NCT03787108
org study id: NL64534.068.18
nct id: NCT03787108
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Obesity is associated with a variety of comorbidities, amongst which non-alcoholic fatty
      liver disease (NAFLD). A recent meta-analysis has shown that the prevalence of NAFLD in obese
      pediatric populations is around 35%, compared to approximately 8% in general pediatric
      populations, making it a very important health threat in these populations. The golden
      standard for diagnosis of NAFLD is liver biopsy. However, since liver biopsy is associated
      with a certain risk of morbidity and mortality, this method is inappropriate for screening
      large populations at-risk for developing NAFLD. Magnetic resonance spectroscopy has
      demonstrated excellent correlation with liver biopsy and the is the most accuratete
      non-invasive method to measure liver fat content in children. However, MRS is expensive and
      not available in all centres. A novel ultrasonographic measurement to quantitatively assess
      liver steatosis is the hepatorenal index (HRI). Previous studies have shown high sensitivity
      and specificity of the HRI, as compared to MRS and liver biopsy. However, this measurement
      has never been validated in children. In this study, the HRI will be compared to MRS in
      children with obesity, to validate the HRI and to determine cut-off points.
Rationale: Obesity is associated with a variety of co-morbidities. Children with obesity are
      more likely to have risk factors associated with cardiovascular disease (eg, hypertension,
      high cholesterol, and type 2 diabetes mellitus), but also non-alcoholic fatty liver disease
      (NAFLD). A recent meta-analysis has shown that the prevalence of NAFLD in obese pediatric
      populations is approximately 35%, compared to approximately 8% in general pediatric
      populations [6], making it a very important health threat in these populations. The golden
      standard for the diagnosis of NAFLD is liver biopsy. However, since liver biopsy is
      associated with a certain risk of morbidity and mortality, this method is inappropriate for
      screening large populations at-risk for developing NAFLD. Magnetic resonance spectroscopy has
      demonstrated excellent correlation with liver biopsy and the most accurate non-invasive
      method to measure liver fat content in children. However, MRS is an expensive method that is
      not available in all centers. A novel ultrasonographic measurement to quantitatively assess
      liver steatosis is the hepatorenal index (HRI), which is calculated as the ratio of hepatic
      and renal ultrasonographic brightness. Previous studies in adults have shown a high
      sensitivity and specificity of the HRI, as compared to liver biopsy as well as H-MRS.
      However, the measurement of the HRI has never been validated in children. The validation of
      this simple, non-invasive method to quantitatively assess fat accumulation in the liver,
      could improve the screening for, and follow-up of, NAFLD in at-risk populations.

      Objective: The aim of this study is to validate the ultrasonographic hepatorenal index in
      children with overweight, obesity and morbid obesity, by using MRS, and to determine cut-off
      points for the HRI according to liver fat percentages measured with MRS.

      Study design: cross-sectional study

      Study population: Overweight and obese children from the Centre for Overweight Adolescent and
      Childrens Healthcare (COACH) program.

      Main study parameters/endpoints: Ultrasonographic hepato-renal index and liver fat percentage
      as determined by magnetic resonance spectroscopy.

      Secondary study parameters/endpoints: correlate liver fat percentage as measured with MRS,
      and HRI, with anthropometric, metabolic and cardiovascular parameters.
observational model: Cohort
time perspective: Prospective
measure: Ultrasonographic hepato-renal index
time frame: Until december 2019
description: Ratio of hepatic and renal echogenicity
measure: Liver fat percentage
time frame: Until december 2019
description: Liver fat percentage will be measured withmagnetic resonance spectroscopy.
measure: BMI z-score
time frame: Until december 2019
description: Secondary outcomes will be correlated with liver fat percentage as measured with MRS and with the ultrasonographic hepato-renal index
measure: Liver enzyme levels
time frame: Until december 2019
description: Secondary outcomes will be correlated with liver fat percentage as measured with MRS and with the ultrasonographic hepato-renal index
measure: Fibrosan values
time frame: Until december 2019
description: Secondary outcomes will be correlated with liver fat percentage as measured with MRS and with the ultrasonographic hepato-renal index
measure: Lipid spectrum
time frame: Until december 2019
description: Secondary outcomes will be correlated with liver fat percentage as measured with MRS and with the ultrasonographic hepato-renal index
measure: Glucose metabolism
time frame: Until december 2019
description: Secondary outcomes will be correlated with liver fat percentage as measured with MRS and with the ultrasonographic hepato-renal index
measure: Blood pressure
time frame: Until december 2019
description: Secondary outcomes will be correlated with liver fat percentage as measured with MRS and with the ultrasonographic hepato-renal index
arm group label: Children with suspected NAFLD
description: Children with overweight or obesity. Both children that are and children that are not suspected of having NAFLD (based on ultrasound and laboratory findings) are included.
intervention type: Other
intervention name: Magnetic resonance spectroscopy measurement
description: Magnetic resonance spectroscopy measurement will be performed to measure liver fat content.
arm group label: Children with suspected NAFLD
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 17 Years
healthy volunteers: No
last name: Anita Vreugdenhil
phone: 0031 43 3875284
email: a.vreugdenhil@mumc.nl
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Netherlands
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
mesh term: Overweight
sharing ipd: Undecided