<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/NCT03242798</url>
  </required_header>
  <id_info>
    <org_study_id>105</org_study_id>
    <nct_id>NCT03242798</nct_id>
  </id_info>
  <brief_title>Assessment of Nutritional Status of Patients With Liver Cirrhosis</brief_title>
  <official_title>Assessment of Nutritional Status of Patients With Liver Cirrhosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Harokopio University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Laikο General Hospital, Athens</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Harokopio University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cirrhosis is the twelfth leading cause of death worldwide. Malnutrition is prevalent among&#xD;
      cirrhotic patients and is an important prognostic factor. Nutritional assessment is therefore&#xD;
      crucial for identifying patients at risk or with already established malnutrition and refer&#xD;
      them for nutritional intervention and support. In the current literature, nutritional&#xD;
      assessment of cirrhotic patients is performed using several tools and methods. However their&#xD;
      accuracy is widely affected by the underline disease and its complications. In addition, for&#xD;
      the majority of the parameters under study, no gold standard tools and methods have been&#xD;
      established so far. Studies on nutritional assessment in cirrhosis usually focus on one or&#xD;
      few aspects of nutritional status and not on a full nutritional assessment combining&#xD;
      information from medical, biochemical, nutritional, and body composition variables. Hence,&#xD;
      the present study aims at a thorough assessment of the nutritional status of 170 cirrhotic&#xD;
      patients using multiple widely available tools and methods, in order to assess their accuracy&#xD;
      and estimate the prevalence of multiple malnutrition phenotypes such as undernutrition,&#xD;
      sarcopenia, sarcopenic obesity and cachexia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study sample will comprise of 170 adults with biopsy proven cirrhosis. A detailed medical&#xD;
      and nutritional assessment will be implemented at baseline. For patients that will receive an&#xD;
      intervention aiming at the cause of cirrhosis (e.g. antivirus therapy for HCV or HBV) the&#xD;
      baseline assessment will take place before the beginning of the therapy and will be repeated&#xD;
      three months after the completion of the medical intervention to explore the impact of the&#xD;
      intervention on nutritional status. Data regarding the survival of all the patients will be&#xD;
      collected one year after the baseline assessment.&#xD;
&#xD;
      More specifically regarding the detailed assessment, firstly, hepatologists of the research&#xD;
      team will complete a full medical record regarding the primary disease, cirrhosis'&#xD;
      complications, comorbidities and medication. The severity of cirrhosis will be assessed using&#xD;
      the Child-Pugh score. Furthermore, in the Laboratory of Clinical Nutrition &amp; Dietetics at&#xD;
      Harokopio University, patients will participate in the following procedures:&#xD;
&#xD;
        -  Anthropometry: Weight, height, waist and mid-arm circumference, and triceps skinfold&#xD;
           will be measured. Body mass index, mid-arm muscle circumference and area will be&#xD;
           estimated using standard equations.&#xD;
&#xD;
        -  Body composition analysis: Total body DXA (Lunar DPX-MD, Madison, WI, USA) will be&#xD;
           performed.&#xD;
&#xD;
        -  Muscle strength and performance status: Handgrip strength measurement based on certain&#xD;
           protocol and the &quot;Short Physical Performance Battery&quot; tool will be implemented.&#xD;
&#xD;
        -  Dietary intake evaluation: Three non-consecutive 24h recalls (two weekdays and one&#xD;
           weekend day) will be recorded. Data will be analyzed to estimate energy, macro- and&#xD;
           micronutrients intake (Nutritionist Pro software, 2.2 version). Food group intake and&#xD;
           meal patterns will also be evaluated.&#xD;
&#xD;
        -  Physical activity assessment: Patients' physical activity levels will be assessed using&#xD;
           the &quot;Harokopio Physical Activity Questionnaire&quot;.&#xD;
&#xD;
      For patients with available upper abdomen computed tomographies skeletal muscle index at L3&#xD;
      will be calculated with the software SliceOmatic V5.0 software, Tomovision, Montreal, PQ. In&#xD;
      addition, patients' nutritional risk or nutritional status will be assessed through several&#xD;
      previously validated tools like the Subjective Global Assessment, the Royal Free Hospital&#xD;
      Global assessment scheme and Liver Disease Undernutrition Screening Tool, the efficacy of&#xD;
      which will be tested in the present study. Patients will be also categorized according to&#xD;
      ESPEN's recent malnutrition diagnostic criteria.&#xD;
&#xD;
      The full assessment will be repeated only for patients who will receive an intervention&#xD;
      aiming at the cause of cirrhosis (e.g. antivirus therapy for HCV or HBV) three months after&#xD;
      the completion of the medical intervention.&#xD;
&#xD;
      One year after the baseline assessment of the study samples, data will be collected regarding&#xD;
      survival, development of complications and decompensated cirrhosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 3, 2016</start_date>
  <completion_date type="Actual">March 2020</completion_date>
  <primary_completion_date type="Actual">October 2018</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>Prevalence of malnutrition phenotypes.</measure>
    <time_frame>Baseline</time_frame>
    <description>Prevalence of different malnutrition phenotypes (e.g. undernutrition, sarcopenia, sarcopenic obesity), in cirrhotic patients of different disease stages, by implementing a thorough nutritional assessment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survival.</measure>
    <time_frame>One year after baseline measurements</time_frame>
    <description>Assessment of survival one year after baseline measurements and association with the malnutrition phenotypes at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Validity test of available tools.</measure>
    <time_frame>Baseline</time_frame>
    <description>Test the sensitivity, specificity, positive and negative prognostic values of already available tools for nutritional screening or assessment against a combined index as the reference tool. If no tool is estimated as valid, a new combination of nutritional, biochemical and/or clinical parameters will be synthesized and its validity as a new screening or assessment tool will be assessed for the detection of cirrhotic patients at risk of malnutrition or already malnourished.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutritional status after medical treatment according to the etiology of cirrhosis.</measure>
    <time_frame>6 months after baseline measurements</time_frame>
    <description>Changes in the nutritional status after medical treatment according to the etiology of cirrhosis, namely antivirus therapy for HCV or HBV cirrhosis, abstinence from alcohol in the alcoholic cirrhosis, immunosuppressive therapy in autoimmune cirrhosis.</description>
  </secondary_outcome>
  <enrollment type="Actual">201</enrollment>
  <condition>Cirrhosis</condition>
  <condition>Malnutrition</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study sample will comprise of 170 adults with biopsy proven cirrhosis visiting hospital&#xD;
        Liver Outpatient Clinics in Athens, Greece.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Adults with biopsy proven cirrhosis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with hepatocellular carcinoma, in hepatic coma, with acquired immunodeficiency&#xD;
        syndrome, with renal or pancreatic insufficiency, receiving enteral nutrition or being&#xD;
        pregnant, will be excluded.&#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>Meropi D. Kontogianni, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Harokopio University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Harokopio University</name>
      <address>
        <city>Kallithea</city>
        <state>Attiki</state>
        <zip>17671</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>August 27, 2022</last_update_submitted>
  <last_update_submitted_qc>August 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Harokopio University</investigator_affiliation>
    <investigator_full_name>Meropi Kontogianni</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>liver cirrhosis</keyword>
  <keyword>malnutrition</keyword>
  <keyword>nutritional status</keyword>
  <keyword>nutritional assessment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Malnutrition</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will be available upon demand.</ipd_description>
  </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/NCT03242798
org study id: 105
nct id: NCT03242798
lead sponsor: 
collaborator: 
has dmc: No
Cirrhosis is the twelfth leading cause of death worldwide. Malnutrition is prevalent among
      cirrhotic patients and is an important prognostic factor. Nutritional assessment is therefore
      crucial for identifying patients at risk or with already established malnutrition and refer
      them for nutritional intervention and support. In the current literature, nutritional
      assessment of cirrhotic patients is performed using several tools and methods. However their
      accuracy is widely affected by the underline disease and its complications. In addition, for
      the majority of the parameters under study, no gold standard tools and methods have been
      established so far. Studies on nutritional assessment in cirrhosis usually focus on one or
      few aspects of nutritional status and not on a full nutritional assessment combining
      information from medical, biochemical, nutritional, and body composition variables. Hence,
      the present study aims at a thorough assessment of the nutritional status of 170 cirrhotic
      patients using multiple widely available tools and methods, in order to assess their accuracy
      and estimate the prevalence of multiple malnutrition phenotypes such as undernutrition,
      sarcopenia, sarcopenic obesity and cachexia.
The study sample will comprise of 170 adults with biopsy proven cirrhosis. A detailed medical
      and nutritional assessment will be implemented at baseline. For patients that will receive an
      intervention aiming at the cause of cirrhosis (e.g. antivirus therapy for HCV or HBV) the
      baseline assessment will take place before the beginning of the therapy and will be repeated
      three months after the completion of the medical intervention to explore the impact of the
      intervention on nutritional status. Data regarding the survival of all the patients will be
      collected one year after the baseline assessment.

      More specifically regarding the detailed assessment, firstly, hepatologists of the research
      team will complete a full medical record regarding the primary disease, cirrhosis'
      complications, comorbidities and medication. The severity of cirrhosis will be assessed using
      the Child-Pugh score. Furthermore, in the Laboratory of Clinical Nutrition & Dietetics at
      Harokopio University, patients will participate in the following procedures:

        -  Anthropometry: Weight, height, waist and mid-arm circumference, and triceps skinfold
           will be measured. Body mass index, mid-arm muscle circumference and area will be
           estimated using standard equations.

        -  Body composition analysis: Total body DXA (Lunar DPX-MD, Madison, WI, USA) will be
           performed.

        -  Muscle strength and performance status: Handgrip strength measurement based on certain
           protocol and the "Short Physical Performance Battery" tool will be implemented.

        -  Dietary intake evaluation: Three non-consecutive 24h recalls (two weekdays and one
           weekend day) will be recorded. Data will be analyzed to estimate energy, macro- and
           micronutrients intake (Nutritionist Pro software, 2.2 version). Food group intake and
           meal patterns will also be evaluated.

        -  Physical activity assessment: Patients' physical activity levels will be assessed using
           the "Harokopio Physical Activity Questionnaire".

      For patients with available upper abdomen computed tomographies skeletal muscle index at L3
      will be calculated with the software SliceOmatic V5.0 software, Tomovision, Montreal, PQ. In
      addition, patients' nutritional risk or nutritional status will be assessed through several
      previously validated tools like the Subjective Global Assessment, the Royal Free Hospital
      Global assessment scheme and Liver Disease Undernutrition Screening Tool, the efficacy of
      which will be tested in the present study. Patients will be also categorized according to
      ESPEN's recent malnutrition diagnostic criteria.

      The full assessment will be repeated only for patients who will receive an intervention
      aiming at the cause of cirrhosis (e.g. antivirus therapy for HCV or HBV) three months after
      the completion of the medical intervention.

      One year after the baseline assessment of the study samples, data will be collected regarding
      survival, development of complications and decompensated cirrhosis.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of malnutrition phenotypes.
time frame: Baseline
description: Prevalence of different malnutrition phenotypes (e.g. undernutrition, sarcopenia, sarcopenic obesity), in cirrhotic patients of different disease stages, by implementing a thorough nutritional assessment.
measure: Survival.
time frame: One year after baseline measurements
description: Assessment of survival one year after baseline measurements and association with the malnutrition phenotypes at baseline.
measure: Validity test of available tools.
time frame: Baseline
description: Test the sensitivity, specificity, positive and negative prognostic values of already available tools for nutritional screening or assessment against a combined index as the reference tool. If no tool is estimated as valid, a new combination of nutritional, biochemical and/or clinical parameters will be synthesized and its validity as a new screening or assessment tool will be assessed for the detection of cirrhotic patients at risk of malnutrition or already malnourished.
measure: Nutritional status after medical treatment according to the etiology of cirrhosis.
time frame: 6 months after baseline measurements
description: Changes in the nutritional status after medical treatment according to the etiology of cirrhosis, namely antivirus therapy for HCV or HBV cirrhosis, abstinence from alcohol in the alcoholic cirrhosis, immunosuppressive therapy in autoimmune cirrhosis.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Meropi D. Kontogianni, PhD
role: Study Director
affiliation: Harokopio University
facility: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: Harokopio University
investigator full name: Meropi Kontogianni
investigator title: Assistant Professor
mesh term: Liver Cirrhosis
mesh term: Malnutrition
mesh term: Fibrosis
sharing ipd: No
ipd description: Data will be available upon demand.