<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/NCT04474743</url>
  </required_header>
  <id_info>
    <org_study_id>A 2018-0129</org_study_id>
    <nct_id>NCT04474743</nct_id>
  </id_info>
  <brief_title>Malnutrition in Chronic Gastrointestinal Diseases, Cross-sectional Study</brief_title>
  <official_title>Multi-center, Controlled Cross-sectional Analysis of the Phenotype of Malnutrition in Patients With Liver Cirrhosis, Chronic Pancreatitis and Short Bowel Syndrome (as Part of the Joint Project &quot;Enteral Nutrition in Malnutrition Due to Diseases of the Gastrointestinal Tract: From Basic Understanding to an Innovative Treatment Concept&quot; (EnErGie))</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medicine Greifswald</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Medical Center Rostock</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Applied Sciences Neubrandenburg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Leibniz Institute for Farm Animal Biology (FBN)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Medicine Greifswald</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>
      Malnutrition and muscle wasting are common consequences of life-threatening, chronic diseases&#xD;
      of the gastrointestinal tract. Such diseases include liver cirrhosis, chronic pancreatitis&#xD;
      and short bowel syndrome. Malnutrition and muscle wasting increase the risk of complications,&#xD;
      reduce the life expectancy and impair the quality of life. The development of malnutrition&#xD;
      and muscle wasting is different, as is the diagnosis and nutritional treatment. There are&#xD;
      also different mechanisms of origin for the underlying diseases. The aim of the study is to&#xD;
      compare data related to nutrition and physical condition of patients with liver cirrhosis,&#xD;
      chronic pancreatitis and short bowel syndrome. Malnutrition and muscle wasting within the&#xD;
      specific diseases will be characterized and possible correlations will be identified.&#xD;
&#xD;
      For this, malnourished and non-malnourished patients of the different diseases are compared&#xD;
      with controls patients with non-specific complaints of the gastrointestinal tract as well as&#xD;
      with healthy study participants.&#xD;
&#xD;
      Data on food intake, physical activity, body composition and body measurements as well as&#xD;
      muscle strength and muscle function are recorded. Blood values as well as transport and&#xD;
      barrier properties of the intestine will also be examined.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Malnutrition and sarcopenia are consequences of life-threatening gastroenterological diseases&#xD;
      such as liver cirrhosis, chronic pancreatitis and short bowel syndrome and are associated&#xD;
      with a poorer clinical outcome and a reduced quality of life. The diagnostic criteria of both&#xD;
      conditions differ, as do the consequences for adequate nutritional therapy. Nevertheless,&#xD;
      malnutrition and sarcopenia are often discussed in confusion in the literature. In addition,&#xD;
      the underlying mechanisms of malnutrition and sarcopenia can differ in the various diseases.&#xD;
      The aim of the study is to compare nutrition-associated parameters from patients with liver&#xD;
      cirrhosis, chronic pancreatitis and short bowel syndrome, to characterize the&#xD;
      disease-specific phenotype of malnutrition and sarcopenia of the examined diseases and to&#xD;
      obtain information on mechanistic relationships. The pathophysiological understanding of the&#xD;
      clinical settings as well as the development of malnutrition and sarcopenia is important for&#xD;
      choosing specific nutritional therapies. For this, malnourished and non-malnourished patients&#xD;
      of each examined disease are compared with controls from patients with non-specific,&#xD;
      abdominal symptoms and healthy control subjects. Data on food intake, physical activity, body&#xD;
      composition and anthropometry as well as muscle strength and muscle function are recorded.&#xD;
      Clinical and chemical blood parameters, the plasma metabolome as well as transport and&#xD;
      barrier proteins of the intestine are also examined.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2018</start_date>
  <completion_date type="Actual">September 13, 2021</completion_date>
  <primary_completion_date type="Actual">September 13, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sarcopenia</measure>
    <time_frame>Baseline</time_frame>
    <description>Descriptive and inferential determination of the prevalence of sarcopenia according to the European Working Group on Sarcopenia in Older People 2 criteria (EWGSOP2 criteria) in malnourished and non malnourished patients with liver cirrhosis, chronic pancreatitis or short bowel syndrome - as a total group and separated by type of disease</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantitative Food Intake</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of quantitative food intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Qualitative Food Intake</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of qualitative food intake assessed by the Study of Health in Pomerania Food Frequency Questionnaire (SHIP-FFQ) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of physical activity assessed by the International Physical Activity Questionnaire (IPAQ) Short Form in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Weight</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of body weight measured in kilograms in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Height</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of height measured in meters in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of body mass index in kg/m^2 (calculated from the values obtained for body weight and height) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Waist Circumference</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of waist circumference measured in centimeters in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hip Circumference</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of hip circumference measured in centimeters in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Waist-to-Hip Ratio</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of waist-to-hip ratio (calculated from the values obtained for waist and hip circumference) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Upper Arm Circumference</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of upper arm circumference measured in centimeters in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Triceps Skinfold Thickness</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of triceps skinfold thickness measured in millimeters in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fat Free Mass</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of fat free mass measured by Bioelectrical Impedance Analysis (BIA) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Skeletal Muscle Mass</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of skeletal muscle mass measured by Bioelectrical Impedance Analysis (BIA) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fat Mass</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of fat mass measured by Bioelectrical Impedance Analysis (BIA) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Body Water</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of total body water measured by Bioelectrical Impedance Analysis (BIA) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Extracellular Water</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of extracellular water measured by Bioelectrical Impedance Analysis (BIA) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase Angle</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of phase angle measured by Bioelectrical Impedance Analysis (BIA) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle Strength</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of muscle strength measured by a handgrip strength dynamometer in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hemoglobin</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of hemoglobin level in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hematocrit</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of hematocrit level in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Corpuscular Volume</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of mean corpuscular volume in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Corpuscular Hemoglobin Concentration</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of mean corpuscular hemoglobin concentration in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reticulocyte Count</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of reticulocyte count in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sodium</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of plasma concentration of sodium in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Potassium</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of plasma concentration of potassium in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Calcium</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of plasma concentration of calcium in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Magnesium</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of plasma concentration of magnesium in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phosphate</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of plasma concentration of phosphate in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Aspartate Transaminase</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of plasma concentration of aspartate transferase in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alanine Aminotransferase</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of plasma concentration of alanine aminotransferase in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gamma-glutamyl Transferase</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of plasma concentration of gamma-glutamyl transferase in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alkaline Phosphatase</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of plasma concentration of alkaline phosphatase in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bilirubin</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of plasma concentration of bilirubin in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>C-reactive Protein</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of plasma concentration of C-reactive protein in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interleukin-1 Beta</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of serum concentration of interleukin-1 beta in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interleukin-6</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of plasma concentration of interleukin-6 in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tumor Necrosis Factor Alpha</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of serum concentration of tumor necrosis factor alpha in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Albumin</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of plasma concentration of albumin in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Creatinine</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of plasma concentration of creatinine in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urea</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of plasma concentration of urea in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Uric Acid</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of plasma concentration of uric acid in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glucose</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of plasma concentration of glucose in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glycated hemoglobin</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of plasma concentration of glycated hemoglobin in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Insulin</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of plasma concentration of insulin in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Cholesterol</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of plasma concentration of total cholesterol in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>High-density Lipoprotein Cholesterol</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of plasma concentration of high-density lipoprotein cholesterol in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Low-density Lipoprotein Cholesterol</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of plasma concentration of low-density lipoprotein cholesterol in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of plasma concentration of triglycerides in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Non-essential Fatty Acids</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of plasma concentration of non-essential fatty acids in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Zinc</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of serum concentration of zinc in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Iron</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of plasma concentration of iron in comparison to control patients and in comparison to healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Metabolome</measure>
    <time_frame>Baseline</time_frame>
    <description>In a participants subgroup, investigations of the plasma metabolome in comparison with control patients and in comparison with healthy control subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intestinal Barrier Function</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of the intestinal barrier function in a patient subgroup in comparison to control patients (using proximal small intestinal biopsies, qRT-PCR (Real Time Polymerase Chain Reaction) of different intestinal barrier markers)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Expression of Intestinal Ion Transporters</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of the expression of intestinal ion transporters in a patient subgroup in comparison to control patients (using proximal small intestinal biopsies, qRT-PCR (Real Time Polymerase Chain Reaction) of different intestinal transport markers)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Malnutrition-Sarcopenia Score</measure>
    <time_frame>Baseline</time_frame>
    <description>Correlative, factorial or other presentation of the results including statistical-mathematical argumentation of the usefulness of a combined malnutrition-sarcopenia score (MaSa score) for practical application.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Validity of the Study of Health in Pomerania Food Frequency Questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of the validity of the Study of Health in Pomerania Food Frequency Questionnaire (SHIP-FFQ) by assessment of percent agreement with the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Factor Analysis of Phenotypes of Sarcopenia and Malnutrition</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of parameters characterizing phenotypes of sarcopenia and malnutrition in the investigated gastroenterological disease (liver cirrhosis, chronic pancreatitis, short bowel syndrome) by factor analysis</description>
  </secondary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Actual">345</enrollment>
  <condition>Liver Cirrhoses</condition>
  <condition>Chronic Pancreatitis</condition>
  <condition>Short Bowel Syndrome</condition>
  <arm_group>
    <arm_group_label>Liver Cirrhosis</arm_group_label>
    <description>Patients diagnosed with liver cirrhosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic Pancreatitis</arm_group_label>
    <description>Patients diagnosed with chronic pancreatitis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Short Bowel Syndrome</arm_group_label>
    <description>Patients diagnosed with short bowel Syndrome.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Patients</arm_group_label>
    <description>Otherwise healthy patients visiting hospital with other non-severe diseases.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Controls</arm_group_label>
    <description>Healthy subjects recruited from the general population.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention - cross-sectional observational only</intervention_name>
    <description>No intervention - cross-sectional observational only</description>
    <arm_group_label>Chronic Pancreatitis</arm_group_label>
    <arm_group_label>Control Patients</arm_group_label>
    <arm_group_label>Healthy Controls</arm_group_label>
    <arm_group_label>Liver Cirrhosis</arm_group_label>
    <arm_group_label>Short Bowel Syndrome</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood Plasma, Faeces, Urine, Proximal Small Intestinal Biopsies&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients eligible for study participation will be recruited at the University hospitals in&#xD;
        the cities of Rostock and Greifswald (Northeast Germany). Hospitalized as well&#xD;
        outcare-patients will be considered for recruitment. Healthy controls will be recruited&#xD;
        from the general public in the city of Neubrandenburg (Northeast Germany).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Liver Cirrhosis:&#xD;
&#xD;
          -  based on clinical and imaging criteria (sonography or computed tomography (CT) or&#xD;
             magnetic resonance imaging (MRI)) without evidence of hepatocellular carcinoma&#xD;
&#xD;
          -  Child-Pugh Stadium A-C&#xD;
&#xD;
        Chronic Pancreatitis:&#xD;
&#xD;
          -  based on imaging criteria (endoscopic ultrasound, computed tomography (CT), magnetic&#xD;
             resonance imaging (MRI), magnetic resonance cholangiopancreatography (MRCP))&#xD;
&#xD;
          -  large and small duct disease&#xD;
&#xD;
          -  with or without exocrine insufficiency&#xD;
&#xD;
          -  with or without endocrine insufficiency&#xD;
&#xD;
          -  patients after left pancreatic resection or pancreaticojejunostomy or duodenal&#xD;
             pancreatic head resection&#xD;
&#xD;
        Short Bowel Syndrome (SBS):&#xD;
&#xD;
        - based on clinical anamnestic criteria and state after bowel resection followed by primary&#xD;
        or secondary oral autonomy (intestinal failure)&#xD;
&#xD;
        Control Patients:&#xD;
&#xD;
          -  patients without known underlying gastroenterological disease with an indication for&#xD;
             esophago-gastro-duodenoscopy for symptom clarification&#xD;
&#xD;
          -  negative Nutritional Risk Screening (NRS-2002 &lt; 3)&#xD;
&#xD;
          -  gastroscopy without clinically relevant result (mild gastritis aspect, small axial&#xD;
             hernia, typical glandular cysts, typical brunneromas can be included)&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        General Exclusion Criteria:&#xD;
&#xD;
          -  parenteral nutrition in the previous 6 months&#xD;
&#xD;
          -  pacemaker or implanted defibrillator&#xD;
&#xD;
          -  pregnancy or lactation&#xD;
&#xD;
          -  lack of ability to answer the questionnaires&#xD;
&#xD;
          -  taking certain medications during the previous 4 weeks (protein pump inhibitors and H2&#xD;
             antagonists, except medication on demand or ≤ 4 weeks continuously, antibiotics,&#xD;
             narcotics, non-opioid analgesics except medication on demand (≤ 1 day/week),&#xD;
             anticholinergics, antidepressants, motility drugs (metoclopramide, motilium,&#xD;
             bromocriptine, prucalopride), thyroid drugs except stable thyroid hormone substitution&#xD;
             with euthyroid metabolism, steroids, immunomodulators, anti-inflammatory biologics)&#xD;
&#xD;
        Subsequent Exclusion of Control Patients:&#xD;
&#xD;
          -  if, contrary to expectations, malnutrition is diagnosed in spite of an inconspicuous&#xD;
             NRS-2002 within the framework of the study&#xD;
&#xD;
          -  as well as in the case of relevant, conspicuous esophago-gastro-duodenoscopy findings&#xD;
&#xD;
        Specific Exclusion Criteria:&#xD;
&#xD;
        Liver Cirrhosis:&#xD;
&#xD;
          -  steatohepatitis according to clinical or laboratory parameters&#xD;
&#xD;
          -  acute alcoholic hepatitis according to clinical and imaging parameters (sonography,&#xD;
             CT, MRI)&#xD;
&#xD;
          -  existing transjugular intrahepatic portosystemic shunt (TIPS)&#xD;
&#xD;
          -  known hepatocellular carcinoma (HCC)&#xD;
&#xD;
          -  state after liver transplantation&#xD;
&#xD;
        Chronic Pancreatitis:&#xD;
&#xD;
          -  acute pancreatitis&#xD;
&#xD;
          -  extrapancreatic infection&#xD;
&#xD;
          -  coexisting liver cirrhosis based on clinical and imaging parameters&#xD;
&#xD;
          -  state after surgery with alteration of food flow (partial or total&#xD;
             pancreaticoduodenectomy)&#xD;
&#xD;
          -  known pancreatic carcinoma or state after therapy of pancreatic carcinoma (surgery or&#xD;
             chemotherapy or radiation)&#xD;
&#xD;
        Short Bowel Syndrome (SBS):&#xD;
&#xD;
          -  acute phase of intestinal insufficiency (less than 28 days after resection)&#xD;
&#xD;
          -  intravenous substitution of macronutrients (water, electrolytes, glucose, amino acids&#xD;
             or lipids (intestinal insufficiency)&#xD;
&#xD;
          -  intramuscular substitution of micronutrients is allowed (e.g. vitamin B12)&#xD;
&#xD;
          -  uncontrolled underlying disease leading to SBS (e.g. active Crohn's disease)&#xD;
&#xD;
        Control Patients:&#xD;
&#xD;
          -  major underlying and concomitant diseases&#xD;
&#xD;
          -  food allergies&#xD;
&#xD;
        Healthy controls:&#xD;
&#xD;
          -  tumor diseases in the past 5 years&#xD;
&#xD;
          -  medically diagnosed, serious chronic diseases or changes in the gastrointestinal tract&#xD;
             that may affect the absorption of nutrients (e.g. celiac disease, chronic inflammatory&#xD;
             bowel disease or irritable bowel syndrome diagnosed according to Rome IV criteria,&#xD;
             relevant bowel resections including short bowel syndrome)&#xD;
&#xD;
          -  rheumatic diseases requiring permanent drug therapy (rheumatoid arthritis,&#xD;
             fibromyalgia)&#xD;
&#xD;
          -  chronic use of anti-inflammatory or pain-relieving drugs or use of anti-inflammatory&#xD;
             or pain-relieving drugs for more than 3 days in the last 3 weeks&#xD;
&#xD;
          -  average daily alcohol consumption &gt; 20 g in women and &gt; 30 g in men&#xD;
&#xD;
          -  diagnosed severe liver disease requiring medical attention and drug therapy (liver&#xD;
             cirrhosis, non-alcoholic steatohepatitis (NASH) / alcoholic steatohepatitis (ASH),&#xD;
             hepatitides)&#xD;
&#xD;
          -  acute or chronic pancreatitis&#xD;
&#xD;
          -  acute and chronic renal failure&#xD;
&#xD;
          -  myocardial infarction or cerebral insult within 6 months prior to examination&#xD;
&#xD;
          -  coronary artery disease/pAVK (peripheral artery disease (PAD))&#xD;
&#xD;
          -  heart failure with stages 3 and 4 according to NYHA (New York Heart Association)&#xD;
             classification&#xD;
&#xD;
          -  severe chronic pulmonary disease (COPD)&#xD;
&#xD;
          -  history of significant neurological or psychiatric diseases (including epilepsy,&#xD;
             bipolar disorders, dementia and neuromuscular diseases)&#xD;
&#xD;
          -  presence of pareses including mono- and diparesis&#xD;
&#xD;
          -  rare congenital metabolic diseases (cystic fibrosis, phenylketonuria)&#xD;
&#xD;
          -  expected altered body composition (extreme sports activity &lt; 2h/day), edema,&#xD;
             amputation of the extremities (arm and/or leg)&#xD;
&#xD;
          -  highly atypical or restrictive dietary choices/concepts followed voluntarily&#xD;
             (macrobiotics, paleo-diet, Atkins diet, Mayo diet, instinctive diets) or due to food&#xD;
             intolerances/allergies&#xD;
&#xD;
          -  simultaneous participation in other studies associated with drug use and potentially&#xD;
             having a significant impact on body composition or dietary behaviour&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Prof. Dr. med. Lamprecht</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medicine Rostock</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Medicine Greifswald</name>
      <address>
        <city>Greifswald</city>
        <zip>17475</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Applied Sciences Neubrandenburg</name>
      <address>
        <city>Neubrandenburg</city>
        <zip>17033</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univeristy Medicine Rostock</name>
      <address>
        <city>Rostock</city>
        <zip>18057</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>November 1, 2021</last_update_submitted>
  <last_update_submitted_qc>November 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 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>Pancreatitis</mesh_term>
    <mesh_term>Pancreatitis, Chronic</mesh_term>
    <mesh_term>Short Bowel Syndrome</mesh_term>
    <mesh_term>Malnutrition</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT04474743
org study id: A 2018-0129
nct id: NCT04474743
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Malnutrition and muscle wasting are common consequences of life-threatening, chronic diseases
      of the gastrointestinal tract. Such diseases include liver cirrhosis, chronic pancreatitis
      and short bowel syndrome. Malnutrition and muscle wasting increase the risk of complications,
      reduce the life expectancy and impair the quality of life. The development of malnutrition
      and muscle wasting is different, as is the diagnosis and nutritional treatment. There are
      also different mechanisms of origin for the underlying diseases. The aim of the study is to
      compare data related to nutrition and physical condition of patients with liver cirrhosis,
      chronic pancreatitis and short bowel syndrome. Malnutrition and muscle wasting within the
      specific diseases will be characterized and possible correlations will be identified.

      For this, malnourished and non-malnourished patients of the different diseases are compared
      with controls patients with non-specific complaints of the gastrointestinal tract as well as
      with healthy study participants.

      Data on food intake, physical activity, body composition and body measurements as well as
      muscle strength and muscle function are recorded. Blood values as well as transport and
      barrier properties of the intestine will also be examined.
Malnutrition and sarcopenia are consequences of life-threatening gastroenterological diseases
      such as liver cirrhosis, chronic pancreatitis and short bowel syndrome and are associated
      with a poorer clinical outcome and a reduced quality of life. The diagnostic criteria of both
      conditions differ, as do the consequences for adequate nutritional therapy. Nevertheless,
      malnutrition and sarcopenia are often discussed in confusion in the literature. In addition,
      the underlying mechanisms of malnutrition and sarcopenia can differ in the various diseases.
      The aim of the study is to compare nutrition-associated parameters from patients with liver
      cirrhosis, chronic pancreatitis and short bowel syndrome, to characterize the
      disease-specific phenotype of malnutrition and sarcopenia of the examined diseases and to
      obtain information on mechanistic relationships. The pathophysiological understanding of the
      clinical settings as well as the development of malnutrition and sarcopenia is important for
      choosing specific nutritional therapies. For this, malnourished and non-malnourished patients
      of each examined disease are compared with controls from patients with non-specific,
      abdominal symptoms and healthy control subjects. Data on food intake, physical activity, body
      composition and anthropometry as well as muscle strength and muscle function are recorded.
      Clinical and chemical blood parameters, the plasma metabolome as well as transport and
      barrier proteins of the intestine are also examined.
observational model: Other
time perspective: Cross-Sectional
measure: Sarcopenia
time frame: Baseline
description: Descriptive and inferential determination of the prevalence of sarcopenia according to the European Working Group on Sarcopenia in Older People 2 criteria (EWGSOP2 criteria) in malnourished and non malnourished patients with liver cirrhosis, chronic pancreatitis or short bowel syndrome - as a total group and separated by type of disease
measure: Quantitative Food Intake
time frame: Baseline
description: Determination of quantitative food intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
measure: Qualitative Food Intake
time frame: Baseline
description: Determination of qualitative food intake assessed by the Study of Health in Pomerania Food Frequency Questionnaire (SHIP-FFQ) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
measure: Physical Activity
time frame: Baseline
description: Determination of physical activity assessed by the International Physical Activity Questionnaire (IPAQ) Short Form in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
measure: Body Weight
time frame: Baseline
description: Determination of body weight measured in kilograms in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
measure: Height
time frame: Baseline
description: Determination of height measured in meters in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
measure: Body Mass Index
time frame: Baseline
description: Determination of body mass index in kg/m^2 (calculated from the values obtained for body weight and height) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
measure: Waist Circumference
time frame: Baseline
description: Determination of waist circumference measured in centimeters in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
measure: Hip Circumference
time frame: Baseline
description: Determination of hip circumference measured in centimeters in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
measure: Waist-to-Hip Ratio
time frame: Baseline
description: Determination of waist-to-hip ratio (calculated from the values obtained for waist and hip circumference) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
measure: Upper Arm Circumference
time frame: Baseline
description: Determination of upper arm circumference measured in centimeters in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
measure: Triceps Skinfold Thickness
time frame: Baseline
description: Determination of triceps skinfold thickness measured in millimeters in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
measure: Fat Free Mass
time frame: Baseline
description: Determination of fat free mass measured by Bioelectrical Impedance Analysis (BIA) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
measure: Skeletal Muscle Mass
time frame: Baseline
description: Determination of skeletal muscle mass measured by Bioelectrical Impedance Analysis (BIA) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
measure: Fat Mass
time frame: Baseline
description: Determination of fat mass measured by Bioelectrical Impedance Analysis (BIA) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
measure: Total Body Water
time frame: Baseline
description: Determination of total body water measured by Bioelectrical Impedance Analysis (BIA) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
measure: Extracellular Water
time frame: Baseline
description: Determination of extracellular water measured by Bioelectrical Impedance Analysis (BIA) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
measure: Phase Angle
time frame: Baseline
description: Determination of phase angle measured by Bioelectrical Impedance Analysis (BIA) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
measure: Muscle Strength
time frame: Baseline
description: Determination of muscle strength measured by a handgrip strength dynamometer in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
measure: Hemoglobin
time frame: Baseline
description: Determination of hemoglobin level in comparison to control patients and in comparison to healthy control subjects
measure: Hematocrit
time frame: Baseline
description: Determination of hematocrit level in comparison to control patients and in comparison to healthy control subjects
measure: Mean Corpuscular Volume
time frame: Baseline
description: Determination of mean corpuscular volume in comparison to control patients and in comparison to healthy control subjects
measure: Mean Corpuscular Hemoglobin Concentration
time frame: Baseline
description: Determination of mean corpuscular hemoglobin concentration in comparison to control patients and in comparison to healthy control subjects
measure: Reticulocyte Count
time frame: Baseline
description: Determination of reticulocyte count in comparison to control patients and in comparison to healthy control subjects
measure: Sodium
time frame: Baseline
description: Determination of plasma concentration of sodium in comparison to control patients and in comparison to healthy control subjects
measure: Potassium
time frame: Baseline
description: Determination of plasma concentration of potassium in comparison to control patients and in comparison to healthy control subjects
measure: Calcium
time frame: Baseline
description: Determination of plasma concentration of calcium in comparison to control patients and in comparison to healthy control subjects
measure: Magnesium
time frame: Baseline
description: Determination of plasma concentration of magnesium in comparison to control patients and in comparison to healthy control subjects
measure: Phosphate
time frame: Baseline
description: Determination of plasma concentration of phosphate in comparison to control patients and in comparison to healthy control subjects
measure: Aspartate Transaminase
time frame: Baseline
description: Determination of plasma concentration of aspartate transferase in comparison to control patients and in comparison to healthy control subjects
measure: Alanine Aminotransferase
time frame: Baseline
description: Determination of plasma concentration of alanine aminotransferase in comparison to control patients and in comparison to healthy control subjects
measure: Gamma-glutamyl Transferase
time frame: Baseline
description: Determination of plasma concentration of gamma-glutamyl transferase in comparison to control patients and in comparison to healthy control subjects
measure: Alkaline Phosphatase
time frame: Baseline
description: Determination of plasma concentration of alkaline phosphatase in comparison to control patients and in comparison to healthy control subjects
measure: Bilirubin
time frame: Baseline
description: Determination of plasma concentration of bilirubin in comparison to control patients and in comparison to healthy control subjects
measure: C-reactive Protein
time frame: Baseline
description: Determination of plasma concentration of C-reactive protein in comparison to control patients and in comparison to healthy control subjects
measure: Interleukin-1 Beta
time frame: Baseline
description: Determination of serum concentration of interleukin-1 beta in comparison to control patients and in comparison to healthy control subjects
measure: Interleukin-6
time frame: Baseline
description: Determination of plasma concentration of interleukin-6 in comparison to control patients and in comparison to healthy control subjects
measure: Tumor Necrosis Factor Alpha
time frame: Baseline
description: Determination of serum concentration of tumor necrosis factor alpha in comparison to control patients and in comparison to healthy control subjects
measure: Albumin
time frame: Baseline
description: Determination of plasma concentration of albumin in comparison to control patients and in comparison to healthy control subjects
measure: Creatinine
time frame: Baseline
description: Determination of plasma concentration of creatinine in comparison to control patients and in comparison to healthy control subjects
measure: Urea
time frame: Baseline
description: Determination of plasma concentration of urea in comparison to control patients and in comparison to healthy control subjects
measure: Uric Acid
time frame: Baseline
description: Determination of plasma concentration of uric acid in comparison to control patients and in comparison to healthy control subjects
measure: Glucose
time frame: Baseline
description: Determination of plasma concentration of glucose in comparison to control patients and in comparison to healthy control subjects
measure: Glycated hemoglobin
time frame: Baseline
description: Determination of plasma concentration of glycated hemoglobin in comparison to control patients and in comparison to healthy control subjects
measure: Insulin
time frame: Baseline
description: Determination of plasma concentration of insulin in comparison to control patients and in comparison to healthy control subjects
measure: Total Cholesterol
time frame: Baseline
description: Determination of plasma concentration of total cholesterol in comparison to control patients and in comparison to healthy control subjects
measure: High-density Lipoprotein Cholesterol
time frame: Baseline
description: Determination of plasma concentration of high-density lipoprotein cholesterol in comparison to control patients and in comparison to healthy control subjects
measure: Low-density Lipoprotein Cholesterol
time frame: Baseline
description: Determination of plasma concentration of low-density lipoprotein cholesterol in comparison to control patients and in comparison to healthy control subjects
measure: Triglycerides
time frame: Baseline
description: Determination of plasma concentration of triglycerides in comparison to control patients and in comparison to healthy control subjects
measure: Non-essential Fatty Acids
time frame: Baseline
description: Determination of plasma concentration of non-essential fatty acids in comparison to control patients and in comparison to healthy control subjects
measure: Zinc
time frame: Baseline
description: Determination of serum concentration of zinc in comparison to control patients and in comparison to healthy control subjects
measure: Iron
time frame: Baseline
description: Determination of plasma concentration of iron in comparison to control patients and in comparison to healthy control subjects
measure: Plasma Metabolome
time frame: Baseline
description: In a participants subgroup, investigations of the plasma metabolome in comparison with control patients and in comparison with healthy control subjects
measure: Intestinal Barrier Function
time frame: Baseline
description: Determination of the intestinal barrier function in a patient subgroup in comparison to control patients (using proximal small intestinal biopsies, qRT-PCR (Real Time Polymerase Chain Reaction) of different intestinal barrier markers)
measure: Expression of Intestinal Ion Transporters
time frame: Baseline
description: Determination of the expression of intestinal ion transporters in a patient subgroup in comparison to control patients (using proximal small intestinal biopsies, qRT-PCR (Real Time Polymerase Chain Reaction) of different intestinal transport markers)
measure: Malnutrition-Sarcopenia Score
time frame: Baseline
description: Correlative, factorial or other presentation of the results including statistical-mathematical argumentation of the usefulness of a combined malnutrition-sarcopenia score (MaSa score) for practical application.
measure: Validity of the Study of Health in Pomerania Food Frequency Questionnaire
time frame: Baseline
description: Determination of the validity of the Study of Health in Pomerania Food Frequency Questionnaire (SHIP-FFQ) by assessment of percent agreement with the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)
measure: Factor Analysis of Phenotypes of Sarcopenia and Malnutrition
time frame: Baseline
description: Determination of parameters characterizing phenotypes of sarcopenia and malnutrition in the investigated gastroenterological disease (liver cirrhosis, chronic pancreatitis, short bowel syndrome) by factor analysis
arm group label: Liver Cirrhosis
description: Patients diagnosed with liver cirrhosis.
arm group label: Chronic Pancreatitis
description: Patients diagnosed with chronic pancreatitis.
arm group label: Short Bowel Syndrome
description: Patients diagnosed with short bowel Syndrome.
arm group label: Control Patients
description: Otherwise healthy patients visiting hospital with other non-severe diseases.
arm group label: Healthy Controls
description: Healthy subjects recruited from the general population.
intervention type: Other
intervention name: No intervention - cross-sectional observational only
description: No intervention - cross-sectional observational only
arm group label: Chronic Pancreatitis
arm group label: Control Patients
arm group label: Healthy Controls
arm group label: Liver Cirrhosis
arm group label: Short Bowel Syndrome
Blood Plasma, Faeces, Urine, Proximal Small Intestinal Biopsies
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Prof. Dr. med. Lamprecht
role: Principal Investigator
affiliation: University Medicine Rostock
facility: 
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Liver Cirrhosis
mesh term: Pancreatitis
mesh term: Pancreatitis, Chronic
mesh term: Short Bowel Syndrome
mesh term: Malnutrition
mesh term: Syndrome
mesh term: Fibrosis