<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/NCT03243994</url>
  </required_header>
  <id_info>
    <org_study_id>H-15019987</org_study_id>
    <nct_id>NCT03243994</nct_id>
  </id_info>
  <brief_title>Small Intestinal Absorption in Patients With Chronic Obstructive Pulmonary Disease and Cor Pulmonale</brief_title>
  <official_title>Small Intestinal Absorption in Patients With Chronic Obstructive Pulmonary Disease Complicated by Cor Pulmonale: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jens Rikardt Andersen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Copenhagen</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>
      Aim: To investigate whether patients with pulmonary hypertension have reduced absorption&#xD;
      capacity compared to COPD patients without cor pulmonale potentially due to venous&#xD;
      obstruction in the portal vein system.&#xD;
&#xD;
      The presence of cor pulmonale was determined by echocardiography. The concentration of&#xD;
      D-xylose and zinc were measured in peripheral blood one, two and three hours after ingestion&#xD;
      and used as markers of absorption. Furthermore, urine was collected for five hours to&#xD;
      determine the amount of excreted D-xylose.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Cor pulmonale is a common complication to Chronic Obstructive Pulmonary Disease&#xD;
      (COPD), and may result in increased pressure in the inferior caval vein and stasis of the&#xD;
      liver. The chronic pulmonary hypertension may lead to stasis in the veins from the small&#xD;
      intestine and thereby compromise absorption of nutrients.&#xD;
&#xD;
      Aim: To investigate whether patients with pulmonary hypertension have reduced absorption&#xD;
      capacity compared to COPD patients without cor pulmonale.&#xD;
&#xD;
      Methods: Absorption of D-xylose (25 g) and zinc (132 mg), administered as a single dose, was&#xD;
      tested in 14 COPD patients, seven with and seven without cor pulmonale. The presence of cor&#xD;
      pulmonale was determined by echocardiography. The concentration of D-xylose and zinc were&#xD;
      measured in peripheral blood one, two and three hours after ingestion and used as markers of&#xD;
      absorption. Furthermore, urine was collected for five hours to determine the amount of&#xD;
      excreted D-xylose.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2016</start_date>
  <completion_date type="Actual">October 1, 2016</completion_date>
  <primary_completion_date type="Actual">October 1, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>All patients had Chronic Obstructive Lung Disease. Those with additional Cor pulmonale was compared to those without</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Absorption fraction of D-xylose</measure>
    <time_frame>3 hours</time_frame>
    <description>plasma concentration, mmol/l</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Absorption of zinc</measure>
    <time_frame>3 hours</time_frame>
    <description>plasma concentration, micromol/l</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absorption fraction of D-xylose</measure>
    <time_frame>5 hours</time_frame>
    <description>urine excretion, mmol</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <condition>Cor Pulmonale</condition>
  <arm_group>
    <arm_group_label>COPD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with COPD without Cor Pulmonale</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COPD + Cor Pulmonale</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with Cor Pulmonale in addition</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Absorption test with D-xylose and zink</intervention_name>
    <description>Absorption of D-xylose (25 g) and zinc (132 mg), administered as a single dose. The concentration of D-xylose and zinc was measured in peripheral blood one, two and three hours after ingestion and used as markers of absorption. Furthermore, urine was collected for five hours to determine the amount of excreted D-xylose.</description>
    <arm_group_label>COPD</arm_group_label>
    <arm_group_label>COPD + Cor Pulmonale</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A diagnosis of COPD&#xD;
&#xD;
          -  Clinically stable = Unchanged medication for COPD for at least 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to understand Danish&#xD;
&#xD;
          -  Other clinically important heart-disease than chronic right heart changes presumably&#xD;
             due to lung disease&#xD;
&#xD;
          -  Clinically significant gastro-intestinal or kidney disease&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Treatment with corticosteroids for at least 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jens R Andersen, MD, MPA</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Copenhagen</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>August 4, 2017</last_update_submitted>
  <last_update_submitted_qc>August 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Copenhagen</investigator_affiliation>
    <investigator_full_name>Jens Rikardt Andersen</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Cor pulmonale</keyword>
  <keyword>COPD</keyword>
  <keyword>Malabsorption</keyword>
  <keyword>D-xylose</keyword>
  <keyword>Zinc</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Pulmonary Heart Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plans</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/NCT03243994
org study id: H-15019987
nct id: NCT03243994
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aim: To investigate whether patients with pulmonary hypertension have reduced absorption
      capacity compared to COPD patients without cor pulmonale potentially due to venous
      obstruction in the portal vein system.

      The presence of cor pulmonale was determined by echocardiography. The concentration of
      D-xylose and zinc were measured in peripheral blood one, two and three hours after ingestion
      and used as markers of absorption. Furthermore, urine was collected for five hours to
      determine the amount of excreted D-xylose.
Background: Cor pulmonale is a common complication to Chronic Obstructive Pulmonary Disease
      (COPD), and may result in increased pressure in the inferior caval vein and stasis of the
      liver. The chronic pulmonary hypertension may lead to stasis in the veins from the small
      intestine and thereby compromise absorption of nutrients.

      Aim: To investigate whether patients with pulmonary hypertension have reduced absorption
      capacity compared to COPD patients without cor pulmonale.

      Methods: Absorption of D-xylose (25 g) and zinc (132 mg), administered as a single dose, was
      tested in 14 COPD patients, seven with and seven without cor pulmonale. The presence of cor
      pulmonale was determined by echocardiography. The concentration of D-xylose and zinc were
      measured in peripheral blood one, two and three hours after ingestion and used as markers of
      absorption. Furthermore, urine was collected for five hours to determine the amount of
      excreted D-xylose.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: All patients had Chronic Obstructive Lung Disease. Those with additional Cor pulmonale was compared to those without
primary purpose: Diagnostic
masking: None (Open Label)
measure: Absorption fraction of D-xylose
time frame: 3 hours
description: plasma concentration, mmol/l
measure: Absorption of zinc
time frame: 3 hours
description: plasma concentration, micromol/l
measure: Absorption fraction of D-xylose
time frame: 5 hours
description: urine excretion, mmol
arm group label: COPD
arm group type: Experimental
description: Patients with COPD without Cor Pulmonale
arm group label: COPD + Cor Pulmonale
arm group type: Experimental
description: Patients with Cor Pulmonale in addition
intervention type: Diagnostic Test
intervention name: Absorption test with D-xylose and zink
description: Absorption of D-xylose (25 g) and zinc (132 mg), administered as a single dose. The concentration of D-xylose and zinc was measured in peripheral blood one, two and three hours after ingestion and used as markers of absorption. Furthermore, urine was collected for five hours to determine the amount of excreted D-xylose.
arm group label: COPD
arm group label: COPD + Cor Pulmonale
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Jens R Andersen, MD, MPA
role: Principal Investigator
affiliation: University of Copenhagen
responsible party type: Sponsor-Investigator
investigator affiliation: University of Copenhagen
investigator full name: Jens Rikardt Andersen
investigator title: Associate Professor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Pulmonary Heart Disease
sharing ipd: No
ipd description: No plans