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Small Intestinal Absorption in Patients With Chronic Obstructive Pulmonary Disease and Cor Pulmonale

Primary Purpose

Chronic Obstructive Pulmonary Disease, Cor Pulmonale

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Absorption test with D-xylose and zink
Sponsored by
Jens Rikardt Andersen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Obstructive Pulmonary Disease focused on measuring Cor pulmonale, COPD, Malabsorption, D-xylose, Zinc

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A diagnosis of COPD
  • Clinically stable = Unchanged medication for COPD for at least 6 months

Exclusion Criteria:

  • Unable to understand Danish
  • Other clinically important heart-disease than chronic right heart changes presumably due to lung disease
  • Clinically significant gastro-intestinal or kidney disease
  • Diabetes
  • Treatment with corticosteroids for at least 6 months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    COPD

    COPD + Cor Pulmonale

    Arm Description

    Patients with COPD without Cor Pulmonale

    Patients with Cor Pulmonale in addition

    Outcomes

    Primary Outcome Measures

    Absorption fraction of D-xylose
    plasma concentration, mmol/l

    Secondary Outcome Measures

    Absorption of zinc
    plasma concentration, micromol/l
    Absorption fraction of D-xylose
    urine excretion, mmol

    Full Information

    First Posted
    July 7, 2017
    Last Updated
    August 4, 2017
    Sponsor
    Jens Rikardt Andersen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03243994
    Brief Title
    Small Intestinal Absorption in Patients With Chronic Obstructive Pulmonary Disease and Cor Pulmonale
    Official Title
    Small Intestinal Absorption in Patients With Chronic Obstructive Pulmonary Disease Complicated by Cor Pulmonale: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2016 (Actual)
    Primary Completion Date
    October 1, 2016 (Actual)
    Study Completion Date
    October 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Jens Rikardt Andersen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease, Cor Pulmonale
    Keywords
    Cor pulmonale, COPD, Malabsorption, D-xylose, Zinc

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    All patients had Chronic Obstructive Lung Disease. Those with additional Cor pulmonale was compared to those without
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    14 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    COPD
    Arm Type
    Experimental
    Arm Description
    Patients with COPD without Cor Pulmonale
    Arm Title
    COPD + Cor Pulmonale
    Arm Type
    Experimental
    Arm Description
    Patients with Cor Pulmonale in addition
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Absorption test with D-xylose and zink
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Absorption fraction of D-xylose
    Description
    plasma concentration, mmol/l
    Time Frame
    3 hours
    Secondary Outcome Measure Information:
    Title
    Absorption of zinc
    Description
    plasma concentration, micromol/l
    Time Frame
    3 hours
    Title
    Absorption fraction of D-xylose
    Description
    urine excretion, mmol
    Time Frame
    5 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: A diagnosis of COPD Clinically stable = Unchanged medication for COPD for at least 6 months Exclusion Criteria: Unable to understand Danish Other clinically important heart-disease than chronic right heart changes presumably due to lung disease Clinically significant gastro-intestinal or kidney disease Diabetes Treatment with corticosteroids for at least 6 months.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jens R Andersen, MD, MPA
    Organizational Affiliation
    University of Copenhagen
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No plans

    Learn more about this trial

    Small Intestinal Absorption in Patients With Chronic Obstructive Pulmonary Disease and Cor Pulmonale

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