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Trial record 6 of 8 for:    XYLOSE OR XYLO-PFAN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03243994
Recruitment Status : Completed
First Posted : August 9, 2017
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
Jens Rikardt Andersen, University of Copenhagen

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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Cor Pulmonale Diagnostic Test: Absorption test with D-xylose and zink Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
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
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Small Intestinal Absorption in Patients With Chronic Obstructive Pulmonary Disease Complicated by Cor Pulmonale: A Pilot Study
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : October 1, 2016
Actual Study Completion Date : October 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: COPD
Patients with COPD without Cor Pulmonale
Diagnostic Test: Absorption test with D-xylose and zink
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.

Experimental: COPD + Cor Pulmonale
Patients with Cor Pulmonale in addition
Diagnostic Test: Absorption test with D-xylose and zink
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 Measures :
  1. Absorption fraction of D-xylose [ Time Frame: 3 hours ]
    plasma concentration, mmol/l


Secondary Outcome Measures :
  1. Absorption of zinc [ Time Frame: 3 hours ]
    plasma concentration, micromol/l

  2. Absorption fraction of D-xylose [ Time Frame: 5 hours ]
    urine excretion, mmol



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03243994


Sponsors and Collaborators
Jens Rikardt Andersen
Investigators
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Principal Investigator: Jens R Andersen, MD, MPA University of Copenhagen

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Responsible Party: Jens Rikardt Andersen, Associate Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03243994     History of Changes
Other Study ID Numbers: H-15019987
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jens Rikardt Andersen, University of Copenhagen:
Cor pulmonale
COPD
Malabsorption
D-xylose
Zinc

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pulmonary Heart Disease
Respiratory Tract Diseases
Heart Diseases
Cardiovascular Diseases