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OpenTrials
Completed

NCT Number: NCT03243994

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Absorption test with D-xylose and zink

Diagnostic Test

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 outcomes

  1. Absorption fraction of D-xylose

    Time frame: 3 hours

    plasma concentration, mmol/l

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Jens Rikardt Andersen

Other

Registry information

Official study title

Small Intestinal Absorption in Patients With Chronic Obstructive Pulmonary Disease Complicated by Cor Pulmonale: A Pilot Study

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 9, 2017
Registry last updated
Aug 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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