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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Cor Pulmonale
• Intervention / Treatment: Diagnostic test: Absorption test with D-xylose and zink

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absorption fraction of D-xylose	plasma concentration, mmol/l	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absorption of zinc	plasma concentration, micromol/l	3 hours
Absorption fraction of D-xylose	urine excretion, mmol	5 hours

Collaborators and Investigators

• Sponsor: Jens Rikardt Andersen
• Investigators: Principal Investigator: Jens R Andersen, MD, MPA, University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: July 7, 2017
• First Submitted That Met QC Criteria: August 4, 2017
• First Posted (Actual): August 9, 2017

Study Record Updates

• Last Update Posted (Actual): August 9, 2017
• Last Update Submitted That Met QC Criteria: August 4, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: COPD; Zinc; Malabsorption; Cor pulmonale; D-xylose
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Heart Disease
• Other Study ID Numbers: H-15019987

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plans

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No