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
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: COPD
Patients with COPD without Cor Pulmonale
|
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
|
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
Time Frame: 3 hours
|
plasma concentration, mmol/l
|
3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Absorption of zinc
Time Frame: 3 hours
|
plasma concentration, micromol/l
|
3 hours
|
|
Absorption fraction of D-xylose
Time Frame: 5 hours
|
urine excretion, mmol
|
5 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jens R Andersen, MD, MPA, University of Copenhagen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-15019987
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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