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
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
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
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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