Chronic Obstructive Pulmonary DiseaseNCT03243994
Small Intestinal Absorption in Patients With Chronic Obstructive Pulmonary Disease and Cor Pulmonale
A study testing Absorption test with D-xylose and zink in people with Chronic Obstructive Pulmonary Disease and Cor Pulmonale, run by Jens Rikardt Andersen.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Cor Pulmonale
- What is being tested?
- Absorption test with D-xylose and zink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2016to 1 Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of COPD
- Clinically stable = Unchanged medication for COPD for at least 6 months
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Being tested
- Absorption test with D-xylose and zink
- Keywords
- Cor pulmonale, COPD, Malabsorption, D-xylose, Zinc
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Pulmonary Heart Disease, Malabsorption Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absorption test with D-xylose and zinkDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| COPD | Experimental | Patients with COPD without Cor Pulmonale Receives: Diagnostic Test: Absorption test with D-xylose and zink |
| COPD + Cor Pulmonale | Experimental | Patients with Cor Pulmonale in addition Receives: Diagnostic Test: Absorption test with D-xylose and zink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absorption fraction of D-xylose
plasma concentration, mmol/l
Measured: 3 hours
Secondary outcomes (2)
Absorption of zinc
plasma concentration, micromol/l
Measured: 3 hours
Absorption fraction of D-xylose
urine excretion, mmol
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start1 Feb 2016
- Primary completion1 Oct 2016
- Study completion1 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All patients had Chronic Obstructive Lung Disease. Those with additional Cor pulmonale was compared to those without
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jens Rikardt Andersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jens Rikardt Andersen, University of Copenhagen
- Investigators
- Jens R Andersen, MD, MPA, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243994
- Sponsor's protocol ID
- H-15019987
- Status last verified
- Aug 2017
- First submitted
- 7 Jul 2017
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Intestinal Absorption in Patients With Chronic Obstructive Pulmonary Disease Complicated by Cor Pulmonale: A Pilot Study
- ClinicalTrials.gov ID
- NCT03243994
- Acronym / sponsor ID
- H-15019987
- Keywords
- Cor pulmonale, COPD, Malabsorption, D-xylose, Zinc
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Jens Rikardt AndersenUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 Oct 2016 (actual)
- Study completion
- 1 Oct 2016 (actual)
- First posted
- 9 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All patients had Chronic Obstructive Lung Disease. Those with additional Cor pulmonale was compared to those without
| Arm | Type | Receives |
|---|---|---|
| COPD | Experimental | Diagnostic Test: Absorption test with D-xylose and zinkPatients with COPD without Cor Pulmonale |
| COPD + Cor Pulmonale | Experimental | Diagnostic Test: Absorption test with D-xylose and zinkPatients with Cor Pulmonale in addition |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A diagnosis of COPD
- Clinically stable = Unchanged medication for COPD for at least 6 months
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Absorption test with D-xylose and zinkAbsorption 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. | Diagnostic test | COPD, COPD + Cor Pulmonale |
Primary outcome
Absorption fraction of D-xylose
Time frame: 3 hours
plasma concentration, mmol/l
2 secondary outcomes
Absorption of zinc
Time frame: 3 hours
Absorption fraction of D-xylose
Time frame: 5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Individual participant dataSharing planned: No. No plans
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens R Andersen, MD, MPA principal investigator
University of Copenhagen
Questions about this trial
What is this clinical trial studying?
A study testing Absorption test with D-xylose and zink in people with Chronic Obstructive Pulmonary Disease and Cor Pulmonale, run by Jens Rikardt Andersen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absorption fraction of D-xylose (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017.