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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03243994
Other study ID # H-15019987
Secondary ID
Status Completed
Phase N/A
First received July 7, 2017
Last updated August 4, 2017
Start date February 1, 2016
Est. completion date October 1, 2016

Study information

Verified date August 2017
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date October 1, 2016
Est. primary completion date October 1, 2016
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Jens Rikardt Andersen

Outcome

Type Measure Description Time frame Safety issue
Primary Absorption fraction of D-xylose plasma concentration, mmol/l 3 hours
Secondary Absorption of zinc plasma concentration, micromol/l 3 hours
Secondary Absorption fraction of D-xylose urine excretion, mmol 5 hours
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