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

NCT03243994 | Completed

• 1 other identifier: H-15019987
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease; Cor Pulmonale

Keywords

Cor pulmonale; COPD; Malabsorption; D-xylose; Zinc

Outcome Measures

Primary Outcomes (1)

• Absorption fraction of D-xylose

  plasma concentration, mmol/l

  3 hours

Secondary Outcomes (2)

• Absorption of zinc

  3 hours

• Absorption fraction of D-xylose

  5 hours

Study Arms (2)

COPD

EXPERIMENTAL

Patients with COPD without Cor Pulmonale

Diagnostic Test: Absorption test with D-xylose and zink

COPD + Cor Pulmonale

EXPERIMENTAL

Patients with Cor Pulmonale in addition

Diagnostic Test: Absorption test with D-xylose and zink

Interventions

Absorption test with D-xylose and zink DIAGNOSTIC_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.

COPD; COPD + Cor Pulmonale

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of COPD
• Clinically stable = Unchanged medication for COPD for at least 6 months

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jens Rikardt Andersen: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Pulmonary Heart Disease; Malabsorption Syndromes

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jens R Andersen, MD, MPA

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: All patients had Chronic Obstructive Lung Disease. Those with additional Cor pulmonale was compared to those without

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: August 9, 2017
• Study Start: February 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: August 9, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share