Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-31 @ 2:41 PM
Study NCT ID:
NCT03243994
Status:
COMPLETED
Last Update Posted:
2017-08-09
First Post:
2017-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Small Intestinal Absorption in Patients With Chronic Obstructive Pulmonary Disease and Cor Pulmonale
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D011660', 'term': 'Pulmonary Heart Disease'}, {'id': 'D008286', 'term': 'Malabsorption Syndromes'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'All patients had Chronic Obstructive Lung Disease. Those with additional Cor pulmonale was compared to those without'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-04', 'studyFirstSubmitDate': '2017-07-07', 'studyFirstSubmitQcDate': '2017-08-04', 'lastUpdatePostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absorption fraction of D-xylose', 'timeFrame': '3 hours', 'description': 'plasma concentration, mmol/l'}], 'secondaryOutcomes': [{'measure': 'Absorption of zinc', 'timeFrame': '3 hours', 'description': 'plasma concentration, micromol/l'}, {'measure': 'Absorption fraction of D-xylose', 'timeFrame': '5 hours', 'description': 'urine excretion, mmol'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cor pulmonale', 'COPD', 'Malabsorption', 'D-xylose', 'Zinc'], 'conditions': ['Chronic Obstructive Pulmonary Disease', 'Cor Pulmonale']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nAim: To investigate whether patients with pulmonary hypertension have reduced absorption capacity compared to COPD patients without cor pulmonale.\n\nMethods: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A diagnosis of COPD\n* Clinically stable = Unchanged medication for COPD for at least 6 months\n\nExclusion Criteria:\n\n* Unable to understand Danish\n* Other clinically important heart-disease than chronic right heart changes presumably due to lung disease\n* Clinically significant gastro-intestinal or kidney disease\n* Diabetes\n* Treatment with corticosteroids for at least 6 months.'}, 'identificationModule': {'nctId': 'NCT03243994', 'briefTitle': 'Small Intestinal Absorption in Patients With Chronic Obstructive Pulmonary Disease and Cor Pulmonale', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Small Intestinal Absorption in Patients With Chronic Obstructive Pulmonary Disease Complicated by Cor Pulmonale: A Pilot Study', 'orgStudyIdInfo': {'id': 'H-15019987'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'COPD', 'description': 'Patients with COPD without Cor Pulmonale', 'interventionNames': ['Diagnostic Test: Absorption test with D-xylose and zink']}, {'type': 'EXPERIMENTAL', 'label': 'COPD + Cor Pulmonale', 'description': 'Patients with Cor Pulmonale in addition', 'interventionNames': ['Diagnostic Test: Absorption test with D-xylose and zink']}], 'interventions': [{'name': 'Absorption test with D-xylose and zink', 'type': 'DIAGNOSTIC_TEST', '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.', 'armGroupLabels': ['COPD', 'COPD + Cor Pulmonale']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jens R Andersen, MD, MPA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plans'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jens Rikardt Andersen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jens Rikardt Andersen', 'investigatorAffiliation': 'University of Copenhagen'}}}}