Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2026-03-02 @ 4:11 AM
Study NCT ID:
NCT06474858
Status:
COMPLETED
Last Update Posted:
2024-06-26
First Post:
2016-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Obesity on COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D004417', 'term': 'Dyspnea'}], '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': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-25', 'studyFirstSubmitDate': '2016-06-22', 'studyFirstSubmitQcDate': '2024-06-25', 'lastUpdatePostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dyspnoea - mMRC', 'timeFrame': 'At inclusion', 'description': 'Level of dyspnoea perceived in daily life measured using the Modified Medical Research Council (mMRC) dyspnoea scale. The mMRC dyspnoea scale ranges from grade 0 to 4. Higher scores mean a worse outcome.'}, {'measure': 'Dyspnoea - NCSI', 'timeFrame': 'At inclusion', 'description': 'Level of dyspnoea perceived in daily life measured using the Nijmegen Clinical Screening Instrument (NCSI). The NCSI ranges from grade 0 to 11. Higher scores mean a worse outcome.'}, {'measure': 'Change in dyspnoea', 'timeFrame': 'Before and after the 6 minute walking test', 'description': 'Level of dyspnoea using the Borg score. The Borg score ranges from grade 0 to 10. Higher scores mean a worse outcome.'}], 'secondaryOutcomes': [{'measure': '6 minute walking test', 'timeFrame': 'At inclusion', 'description': 'distance walked in 6 minutes measured in metres'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'Obesity', 'Chronic Obstructive Pulmonary Disease', 'Dyspnea', 'HRQoL', 'Symptoms', 'Dynamic hyperinflation'], 'conditions': ['COPD', 'Obesity', 'Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether obese COPD patients experience more or less discomfort in daily life. Furthermore the investigators will evaluate if body composition or body fat distribution has effects on symptoms and performance.', 'detailedDescription': 'Chronic Obstructive Pulmonary Disease (COPD) and Obesity are two major health problems. The prevalence of both is growing and there is a complex interaction between COPD and obesity. On the one hand obesity impairs lung function, with decreasing static lung volumes being the most significant effect. On the other hand there seems a beneficial role of obesity on lung function in COPD patients. This is because obese COPD patients tend to have less hyperinflation than non-obese COPD patients . An interesting question is what the net effect of these changes in lung function is on respiratory symptoms and quality of life.\n\nIn this observational study, the investigators will compare obese and non-obese COPD patients. Pulmonary function, dyspnea and quality of life will be compared between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with a diagnosis of COPD who visit a Pulmonologist at Rijnstate Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with COPD by a Pulmonologist defined as an obstructive lung function test with FEV1/FVC \\< 0.7 and FEV1 \\< 80% predicted\n* No exacerbation of COPD at time of inclusion\n* Age \\> 18 years\n* Able to perform lung function tests and fill in the questionnaires.\n\nExclusion Criteria:\n\n* Not able to perform lung function tests or fill in the questionnaires\n* Diagnosis of Asthma\n* Diagnosis of neuromuscular disease\n* Diagnosis of heart failure\n* Treatment for lung Malignancy in the past\n* Active Malignancy'}, 'identificationModule': {'nctId': 'NCT06474858', 'briefTitle': 'Effects of Obesity on COPD', 'organization': {'class': 'OTHER', 'fullName': 'Rijnstate Hospital'}, 'officialTitle': 'A Prospective Observational Study on the Effects of Obesity on Symptoms, Health Related Quality of Life and Pulmonary Function in COPD Patients', 'orgStudyIdInfo': {'id': '2014/113'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal weight', 'description': 'COPD patients with BMI 18.5-24.99'}, {'label': 'Obese', 'description': 'COPD patients with BMI ≥ 30'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Arnhem', 'country': 'Netherlands', 'facility': 'Department Of Pulmonology, Rijnstate Hospital, The Netherlands', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}], 'overallOfficials': [{'name': 'Safir Zewari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rijnstate Hospital, Arnhem, The Netherlands'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rijnstate Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}