Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-02-28 @ 7:28 AM
Study NCT ID:
NCT00865293
Status:
UNKNOWN
Last Update Posted:
2009-07-14
First Post:
2009-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expiratory Airflow Limitation in Subjects With Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'lastUpdateSubmitDate': '2009-07-13', 'studyFirstSubmitDate': '2009-03-18', 'studyFirstSubmitQcDate': '2009-03-18', 'lastUpdatePostDateStruct': {'date': '2009-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The difference in mean values of FEF25-75/FVC between subjects with obesity and controls in supine position', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'The capacity of FOT as a measurement tool for small airways obstruction. The effects of posture and obesity on lung volumes, diffusion capacity, air flow limitation. The effect of bronchodilation by salbutamol on posture dependent flow limitation.', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity', 'expiratory flow limitation', 'EFL', 'posture', 'small airways obstruction', 'FOT'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate posture dependent small airway obstruction in subjects with obesity, and to study the capacity of FOT as a measurement tool for small airways obstruction.', 'detailedDescription': 'Obesity is a cause of dyspnea due to mechanical impairment of pulmonary ventilation. One of the causes of this impairment is expiratory flow limitation, which is related to decreased lung volume. As a result, obesity can cause an asthma-like symptoms. Therefore, some patients with obesity are misdiagnosed as asthma-patients, and treated with asthma medication. The effects of bronchodilators on the mechanical airway obstruction in obese subjects have not been well established.\n\nPosture also has effect on lung volumes: they are decreased in supine position. Therefore, the interaction of obesity and supine posture might result in a larger decrease in lung volumes, and thereby a more increased airflow limitation. It has been suggested that both obesity and supine posture result in an obstruction of peripheral airways. Such an obstruction can be measured by spirometry, using the ratio of forced expiratory flow between 25 and 75% and vital capacity. This measure is highly variable, however.\n\nThe forced oscillation technique (FOT) is a non-invasive method to measure the resistance and reactant of the respiratory system. Particularly the reactance has been shown useful in the measurement of airflow limitations.\n\nThe investigators hypothesize that obesity causes a posture dependent end- expiratory airflow limitation due to a mechanical compression of lung tissue, resulting in increased resistance and reactance in the airways. Therefore, the investigators expect no protective effect of bronchodilation by salbutamol. The investigators expect that reactance measured by FOT detects differences in airflow limitation and correlates with airflow limitation as measured by spirometry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healty volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria obese population:\n\n* Male/female, age 25-60\n* BMI (body mass index) 30-40 kg/m2\n* Non or ex smokers with \\< 10 packyears\n\nInclusion Criteria control population:\n\n* Male/female, age 25-60\n* BMI (body mass index) 18.5-25 kg/m2\n* Non or ex smokers with \\<10 packyears\n\nExclusion Criteria obese population:\n\n* Asthma\n* COPD (FEV1/FVC\\<0.70)\n* Reversibility \\>9% in FEV1 (400 microgram salbutamol)\n* Other significant neuromuscular, cardiac or lung disease\n\nExclusion Criteria control population:\n\n* Asthma\n* COPD (FEV1/FVC\\<0.70)\n* Other significant neuromuscular, cardiac or lung disease\n* Reversibility \\>9% in FEV1 (400 microgram salbutamol)'}, 'identificationModule': {'nctId': 'NCT00865293', 'acronym': 'EFL', 'briefTitle': 'Expiratory Airflow Limitation in Subjects With Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Medical Center Alkmaar'}, 'officialTitle': 'Obesity and Expiratory Flow Limitation (EFL)', 'orgStudyIdInfo': {'id': 'Obesity MCA 2009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obesity', 'description': 'Subjects with obesity, defined as BMI \\> 30, aged 25-60'}, {'label': 'Control', 'description': 'Subjects with a BMI 18,5-25, aged 25-60'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'J. G. van den Aardweg', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical Center Alkmaar'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical Center Alkmaar', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. J.G. van den Aardweg', 'oldOrganization': 'Medical Center Alkmaar'}}}}