Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-27 @ 1:34 PM
Study NCT ID:
NCT06421168
Status:
COMPLETED
Last Update Posted:
2024-05-20
First Post:
2024-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Function in Bariatric Surgery Candidates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'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': 'RETROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1834}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-15', 'studyFirstSubmitDate': '2024-05-13', 'studyFirstSubmitQcDate': '2024-05-15', 'lastUpdatePostDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FEV1, FVC, FEV1/FVC% in class 1, 2, and 3 obesity', 'timeFrame': 'At the time of pulmonary function testing', 'description': 'Class 1 obesity: 27.5 kg/m2 \\< body mass index \\< 32.5 kg/m2; Class 2 obesity: 32.5 kg/m2 \\< body mass index \\< 37.5 kg/m2; Class 2 obesity: body mass index \\> 37.5 kg/m2.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Function Decreased', 'Obesity']}, 'descriptionModule': {'briefSummary': 'This study aims to retrospectively investigate the impact of body mass index on lung function metrics, e.g. FEV1%, FVC%, FEV1/FVC%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Bariatric surgery candidates who completed lung function tests preoperatively were enrolled.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with obesity (BMI ≥ 27.5 kg/m2 according to Chinese guidelines, guidelines from the American Society for Metabolic and Bariatric Surgery and International Federation for the Surgery of Obesity and Metabolic Disorders);\n* Age \\> 16 years;\n* Complete preoperative pulmonary function tests\n\nExclusion Criteria:\n\n* Patients with a history of lung surgery and/or respiratory diseases (e.g. asthma, pulmonary emphysema, and interstitial pulmonary fibrosis).'}, 'identificationModule': {'nctId': 'NCT06421168', 'briefTitle': 'Lung Function in Bariatric Surgery Candidates', 'organization': {'class': 'OTHER', 'fullName': 'China-Japan Friendship Hospital'}, 'officialTitle': 'The Impact of Body Mass Index on Lung Function in Bariatric Surgery Candidates', 'orgStudyIdInfo': {'id': 'CJBariatric006'}}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'country': 'China', 'facility': 'Yuntao Nie', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Yuntao Nie, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'China-Japan Friendship Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yuntao Nie', 'investigatorAffiliation': 'China-Japan Friendship Hospital'}}}}