Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2026-01-24 @ 7:53 PM
Study NCT ID:
NCT03623204
Status:
COMPLETED
Last Update Posted:
2018-08-09
First Post:
2018-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evolution of Dyspnea After Bariatric Surgery in Patient With Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D004417', 'term': 'Dyspnea'}], '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'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-08', 'studyFirstSubmitDate': '2018-08-07', 'studyFirstSubmitQcDate': '2018-08-08', 'lastUpdatePostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dyspnea in daily living evaluated using the mMRC scale', 'timeFrame': 'Month 6', 'description': 'Dyspnea in daily living evaluated using the mMRC scale'}, {'measure': 'Dyspnea in daily living evaluated using the mMRC scale', 'timeFrame': 'Month 12', 'description': 'Dyspnea in daily living evaluated using the mMRC scale'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Dyspnea', 'Bariatric Surgery'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '28931052', 'type': 'BACKGROUND', 'citation': 'Boissiere L, Perotin-Collard JM, Bertin E, Gaubil I, Diaz Cives A, Barbe C, Dury S, Nardi J, Lebargy F, Deslee G, Launois C. Improvement of dyspnea after bariatric surgery is associated with increased Expiratory Reserve Volume: A prospective follow-up study of 45 patients. PLoS One. 2017 Sep 20;12(9):e0185058. doi: 10.1371/journal.pone.0185058. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'Obesity, defined as a Body Mass Index greater than or equal to 30 kg/m2, represents a significant public health issue. Dyspnea is a very common and crippling symptom in obesity. About 80% of people with obesity experience dyspnea in daily living. Bariatric surgery has been demonstrated to be an excellent treatment for obesity by inducing significant weight loss. Nevertheless, changes in dyspnea in daily living after bariatric surgery and the links between variations in dyspnea and lung function tests after bariatric surgery have not been previously investigated.', 'detailedDescription': 'The objective of this study was to determine if bariatric surgery is associated with an improvement of dyspnea in daily living according to the mMRC scale in patients with obesity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with obesity and who underwent bariatric surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obesity\n* scheduled bariatric surgery\n\nExclusion Criteria:\n\n\\- age \\< 18 years old'}, 'identificationModule': {'nctId': 'NCT03623204', 'acronym': 'OBES-DYSP', 'briefTitle': 'Evolution of Dyspnea After Bariatric Surgery in Patient With Obesity', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Reims'}, 'officialTitle': 'Evolution of Dyspnea After Bariatric Surgery in Patient With Obesity', 'orgStudyIdInfo': {'id': '2017Ao007'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with bariatric surgery for obesity', 'interventionNames': ['Other: Dyspnea evaluation']}], 'interventions': [{'name': 'Dyspnea evaluation', 'type': 'OTHER', 'armGroupLabels': ['Patients with bariatric surgery for obesity']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Reims', 'country': 'France', 'facility': 'Damien JOLLY', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Reims', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}