Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT05307133
Status:
COMPLETED
Last Update Posted:
2025-03-05
First Post:
2022-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oxytocin and Sleeve Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2022-03-24', 'studyFirstSubmitQcDate': '2022-03-24', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plasma leves of oxytocin', 'timeFrame': '6 months', 'description': 'Correlation between plasma leves of oxytocin (pcgr/ml) and weight loss (BMI Kg/m2) 6 months after sleeve gastrectomy'}], 'secondaryOutcomes': [{'measure': 'sleeve gastrectomy', 'timeFrame': '6 months', 'description': 'Correlation between weight 6 months after sleeve gastrectomy and fibrosis within adipose tissue'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity, Morbid']}, 'descriptionModule': {'briefSummary': 'Morbid obesity has become a common condition and there is no effective drug that is able to induce a sustained weight loss. Currently bariatric surgery remains the only effective means that is able to lead to long term sustained weight loss. Oxytocin is a hormone secreted by the hypophysis that regulates negatively the adipogenesis and positively the osteogenesis. Oxytocin also regulates appetite and its role in weight loss in humans has not been investigated so far. The aim of the present study is to elucidate whether plasma levels of oxytocin and sleeve gastrectomy induced weight loss are correlated in pre-menopausal morbidly obese women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18-65, pre-menopausal,\n* able to read and understand the written informed consent,\n* with a BMI \\> 40 or 35\n* with at least one obesity linked comorbidity among blood hypertension,\n* type 2 diabetes,\n* sleep apnea syndrome,\n* invalidating arthritis,\n* indication for sleeve gastrectomy\n* accepted by the multidisciplinary committee and the CPAM (local health care system agency),\n* affiliation to the Fre,nch health care system,\n* signature of the informed consent.\n\nExclusion Criteria:\n\n* Post-menopausal women,\n* any other bariatric procedure that sleeve gastrectomy, history of any other bariatric procedure,\n* pregnancy,\n* age less than 18 years under, under guardianship\n* Patients undergoing any other procedure that the planned sleeve gastrectomy or undergoing a second bariatric procedure for a complications during the 6 months follow-up.'}, 'identificationModule': {'nctId': 'NCT05307133', 'acronym': 'BARIA', 'briefTitle': 'Oxytocin and Sleeve Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Oxytocin Serum Variation Following Laparoscopic Sleeve Gastrectomy in Morbidly Obese Women', 'orgStudyIdInfo': {'id': '21-AOI-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Pre menopausal women undergoing sleeve gastreexctomy for morbid obesity', 'description': 'After the indication for sleeve gastrectomy has been retained by the multidisciplinary committee eligible patients will be contacted and offered to participate in the BARIAXYTOCINE study. At the time of the first outpatient visit (V1), body densitometry and blood sample for estradiol, leptin and oxytocin will be done. Patients will undergo surgery within one month and 6 months after surgery they will undergo the same work-up (V2).', 'interventionNames': ['Other: Sleeve Gastreextomy']}], 'interventions': [{'name': 'Sleeve Gastreextomy', 'type': 'OTHER', 'description': 'The aim of the present study is to elucidate whether serum levels of oxytocin and sleeve gastrectomy induced weight loss are correlated in pre-menopausal morbidly obese women.', 'armGroupLabels': ['Pre menopausal women undergoing sleeve gastreexctomy for morbid obesity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06001', 'city': 'Nice', 'state': 'Alpes-maritimes', 'country': 'France', 'facility': 'CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Iannelli Antonio, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Nice, Service de Chirurgie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}