Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 12:32 AM
Study NCT ID:
NCT03558360
Status:
UNKNOWN
Last Update Posted:
2021-12-23
First Post:
2018-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preoperative Dry Lean Body Mass as a Prognostic Factor for Excess Weight Loss After Bariatric Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-22', 'studyFirstSubmitDate': '2018-06-04', 'studyFirstSubmitQcDate': '2018-06-14', 'lastUpdatePostDateStruct': {'date': '2021-12-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of dry lean mass in pre-operative by impedance measurement', 'timeFrame': '12 months after bariatric surgery', 'description': 'Excess weight loss at M12: ideal weight is defined in relation to height for a BMI of 25.0 kg/m2. Excess weight is the difference between the observed weight and the ideal weight. Excess weight loss is the ratio of weight loss to excess weight.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lean body mass', 'bariatric surgery'], 'conditions': ['Bariatric Surgery Candidate']}, 'descriptionModule': {'briefSummary': 'Bariatric surgery is currently the only method that has proven long-term effectiveness in obesity. Although the benefit of physical activity on weight loss has been demonstrated, no correlation has ever been reported between preoperative lean body mass and postoperative weight loss. Dry lean mass is probably an essential prognostic factor for the effectiveness of bariatric surgery.\n\nThe main objective of this study is to define a preoperative dry lean body mass threshold as a worst prognostic factor for weight loss one year after bariatric surgery.\n\nThe management of patients included in this study was modelled on the management usually offered to patients followed for the same pathology in the diabeto-endocrinology department. There are no study-specific examinations that are not part of current practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting (or having presented since 2014) an obesity with a bariatric surgery project and followed by endocrinologist doctors.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI ≥ 40 or BMI ≥ 35 kg/m2 and a complication that can be improved after bariatric surgery: cardiovascular disease including hypertension, severe metabolic disorder including type 2 diabetes, sleep apnea syndrome or other severe respiratory disorder, hepatic steatosis, disabling osteoarticular disease.\n* Patient requiring bariatric surgery (sleeve-gastrectomy or gastric bypass)\n* Patient who has agreed to participate in the study\n* Patient with social security coverage.\n\nExclusion Criteria:\n\n* Patient with a contraindication to bariatric surgery (cognitive or psychological disorders, severe eating disorders, addiction to alcohol or psychoactive substances, contraindication to general anaesthesia, multiple history of digestive surgery, high risk of undernutrition (progressive cancer, chronic inflammatory bowel disease, cirrhosis, severe renal insufficiency...)\n* Pregnant or lactating women\n* Minor patient\n* Major patient under tutorship, curatorship, or deprived of liberty\n* Patient unable to understand protocol and / or give express consent\n* Patient not affiliated with a social security system or beneficiary of such a scheme\n* Patient participating in an intervention-type clinical research protocol likely to modify the evaluations of this protocol\n* adults under the protection of justice'}, 'identificationModule': {'nctId': 'NCT03558360', 'acronym': 'MMS-CB', 'briefTitle': 'Preoperative Dry Lean Body Mass as a Prognostic Factor for Excess Weight Loss After Bariatric Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Departemental Vendee'}, 'officialTitle': 'Preoperative Dry Lean Body Mass as a Prognostic Factor for Excess Weight Loss After Bariatric Surgery.', 'orgStudyIdInfo': {'id': 'CHD 048-17'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bariatric surger', 'description': 'Bariatric surgery and impedance measurement', 'interventionNames': ['Diagnostic Test: Impedance measurement']}], 'interventions': [{'name': 'Impedance measurement', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of dry lean body mass berfore bariatric surgery by impedance measurement.', 'armGroupLabels': ['Bariatric surger']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85925', 'city': 'La Roche-sur-Yon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'François ETCHEVERRIGARAY', 'role': 'CONTACT', 'email': 'francois.etcheverrigaray@chd-vendee.fr'}, {'name': 'Barbara FEIGEL-GUILLER, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Departemental Vendée', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}], 'centralContacts': [{'name': 'François ETCHEVERRIGARAY, PharmD', 'role': 'CONTACT', 'email': 'francois.etcheverrigaray@chd-vendee.fr', 'phone': '+33 2 51 44 65 72'}], 'overallOfficials': [{'name': 'Barbara FEIGEL-GUILLER, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre Hospitalier Départemental Vendée'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Departemental Vendee', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}