Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2026-01-01 @ 8:45 PM
Study NCT ID:
NCT05582668
Status:
COMPLETED
Last Update Posted:
2025-02-25
First Post:
2022-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sarcopenia After Bariatric Surgery in Older Patients: a Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050110', 'term': 'Bariatric Surgery'}], 'ancestors': [{'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-07-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2022-10-12', 'studyFirstSubmitQcDate': '2022-10-12', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of older patients with sarcopenia after bariatric surgery compared to non-surgical control patients.', 'timeFrame': 'At least one year post surgery', 'description': 'a) Sarcopenia will be classified according to the criteria form the European Working Group on Sarcopenia in Older People revised guidelines (EWGSOP2) based on skeletal muscle mass, muscle strength and physical performance criteria.'}], 'secondaryOutcomes': [{'measure': '1. Appendicular skeletal muscle mass older of patients after bariatric surgery compared to non-surgical control patients', 'timeFrame': 'At least one year post surgery', 'description': '1\\. Appendicular skeletal muscle mass older of patients after bariatric surgery compared to non-surgical control patients'}, {'measure': '2. The prevalence of nutrient deficiencies in older patients after bariatric surgery compared to non-surgical control patients.', 'timeFrame': 'At least one year post surgery', 'description': 'a. Indices of nutrient deficiencies will include reported dietary intake of protein, zinc, selenium, and blood levels of Vitamin D, zinc, and selenium.'}, {'measure': '3. Markers of chronic systemic inflammation in older patients after bariatric surgery compared to non-surgical control patients', 'timeFrame': 'At least one year post surgery', 'description': 'Inflammatory markers will include CRP, IL-1β, IL-6, IL-8, TNF-α'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight and Obesity', 'Bariatric Surgery', 'Aging', 'Sarcopenic Obesity']}, 'referencesModule': {'references': [{'pmid': '40468919', 'type': 'DERIVED', 'citation': 'Eksteen G, Vanuytsel T, Vangoitsenhoven R, Mertens A, Lannoo M, De Leus E, Van der Schueren B, Matthys C. Sarcopenia, Muscle Mass and Protein Intake in Adults Older Than 65 Years After Earlier Bariatric Surgery. J Cachexia Sarcopenia Muscle. 2025 Jun;16(3):e13839. doi: 10.1002/jcsm.13839.'}]}, 'descriptionModule': {'briefSummary': 'The retrospective cohort study will compare the prevalence of sarcopenia and associated factors between older patients who have undergone bariatric surgery and older patients with obesity without previous bariatric surgery.', 'detailedDescription': 'The aim of the study is to compare the prevalence of sarcopenia and nutritional status between adults older than 65 years who have previously undergone bariatric surgery and patients with obesity but without previous bariatric surgery. Current sarcopenia will be assessed during a cross-sectional assessment after surgery using the criteria from the European Working Group on Sarcopenia in Older People (EWGSOP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with overweight, obesity or after bariatric surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Age 65 years or older\n* Cohort 1 (exposed): Previous bariatric surgery for obesity at least 1 one year ago\n* Cohort 2 (unexposed): No previous weight loss surgery\n\nExclusion Criteria:\n\n* Current diagnosis of cancer\n* Advanced organ failure, including chronic kidney disease Stage 5, liver cirrhosis Stage 3, intestinal failure, heart failure stage D, or chronic obstructive pulmonary disease stage 4.\n* Immobility\n* Neuromuscular degenerative conditions'}, 'identificationModule': {'nctId': 'NCT05582668', 'acronym': 'SABO', 'briefTitle': 'Sarcopenia After Bariatric Surgery in Older Patients: a Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Sarcopenia After Bariatric Surgery in Older Patients: a Cohort Study', 'orgStudyIdInfo': {'id': 'S66815'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Cohort 1: Older patients with overweight, obesity after bariatric surgery', 'interventionNames': ['Procedure: Bariatric surgery']}, {'label': 'Cohort 2', 'description': 'Cohort 2: Older patients with overweight, obesity without bariatric surgery'}], 'interventions': [{'name': 'Bariatric surgery', 'type': 'PROCEDURE', 'description': 'Bariatric surgery', 'armGroupLabels': ['Cohort 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Obesity Clinic University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}