Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT06059651
Status:
RECRUITING
Last Update Posted:
2025-02-17
First Post:
2023-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Metabolic & Bariatric Surgery on Lipid Metabolism, Myeloid-Derived Suppressor Cells, and Cancer Cell Biology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053858', 'term': 'Metabolic Networks and Pathways'}, {'id': 'D050110', 'term': 'Bariatric Surgery'}], 'ancestors': [{'id': 'D008660', 'term': 'Metabolism'}, {'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-13', 'studyFirstSubmitDate': '2023-09-22', 'studyFirstSubmitQcDate': '2023-09-22', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in insulin-inhibited adipose tissue lipolysis', 'timeFrame': 'Baseline, week 52'}, {'measure': 'Change in the number of circulating myeloid-derived suppressor cells', 'timeFrame': 'Baseline, week 52'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'This study aims to determine the relationship between lipid kinetics changes and blood immunosuppressive cells by metabolic surgery in two patient cohorts.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '35 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include women with class III obesity who plan to undergo or have completed treatment with metabolic and bariatric surgery.', 'healthyVolunteers': True, 'eligibilityCriteria': 'For an eligible subject, all the following must be answered "yes":\n\n* Biological female sex\n* Age \\>=35 and \\<=60 years (including pre- and postmenopausal)\n* Self-reported white or black race\n* The study will enroll approximately 50% white and 50% black subjects\n* Body mass index \\>/=40 kg/m2\n* Have a diagnosis of hyperlipidemia (high triglycerides and LDL-cholesterol) or in treatment with any medication for hyperlipidemia at enrollment\n* Ability to provide written informed consent\n* Allow the collection and storage of biospecimens and data for future use\n* Not having yet started the pre-op liquid diet before the bariatric surgery\n\nFor an eligible subject, all the following must be answered "no":\n\n* Have type one or type two diabetes\n* Use of anti-inflammatory medications, such as glucocorticoids or non-steroidal anti-inflammatory medications, within the past 15 days\n* Use of medication approved for obesity management, including, but not limited to, phentermine-topiramate (Qsymia), orlistat (Xenical), naltrexone-bupropion (Contrave), liraglutide (Saxenda), and semaglutide (Wegovy)\n* History of cancer of any type\n* History of chronic conditions known to cause inflammation, such as tuberculosis, autoimmune disease, and human immunodeficiency virus\n* An acute history (within the past 60 days) or confirmed or suspected SARS-CoV-2 (COVID-19) infection\n* Currently pregnant, breastfeeding, or planning to become pregnant within the next 52 weeks\n* Currently participating in another study with competing outcomes\n* Any other situation that, in the opinion of the investigator, would negatively impact subject safety or successful compliance with the protocol'}, 'identificationModule': {'nctId': 'NCT06059651', 'briefTitle': 'The Effects of Metabolic & Bariatric Surgery on Lipid Metabolism, Myeloid-Derived Suppressor Cells, and Cancer Cell Biology', 'organization': {'class': 'OTHER', 'fullName': 'Pennington Biomedical Research Center'}, 'officialTitle': 'The Effects of Metabolic & Bariatric Surgery on Lipid Metabolism, Myeloid-Derived Suppressor Cells, and Cancer Cell Biology', 'orgStudyIdInfo': {'id': 'PBRC 2023-026'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Cohort #1 (within-subject) will enroll up to 10 women with class III obesity who plan to undergo Roux-en-Y metabolic and bariatric surgery as a standard of obesity care. Subjects will complete study measures preoperatively and one year postoperatively.', 'interventionNames': ['Procedure: Metabolic & Bariatric Surgery']}, {'label': 'Cohort 2', 'description': 'Cohort #2 (between-subject) will enroll up to 10 women with a history of class III obesity who underwent Roux-en-Y metabolic and bariatric surgery as a standard of obesity care approximately one year before enrollment. Subjects in this cohort will be matched on demographic and clinical variables to those in Cohort #1.', 'interventionNames': ['Procedure: Metabolic & Bariatric Surgery']}], 'interventions': [{'name': 'Metabolic & Bariatric Surgery', 'type': 'PROCEDURE', 'description': 'Roux-en-Y metabolic and bariatric surgery', 'armGroupLabels': ['Cohort 1', 'Cohort 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Justin Brown', 'role': 'CONTACT'}], 'facility': 'Pennington Biomedical Resarch Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}], 'centralContacts': [{'name': 'Zubaidah Nor Hanipah, M.D.', 'role': 'CONTACT', 'email': 'Zubaidah.NorHanipah@pbrc.edu', 'phone': '2257632831'}], 'overallOfficials': [{'name': 'Justin Brown, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pennington Biomedical Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pennington Biomedical Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Cancer Metabolism Program', 'investigatorFullName': 'Justin Brown', 'investigatorAffiliation': 'Pennington Biomedical Research Center'}}}}