Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-02-17 @ 11:35 PM
Study NCT ID:
NCT06342050
Status:
COMPLETED
Last Update Posted:
2025-05-22
First Post:
2024-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Socioecological Factors Associated With Ethnic Disparities in Bariatric Surgery Utilization and Post-WLS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], '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': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-03-19', 'size': 316789, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-27T14:38', 'hasProtocol': True}, {'date': '2024-03-19', 'size': 297665, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-03-27T14:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '2 blood sample tubes collected at the same timepoint and 1 stool sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2024-02-22', 'studyFirstSubmitQcDate': '2024-03-27', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gut Microbial Composition', 'timeFrame': 'Stool samples will be collected at one time point only, within a week to their in person appointment.', 'description': 'Gut microbial composition will be measured by performing whole metagenome sequencing in samples previously stored in Zymo stool collection tubes.'}, {'measure': 'Blood Microbial Composition', 'timeFrame': 'Blood samples will be collected in fasting conditions at the Baseline visit.', 'description': 'Blood microbial composition will be measured by performing 16S rRNA (ribosomal ribonucleic acid) in blood samples previously stored in Zymo blood collection tubes.'}, {'measure': 'Body Weight (kg)', 'timeFrame': 'Baseline', 'description': 'Body weight will be measured with a calibrated SECA scale.'}, {'measure': 'Body Height (meters)', 'timeFrame': 'Baseline', 'description': 'Body height will be measured with a stadiometer.'}, {'measure': 'Fat Mass (Kg)', 'timeFrame': 'Baseline', 'description': 'Body fat mass will be measured by using the SECA mBCA 515.'}, {'measure': 'Fat-free Mass (Kg)', 'timeFrame': 'Baseline', 'description': 'Fat-free mass will be measured by using the SECA mBCA 515.'}, {'measure': 'Body water (%)', 'timeFrame': 'Baseline', 'description': 'Body water percentage will be measured by using the SECA mBCA 515.'}, {'measure': 'Skeletal Muscle Mass (kg)', 'timeFrame': 'Baseline', 'description': 'Skeletal muscle mass will be measured by using the SECA mBCA 515.'}, {'measure': 'Fasting Glucose (mg/dL)', 'timeFrame': 'Baseline', 'description': 'Fasting glucose will be measured after a 12h fast.'}, {'measure': 'Fasting Insulin (mIU/L)', 'timeFrame': 'Baseline', 'description': 'Fasting insulin will be measured after a 12h fast.'}, {'measure': 'Lipopolysaccharides (%)', 'timeFrame': 'Baseline', 'description': 'Lipopolysaccharides will be measured after a 12h fast.'}, {'measure': 'Lipopolysaccharides binding protein (mIU/L)', 'timeFrame': 'Baseline', 'description': 'Lipopolysaccharides binding protein will be measured after a 12h fast.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Weight loss surgery', 'Bariatric surgery', 'Gut Microbiome', 'Blood Microbiome'], 'conditions': ['Obesity', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'The goal of this cross-sectional observational study is to examine potential relationships between the blood and gut microbiota of patients with obesity before and after weight loss surgery (WLS) and evaluate potential ethnic differences in the blood and gut microbiotas before and after the WLS.\n\nThe main aims / objectives of this sub-study are:\n\n* Aim 1. Compare the relationship between the blood and the gut microbiomes among a sample of (1) pre-WLS and (2) 6-month post-WLS participants.\n\nHypothesis: Blood bacterial composition will resemble that of the gut microbiome among pre-WLS participants. Because the effect of WLS on the blood microbiome is not known, our post-WLS results will be mostly exploratory.\n\n* Aim 2. Determine racial differences in the blood microbiome of the pre- and post-WLS groups.\n\nHypothesis2: Ethnic differences will be detected in both the pre- and post-WLS groups.', 'detailedDescription': 'A subgroup of participants from the main study will be invited to participate in a cross-sectional sub study evaluating the relationship between blood and gut microbiotas. A total of 100 participants will be recruited, 50 participants will be recruited from the "non-completers" and the other 50 participants will be recruited from the "6 months post-WLS" follow-up group of our main project.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Investigators will recruit in the following manner:\n\n* Non-surgery participants from the "non-completers" group from the main study\n* Participants who had bariatric surgery 6 months prior to their enrollment into this sub study, will be recruited from the "early and late completers" in the main study. If additional participants are needed, particularly due to strict ethnic requirements (limited to NHW and NHB), first, invitation emails will be sent to the Weight Wellness Clinic patients, and if recruiting at the expected rate continues to be an issue, advertisements through IRB-approved flyers on social media or in the clinic setting will be posted.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-60 years old\n* Will belong to either Non-Hispanic Whites (NHW) or Non-Hispanic Blacks (NHB) ethnic groups\n* "No-WLS" participants will have a BMI \\>35 kg/m2 (threshold BMI for WLS) whereas "6 months post-WLS" participants will have no BMI requirements.\n\nExclusion Criteria:\n\n* Having taken antibiotics in the previous 6 months;\n* Metformin, proton pump inhibitors, probiotics, or prebiotics in the previous month;\n* Currently following a vegetarian diet;\n* Pregnancy;\n* Having any infection in the previous month; and\n* Having a comorbid disease that might alter the blood microbiome composition (e.g., renal failure) or the intestinal permeability (e.g., IBS).'}, 'identificationModule': {'nctId': 'NCT06342050', 'briefTitle': 'Socioecological Factors Associated With Ethnic Disparities in Bariatric Surgery Utilization and Post-WLS', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Socioecological Factors Associated With Ethnic Disparities in Bariatric Surgery Utilization and Post-Operative Weight Loss (Substudy)', 'orgStudyIdInfo': {'id': 'STU-2023-0548'}, 'secondaryIdInfos': [{'id': 'R01MD011686', 'link': 'https://reporter.nih.gov/quickSearch/R01MD011686', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'WLS non-completers', 'description': 'Participants who did not have WLS as part of the main study'}, {'label': 'WLS completers', 'description': 'Participants who had WLS as part of the main study'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Benjamin Schneider, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor & Division Chief - Bariatric & Foregut Surgery', 'investigatorFullName': 'Benjamin Schneider', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}