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Gut Microbiota in Metabolic Surgery

Recruitingn/aAges 21 Years - 65 YearsAllVanderbilt University Medical Center
NCT05000996 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Metabolic surgery is an emerging option to treat obesity-related metabolic diseases (e.g., type 2 diabetes) and prevent cardiovascular disease (CVD). Metabolic surgery can profoundly alter the gut microbiota; meanwhile, gut microbiota may affect surgical outcomes. Longitudinal studies that examined pre- to post-surgery changes in gut microbiota and its relation to cardiometabolic health after surgery are limited. Furthermore, few studies have included African Americans, a population with high rates of cardiometabolic diseases. The investigators aim to fill these research gaps by establishing a longitudinal, observational study of metabolic surgery patients and applying multi-omics to identify stool, blood, and/or tissue microbial features related to post-surgery cardiometabolic outcomes. In the current study, the investigators plan to enroll up to 300 patients who undergo metabolic surge

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📋 Eligibility rules (as published)
Inclusion Criteria: * Be approved and scheduled for metabolic surgery at the Vanderbilt University Medical Center * Have a history of type 2 diabetes, hypertension, or dyslipidemia * Be able and willing to provide personal information and biological samples needed for the study Exclusion Criteria: * Prior gastric operations * A history of coronary artery disease, stroke, heart failure, HIV infection, or untreated viral hepatitis * Chemotherapy or radiotherapy for cancer within 2 years * Current inflammatory bowel disease or celiac disease * Vomiting, constipation, or diarrhea within 7 days or use of antibiotics within 2 months
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What it tests

  • Bariatric Surgery
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Where

1 site
Vanderbilt_University MC
Nashville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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