Examining gut microbiota changes in patients undergoing metabolic surgery
Official title: The Gut Microbiota in Metabolic Surgery: A Multi-Ethnic, Multi-Omic, Longitudinal Study
Run by Vanderbilt University Medical Center · NCT05000996 · Data updated 2026-11-12
This study is testing how metabolic surgery affects gut bacteria and heart health in patients, especially focusing on the African American community, over the next 10 years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 21 Years to 65 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Nashville, Tennessee) |
| Status | Recruiting |
| Started | August 19, 2021 |
| Main results expected | December 31, 2028 |
| Study ends | January 1, 2035 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT05000996 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals approved for metabolic surgery who have a history of type 2 diabetes, hypertension, or dyslipidemia.
✕Probably not a fit
Patients with prior gastric operations, certain cardiovascular conditions, or current gastrointestinal diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the impact of metabolic surgery on gut microbiota and its relationship with cardiometabolic health outcomes. By enrolling up to 300 patients scheduled for metabolic surgery at Vanderbilt University Medical Center, the study aims to track changes in gut microbiota from pre-surgery to post-surgery over a period of up to 10 years. The research will utilize multi-omics approaches to analyze stool, blood, and tissue samples, focusing particularly on the underrepresented African American population with high rates of cardiometabolic diseases. The goal is to fill existing research gaps and better understand how gut microbiota influences surgical outcomes.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of obesity-related metabolic diseases, enhancing surgical outcomes for patients.
How similar studies have gone: While there is limited research on the specific relationship between gut microbiota and metabolic surgery outcomes, similar studies have shown promising results in understanding microbiota's role in metabolic health.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Vanderbilt_University MC
Nashville, Tennessee, United States Recruiting
Study contacts
- Study coordinator: Danxia Yu, PhD
- Email: danxia.yu@vumc.org
- Phone: 615-936-7389
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.