Gut Microbiota in Metabolic Surgery Study

This study is looking at how metabolic surgery, like Roux-en-Y gastric bypass (RYGB) and vertical sleeve gastrectomy (VSG), affects the bacteria in your gut (gut microbiota) and how this relates to your heart health over time. Researchers want to understand if changes in gut bacteria after surgery can help prevent heart problems in people with conditions like type 2 diabetes, high blood pressure, and high cholesterol. You may be able to join if you are between 21 and 65 years old, are approved for metabolic surgery at Vanderbilt University Medical Center, and have a history of type 2 diabetes, high blood pressure, or high cholesterol. The study will look at your risk of heart disease for up to 10 years after surgery. The current status of this study is unclear.

Study design
This is an observational study involving 300 participants. It will follow people over time to see how their gut bacteria change after metabolic surgery.
What's involved
You would need to provide personal information and biological samples (stool, blood, and/or tissue) before and after your surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from before surgery to 1 to 3 years after surgery, and then up to 10 years after surgery to assess their risk of heart disease.

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NCT05000996

Gut Microbiota in Metabolic Surgery

Recruiting
Not specifiedAges 21–65Observational
Vanderbilt University Medical Center
~300 participants
Updated 2025-11-04 on ClinicalTrials.gov
What's tested:Bariatric Surgery

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Estimated 10-year risk of atherosclerotic cardiovascular disease
Measured over From before surgery to 1 to 3-year after surgery to 10-year after surgery
Bariatric Surgery Candidate
Cardiovascular Diseases
Type 2 Diabetes
Dyslipidemias
Hypertension
Morbid Obesity
1 sites across 1 states
Tennessee1

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Eligibility criteria

Inclusion

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

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
  • Estimated 10-year risk of atherosclerotic cardiovascular diseaseFrom before surgery to 1 to 3-year after surgery to 10-year after surgery

    The 10-year risk of atherosclerotic cardiovascular disease based on the American College of Cardiology/American Heart Association pooled cohort equations, incorporating age, sex, race, systolic blood pressure, total cholesterol, HDL cholesterol, diabetes status, hypertension status, and smoking