Clinical trial

Gut Microbiota in Metabolic Surgery

Recruiting now · Not applicable · 1 countries · Registry ID NCT05000996

Recruiting nowNot applicableObservational

What this study is about

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 surgery at Vanderbilt University Medical Center and follow them for up to 10 years after surgery. Fasting blood and stool samples will be collected at pre-surgery and 3-month, 1-year, 2-year, and 3-year post-surgery clinical visits. Tissue samples (e.g., biopsies of the liver and adipose and remnants of the stomach) will be collected during operation. Meanwhile, participants will complete a REDCap survey at baseline and 1-year, 2-year, and 3-year post-surgery. Participants' electronic medical records will be used to obtain additional information and facilitate long-term follow-up. The investigators will evaluate pre- to post-surgery changes in the fecal microbiome and fecal and blood levels of metabolites and proteins and the associations of microbiome, metabolites, and proteins with cardiometabolic improvements after surgery. This study will advance our understanding of the role of gut microbiota in metabolic surgery, which may translate into novel approaches to identify and treat obese patients for better cardiometabolic health.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age21 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionBariatric Surgery Candidate, Cardiovascular Diseases, Type 2 Diabetes, Dyslipidemias, Hypertension, Morbid Obesity

Full registry 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

Treatments and study arms

Bariatric Surgery

Procedure

Roux-en-Y gastric bypass (RYGB) and vertical sleeve gastrectomy (VSG)

Primary outcomes

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Vanderbilt_University MC🇺🇸 Nashville, Tennessee, United States

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Danxia Yu, PhDContact

Email · Call 6159367389

Britt Biesinger, MPHContact

Email · Call 615-421-8055