About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
We plan to enroll 300 patients who undergo metabolic surgery at the Vanderbilt University Medical Center and follow them up to 10 years after surgery
Trial design
Cohort
Prospective
Treatments tested in this trial
Bariatric Surgery
Procedure/SurgeryRoux-en-Y gastric bypass (RYGB) and vertical sleeve gastrectomy (VSG)
Treatment groups
Trial outcomes
Primary outcomes
Estimated 10-year risk of atherosclerotic cardiovascular disease
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
Secondary outcomes
Glycated hemoglobin
Blood pressure
Blood cholesterol
Total, low-density, and high-density lipoprotein cholesterol
Blood inflammatory proteins
high-sensitivity C-reactive protein
Sponsors and contacts
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Vanderbilt University Medical Center
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
National Cancer Institute (NCI)
Collaborator