Gut Microbiota in Metabolic Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-65
SponsorVanderbilt University Medical Center

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Bariatric Surgery

    Procedure/Surgery

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
From before surgery to 1 to 3-year after surgery to 10-year after surgery

Secondary outcomes

1

Glycated hemoglobin

Time frame
From before surgery to 1 to 3-year after surgery to 10-year after surgery
2

Blood pressure

Time frame
From before surgery to 1 to 3-year after surgery to 10-year after surgery
3

Blood cholesterol

Total, low-density, and high-density lipoprotein cholesterol

Time frame
From before surgery to 1 to 3-year after surgery to 10-year after surgery
4

Blood inflammatory proteins

high-sensitivity C-reactive protein

Time frame
From before surgery to 1 to 3-year after surgery to 10-year after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt University Medical Center

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

National Cancer Institute (NCI)

Collaborator