Recruiting

Metabolic Surgery

Sponsor:

Vanderbilt University Medical Center

Code:

NCT05000996

Conditions

Bariatric Surgery Candidate

Cardiovascular Diseases

Type 2 Diabetes

Dyslipidemias

Hypertension

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

Bariatric Surgery

Study Details

Brief summary:

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.

Conditions

Bariatric Surgery Candidate

Cardiovascular Diseases

Type 2 Diabetes

Dyslipidemias

Hypertension

Study ID

NCT05000996

Start date

Aug 19, 2021

Status verified date

Nov, 2025

Completion date

Jan 1, 2035

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Interventions

Bariatric Surgery

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

Primary outcome measure

  • Estimated 10-year risk of atherosclerotic cardiovascular disease [ Time Frame: From before surgery to 1 to 3-year after surgery to 10-year after surgery ]

Central Contacts and Locations

Central contacts

Locations

Vanderbilt_University MC

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Nov 4, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2025-11-04.