Actively Recruiting

Age: 21Years - 65Years
All Genders
NCT05000996

Gut Microbiota in Metabolic Surgery

Led by Vanderbilt University Medical Center · Updated on 2025-11-04

300

Participants Needed

1

Research Sites

697 weeks

Total Duration

On this page

Sponsors

V

Vanderbilt University Medical Center

Lead Sponsor

N

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

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

Gut Microbiota in Metabolic Surgery

Who Can Participate

Age: 21Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Vanderbilt_University MC

Nashville, Tennessee, United States, 37232

Actively Recruiting

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Research Team

D

Danxia Yu, PhD

CONTACT

C

Charles R Flynn, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Gut Microbiota in Metabolic Surgery | DecenTrialz