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NCT Number: NCT05000996

Gut Microbiota in Metabolic Surgery

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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bariatric surgery

Procedure

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

Primary outcomes

  1. 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

    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

  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

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

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

  4. Blood inflammatory proteins

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

    high-sensitivity C-reactive protein

Study contacts

Contact information is provided by the study sponsor or research team.

Charles R Flynn, PhD

CONTACT

[email protected]

615-343-8329

Danxia Yu, PhD

CONTACT

[email protected]

615-936-7389

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

The Gut Microbiota in Metabolic Surgery: A Multi-Ethnic, Multi-Omic, Longitudinal Study

Important dates

Study start
2021
Primary completion
2028
Study completion
2035
First posted
Aug 11, 2021
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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