Gut Microbiota in Metabolic Surgery
The Gut Microbiota in Metabolic Surgery: A Multi-Ethnic, Multi-Omic, Longitudinal Study
2 other identifiers
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2021
CompletedFirst Posted
Study publicly available on registry
August 11, 2021
CompletedStudy Start
First participant enrolled
August 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2035
November 4, 2025
November 1, 2025
7.4 years
August 2, 2021
November 2, 2025
Conditions
Outcome Measures
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
From before surgery to 1 to 3-year after surgery to 10-year after surgery
Secondary Outcomes (4)
Glycated hemoglobin
From before surgery to 1 to 3-year after surgery to 10-year after surgery
Blood pressure
From before surgery to 1 to 3-year after surgery to 10-year after surgery
Blood cholesterol
From before surgery to 1 to 3-year after surgery to 10-year after surgery
Blood inflammatory proteins
From before surgery to 1 to 3-year after surgery to 10-year after surgery
Interventions
Roux-en-Y gastric bypass (RYGB) and vertical sleeve gastrectomy (VSG)
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt_University MC
Nashville, Tennessee, 37232, United States
Related Publications (1)
Yu D, Shu XO, Howard EF, Long J, English WJ, Flynn CR. Fecal metagenomics and metabolomics reveal gut microbial changes after bariatric surgery. Surg Obes Relat Dis. 2020 Nov;16(11):1772-1782. doi: 10.1016/j.soard.2020.06.032. Epub 2020 Jun 27.
PMID: 32747219RESULT
Biospecimen
Stool; Blood (plasma, serum, white blood cells, and red blood cells); Tissue (subcutaneous adipose, omentum, skeletal, jejunum, and stomach)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
August 2, 2021
First Posted
August 11, 2021
Study Start
August 19, 2021
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
January 1, 2035
Last Updated
November 4, 2025
Record last verified: 2025-11