Bariatric Surgery CandidateNCT05000996
Gut Microbiota in Metabolic Surgery
An observational study of Bariatric Surgery Candidate and Cardiovascular Diseases, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Bariatric Surgery Candidate, Cardiovascular Diseases, Type 2 Diabetes
- What is being tested?
- Bariatric Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2021to 1 Jan 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt_University MC
Nashville, Tennessee, 37232
Danxia Yu, PhD, 6159367389, danxia.yu@vumc.org
Britt Biesinger, MPH, 615-421-8055, britt.t.biesinger@vumc.org
About this study
Official title: The Gut Microbiota in Metabolic Surgery: A Multi-Ethnic, Multi-Omic, Longitudinal Study
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, Morbid Obesity
- Being tested
- Bariatric Surgery
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Type 2, Dyslipidemias, Hypertension, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric SurgeryProcedure or surgery
Roux-en-Y gastric bypass (RYGB) and vertical sleeve gastrectomy (VSG)
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From before surgery to 1 to 3-year after surgery to 10-year after surgery
Secondary outcomes (4)
Glycated hemoglobin
Measured: From before surgery to 1 to 3-year after surgery to 10-year after surgery
Blood pressure
Measured: From before surgery to 1 to 3-year after surgery to 10-year after surgery
Blood cholesterol
Total, low-density, and high-density lipoprotein cholesterol
Measured: From before surgery to 1 to 3-year after surgery to 10-year after surgery
Blood inflammatory proteins
high-sensitivity C-reactive protein
Measured: From before surgery to 1 to 3-year after surgery to 10-year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start19 Aug 2021
- Primary completion31 Dec 2028 (estimated)
- Study completion1 Jan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Danxia Yu, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000996
- Sponsor's protocol ID
- VUMC_IRB#201652
- Other IDs
- R01DK126721
- Status last verified
- Nov 2025
- First submitted
- 2 Aug 2021
- Last updated
- 4 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32747219
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Gut Microbiota in Metabolic Surgery: A Multi-Ethnic, Multi-Omic, Longitudinal Study
- ClinicalTrials.gov ID
- NCT05000996
- Acronym / sponsor ID
- VUMC_IRB#201652
- Conditions
- Bariatric Surgery Candidate, Cardiovascular Diseases, Type 2 Diabetes, Dyslipidemias, Hypertension, Morbid Obesity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Cancer Institute (NCI)
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 1 Jan 2035 (estimated)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric SurgeryRoux-en-Y gastric bypass (RYGB) and vertical sleeve gastrectomy (VSG) | Procedure or surgery | – |
Primary outcome
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
4 secondary outcomes
Glycated hemoglobin
Time frame: From before surgery to 1 to 3-year after surgery to 10-year after surgery
Blood pressure
Time frame: From before surgery to 1 to 3-year after surgery to 10-year after surgery
Blood cholesterol
Time frame: From before surgery to 1 to 3-year after surgery to 10-year after surgery
Blood inflammatory proteins
Time frame: From before surgery to 1 to 3-year after surgery to 10-year after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Results publication: PubMed 32747219Yu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery Candidate and Cardiovascular Diseases, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danxia Yu, PhD (615-936-7389, danxia.yu@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05000996, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025; AzTrials last refreshed its copy on 26 Oct 2026.