Gut Microbiota in Metabolic Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bariatric Surgery.
- Who it may be relevant to
- Registry conditions: Bariatric Surgery Candidate, Cardiovascular Diseases, Type 2 Diabetes, Dyslipidemias. Basic parameters: 21 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Gut Microbiota in Metabolic Surgery: A Multi-Ethnic, Multi-Omic, Longitudinal Study
Overview
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.
Interventions
- Procedure Bariatric Surgery
Roux-en-Y gastric bypass (RYGB) and vertical sleeve gastrectomy (VSG)
Primary outcome measures
- 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]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Vanderbilt_University MC — Nashville
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. PMID 32747219
Identifiers
NCT: NCT05000996 · VUMC_IRB#201652 · R01DK126721