Clinical trial NCT05000996: Gut Microbiota in Metabolic Surgery
Official title: The Gut Microbiota in Metabolic Surgery: A Multi-Ethnic, Multi-Omic, Longitudinal Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bariatric Surgery Candidate
Cardiovascular Diseases
Type 2 Diabetes
Dyslipidemias
Hypertension
Morbid Obesity
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: National Cancer Institute (NCI)
First posted: 2021-08-11
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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.


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

Primary outcomes:
measure: Estimated 10-year risk of atherosclerotic cardiovascular disease
timeFrame: From before surgery to 1 to 3-year after surgery to 10-year after surgery
Secondary outcomes:
measure: Glycated hemoglobin
timeFrame: From before surgery to 1 to 3-year after surgery to 10-year after surgery
measure: Blood pressure
timeFrame: From before surgery to 1 to 3-year after surgery to 10-year after surgery
measure: Blood cholesterol
timeFrame: From before surgery to 1 to 3-year after surgery to 10-year after surgery
measure: Blood inflammatory proteins
timeFrame: From before surgery to 1 to 3-year after surgery to 10-year after surgery
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt_University MC
state: Tennessee
Study officials:
References:
citation: 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.