Gut Microbiota in Metabolic Surgery

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT05000996
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Bariatric Surgery — PROCEDURE
    Roux-en-Y gastric bypass (RYGB) and vertical sleeve gastrectomy (VSG)

Study Details

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.

Key Dates

Start date
Aug 19, 2021
Status verified
Nov 2025
Primary completion
Dec 31, 2028
Completion
Jan 1, 2035

Study Design

Enrollment
300 participants (estimated)

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt_University MCNashvilleTennessee37232
Danxia Yu, PhD
[email protected]
6159367389
Britt Biesinger, MPH
[email protected]
615-421-8055

Find similar trials in Nashville, TN

By condition
Hypertension (high blood pressure)Type 2 diabetes
By specialty
CardiologyHeart diseaseEndocrinologyMetabolic healthWeight loss
By research site
Vanderbilt_University MC· Nashville, TN

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