Gut Microbiota in Metabolic Surgery
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
🗓️ Study Start (Actual) 19 August 2021
🗓️ Primary Completion (Estimated) 1 June 2026
✅ Study Completion (Estimated) 1 June 2031
👥 Enrollment (Estimated) 300
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Nashville, Tennessee, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 21 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 2 August 2021
  • First Submitted that Met QC Criteria 10 August 2021
  • First Posted 11 August 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 26 September 2023
  • Last Update Posted 28 September 2023
  • Last Verified September 2023