Gut Microbiota in Metabolic Surgery

  • STATUS
    Recruiting
  • End date
    Jun 1, 2031
  • participants needed
    300
  • sponsor
    Vanderbilt University Medical Center
Updated on 20 September 2021
diabetes
cardiovascular disease
hypertension
fasting
dyslipidemia

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 and 1-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 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 the associations of microbiome and metabolites with CVD risk score and improvements in hypertension, diabetes, and dyslipidemia 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.

Details
Condition Morbid obesity, NIDDM, Diabetes Mellitus, Vascular Diseases, Hypertension, Dyslipidemia, Cardiovascular Disease, Bariatric Surgery Candidate, Elevated Blood Pressure, type 2 diabetes mellitus, severe obesity, high blood pressure, arterial hypertension, cardiovascular diseases, cardiovascular disease (cvd), cardiovascular system diseases, cardiovascular disorders, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment Bariatric Surgery
Clinical Study IdentifierNCT05000996
SponsorVanderbilt University Medical Center
Last Modified on20 September 2021

Eligibility

Yes No Not Sure

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
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