Bariatric Surgery Candidate, Cardiovascular Diseases, Dyslipidemias, Hypertension, Morbid Obesity, Type 2 Diabetes
Conditions
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.
Interventions
PROCEDUREBariatric Surgery
Roux-en-Y gastric bypass (RYGB) and vertical sleeve gastrectomy (VSG)
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Cancer Institute (NCI)
Vanderbilt University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated 10-year risk of atherosclerotic cardiovascular disease | From before surgery to 1 to 3-year after surgery to 10-year after surgery | The 10-year risk of atherosclerotic cardiovascular disease based on the American College of Cardiology/American Heart Association pooled cohort equations, incorporating age, sex, race, systolic blood pressure, total cholesterol, HDL cholesterol, diabetes status, hypertension status, and smoking |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | From before surgery to 1 to 3-year after surgery to 10-year after surgery | — |
| Glycated hemoglobin | From before surgery to 1 to 3-year after surgery to 10-year after surgery | — |
| Blood cholesterol | From before surgery to 1 to 3-year after surgery to 10-year after surgery | Total, low-density, and high-density lipoprotein cholesterol |
| Blood inflammatory proteins | From before surgery to 1 to 3-year after surgery to 10-year after surgery | high-sensitivity C-reactive protein |
Countries
United States
Contacts
Primary ContactDanxia Yu, PhD
Backup ContactCharles R Flynn, PhD
Outcome results
None listed