Gut Microbiota in Metabolic Surgery

Hypertension Clinical Trial

Official title:

The Gut Microbiota in Metabolic Surgery: A Multi-Ethnic, Multi-Omic, Longitudinal Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05000996
• Other study ID #: VUMC_IRB#201652
• Secondary ID: R01DK126721
• Status: Recruiting
• Start date: August 19, 2021
• Est. completion date: June 1, 2031

Study information

• Verified date: September 2023
• Source: Vanderbilt University Medical Center
• Contact: Danxia Yu, PhD
• Phone: 615-936-7389
• Email: danxia.yu[@]vumc.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 1, 2031
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Cardiovascular Diseases
• Dyslipidemias
• Hypertension
• Morbid Obesity
• Obesity, Morbid
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbilt_University MC	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Cancer Institute (NCI), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated 10-year risk of atherosclerotic cardiovascular disease	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	From before surgery to 1 to 3-year after surgery to 10-year after surgery
Secondary	Glycated hemoglobin		From before surgery to 1 to 3-year after surgery to 10-year after surgery
Secondary	Blood pressure		From before surgery to 1 to 3-year after surgery to 10-year after surgery
Secondary	Blood cholesterol	Total, low-density, and high-density lipoprotein cholesterol	From before surgery to 1 to 3-year after surgery to 10-year after surgery
Secondary	Blood inflammatory proteins	high-sensitivity C-reactive protein	From before surgery to 1 to 3-year after surgery to 10-year after surgery