Vanderbilt_University MC
Nashville, Tennessee, 37232, United States
Location status: Recruiting
Location contact
Britt Biesinger, MPH
CONTACT
Danxia Yu, PhD
CONTACT
NCT Number: NCT05000996
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.
Interested in participating?
Request Info21 year–65 year
All sexes
Observational
Nashville, Tennessee, 37232, United States
Location status: Recruiting
Britt Biesinger, MPH
CONTACT
Danxia Yu, PhD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Roux-en-Y gastric bypass (RYGB) and vertical sleeve gastrectomy (VSG)
Time frame: 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
Time frame: From before surgery to 1 to 3-year after surgery to 10-year after surgery
Time frame: From before surgery to 1 to 3-year after surgery to 10-year after surgery
Time frame: From before surgery to 1 to 3-year after surgery to 10-year after surgery
Total, low-density, and high-density lipoprotein cholesterol
Time frame: From before surgery to 1 to 3-year after surgery to 10-year after surgery
high-sensitivity C-reactive protein
Contact information is provided by the study sponsor or research team.
Charles R Flynn, PhD
CONTACT
Danxia Yu, PhD
CONTACT
Vanderbilt University Medical Center
Other
The Gut Microbiota in Metabolic Surgery: A Multi-Ethnic, Multi-Omic, Longitudinal Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05367479
Bariatric Surgery Candidate, Body Weight
Milwaukee, Wisconsin, United States
View Trial DetailsNCT03517072
Bariatric Surgery Candidate, Body Weight
Arras, France
View Trial DetailsNCT05650307
Bariatric Surgery Candidate, Behavior
Cleveland, Ohio, United States
View Trial DetailsNCT05404061
Bariatric Surgery Candidate, Body Weight
London, United Kingdom
View Trial Details