Gut Microbiota in Metabolic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-19

Study Completion Date

2035-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intestinal Microbiota in Patients Before and After Bariatric Surgery and Healthy Controls

NCT02563119

Obesity

COMPLETED NA

Bariatric Surgery-Induced Shift in Gut Microbiome and NAFLD

NCT04263376

Obesity Diabetes Mellitus, Type 2 NAFLD

COMPLETED

Bariatric Surgery: Microbiome & Diabetes

NCT03723486

Obesity

UNKNOWN

The Role of the Omentum in the Treatment of Morbid Obesity

NCT00212160

Obesity

COMPLETED NA

Adaptation of Human Gut Microbiota to Energetic Restriction

NCT01454232

Obesity Metabolic Diseases Nutrition Disorders +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bariatric Surgery

Roux-en-Y gastric bypass (RYGB) and vertical sleeve gastrectomy (VSG)

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No