Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01DK126721 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bariatric Surgery | Procedure | Roux-en-Y gastric bypass (RYGB) and vertical sleeve gastrectomy (VSG) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Glycated hemoglobin | From before surgery to 1 to 3-year after surgery to 10-year after surgery | |
| Blood pressure | From before surgery to 1 to 3-year after surgery to 10-year after surgery | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
We plan to enroll 300 patients who undergo metabolic surgery at the Vanderbilt University Medical Center and follow them up to 10 years after surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danxia Yu, PhD | Contact | 615-936-7389 | danxia.yu@vumc.org | |
| Charles R Flynn, PhD | Contact | 615-343-8329 | robb.flynn@vumc.org |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt_University MC | Recruiting | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32747219 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 17, 2023 | Sep 26, 2023 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003924 | Diabetes Mellitus, Type 2 |
| D050171 | Dyslipidemias |
| D006973 | Hypertension |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Stool; Blood (plasma, serum, white blood cells, and red blood cells); Tissue (subcutaneous adipose, omentum, skeletal, jejunum, and stomach)
| 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 |
| Blood inflammatory proteins | high-sensitivity C-reactive protein | From before surgery to 1 to 3-year after surgery to 10-year after surgery |
| D004700 | Endocrine System Diseases |
| D052439 | Lipid Metabolism Disorders |
| D014652 | Vascular Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |