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| Name | Class |
|---|---|
| Ethicon Endo-Surgery | INDUSTRY |
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The investigators wish to study the effects of three forms of bariatric surgery: Roux-en-Y gastric bypass, Sleeve Gastrectomy, and Gastric Banding. The surgery is not part of the clinical trial. If your insurance does not cover the procedure, then you are responsible for payment of the surgical process. We are doing pre and post surgery testing to provide a better understanding of the effect of bariatric surgery-induced weight loss on metabolic function.
Bariatric surgery is the most effective weight loss therapy for obesity. Moreover, the early improvement in insulin sensitivity and the resolution of type 2 diabetes after bariatric surgery has led to the hypothesis that bariatric surgery has specific beneficial effects on glucose homeostasis beyond weight loss alone. However, this hypothesis has never been adequately evaluated in human subjects. Therefore, the primary goal of this proposal is to provide a better understanding of the effect of bariatric surgery-induced weight loss on insulin action and pancreatic beta cell function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastric Bypass | morbidly obese subjects undergoing gastric bypass surgery |
| |
| gastric banding | morbidly obese subjects undergoing laparoscopic gastric banding surgery |
| |
| sleeve gastrectomy | morbidly obese subjects undergoing sleeve gastrectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gastric bypass | Procedure | Roux-en-Y gastric bypass |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The effect of bariatric surgery-induced weight loss (Roux-en-Y gastric bypass, sleeve gastrectomy, and laparoscopic adjustable banding) on insulin action | at 20% weight loss post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of bariatric surgery-induced weight loss Roux-en-Y gastric bypass, sleeve gastrectomy, and laparoscopic adjustable gastric banding) on pancreatic beta cell response | at 20% weight loss post surgery | |
| Determine the effect of bariatric surgery induced weight loss (Roux-en-Y gastric bypass, sleeve gastrectomy, and laparoscopic adjustable gastric banding) on gut microbiota. |
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Inclusion Criteria:
Exclusion Criteria:
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A total of 20 (per surgical group) morbidly obese (BMI ≥ 35 kg/m²) subjects scheduled for bariatric surgical procedures will participate in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Klein, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31004409 | Derived | Yoshino J, Patterson BW, Klein S. Adipose Tissue CTGF Expression is Associated with Adiposity and Insulin Resistance in Humans. Obesity (Silver Spring). 2019 Jun;27(6):957-962. doi: 10.1002/oby.22463. Epub 2019 Apr 19. | |
| 28938478 | Derived | Harris LLS, Smith GI, Mittendorfer B, Eagon JC, Okunade AL, Patterson BW, Klein S. Roux-en-Y Gastric Bypass Surgery Has Unique Effects on Postprandial FGF21 but Not FGF19 Secretion. J Clin Endocrinol Metab. 2017 Oct 1;102(10):3858-3864. doi: 10.1210/jc.2017-01295. |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D009765 | Obesity |
| D015431 | Weight Loss |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015390 | Gastric Bypass |
| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
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plasma, tongue tissue, muscle tissue, fat tissue,liver tissue, colon tissue, stool
| gastric banding | Procedure | laparoscopic adjustable gastric banding |
|
|
| sleeve gastrectomy | Procedure | vertical sleeve gastrectomy |
|
|
| at 20% weight loss post surgery |
| Identify host genes that co-vary with an altered metagenome in obese individuals that undergo bariatric surgery | at 20% weight loss post surgery. |
| Investigate how the metagenome is affected by bariatric surgery procedures leading to weight reduction | at 20% weight loss post surgery |
| The effect of bariatric surgery-induced weight loss (Roux-en-Y gastric bypass, sleeve gastrectomy, and laparoscopic adjustable gastric banding) on postprandial plasma fibroblast growth factor (FGF)21 and FGF19 responses. | at 20% weight loss post surgery |
| 26607940 | Derived | Magkos F, Bradley D, Eagon JC, Patterson BW, Klein S. Effect of Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding on gastrointestinal metabolism of ingested glucose. Am J Clin Nutr. 2016 Jan;103(1):61-5. doi: 10.3945/ajcn.115.116111. Epub 2015 Nov 25. |
| 24891156 | Derived | Bradley D, Magkos F, Eagon JC, Varela JE, Gastaldelli A, Okunade AL, Patterson BW, Klein S. Matched weight loss induced by sleeve gastrectomy or gastric bypass similarly improves metabolic function in obese subjects. Obesity (Silver Spring). 2014 Sep;22(9):2026-31. doi: 10.1002/oby.20803. Epub 2014 May 28. |
| 23610059 | Derived | Magkos F, Bradley D, Schweitzer GG, Finck BN, Eagon JC, Ilkayeva O, Newgard CB, Klein S. Effect of Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding on branched-chain amino acid metabolism. Diabetes. 2013 Aug;62(8):2757-61. doi: 10.2337/db13-0185. Epub 2013 Apr 22. |
| 23457410 | Derived | Kohli R, Bradley D, Setchell KD, Eagon JC, Abumrad N, Klein S. Weight loss induced by Roux-en-Y gastric bypass but not laparoscopic adjustable gastric banding increases circulating bile acids. J Clin Endocrinol Metab. 2013 Apr;98(4):E708-12. doi: 10.1210/jc.2012-3736. Epub 2013 Mar 1. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D005763 |
| Gastroenterostomy |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D013505 | Digestive System Surgical Procedures |