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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK101578 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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For this purpose, we will compare the effects of targeted 16-18% (with a range of 16-25%) weight loss induced by Roux-en-Y Gastric bypass (RYGB) surgery with the same weight loss induced by a low-calorie diet (LCD) on liver and skeletal muscle insulin sensitivity, beta-cell function, and 24-hour metabolic homeostasis in obese subjects with or without T2D.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roux-en-Y gastric bypass (RYGB) | Experimental | Subjects in this group are scheduled to undergo roux-en-Y gastric bypass surgery to obtain approximately 16-18% (with a range of 16-25%) weight loss. |
|
| Low-calorie diet | Active Comparator | Subjects in this group will participate in a low-calorie diet intervention to obtain approximately 16-18% (with a range of 16-25%) weight loss. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roux-en-Y gastric bypass surgery | Procedure | A surgical procedure to help subjects lose approximately 16-18% (with a range of 16-25%) of their body weight. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in hepatic insulin sensitivity | The outcome will be assessed by hyperinsulinemic-euglycemic-pancreatic-clamp procedure before and after weight loss. | 6 months (before and after targeted weight loss) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in skeletal muscle and adipose tissue insulin sensitivity | The outcome will be assessed by hyperinsulinemic-euglycemic-pancreatic-clamp procedure before and after weight loss. | 6 months (before and after targeted weight loss) |
| Changes in Beta-cell function |
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Inclusion Criteria:
For RYGB group:
For Low-Calorie Diet group:
Exclusion Criteria:
For both RYGB & Low-Calorie Diet groups
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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 |
|---|---|---|---|
| 39264820 | Result | Petersen MC, Yoshino M, Smith GI, Gaspar RC, Kahn M, Samovski D, Shulman GI, Klein S. Effect of Weight Loss on Skeletal Muscle Bioactive Lipids in People With Obesity and Type 2 Diabetes. Diabetes. 2024 Dec 1;73(12):2055-2064. doi: 10.2337/db24-0083. | |
| 40208704 | Result | Samovski D, Smith GI, Palacios H, Pietka T, Fuchs A, Patti GJ, Nawaz A, Kahn CR, Klein S. Effect of Marked Weight Loss on Adipose Tissue Biology in People With Obesity and Type 2 Diabetes. Diabetes Care. 2025 Aug 1;48(8):1342-1351. doi: 10.2337/dc24-2739. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
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| Low-calorie diet | Behavioral | Subjects will meet with a dietitian and/or behaviorist over approximately 6 months to lose approximately 16-18% (with a range of 16-25%) of their body weight. |
|
The outcome will be assessed as the product of beta-cell glucose sensitivity (ratio of post-meal insulin secretion rate to post-meal plasma glucose) during mixed-meal test and whole-body insulin sensitivity before and after weight loss. |
| 6 months (before and after targeted weight loss) |
| Changes in glucose kinetics (glucose concentration and rate of appearance into the systemic circulation) in response to mixed-meal ingestion | The outcome will be measured by using dual glucose tracer mixed meal metabolic test and serial blood sampling for 4 hours before and after weight loss | 6 months (before and after targeted weight loss) |
| Changes in 24-hour plasma glucose profile | The outcome will be determined by obtaining serial plasma glucose concentration measurements for 24 hours before and after weight loss | 6 months (before and after targeted weight loss) |
| Changes in 24-hour plasma insulin profile | The outcome will determined by obtaining serial plasma insulin concentration measurements for 24 hours before and after weight loss | 6 months (before and after targeted weight loss) |
| Changes in 24-hour plasma free fatty acid profile | The outcome will determined by obtaining serial plasma free fatty acid concentration measurements for 24 hours before and after weight loss | 6 months (before and after targeted weight loss) |
| Changes in body fat mass | The outcome will be measured by using dual-energy X-ray absorptiometry before and after weight loss | 6 months (before and after targeted weight loss) |
| Changes in intra-abdominal adipose tissue volume | The outcome will be measured by using magnetic resonance imaging before and after weight loss | 6 months (before and after targeted weight loss) |
| Changes in intrahepatic triglyceride content | The outcome will be measured by using magnetic resonance imaging before and after weight loss | 6 months (before and after targeted weight loss) |
| Changes in fat free mass | The outcome will be measured by using dual-energy X-ray absorptiometry before and after weight loss | 6 months (before and after targeted weight loss) |
| 40261704 | Result | Smith GI, Klein S. Plasma endotrophin levels correlate with insulin resistance in people with obesity. J Clin Invest. 2025 Apr 22;135(12):e190577. doi: 10.1172/JCI190577. eCollection 2025 Jun 16. No abstract available. |
| 32813948 | Result | Yoshino M, Kayser BD, Yoshino J, Stein RI, Reeds D, Eagon JC, Eckhouse SR, Watrous JD, Jain M, Knight R, Schechtman K, Patterson BW, Klein S. Effects of Diet versus Gastric Bypass on Metabolic Function in Diabetes. N Engl J Med. 2020 Aug 20;383(8):721-732. doi: 10.1056/NEJMoa2003697. |
| 32651241 | Derived | van Vliet S, Koh HE, Patterson BW, Yoshino M, LaForest R, Gropler RJ, Klein S, Mittendorfer B. Obesity Is Associated With Increased Basal and Postprandial beta-Cell Insulin Secretion Even in the Absence of Insulin Resistance. Diabetes. 2020 Oct;69(10):2112-2119. doi: 10.2337/db20-0377. Epub 2020 Jul 10. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001836 | Body Weight Changes |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |