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| ID | Type | Description | Link |
|---|---|---|---|
| RC1DK086037 | U.S. NIH Grant/Contract | View source | |
| R01DK095128-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This research study is being performed to begin to determine the effectiveness of two dominant bariatric surgery procedures versus an intensive lifestyle intervention to induce weight loss in patients and promote improvements in Type 2 diabetes mellitus (T2DM) in moderately obese patients.
T2DM is currently the 6th leading cause of mortality in the United States and is a major cause of kidney failure, blindness, amputations, heart attack, and other vascular and gastro-intestinal dysfunctions. Traditionally, treatments include intensive lifestyle modifications with or without glucose lowering agents. Neither treatment alone, or in combination, results in complete resolution of diabetes and its potential long-term complications. Bariatric surgery has been proven as an effective treatment to accomplish sustained and significant weight loss for those with severe obesity and has been shown to induce long-term remission of T2DM. However, despite enthusiasm for these potential treatment options, it is not clear whether diabetes is influenced by the type of surgery or by the amount of weight lost or if bariatric surgery is more effective than non-surgical weight loss induced by diet and physical activity in T2DM patients with moderate BMIs (30-40kg/m2; Class I and Class II obesity, or approximately 65-95 pounds overweight depending on your height). More well-controlled studies are needed to more completely inform health care decision making and clinical practice in this area. This research study aims to obtain preliminary information regarding the effectiveness of two major types of bariatric surgery, Laparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding versus an intensive lifestyle intervention to induce weight loss with diet and increased physical activity.
The Specific Aims of the first phase of the study are as follows:
Aim 1. To determine the feasibility of performing a randomized trial comparing two major types of bariatric surgery, Laparoscopic Roux en Y Gastric Bypass (RNY) and Laparoscopic Adjustable Gastric Banding (GB) versus a lifestyle weight loss intervention (LWLI) induced by diet and increased physical activity in moderately obese patients (Class I and II obesity) with T2DM. We hypothesize that: 1) A randomized design with both surgical and non-surgical arms will be both feasible and acceptable to participants and to providers 2) There will be no difference in retention rates between the LWLI and surgical arms (RNY, GB) of the study and it will provide estimates of overall retention for future studies.
Aim 2. To obtain preliminary information regarding the effectiveness of two dominant bariatric surgery procedures versus an intensive lifestyle intervention to induce weight loss with diet and increased physical activity. We hypothesize that: 1) RNY will be superior to GB and LWLI in weight lost in 12 months.
Aim 3. To explore the feasibility, methods for, and implementation of a range of early outcome measures including; resolution of diabetes, glucose control, medication usage, insulin resistance, beta cell function, body composition, objective measures of physical activity, and several psychosocial measures. We hypothesize that: 1) Participants will be willing to undergo a range of early outcome testing measures to assess metabolic change, body composition alterations, objective physical activity, and psychosocial factors. 2) Measures of T2DM improvement including an intravenous glucose tolerance test (IVGTT) will be feasible in a subset of participants in each study arm and RNY will be superior to both GB and LWLI for the clinical and metabolic improvement of T2DM. 3) The LWLI group will show improvements in physical activity compared to RNY and GB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roux-en-Y Gastric Bypass Surgery | Experimental | Roux-en-Y Gastric Bypass Surgery |
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| Laparoscopic Adjustable Gastric Banding | Experimental | Laparoscopic Adjustable Gastric Banding |
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| Lifestyle/Behavioral Weight Loss | Experimental | Lifestyle Weight Loss Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roux-en-Y Gastric Bypass Surgery | Procedure | Participants assigned to the Roux-en-Y Gastric Bypass treatment group will undergo a surgical procedure that limit foods intake and causes nutrients malabsorption. The procedure is performed with small incisions or laparoscopically. A small stomach pouch is created, the size of an egg, and the small intestine is connected to the pouch. Some of the stomach and small intestine are consequently bypassed by this anatomic change. Those in this treatment group will begin a gradual diet post surgery and will take life long vitamin supplements. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of performing a randomized trial comparing two major types of bariatric surgery versus a lifestyle weight loss intervention (LWLI) induced by diet and increased physical activity in moderately obese patients with T2DM. | 6 months, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Preliminary information regarding the effectiveness of two dominant bariatric surgery procedures versus an intensive lifestyle intervention to induce weight loss with diet and increased physical activity. | 6 months, 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anita P Courcoulas, MD, MPH | University of Pittsburgh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William F Gourash | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38411644 | Result | Courcoulas AP, Patti ME, Hu B, Arterburn DE, Simonson DC, Gourash WF, Jakicic JM, Vernon AH, Beck GJ, Schauer PR, Kashyap SR, Aminian A, Cummings DE, Kirwan JP. Long-Term Outcomes of Medical Management vs Bariatric Surgery in Type 2 Diabetes. JAMA. 2024 Feb 27;331(8):654-664. doi: 10.1001/jama.2024.0318. | |
| 38829663 | Result | Courcoulas AP, Patti ME, Kirwan JP. Medical Management vs Bariatric Surgery in Type 2 Diabetes-Reply. JAMA. 2024 Jul 2;332(1):76-77. doi: 10.1001/jama.2024.8852. No abstract available. |
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| Laparoscopic Adjustable Gastric Banding | Procedure | Those assigned to the Laparoscopic Adjustable Gastric Banding study group will undergo a surgical procedure where an adjustable silicone band is placed around the upper stomach to decrease its capacity so that you will feel full sooner. It will assist in weight loss by helping you to limit intake of calories. The band will be placed by using several small incisions and telescopic instruments. A thin tube connects the band to an access port just under the skin that you may be able to feel but you will not be able to see it. This allows the band to be tightened or loosened to decrease or increase your stomach capacity as needed. The surgery will take on average 30-45 minutes. |
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| Lifestyle Weight Loss Intervention | Behavioral | Participants will receive a standard behavior weight control program in an in-person format over a period of 12 months conducted by an experienced team of weight loss counselors. During the initial 6 months of study treatment, will attend weekly in-person individual sessions with a weight loss counselor. During months 7-12, will attend in-person sessions on the 1st and 3rd week of the month and will receive a brief (less than 10 minutes in duration) telephone call on the 2nd and 4th week of the month. Each session will focus on a specific behavioral topic related to weight loss, eating behaviors, or exercise behaviors. |
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| 39267261 | Result | Lundholm MD, Kirschling S, Hu B, Aminian A, Arterburn DE, Courcoulas AP, Cummings DE, Gourash WF, Patti ME, Schauer PR, Simonson DC, Vernon AH, Kirwan JP, Kashyap SR. Long-term outcomes of metabolic surgery versus medical/lifestyle therapy on metabolic dysfunction-associated fatty liver disease in adults with obesity and type 2 diabetes. Diabetes Obes Metab. 2024 Dec;26(12):6055-6061. doi: 10.1111/dom.15932. Epub 2024 Sep 12. No abstract available. |
| 39903478 | Result | Simonson DC, Gourash WF, Arterburn DE, Hu B, Kashyap SR, Cummings DE, Patti ME, Courcoulas AP, Vernon AH, Jakicic JM, Kirschling S, Aminian A, Schauer PR, Kirwan JP. Health-Related Quality of Life and Health Utility After Metabolic/Bariatric Surgery Versus Medical/Lifestyle Intervention in Individuals With Type 2 Diabetes and Obesity: The ARMMS-T2D Study. Diabetes Care. 2025 Apr 1;48(4):537-545. doi: 10.2337/dc24-2046. |
| 24899268 | Result | Courcoulas AP, Goodpaster BH, Eagleton JK, Belle SH, Kalarchian MA, Lang W, Toledo FG, Jakicic JM. Surgical vs medical treatments for type 2 diabetes mellitus: a randomized clinical trial. JAMA Surg. 2014 Jul;149(7):707-15. doi: 10.1001/jamasurg.2014.467. |
| 31917447 | Result | Courcoulas AP, Gallagher JW, Neiberg RH, Eagleton EB, DeLany JP, Lang W, Punchai S, Gourash W, Jakicic JM. Bariatric Surgery vs Lifestyle Intervention for Diabetes Treatment: 5-Year Outcomes From a Randomized Trial. J Clin Endocrinol Metab. 2020 Mar 1;105(3):866-76. doi: 10.1210/clinem/dgaa006. |
| 26132586 | Result | Courcoulas AP, Belle SH, Neiberg RH, Pierson SK, Eagleton JK, Kalarchian MA, DeLany JP, Lang W, Jakicic JM. Three-Year Outcomes of Bariatric Surgery vs Lifestyle Intervention for Type 2 Diabetes Mellitus Treatment: A Randomized Clinical Trial. JAMA Surg. 2015 Oct;150(10):931-40. doi: 10.1001/jamasurg.2015.1534. |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D050197 | Atherosclerosis |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
| D001766 | Blindness |
| D006973 | Hypertension |
| D009369 | Neoplasms |
| D009203 | Myocardial Infarction |
| D003643 | Death |
| D003920 | Diabetes Mellitus |
| D004194 | Disease |
| D004066 | Digestive System Diseases |
| D007249 | Inflammation |
| D007333 | Insulin Resistance |
| D051437 | Renal Insufficiency |
| D008107 | Liver Diseases |
| D009767 | Obesity, Morbid |
| D065626 | Non-alcoholic Fatty Liver Disease |
| D009043 | Motor Activity |
| D001835 | Body Weight |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |
| D006946 | Hyperinsulinism |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D005234 | Fatty Liver |
| D001836 | Body Weight Changes |
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