The TRIABETES - ARMMS-T2D Study: A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes

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.

Sex

All

Minimum age

25 Years

Maximum age

55 Years

Inclusion Criteria:

* Age 25 to 55 years
* Mild to moderate obesity with a BMI between 30 and 40 kg/m2
* For potential subjects with BMI 35 to 40 kg/m2: T2DM confirmed by either a documented fasting blood glucose \> 126 mg/dl OR treatment with an anti-diabetic medication
* For potential subjects with BMI 30 to 35 kg/m2: T2DM that is difficult to control medically and is recommended for the study by the subject's endocrinologist AND treatment with an anti-diabetic medication
* Willingness to be randomized to a surgical intervention

Exclusion Criteria:

* Prior bariatric or foregut surgery
* Poor overall general health
* Impaired mental status
* Drug and/or alcohol addiction
* Current smoking
* Pregnant or plans to become pregnant
* Type 1 Diabetes Mellitus
* Portal hypertension and/or Cirrhosis
* Failed study-related nutrition or psychological assessment
* Current participation in any other research study
* Inability to provide informed consent
* Unlikely to comply with study protocol
* Unable to communicate with study staff
* Unable to exercise (walk a city block or a flight of stairs)

• RESULTCourcoulas 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. PMID 38411644
• RESULTCourcoulas 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. PMID 38829663
• RESULTLundholm 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. PMID 39267261
• RESULTSimonson 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. PMID 39903478
• RESULTCourcoulas 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. PMID 24899268
• RESULTCourcoulas 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.