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

Running, not enrolling · Not applicable

Conditions studied: Type 2 Diabetes Mellitus, Obesity

In brief

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.

Key facts

Study ID

NCT01047735

Run by

University of Pittsburgh

People needed

69

Starts

2009-09-01

Expected to finish

2028-07-01

Last updated by the study team

2026-06-11

Who can join

Age: 25 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• William F Gourash — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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