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

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.

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.

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.