Roux-en-Y-Gastric Bypass vs. Lifestyle Modification and Medical Therapy in the Treatment of Type 2 Diabetes

NAUnknownINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

October 31, 2010

Primary Completion Date

October 31, 2013

Study Completion Date

October 31, 2014

Conditions
Type 2 Diabetes
Interventions
PROCEDURE

Roux-en-Y-Gastric Bypass

Standard laparoscopic gastric bypass. Preoperative preparation will include antibiotic prophylaxis given less than 60 minutes prior to making the first incision. Under general anesthesia with endotracheal intubation, a laparoscopic gastric bypass will be performed in the usual fashion.

BEHAVIORAL

Intensive lifestyle modification and Optimal medical Therapy

Very low calorie diet consisting of 5 feedings: 2 liquid meal replacements, 2 low-calorie snacks, and 1 small meal of known caloric content. After 10% weight loss is achieved, the subjects will received individualized nutrition sessions beginning bi-weekly but extending time intervals as the weight loss progresses.

Trial Locations (1)

10065

RECRUITING

Weill Cornell Medical College, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Medtronic - MITG

INDUSTRY

lead

Weill Medical College of Cornell University

OTHER