Feasibility, Efficacy, and Mechanisms of Surgical vs Medical Diabetes Treatment
The overall goal of the research study is to demonstrate our capacity to identify, recruit,
randomize, and track outcomes for 40 adult Group Health members identified as having T2DM
and a BMI between 30-40 kg/m2.
Our cohort recruitment strategy will utilize the GH administrative and clinical databases to
identify patients with T2DM and a BMI of 30-40 kg/m2. Sufficient numbers (N=4,000) of these
individuals will be mailed and surveyed to identify the small minority without strong
preferences regarding medical vs. surgical diabetes/obesity treatment. This subset will be
invited to become better informed about both strategies using a novel, standardized patient
decision aid for shared decision making (SDM) related to bariatric surgery: a high-quality
educational video that provides balanced and frequently updated information about the risks
and benefits of surgical and non-surgical care. After viewing SDM tool, potential subjects'
"willingness to randomize" will be assessed, and a subset of willing patients will actually
undergo randomization to either RYGB or a state-of-the-art intensive but reproducible
Forty patients will be randomized to either RYGB or an intensive medical/lifestyle
intervention. Twenty members will be randomly assigned to intensive behavioral/medical
treatment, and twenty will be randomly assigned to receive gastric bypass surgery. In the
non-surgical group, the investigators will study the feasibility and resources needed to
deploy a state-of-the-art intensive behavioral intervention to promote weight loss, which
includes dietary and exercise components. It will be coupled with diabetes pharmacotherapy
treatment consistent with Group Health Clinical Practice Guidelines
Patients randomized to the surgical arm will undergo a standard laparoscopic proximal RYGB,
as commonly practiced by GH surgeons. The operation and post-operative care will be
performed at GH by Dr. Steven Bock, Dr. Jeffery Lander, and their clinical staff, including
a team of nutritionists and a Registered Nurse Case Manager who coordinates the care of
patients in the GH Bariatric Surgery Program. Surgical patients will also undergo a
standardized 8-week pre-operative and 10-month post-operative behavioral treatment regimen
with the GH Bariatric Surgery Program.
Participants will have follow-up research visits at 3, 6, 9, and 12 months after
randomization, where they will have the following measurements: standardized physically exam
by Dr. Foster-Schubert; weight, waist and hip circumferences; systolic and diastolic blood
pressure; resting 1-minute pulse; and fasting (12-hour) blood (50 ml) collection.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Explore the feasibility of a set of novel methods to create an appropriate randomization cohort of patients with type 2 diabetes mellitus (T2DM) and a body mass index (BMI) of 30-40 kg/m2 who are willing to be randomized into either roux-en-Y gastric bypass (RYGB) surgery or an intensive medical/lifestyle intervention. This will be assessed by comparing the number of people recruited to the number randomized and subsequently enrolled in the study.
April 2011 - January 2012
David E Cummings, MD
University of Washington
United States: Institutional Review Board
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|Group Health Research Institute||Seattle, Washington 98101|