Calorie Reduction Or Surgery: Seeking Remission for Obesity And Diabetes
Calorie Reduction Or Surgery: Seeking Remission for Obesity And Diabetes
The escalating pandemics of obesity and type 2 diabetes mellitus (T2DM) are among the most
 significant contributors to morbidity and mortality worldwide. Roux-en-Y gastric bypass
 (RYGB) surgery causes profound weight loss and dramatically ameliorates T2DM through
 mechanisms beyond just weight loss, but its role in diabetes management and the nature of its
 weight-independent anti-diabetes effects are not well established because of a paucity of
 appropriate randomized trials, the execution of which is hindered by numerous obstacles. The
 investigators therefore propose a feasibility study 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.
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
 medical/lifestyle intervention.

 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
 (http://incontext.ghc.org/clinical/clin_topics/diabetes2/dm2_poc.html).

 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.
Inclusion Criteria:

 -  currently enrolled at Group Health

 -  currently enrolled in a GH insurance product that provides coverage for laparoscopic
 gastric bypass (e.g., Medicare, PEBB, or has GH bariatric coverage rider)

 -  age on January 1, 2011 will be between 25 and 65 years

 -  Diabetes: must meet one or more of the following criteria during the past two years
 (10/1/08 - 9/30/10):

 1. 1+ fills for a diabetes-specific medication (oral or insulin)

 2. Hemoglobin A1c ≥7.0% on one or more occasions

 3. Fasting Blood glucose ≥126 mg/dL on two or more occasions [separate days]

 4. Random glucose ≥200 mg/dl on two or more occasions [separate days]

 5. One fasting blood glucose ≥126 mg/dL plus one random glucose ≥200 mg/dl [must
 occur on separate days]

 6. One or more inpatient (primary or secondary hospital discharge) code related to
 diabetes. See list below.

 7. Two or more outpatient ICD-9 codes related to diabetes (ambulatory visits (AV)
 only - not telephone, email, emergency department, lab, radiology, or other (IS,
 OE) encounter types) [Two visits must occur on separate days]

 -  Obesity: All patients must have a body mass index [BMI] between 30 and <40kg/m2;
 weight measurement must be within the past two years (10/1/08 - 9/30/10)

 Exclusion Criteria:

 -  Pregnancy within the past one year (10/1/09 - 9/30/10)

 -  Excluded if the following conditions are recorded within the past two years (10/1/08 -
 9/30/10):

 1. malignant tumor

 2. ascites

 3. peritoneal effusion

 4. cirrhosis

 5. schizophrenia

 6. schizoaffective disorder

 7. bipolar disorder

 8. dementia

 9. HIV

 10. inflammatory bowel disease

 11. dialysis

 -  Exclude if occurred between 1/1/95 - 9/30/10:

 1. Any prior bariatric or major gastrointestinal operation

 2. Any prior liver, heart, intestinal, and/or lung transplant