Calorie Reduction Or Surgery: Seeking Remission for Obesity And Diabetes

Feasibility, Efficacy, and Mechanisms of Surgical vs Medical Diabetes Treatment

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