calorie reduction or surgery: seeking remission for obesity and diabetes

Conditions: Diabetes Mellitus, Type 2; Obesity

Summary: 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.

Eligibility criteria:
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