Calorie Reduction Or Surgery: Seeking Remission for Obesity And Diabetes
Condition: Diabetes Mellitus, Type 2; Obesity
MeSH terms: Diabetes Mellitus; Obesity; Diabetes Mellitus, Type 2
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): laparoscopic Roux-en-Y gastric bypass (RYGB) procedure; Lifestyle Intervention
Intervention type(s): Procedure; Behavioral
Intervention description(s): The laparoscopic Roux-en-Y gastric bypass (RYGB) procedure is the most commonly performed bariatric procedure in the United States. Patients randomized to the surgical arm will undergo a standard laparoscopic proximal RYGB, as commonly practiced by GH surgeons, using a 90-cm alimentary limb, 50-cm biliopancreatic limb, antecolic/antegastric approach, and totally stapled technique.; The lifestyle intervention includes behavior-modification skills counseling combined with training in diet and exercise change. The focus of the exercise intervention is a gradual increase in brisk walking or other activities of similar moderate aerobic intensity. The exercise prescription will consist of at least 45 minutes of exercise, 5 days per week for 12 months. The diet intervention will be conducted by a research dietician with training in behavior modification, with supervision by Dr. Foster-Schubert. In week 1 the dietician will meet for a 60-minute individual session with participants at the FHCRC Prevention Center. Over the next 23 weeks the dietician will conduct one 30-minute group session per week.
Other intervention name(s): weight loss surgery; bariatric surgery; Diet and Exercise Program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment