Surgery or Lifestyle With Intensive Medical Management in the Treatment of Type 2 Diabetes

Inclusion Criteria:

- Potential participants will be those with T2DM, with a diagnosis of diabetes of at
least one year in duration,

- BMI 30-45 kg/m2 for the LAGB compared to intensive medical weight and diabetes
management and BMI 30-42 kg/m2 for LRYGB compared to intensive medical weight and
diabetes management,

- Age 21-65 years,

- With a strong desire for substantial weight loss, who are free from active
cardiovascular or other diseases that would render them unable to partake in a
structured exercise program or to undergo a bariatric surgical procedure, and who are
committed to life long medical and nutritional follow up.

Exclusion Criteria:

- Detectable levels of GAD antibody or a history of diabetic ketoacidosis or
uncontrolled T2DM (consistent fasting blood glucose >200 mg/dl or HbA1c above twice
normal);

- Previous gastrointestinal surgery, inflammatory bowel disease, esophageal diseases
including severe intractable esophagitis, Barrett's Disease, esophageal dysmotility or
other impaired gastric motility (gastroparesis), or hiatal hernia >3 cm in size,
chronic or acute bleeding conditions including peptic ulcer disease, portal
hypertension (gastric or esophageal varices), chronic pancreatitis, or cirrhosis of
the liver;

- Malignant or debilitating medical conditions, severe cardiopulmonary disease including
uncontrolled hypertension (repeated systolic measures >160 or diastolic > 95 mm Hg on
more than one day), unstable angina pectoris, recent myocardial infarction within 6
months, history of coronary artery bypass surgery or angioplasty, congestive heart
failure, arrhythmia, stroke or transient ischemic attacks, urinary albumin excretion
>300 mcg/mg creatinine and/or serum creatinine >1.5 mg/dL (permitting safety of
increased dietary protein intake),

- Any endocrine disorder other than T2DM or thyroid disease which is stable on
replacement therapy, including Cushing's syndrome;

- Any previous history of eating disorders, history of drug and/or alcohol abuse within
2 years of the screening visit, history of impaired mental status by DSM-IV
(Diagnostic and Statistical Manual, 4th Edition) criteria and including, but not
limited to active substance abuse, a history of schizophrenia, borderline personality
disorder, uncontrolled depression, suicidal attempts within the past two years or
current suicidal tendencies or ideations.

- Subjects will be excluded if there is a history of significant weight loss (>3%)
within the previous 3 months or participation in alternate medically supervised
exercise or weight reduction program within the previous 3 months, or with use of
prescription or over the counter weight reduction medications or supplements within
one month of the Screening Visit and for the duration of study participation.

- Women who are lactating, planning pregnancy, or unwilling to use contraception during
the course of the trial.