Laparoscopic Gastric Bypass for Type 2 Diabetes Mellitus With Body Mass Index (BMI) < 35
Laparoscopic Gastric Bypass for Type 2 Diabetes Mellitus With Body Mass Index (BMI) < 35
The aim of this study is to evaluate the effect of Roux-en-y gastric bypass (RYGB) in
 controlling diabetes in subjects with mild obesity (BMI 26-35). The primary endpoint will be
 the reduction of HbA1c (< 7%), a standard measure of diabetes control; the secondary
 endpoints will be changes blood sugar , vitamin levels, insulin, c-peptide, and lipids
 levels, as well as retinal eye examinations, urinalysis to assess kidney function, carotid
 ultrasound as a marker of cardiovascular function, and alterations in diabetic medications.
 Fifty subjects with medically documented type 2 Diabetes Mellitus (T2DM) with BMIs between 26
 and 35 will undergo standard laparoscopic RYGB. Prior and after surgery, the subjects will
 undergo a clinical evaluation in regard to the primary and secondary endpoints listed. The
 pre-surgery evaluation is directed toward establishing the existence of diabetes related
 complications prior to surgery. After surgery subjects will be closely monitored for
 complications and required changes in their diabetes management. Repeat assessments will be
 made at 1, 3, 6, and 12 months and at two years.
The primary endpoint will be the reduction of HbA1c and secondary endpoints will be multiple
 associated parameters as listed below. A group of 50 subjects with medically documented T2DM
 and BMI of 26-35 will undergo standard laparoscopic RYGB. Prior to surgery, the subjects will
 undergo the standard pre-operative work up required for conventional bariatric surgery. This
 includes full history and physical exam, medical/cardiac clearances as needed, nutrition
 consultation and a gastrointestinal consultation for upper endoscopy. After thorough
 explanation an approved informed consent will be signed. Baseline parameters, as listed
 below, will be measured for each subject to identify possible complications of diabetes prior
 to the surgical intervention..

 After surgery perioperative complications will be monitored and required modifications of
 diabetes management advised. Followed up measurements at 1, 3, 6, 12, and 24 months is
 consistent with standard clinical practice guidelines. Data analysis will be ongoing to
 observe the effects of the surgical intervention on glucose homeostasis.

 -  Baseline parameters

 -  History and Physical Exam

 -  Weight/BMI/ body composition with the Tanita 310.

 -  Waist Circumference

 -  Blood Pressure

 -  CBC

 -  HbA1c

 -  Fasting glucose

 -  Vitamin B6, B12, Folate,and Iron status

 -  Lipid Profile -total cholesterol, HDL, LDL, triglyceride

 -  Fasting Insulin and C-peptide

 -  Stimulated C-peptide

 -  EKG

 -  Retinal exam

 -  Urinalysis (assess for proteinuria and microalbuminuria)

 -  Comprehensive foot exam

 -  Medications and dosage

 -  Quality of Life Score (SF-36)

 -  Carotid ultrasound (intima-media thickness)

 Follow-up:

 4 Weeks:

 -  Physical Examination, wound check, Body weight, BMI,

 -  Glucose Diary (pre and postprandial glucose levels as required)

 -  Insulin and C-peptide

 -  Lipid profile

 -  Medication use

 3 Months, 6 months,

 Same as above plus:

 -  HbA1c

 -  Vitamin levels and iron status

 -  Retinal exam

 -  Annually the baseline measurements will be repeated
Inclusion Criteria:

 Adult males and females who meet the following inclusion criteria will be offered the
 opportunity to participate in the study:

 1. Diagnosis of type 2 Diabetes Mellitus (T2DM) confirmed by the following criteria:

 1. normal or high C-peptide level (> 0.9 ng/ml) to exclude type 1 Diabetes Mellitus

 2. positive glucagon test to confirm T2DM

 3. fasting plasma glucose of 126 mg/dl or more on at least two occasions

 2. Body mass index (BMI) 26 kg/m2 or greater, and less than 35 kg/m2

 3. History of T2DM for not longer than 8 years, as long-standing disease beyond 8 years
 correlates with failure to achieve diabetes resolution after gastric bypass

 4. No contraindication for surgery or general anesthesia as determined by a
 multidisciplinary bariatric surgery team (surgeon, anesthesiologist, internist,
 dietitian, psychologist)

 5. Between 18 and 65 year of age

 6. Able to provide informed consent

 7. If a female with reproductive potential, she has to agree to use a reliable method of
 birth control for at least one year from the date of surgery

 Exclusion Criteria

 Subjects who meet any of the following exclusion criteria will not be eligible to
 participate in the study:

 1. Enrollment in another clinical study, which involves an investigational drug

 2. Diagnosis of type 1 Diabetes Mellitus or other genetic forms of Diabetes Mellitus

 3. Significant renal failure of chronic liver disease (except NAFLD)

 4. Major psychological disorders

 5. Pregnancy - all female subjects will have serum beta-hCG prior to operation, and must
 use birth control of their choice to avoid pregnancy during the first year after
 surgery

 6. Previous gastric or esophageal surgery

 7. Immunosuppressive drugs including corticosteroids

 8. Coagulopathy defined as an INR > 1.5 or platelet count < 50,000/µl

 9. Anemia defined as a Hb <10.0 g/dl

 10. Inflammatory bowel diseases or other medical condition that would serve as a
 contraindication to gastric bypass (eg. celiac sprue, pancreatic insufficiency)

 11. A severe concurrent illness that is likely to limit life or require extensive systemic
 treatment (e.g. cancer)

 12. A pre-existing major complication of diabetes:

 1. unstable, proliferative retinopathy

 2. severe autonomic cardiac neuropathy or intestinal neuropathy

 3. Myocardial infarction within the previous year, current unstable angina, or
 poorly-controlled congestive heart failure (Stage III)