A Trial of the Jejunal to Ileal Diversion Endoscopic Procedure (Side-to-Side Anastomosis)

Inclusion Criteria:

• 18 to 65 years of age
• A BMI ≥ 30 kg/m2 and < 50 kg/m2 If subject has Type 2 Diabetes
• HbA1c ≥ 6.5% and ≤ 9%
• Fasting plasma glucose greater than 110 mg/dl
• Treatment with up to 2 oral diabetic medications
• Able to understand and sign informed consent document
• If subject is female, she must commit to not becoming pregnant for 18 months and agree to use of contraceptives during this period

Exclusion Criteria:

• Any conditions for which endoscopy/colonoscopy would be contraindicated.
• Congenital or acquired anomalies of the GI tract, including atresias, stenosis or malrotation.
• Previous abdomino-pelvic surgery that may result in adhesions or anatomical changes that may interfere with placement of the GIW device.
• Diagnosis of Type 2 diabetes less than 6 months
• More than 2 oral diabetic medications
• Use of insulin
• If on metformin, history of polycystic ovarian syndrome (PCOS)
• Use of Dipeptidyl peptidase-4 (DPP-4) inhibitors
• Use of GLP-1 agonists
• Use of Use of alpha-glucosidase inhibitors
• Type 1 Diabetes
• Unable or unwilling to perform home blood glucose monitoring
• History of or suspected gastrointestinal disease (e.g. cirrhosis, inflammatory bowel disease)
• History of active malignancy (i.e. not in remission) with the exception of squamous or basal cell carcinoma of the skin
• Any blood coagulation disorder
• Implanted cardiac pacemaker, defibrillator or other implanted electric device - Ongoing systemic infection
• Chronic pancreatitis
• Chronic liver disease of any cause
• Poorly controlled psychiatric disease (e.g. ongoing major depression, schizophrenia, borderline personality, suicidality, psychosis)
• Any history of an eating disorder within the past 5 years
• Pre-existing severe comorbid cardio-respiratory disease (e.g. congestive heart failure, cardiac arrhythmia, coronary artery disease, chronic obstructive lung disease, pulmonary embolism)
• Uncontrolled hypertension (systolic BP > 150 mm Hg or diastolic BP > 100 mm Hg)