Procedure for Duodenal-Ileal Diversion With a Sleeve Gastrectomy for Patients With Obesity and Type 2 Diabetes Mellitus

Inclusion Criteria: * Age 19-65 years at screening * Body mass index (BMI) ≥35 and ≤50 * T2DM diagnosis ≥6 months but \< 10 years, with 1 or more oral diabetes medications, HbA1c ≥ 6.5% but \< 10.0% at time of enrollment. * HbA1c must be stable over a 3-month period. * Weight stable over 3-month period * Obesity-related comorbidities (hypertension, dyslipidemia, sleep apnea) must be well-controlled * Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for a duration of 2 years * If female, subject must commit to not becoming pregnant for 24 months and agree to use contraception during this period * Able to understand and sign informed consent documents. Exclusion Criteria: * Known or suspected allergy to nickel or titanium or nitinol * Type 1 diabetes or poorly controlled type 2 diabetes * Use of injectable insulin * Any documented conditions for which endoscopy would be contraindicated * Contraindication to general anesthesia * History of chronic gastrointestinal disease * Congenial or acquired anomalies of the GI tract * Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding gallbladder), pancreas, or right colon. * Uncontrolled hypertension * Pre-existing severe comorbid cardio-respiratory disease * History of chronic gastrointestinal disease * Specific genetic or hormonal cause of obesity * Recent tobacco/nicotine product cessation (within 3 months prior)