Neujia Anastomosis for Treatment of Obesity and Type II Diabetes

Inclusion Criteria:

1. Age ≥ 22 and \< 65 years, estimated life expectancy ≥ 2 years;
2. BMI ≥ 30 and \< 40 kg/m2;
3. HbA1c ≥ 8.0 and ≤ 11%;
4. Fasting Glucose (FG) ≥ 126 mg/dL;
5. Under active medical care with ≥ 6-months treatment on ≥ 2 anti-diabetic medications;
6. T2DM diagnosed ≤ 10 years prior to enrollment;
7. Non-fasting random or stimulated C-peptide ≥ 2 ng/mL (660 pmol/l);
8. Willing and able to provide informed consent, comply, and be geographically stable

Major Exclusion Criteria:

1. Type I diabetes, positive autoantibodies to glutamic acid decarboxylase 65 (GAD65), secondary diabetes;
2. Hypoglycemia unawareness or serious hypoglycemia with loss of consciousness or confusion sufficient to prevent self-treatment in last 6 months;
3. Any condition for which endoscopy or colonoscopy would be contraindicated;
4. Any condition for which general anesthesia would be contraindicated;
5. Congenital or acquired anomalies of the gastrointestinal (GI) tract, abnormal GI anatomical finding, or anatomy precluding deep small bowel enteroscopy sufficient to prevent endoscopic advancement to the target treatment site;
6. Previous laparoscopic or open abdominal or pelvic surgery (except for prior caesarian section or laparoscopic cholecystectomy, which are allowed);
7. History of abdominal or pelvic infection or disease or procedures that may have resulted in abdominal adhesions;
8. Known history of autoimmune bowel disease or chronic inflammatory bowel disease (IBD);
9. Active inflammatory gastrointestinal disease (e.g., pancreatitis, hepatitis) or systemic infection (e.g., tuberculosis, malaria);
10. Known history of chronic liver disease (except nonalcoholic steatohepatitis (NASH)/ nonalcoholic fatty liver disease (NAFLD)), hepatic cirrhosis, or current transaminase/alkaline phosphatase elevation above three times the upper limit of normal (in the absence of NASH/NAFLD);
11. Severe or unstable pulmonary or circulatory comorbidities posing risks to the patient that may confound the results of the study in investigator's judgment;
12. History of cardiovascular event within last 6 months or with chronic sequela;
13. Uncontrolled hypertension with systolic blood pressure (SBP) over 160 mmHg or diastolic blood pressure (DBP) over 110 mmHg;
14. Estimated glomerular filtration rate (eGFR) \< 30 mL/min per 1.73 m2;
15. Currently taking pre-meal, bolus, or premixed insulin (patients on basal insulin only are allowed);
16. Malignancy that required therapy in the last 5 years (unless cancer only in situ e.g. basal cell carcinoma (BCC)), history of organ transplantation, or currently on immune-suppressive, chemotherapeutic, or radiation therapy;
17. History of vasculopathy, coagulopathy, or currently on anti-coagulation therapy;
18. Abnormal wound healing, e.g., human immunodeficiency virus (HIV), corticosteroid, or immunosuppressive agent use;
19. Planned magnetic resonance imaging (MRI) or any condition for which MRI is likely to be indicated within 3 months;
20. Pregnant or planning on becoming pregnant within 12 months of procedure;\
21. Known serious or uncontrolled psychiatric disease, eating disorder, or active alcohol or drug addiction.