4. Need to address the “real world” in investigational protocols 50 % of Diabetics in the world have BMI<35 Int J Clin Practice, 2007(NHANES and SHIELD) Dtsch Int Arztebl. 2010, 107 SOARD, 2010

9. Ileal Transposition with sleeve gastrectomy and with or without duodenal exclusion without duodenal exclusion

10. What are the proposed novel procedures? Duodenal jejunal bypass

11. Text Not at new concept at all !! Studied back on early 80’s by Koopmans and Scalfani in animals. Very high mortality rates reported in animals

12. IT + SG +- Duodenal Exclusion IT + SG IT+ SG + Duodenal Exclusion 1) Surg Endosc, March 2008 2) Surg Endosc, Jun 2008 3)Surg Endosc, 2009 4)J Gastro Intest Surg, 2010 5) World J Surg, 2011 Almost Exclusively Championed by De Paula

13. Outcomes * A1c < 7 % #PTS Preop BMI(mean) TBWL % DM remission * FU (mean) Study 1,March2008 Both SGIT+DSGIT 39 30,1 22 86,9 7 mo Study 2,June 2008 Both SGIT+DSGIT 60 30,1 23 86,7 7,4 mo Study 3,2009 DSGIT ONLY 69 25,7 17,7 95,7 21,7mo Study 4,2010 Both SGIT+DSGIT 72 27 22 86,5 90% Lipid profile improvement 24,5 mo Study 5,2011 DSGIT ONLY 454 29,7 BMI to 25,9 @ 1 mo 1 mo study 1 mo study

15. And Complications and Mortality? Major Complications(%) Intraop complications(%) Mortality(%) Study 1,March2008 Both SGIT+DSGIT 10,5 7,7 -30% related to ischemia of the transposed ileum 2,6 Study 2,June 2008 Both SGIT+DSGIT 11,7 5 0 Study 3,2009 DSGIT ONLY 7,7 5 0 Study 4,2010 Both SGIT+DSGIT 13,9 8,3 0 Study 5,2011 DSGIT ONLY 6,4 4 -50% related to ischemia of the transposed ileum 0,4

18. And Duodenal jejunal bypass?

19. Time Post Surgery (month) Time Post Surgery (month) R Cohen et.al SOARD, 2007 4 9 8 7 6 5 0 1 2 3 4 5 6 7 8 9 HbA 1c (%) 26 30 29 28 27 0 1 2 3 4 5 6 7 8 9 BMI (kg/m2)

21. Results - 20% of all med free with A1c<6.5% @ 12 mo. - Significant decrease in med score @ 6 and 12 mo Cohen R & Klein S ,2011 Mean preop BMI 27.8 WL 6.9+- 4.9% @ 3mo Most returned to baseline @12mo. 5 gained weight x baseline

22. Delta BMI x A1c Delta BMI HAS NO IMPACT in the negative variation of A1c from preop to 12 months

23. Beta cell function T2DM x NGT T2DM x NGT Cohen R & Klein S ,2011

25. Sleeve Gastrectomy + Duodenal Jejunal Bypass Non restrictive SG Pylorus preserving duodenal exclusion ( 100 cm biliary and 150 cm alimentary limbs

34. We are not alone Biliopancreatic Diversion Preserving the Stomach and Pylorus in the Treatment of Hypercholesterolemia and Diabetes Type II: Results in the First 10 cases Giuseppe Noya , 1999, Obesity Surgery Excellent reported results, 7 “controlled”pts

35. We are not alone 1.9% major complication rate

36. DJB-literature 1.3% major complication rate Remission Improvement Remission and Improvement LSG+DJB 93% 7% 100%

37. DJB-literature Modest decrease in BMI, with decrease in A1c @ 6 mo

39. De Paula’s CT COMPARED IT + SG x IT+SG+ Duod Exclusion( only variable)

40. Adding a duodenal exclusion improves results

41. • GI Bypass Surgery (Duodenal Exclusion) Repair of underlying pathophysiologic mechanisms of diabetes?

42. Why Sleeved DJB? X No gastric remnant No dumping Pylorus-preserving Well known Easier ? BETTER THAN RNYGB?

44. Released Sept 2010