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Endoluminal Duodenal - Jejunal Sleeve , Fat Reduction ... And the Future Francesco Rubino , MD

Endoluminal Duodenal - Jejunal Sleeve , Fat Reduction ... And the Future Francesco Rubino , MD Chief , Section of Gastrointestinal Metabolic Surgery Director ; Diabetes Surgery Center Weill Cornell Medical College - New York Presbyterian Hospital New York, NY USA.

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Endoluminal Duodenal - Jejunal Sleeve , Fat Reduction ... And the Future Francesco Rubino , MD

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  1. EndoluminalDuodenal-JejunalSleeve, Fat Reduction... And the Future Francesco Rubino, MD Chief, Section of GastrointestinalMetabolicSurgery Director; DiabetesSurgeryCenter Weill CornellMedicalCollege- New York PresbyterianHospital New York, NY USA First Canadian Summit on Metabolic Surgery for T2DM Montreal, May 6-7, 2010

  2. METHODS Intraluminal Duodenal Sleeve

  3. Controls: Fenestrated Duodenal Sleeve

  4. Fig 1 b

  5. Goto-Kakizaki Rat (GK) • Complete tube (n=12) • Fenestrated Tube (n=12) • No tube (Sham) (n=6) 2 & 3 pair-fed to 1

  6. OGTT AUC: P< 0.01

  7. « Larry »

  8. « Larry »

  9. « Larry »

  10. « Larry »

  11. « Larry »

  12. GK Rats: GIP-Response to Glucose

  13. Wistar Rats: GIP-Response to Glucose

  14. ELS Improves IP Glucose Tolerance (Kaplan et al)

  15. Endoluminal Sleeve - EndoBarrier™ Food bypasses the duodenum and proximal jejunum CONFIDENTIAL

  16. Week 1 Data Summary EndoBarrier™ Diabetes Trial (Chile) *Food intake held identical

  17. EndoBarrier™ Improves HbA1c EndoBarrier™ Diabetes Trial (Chile) Week 12 Week 30 N=9 N=4 N=8 N=3 *Week 30 p=0.004

  18. Endoluminal Sleeve: Mechanisms • Isolation of Duodenal Mucosa from Nutrients Contact • Bile isolated from nutrients • No expedited delivery of nutrients to the distal gut

  19. Endoluminal Sleeve: Clinical Applications • Primary Therapy of Diabetes ? • Long-term ? • BMI> 35 ? • BMI < 35 ? • Diagnostic value ? • Pre-surgical Test to select candidates for gastric bypass surgery • Integrated Interventional-Drug approach • “Adjuvant Therapy”

  20. EndoBarrier Weight Loss Results At 6 Months

  21. EndoBarrier Glucose Improvement at 6 Months

  22. Surgery, Adiposity and Diabetes Liposuction does not improve diabetes Surgical resection of greater omentum does not resolve diabetes S. Klein et al. (ADA 2009)

  23. Metabolic Surgery… the future • Multidisciplinary approach and guidelines/standards of care development

  24. Annals of Surgery; March 2010

  25. DSS Reccommendations are Endorsed by: ASMBS IFSO The Obesity Society (TOS) Int. Ass Study of Obesity (IASO) Diabetes UK

  26. Bariatric surgery should be considered for adults with BMI > 35 kg/m2 and type 2 diabetes, especially if the diabetes is difficult to control with lifestyle and pharmacologic therapy. (B) • Surgery should be considered in pts with BMI > 35 and inadequately controlled diabetes.

  27. in patients with type 2 diabetes and BMI of 30–35kg/m2, there is currently insufficient evidence to generally recommend surgery in patients with BMI35 kg/m2 outside of a research protocol. • Surgery may be considered as a non-primary alternative in pts with uncontrolled diabetes and BMI 30-35.

  28. Metabolic Surgery… the future • Solving the BMI issue…

  29. DSS- BMI • Controlled clinical trials in these patients should be performed to determine the safety and efficacy of GI metabolic surgery (A) as well as to identify parameters other than BMI as criteria for appropriate patient selection (A). SAME LANGUAGE IN ADA’ STANDARDS OF CARE DOCUMENT

  30. Diabetologia 1996

  31. Metabolic Surgery… the future • Solving the BMI issue… • Diabetes-specific criteria for surgical indication • Risk-Stratification in diabetes • Improve Standards of Clinical Research

  32. Patient Factors and Outcomes Associated with T2DM Resolution (N=191) Schauer et al. Annals of Surgery Oct 2003

  33. The “Bad Reputation” of Bariatric Surgery * Any Textbook

  34. DSS- Research • Randomized controlled trials are strongly encouraged to assess the utility of GI surgery to treat T2DM (A). In patients with BMI <35 kg/m2, determining the appropriate use of GI surgery for the treatment of T2DM is an important research priority (A).

  35. Worldwide Consortium for RandomizedClinical Trials in DiabetesSurgery (WORLDCords) Diabetes Surgery Center Weill CornellMedicalCollege-New York PresbyterianHospital

  36. Cornell’s Study RYGB (Lap) vs MedicalTherapy and Lifestyle Modification PI: Francesco Rubino SteeringCommittee: H. Lebovitz, J. Buse, A. Goldfine, J. Roth B. Zinman, B. Wolfe, JP Despres, S. Belle

  37. Participating Countries REGIONAL Chapters: • Europe (centers already available in Italy, Netherlands, Belgium, Spain, England,) • South-Central America (Mexico?, Brasil, Argentina, Chile, Venezuela,) • North America (Cornell, Tuffs, Univ. of Maryland, Mount Sinai?) • Asia (Philippines, India, Taiwan, Japan) • Middle East (Quatar, UAE, SA)

  38. International Consortium for Diabetes Surgery Weill Cornell –NYP Study (50 pts) US Multicenter Study 200 patients Worldwide Consortium for RCT 500-800 pts

  39. Metabolic Surgery… the future • Solving the BMI issue… • Diabetes-specific criteria for surgical indication • Risk-Stratification in diabetes • Improve Standards of Clinical Research • Elucidation of Mechanisms of Action • Novel Surgical Procedures • Endoluminal Approaches • Novel Targets for Drugs Re-thinking of Diabetes and Obesity

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