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

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Presentation on theme: "Endoluminal Duodenal-Jejunal Sleeve, Fat Reduction... And the Future"— Presentation transcript:

1 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 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 15

16 Week 1 Data Summary EndoBarrier™ Diabetes Trial (Chile) EndoBarrier
Sham p value Weight change (kg)* -4.66 -5.38 NS Fasting plasma glucose – change (mg/dl) - 52  44 +17  78 p = 0.17 Mixed meal tolerance (AUC) -18.6% +10.1% p = 0.05 7-point glucose profile – aggregate change (mg/dl) -58  55 +1.1  46 p < 0.05 *Food intake held identical 16

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

26 The Obesity Society (TOS) Int. Ass Study of Obesity (IASO) Diabetes UK
DSS Reccommendations are Endorsed by: ASMBS IFSO The Obesity Society (TOS) Int. Ass Study of Obesity (IASO) Diabetes UK 26

27 Surgery should be considered in pts with BMI > 35 and inadequately controlled diabetes.
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)

28 Surgery may be considered as a non-primary alternative in pts with uncontrolled diabetes and BMI 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.

29 Metabolic Surgery… the future
Solving the BMI issue…

30 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

31 Diabetologia 1996

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

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

34 The “Bad Reputation” of Bariatric Surgery
* Any Textbook

35 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).

36 Diabetes Surgery Center
Worldwide Consortium for Randomized Clinical Trials in Diabetes Surgery (WORLDCords) Diabetes Surgery Center Weill Cornell Medical College-New York Presbyterian Hospital

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

38 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)

39 International Consortium for Diabetes Surgery
Weill Cornell –NYP Study (50 pts) US Multicenter Study 200 patients Worldwide Consortium for RCT pts

40 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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