Presentation is loading. Please wait.

Presentation is loading. Please wait.

Endoluminal Duodenal-Jejunal Sleeve, Fat Reduction... And the Future Francesco Rubino, MD Chief, Section of Gastrointestinal Metabolic Surgery Director;

Similar presentations


Presentation on theme: "Endoluminal Duodenal-Jejunal Sleeve, Fat Reduction... And the Future Francesco Rubino, MD Chief, Section of Gastrointestinal Metabolic Surgery Director;"— 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) 1.Complete tube (n=12) 2.Fenestrated Tube (n=12) 3.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 EndoBarrierSham p value Weight change (kg)* NS Fasting plasma glucose – change (mg/dl) - 52   78 p = 0.17 Mixed meal tolerance (AUC) -18.6%+10.1% p = point glucose profile – aggregate change (mg/dl) -58   46 p < 0.05 * Food intake held identical EndoBarrier™ Diabetes Trial (Chile)

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

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

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

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

29 Metabolic Surgery… the future Solving the BMI issue…

30 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). DSS- BMI 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 * Any Textbook The “Bad Reputation” of Bariatric Surgery

35 Randomized controlled trials are strongly encouraged to assess the utility of GI surgery to treat T2DM (A). In patients with BMI <35 kg/m 2, determining the appropriate use of GI surgery for the treatment of T2DM is an important research priority (A). DSS- Research

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

37 RYGB (Lap) vs 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 Cornell’s Study

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

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


Download ppt "Endoluminal Duodenal-Jejunal Sleeve, Fat Reduction... And the Future Francesco Rubino, MD Chief, Section of Gastrointestinal Metabolic Surgery Director;"

Similar presentations


Ads by Google