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


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 Chief , Section of Gastrointestinal Metabolic Surgery

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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


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METHODS

Intraluminal Duodenal Sleeve


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Controls: Fenestrated Duodenal Sleeve


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Fig 1 b


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Goto-Kakizaki Rat (GK)

  • Complete tube (n=12)

  • Fenestrated Tube (n=12)

  • No tube (Sham) (n=6)

    2 & 3 pair-fed to 1


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OGTT

AUC: P< 0.01


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« Larry »


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« Larry »


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« Larry »


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« Larry »


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« Larry »


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GK Rats: GIP-Response to Glucose


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Wistar Rats: GIP-Response to Glucose


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ELS Improves IP Glucose Tolerance (Kaplan et al)


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Endoluminal Sleeve - EndoBarrier™

Food bypasses the duodenum and proximal jejunum

CONFIDENTIAL


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Week 1 Data Summary

EndoBarrier™ Diabetes Trial (Chile)

*Food intake held identical


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EndoBarrier™ Improves HbA1c

EndoBarrier™ Diabetes Trial (Chile)

Week 12

Week 30

N=9

N=4

N=8

N=3

*Week 30 p=0.004


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Endoluminal Sleeve: Mechanisms

  • Isolation of Duodenal Mucosa from Nutrients Contact

  • Bile isolated from nutrients

  • No expedited delivery of nutrients to the distal gut


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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”


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EndoBarrier Weight Loss Results At 6 Months


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EndoBarrier Glucose Improvement at 6 Months


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Surgery, Adiposity and Diabetes

Liposuction does not improve diabetes

Surgical resection of greater omentum does not resolve diabetes

S. Klein et al. (ADA 2009)


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Metabolic Surgery… the future

  • Multidisciplinary approach and guidelines/standards of care development


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Annals of Surgery; March 2010


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DSS Reccommendations are

Endorsed by:

ASMBS

IFSO

The Obesity Society (TOS)

Int. Ass Study of Obesity (IASO)

Diabetes UK


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  • 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.


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  • 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.


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Metabolic Surgery… the future

  • Solving the BMI issue…


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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


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Diabetologia 1996


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Metabolic Surgery… the future

  • Solving the BMI issue…

  • Diabetes-specific criteria for surgical indication

  • Risk-Stratification in diabetes

  • Improve Standards of Clinical Research


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Patient Factors and Outcomes Associated with T2DM Resolution (N=191)

Schauer et al. Annals of Surgery Oct 2003


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The “Bad Reputation” of Bariatric Surgery

* Any Textbook


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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).


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Worldwide Consortium for RandomizedClinical Trials in DiabetesSurgery

(WORLDCords)

Diabetes Surgery Center

Weill CornellMedicalCollege-New York PresbyterianHospital


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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


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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)


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International Consortium for Diabetes Surgery

Weill Cornell –NYP

Study (50 pts)

US Multicenter Study

200 patients

Worldwide Consortium for RCT

500-800 pts


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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