1. Jaime Ponce MD, FACS, FASMBS Director of Bariatric Surgery Hamilton Medical Center Dalton Georgia USA LAGB Weight Loss and Diabetes 2010 Minimally Invasive Surgery Symposium San Diego CA February 25, 2010

2. Disclosures Allergan: – Consultant, Proctor, Research, Speaker, use the Lap-Band ® in my private practice Ethicon Endo-Surgery: – Consultant, Proctor, Speaker, use the Realize™ Band in my private practice

3. Effects in Diabetes and Metabolic Syndrome Weight loss has a positive effect LAGB programs with good understanding and intense follow-up, have documented significant improvement in DM and Metabolic Syndrome

4. Change in Diabetes Status 1 Year After LAP-BAND System Surgery  Remission = Normal fasting glucose, HbA 1c, * insulin, C- peptide, and no diabetes medication  32 patients (64%)  Improved = Significant improvement in control and reduction of diabetes medication  13 patients (26%)  No change = No change in diabetic control or therapy  5 patients (10%) *At 1 year only 3 (6%) had HbA 1c >7%. Dixon et al. Diabetes Care. 2002;25:358-363

5. Predictors of Remission Weight loss (% EWL) – pr 2 = 0.37, P<0.001 Time with a diagnosis of diabetes – pr 2 = 0.24, P=0.003 – Combined pr 2 = 0.44, P<0.001 Dixon et al. Diabetes Care. 2002;25:358-363.

6. Change with Weight Loss: HOMA %S Normal fasting glucose Impaired fasting glucose Type 2 diabetes Diabetic Medicine 2003;20:127-34.

7. Change with Weight Loss: HOMA %S & %B Normal fasting glucose Impaired fasting glucose Type 2 diabetes

8. Change with Weight Loss: HOMA %S & %B, HbA1c Normal fasting glucose Impaired fasting glucose Type 2 diabetes

9. Change with Weight Loss: HOMA %S & %B, HbA1c Normal fasting glucose Impaired fasting glucose Type 2 diabetes Time with diabetes R=-0.36, p=0.02

10. Fasting plasma glucose: Median +/- IQ range * and ** are significantly different p<0.001 when grouped together ** * ** *

11. HTN and T2DM After LAGB in Glucose Intolerance Subjects Pontiroli, et al Univ of Milano, Italy: Diabetes Care Nov 2005;28:2703-9 – 4-year case-controlled study in impaired Glucose-Tolerance pts: LAGB vs conventional diet in prevention (56 vs 29 pts) and remission (17 vs 20 pts) of DM – 73 LAGB pts vs 49 pts refused LAGB but agreed f/u with diet – BMI change: 45.9 to 37.7 vs 45.2 to 46.5 – Progression to T2DM: 0% vs 17.2% – Remission T2DM: 45% vs 4% – Progression to HTN: 1.4% vs 25.6% – Remission HTN: 20.5% vs 2.3%

12. LAGB and Diabetes Dolan and Fielding. Obes Surg, 2004 – 88 patients, BMI 45, Type II DM – 2 years after surgery 51% EWL 65% patients off all medications (insulin, oral) 30% EWL by 6 months after surgery--> more likely to be off all DM medications

13. Resolution Rate of T2DM Ponce, et al. Obes Surg (2004):14,1335-42 P 5 years vs <5 years at 12 and 18 months. 12 Months18 Months <5 Years’ Duration T2DM Resolution Rate (%) 82.8% 33.3% >5 Years’ Duration T2DM 90.9% 33.3% n=35n=18 n=22 n=12 All T2DM n=53 n=34 66% 70.5%

14. HbA 1c in T2DM Patients Ponce, et al. Obes Surg (2004):14,1335-42 Preop12 Months18 Months HbA 1c (%) 7.25 7.00 7.7 5.87 5.64 6.35 5.68 5.40 6.25 All T2DM Patients <5 Years’ Duration T2DM >5 Years’ Duration T2DM. n=35n=17 n=22n=11 n=35n=18n=53n=52 n=33

15. %EWL in T2DM According to Resolution Ponce, et al. Obes Surg (2004):14,1335-42 Resolution No Resolution %EWL 45.0% 27.0% 53.9% 27.5% 59.1% 26.5% 12 Months18 Months24 Months n=35n=17n=24n=9n=12n=3 P<0.001 P=0.005

16. Rates of DM resolution after Bariatric Operations Parikh et al, NYU JACS 2007;205:631-5 LAGB (n=218); RYGB (n=53); BPD/DS (n=11)

17. Swedish Band for the treatment of T2DM in Morbidly Obese Brancatisano et al. SOARD 4(2008):423-9

19. Change in Glycosylated Hemoglobin (HbA1c) SAGB (2003-2006) US Study Normal range for HbA1C 4.3-6.1% * P <0.001 by t-test analysis

20. THE MANAGEMENT OF OBESITY A PROSPECTIVE RANDOMISED CONTROLLED TRIAL OF MEDICAL VERSUS SURGICAL THERAPY Paul O’Brien,. Paul O’Brien, John Dixon, Cheryl Laurie, Stewart Skinner, Joe Proietto, John McNeil, Boyd Strauss, Sharon Marks, Linda Schachter, Leon Chapman and Margaret Anderson. Centre for Obesity Research and Education Monash University, Melbourne, Australia Annals of Internal Medicine, May, 2006

21. RCT of Medical vs Surgical Therapy for Obesity % of Excess Weight Lost 87 87 % 21%

22. Effect on Metabolic Syndrome RCT of Medical vs Surgical Therapy for Obesity Effect on Metabolic Syndrome N.S. P < 0.001 % 38% 24% 38% 3% Surgical Change vs Medical Change P < 0.006

23. The Management of Type-2 Diabetes A Randomized Controlled Trial of Surgical and Non-surgical Therapy The Management of Type-2 Diabetes A Randomized Controlled Trial of Surgical and Non-surgical Therapy John B. Dixon, Paul E. O'Brien, Julie Playfair, Stewart Skinner, Joseph Proietto, Linda M Schachter, Leon Chapman, Margaret Anderson Centre for Obesity Research and Education Monash University, Melbourne JAMA, Feb, 2008

24. Type-2 Diabetes – A Randomised Trial Weight Loss - % of excess weight lost 65 65 % 6%

25. Type 2 Diabetes – A Randomised Trial Weight Loss – Change in BMI 36.3 28.4 37.1

26. Type 2 Diabetes – A Randomised Trial Remission of Diabetes - ITT 73% 13%

27. Type-2 Diabetes – A Randomised Trial Effect on Metabolic Syndrome (ATP III criteria) (N.S.) P < 0.001 % 97% 88% 97% 28% Non-surgical vs Surgical Change P < 0.001

28. Buchwald diabetes meta-analysis The American Journal of Medicine (2009) 122, 248-256

29. What is the mechanism of action? In RNY: – Schauer, et al (Ann Surg, 2003): 83% resolution, only 30% had “immediate resolution” probably associated “hormonal effects”…concluded that resolution of diabetes was primarily “weight-loss driven” – Weight regain may affect negatively diabetes remission

30. What is the mechanism of action? LAGB: – Reduced caloric intake – Weight loss

31. Thank You Hamilton Ambulatory Surgery Center Dalton, GA