1. Bariatric/Metabolic Surgery and Type 2 Diabetes September 2015 Deron Ludwig MD/Erik Simchuk MD North Valley Surgical Associates Chico, CA.

2. Disclosures None

3. Scope of the Problem 50% of Americans Diabetic (12-14%) or Pre- Diabetic (38%) Most T2, Most common cause Obesity JAMA Sept 2015

4. Obesity Epidemic

6. What We Eat

7. How Much We Eat

9. Hidden Danger in Our Food

10. Hidden Danger in our Food

11. WLS Procedure Type

13. Health Outcome: WLS

14. Long-Term effects Of RYGB Ave f/u 6.9 years EWL 60% Insulin use 40% to 6% HTN 73% to 54% DL 71% to 54% Obesity Surg. 2014

15. LRYGB 10 YEARS EWL 57% T2DM 83% HTN 87% DL 67% OSA 76% Soard June 2009

16. LSG 5 year Results 30 Patients EWL Year 1: 65% Year 3: 62% Year 5: 56% No Deaths or Major Morbidity Am J Surg 2014

17. Long-Term outcome after LSG 161 PT – EWL at 5 years: 63% – DL 81% – T2DM 85% – New GERD 27% Soard Apr 2014

18. LRYGB vs LSG prospective 5 yr results EWL LRYGB: 69% EWL LSG: 67% WL failures no different/Comparable effectiveness Obesity Surg July 2014

19. LRYGB vs LSG Retrospective: 200 Pt. each EWL same at 12 and 18 months Similar resolution comorbidities except slightly higher DM resolution of LRYGB Soard July 2011

20. LRYGB and LSG Both very effective and comparable for both weight-loss and improvement in health in short and long-term

21. DIABESITY A direct relationship exist between the obesity epidemic and an emerging epidemic of diabetes in America. In the past two decades the rate of obesity has doubled in America. In the past two decades the rate of diabetes has doubled in America. Source: Diabesity, Dr. Katherine Kaufman, former ADA president, Bantam Books, 2005

22. DIABESITY Diabetes is the sixth leading cause of death in the USA. 2002: 71,000 Americans died from diabetes, but another 186,000 died from diabetes related conditions. Diabetes increases the risk for heart disease sixfold and multiplies the risk of stroke by four. Source: Diabesity, Dr. Katherine Kaufman, former ADA president, Bantam Books, 2005

23. DIABETES

24. DIABESITY Diabetes is the most costly disease in America, consuming one out of every 7 dollars. – Today 1 in 5 dollars $137.7 billion per year with $92 billion spent on medical care and the remainder on lost wages, lost productivity. Source: Diabesity, Dr. Katherine Kaufman, former ADA president, Bantam Books, 2005

25. T2 Diabetes

26. DIABESITY Cost of Diabetes 2012: 245 billion Am Diabetes Assoc

27. DIABESITY The annual cost of diabetes medical care was $10,683 in 2002 and $13,700 in 2012 http://www.diabetes.org/diabetes-statistics/cost

28. Cost of Diabetes 2012

29. Who Would Have Thought It? An Operation Proves to Be the Most Effective Therapy for Adult-Onset Diabetes Mellitus, Pories WJ, Swanson MS, MacDonald KG et al. Annals of Surgery, 222:3, 1995 Could an Operation Cure Type II Diabetes?

30. Traditional: Maximize diabetic control through strict diet, oral medications, insulin, or even insulin pump to slow the progression of diabetes and its sequela Paradigm Shift Bariatric Surgery today: If a patient has T2 Diabetes and Morbid Obesity (BMI ≥35) Bariatric Surgery in ideal world: WLS for T2 diabetics with BMI ≥30

31. T2 Diabetes

32. International Diabetes Federation Position Statement 2010/2011 Bariatric surgery appropriate if T2DM and BMI >35 Surgery should be prioritized if BMI >35 and T2DM – Previous wording surgery an “option” – That group often refractory to medical mgt Surgery considered for BMI >30 if not meeting medical treatment targets

33. T2 Diabetes

34. Case Study 62 y/o M: 404 lb. (BMI 63.3): MI/CAGB, CHF, Severe T2DM on 3 pills and >150 u insulin-10 YR duration, Diabetic ulcer, DL, OSA on BIPAP and O2, edema, CKD, narcotics for LBP/JT pain LRYGB 2006: Today: Wt. 200 lb.(BMI 27): OSA, DL, Renal, edema-resolved T2DM: improved with 35 u insulin/d – WLS effects: DURATION/INSULIN

35. Results of Bariatric Surgery Diabetes 240 patients with T2DM F/U mean 20 months, 80% Clinical resolution: 83% (NL FBG and HGBa1C and no meds) Marked improvement 17% – 100% response rate! Predictors of remission: duration less than 5 years, no insulin Schauer PR,Burguera B. Effect of Lap r-y gastric bypass on Type II diabetes. Annals of Surgery Oct 2003.

36. Results of Bariatric Surgery Diabetes 117 patients with T2DM Remission: 72 (74%) Improvement: 25 (26%) Predictors of remission: Waist circumference (odds ration 2.4), absence of insulin treatment Torquati. Is Roux-enY gastric bypass surgery the most effective treatment for Type 2 diabetes in morbidly obese patients? Journal of gastrointestinal surgery 2005.

37. Results of Bariatric Surgery Diabetes 608 Patients (open RYGB) 14 year follow-up 50% EBW loss 83% clinical resolution diabetes Ave 108 lb weight loss Pories WJ. Ann Surg 1995.

38. Results of Bariatric Surgery Diabetes 154 patients with T2DM 1 year postop: 83% resolution 5 years postop: 86% resolution Sugerman HJ, Wolfe LG. Ann Surg, Jun 2003

39. Long-Term T2 DM remission LSG 88% off meds at 3 months 85% at 3 years 77% at 5 years Soard July 2013/Dr Abbatini

40. Bariatric Surgery vs Intensive Medical NEJM 2012 Randomized controlled, 1 center (STAMPEDE), 1 year, 150 pt: Medical/LSG/RYGB Target A1c(6.0%) Medical 12%, Surgical 40% Insulin use 38% in Med grp at 12 mo. / 4%RYGB-8%LSG surgery grp EWL 88% RYGB/81% LSG/13% Med AVE PRE A1C 9%/Duration 9 yr. NEJM 2012/Dr Schauer

41. Bariatric Surgery vs Medical treatment 3 year Outcomes NEJM 2014 Primary End point A1C <6.0% 150 pt RCT – WLS: bypass 38%, Sleeve: 24% – Medical Group: 5% Secondary End points: QOL, WT, glucose lowering meds all significantly greater in surgical group NEJM 2014/Dr Schauer

42. Metabolic surgery vs. Conventional Medical 5yr RCT medical vs. Surgery (RYGB/BPD) – 40% CR at 5 yr (A1C <6.5%)-surgical grp (RYGB) – 27% of medical had DM complic vs. none – Wt loss, Lower lipids, CV risk, Med use in surg The LANCET, Dr Mingrone, Sept 2015

43. LSG vs Medical mgt At 2 years 76% surgical able to stop or reduce meds vs 26% – VA group with intense medical “MOVE” pgm 52% in medical group needed more meds Dr Malbotra

44. T2DM Class 1 Obesity BMI≥ 30 4 RCT and 16 observational studies showing benefit – Not usually covered by insurance or MEDICARE Same benefit as higher BMI for T2DM Lap Band

45. Class 1 Obesity Dr Abbatini/SOARD: T2DM BMI 30-34: 18 patients – 9 LSG: 88.8% resolution@1year – 9 Medical: no change D Lakdawala/SOARD: 52 Patients: LRYGB – EWL 72%@1yr, 68%@5yr – DM2: CR 73%@1yr/58%@ 5yr

46. Class 1 Obesity RCT: 61 pt, BMI 30-35: Surgery vs. Lifestyle intervention. Endpoints: DM remission full/ partial, medication reduction 3 yr: 40% RYGB full or partial remission – 65% off insulin or oral DM meds – None in medical control grp

47. T2DM: Paradigm Shift? Tremendous rapid/durable response with bypass and sleeve (100% improvement, majority CR) WLS should be prioritized for all T2DM with morbid obesity who are Surgical Candidates The earlier the intervention the better the CR rates (drop at 5 yr with large drop at 7)

48. What about Morbidly Obese Type 1 DM? WLS: Sleeve or bypass improves insulin sensitivity/control, Improves other comorbid conditions like HTN/DL/OSA the same as Pt’s withT2DM Consider WLS referral for selected T1DM with morbid obesity

49. Type 1 Diabetes Case Report 41F T1 DM x10 years, insulin pump 6 yr, BMI 38 – 4.8 units insulin/hr, A1c Pre: 9.8% – Severe hypertriglyceridemia: 950-3000 – GERD/SUI 10 months post LSG : 80lb wt loss, BMI 25 Insulin.3u/hr night,.6u/hr day, A1C 6.8% Trig: 106, SUI/GERD resolved

50. What About Surgical Risk? Intl Journal of Cardiology Mar 2014 – 29000 pt’s, 14 studies – After surgery 50% less risk of CVA or MI – 40% lower death rate Amer J Cardiol 2011: 52 studies/ 16,867 pt 40% reduction in 10-yr Coronary dz risk

51. What About Surgical Risk? SOS study surgery vs medical group – CV dz decreased by 72% at 5 years – Mortality from cardiac dz 59% lower – Mortality all causes 29% lower, 10.9 yr f/u (used mostly VBG/band, 2010 surgery pt vs 2037 med) National Health and Nutrition Survey 99-2006 Coronary heart risk increases with BMI >30

52. What About Surgical Risk? Univ Utah 7,925 RYGB, 1984-02 compared to random controls with BMI>35 7 yr f/u: 40% lower death rate in surgical group – 92%less for T2DM – 59% less cardiac – 60% less for CA

53. What About Surgical Risk? 1035 bariatric pt (1986-02) 5746 matched medical controls 5 yr F/U EWL 67% Mortality 0.68% vs 6.17% Relative RR: 89% Dr Christou, Ann of Surg Sept 2004

54. FIVE-YEAR MORTALITY REDUCTION 89 Percent Reduction in Risk of Death Over Five Years * Includes perioperative (30-day) mortality of 0.4%. p-value 0.001 Christou NV, Sampalis JS, Liberman M, et al. Surgery Decreases Long-Term Mortality, Morbidity, and Health Care Use in Morbidly Obese Patients. Annals of Surgery 2004;240(3):416-424.

55. What About Surgical Risk? People with BMI >30 have 50%-100% increased risk of premature death compared to healthy weight Risk of WLS today is 0.1%, less than gallbladder (0.7%) or hip replacement (0.93%) – Caveats: COE, Laparoscopic Overall risk of major complications 4.3%

56. Why Surgery? WLS alleviates associated comorbid disease and prolongs length of life Risk of WLS today is far less than the natural history of severe obesity and associated health risks

57. Medical Co-Morbidities Resolved Wittgrove AC,Clark GW. Laparoscopic Gastric bypass roux-en-y-500 patients. Obes Surg 2000. And others.