International Diabetes Federation (IDF) Position Statement

1. International Diabetes Federation (IDF) Position Statement Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes Taskforce on Epidemiology and Prevention Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

2. Duality of Interest Declaration The International Diabetes Federation makes every effort to avoid any actual or potential conflicts of interest that may arise as a result of an outside relationship or a personal, professional, or business interest of a member of the writing panel. Specifically, all members of the writing group are required to declare all such relationships that might be perceived as real or potential conflicts of interest. Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

3. National and international guidelines for eligibility for bariatric surgery (adults) The guidelines above are qualified by the following common elements: Appropriate non-surgical weight loss measures have been tried and failed; there is the provision for, and a commitment to, long term follow-up; and individual risk to benefit ratio needs to be evaluated Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

4. Why? We are in the middle of a global type 2 diabetes epidemic and the numbers are continuing to escalate. The epidemic is strongly correlated with increases in obesity and physical inactivity. The need for strategies to prioritise severely obese persons with type 2 diabetes to ensure that bariatric interventions are available to those most likely to benefit. The International Diabetes Federation has not previously considered this rapidly developing area of care for world-wide use. Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

5. Ischemic stroke Depression Sleep apnoa Coronary heart disease Respiratory disease Type 2 Diabetes Gallbladder disease Dyslipidemia Cancer (breast, endometrial, colon, prostate) Hormonal abnormalities and pregnancy complications Osteoarthritis Hyperuricemia and gout Obesity:a chronic and complex disorder Obesity and type 2 diabetes are serious chronic diseases associated with complex metabolic dysfunctions that increase the risk for ill health and death Societal prejudices about severe obesity, which also exist within the health care system, should not act as a barrier to the provision of clinically effective and cost-effective treatment options Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

6. Health & Socio-economic Impact of Diabetes Over 75% of all heart deaths occur in people with diabetes or pre-diabetes Leading cause of adult blindness 50% of all non-traumatic lower limb amputations from diabetes Leading cause of end stage kidney failure

7. Global projections for the diabetes epidemic: 2010-2030 (millions) 55.2 66.2 20% 37.4 53.2 42% 76.7 112.8 47% 26.6 51.7 94% 58.7 101.0 72% 12.1 23.9 98% 18.0 29.6 65% World 2010 = 285 million 2030 = 438 million Increase 54% Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

8. Where do nations rank in the global obesity stakes?

9. OECD Predictions for Future Overweight Rates Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

10. Tackling “Diabesity” globally Continuing population-based prevention efforts are essential to prevent the onset of obesity and type 2 diabetes, given the escalating global obesity & diabetes crisis At the same time, effective treatment must also be available for people who have developed type 2 diabetes. The available therapies for health care providers are inadequate Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

11. Specific goals of the IDF Position Statement Develop practical recommendations for clinicians on patient selection and management Identify barriers to surgical access Suggest health policies that ensure equitable access to surgery Identify priorities for research Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

12. IDF Taskforce Consensus Panel – global representation Professor Linong Ji Dr. Muffazal Lakdawala Professor Wei-Jei Lee Professor Pierre Lefebvre Dr. Carel le Roux Professor Jean-Claude Mbanya Professor Gertrude Mingrone Dr. Philip R. Schauer Professor Luc Van Gaal Dr. David Whiting Professor Bruce M. Wolfe Conveners: • Professor George Alberti • Professor John B. Dixon • Professor Francesco Rubino • Professor Paul Zimmet Attendees: • Professor Stephanie Amiel • Professor Louise A. Baur • Professor Nam H. Cho • Dr. Bruno Geloneze • Professor Jan Willem Greve Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

13. The IDF Position Statement on Bariatric Surgery in obese type 2 diabetes Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

14. Bariatric Surgery: What is it? Various types of surgery on the gastrointestinal tract Originally developed to treat morbid obesity (“bariatric surgery”) Additional to behavioural & medical approaches, it provides an important option for treating type 2 diabetes in severely obese patients - often normalising blood glucose levels, within days in some procedures - reducing or avoiding the need for medications Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

15. The classification of weight category by BMI For Asian populations classifications remain the same as the internationalclassification but that public health action points for interventionsare set at 23, 27.5, 32.5 and 37.5 We address eligibility and prioritization for bariatric surgery within thecoloured zones above Source: Adapted from WHO 200475. Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

16. Bariatric surgery: Which persons with obese type 2 diabetes should be considered? Bariatric surgery is an appropriate treatment for people with type 2 diabetes and obesity not achieving recommended treatment targets with medical therapies, especially when there are other major co-morbidities. Surgery should be an accepted option in people who have type 2 diabetes and BMI of 35 or more Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

17. Bariatric surgery: Which obese type 2 diabetes should be considered? Surgery should also be considered as an alternative treatment option in persons with BMI 30 to 35 when diabetes cannot be adequately controlled by optimal medical regimen, especially in the presence of other major cardiovascular disease risk factors In Asian, and some other ethnicities of increased risk, BMI action points may be lower e.g. BMI 27.5 to 32.5 Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

18. Eligibility and prioritisation for bariatric surgery based on failed non-surgical weight loss therapy*, BMI, ethnicity** and disease control * In all cases patients should have failed to lose weight and sustain significant weight loss through non-surgical weight management programmes, and have type -2 diabetes that has not responded adequately to lifestyle measures (+/- metformin) with a HbA1c <7% ** Action points should be lowered by 2.5 BMI point levels for Asians74. *** HbA1c > 7.5 despite fully optimised conventional therapy, especially if weight is increasing, or other weight responsive co-morbidities not achieving targets on conventional therapies. For example blood pressure, dyslipidaemia and obstructive sleep apnoea. Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

19. Eligibility and prioritisation for bariatric surgery based on failed non-surgical weight loss therapy*, BMI, ethnicity** and disease control *** HbA1c > 7.5 despite fully optimised conventional therapy, especially if weight is increasing, or other weight responsive co-morbidities not achieving targets on conventional therapies. For example blood pressure, dyslipidaemia and obstructive sleep apnoea. Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

20. Lifestyle Modification • diet modification • weight control • physical activity Metformin Basal Premixed Basal Bolus insulin Management Algorithm for Metabolic Control in Type 2 Diabetes Bariatric Surgery BMI > 35 eligible BMI > 40 prioritised Sulphonylurea Bariatric Surgery BMI > 30 eligible & BMI > 35 prioritized *If HbA1c >7.5% despite optimized conventional therapy, especially if weight is increasing, or if other weight responsive comorbidities are not reaching target on conventional therapy. Acarbose DPP-4 inhibitor Glitazone Insulin Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

21. Bariatric surgery for obese adolescents with type 2 diabetes An Australian report* recommends surgery be considered if adolescents have BMI >40 , or >35 with severe co-morbidities, are 15 years or over & can provide informed consent This IDF position statement advises that only 2 procedures, Roux-en-Y gastric bypass &laparoscopic gastric banding are currently conventional bariatric surgical procedures for adolescents *Baur LA & Fitzgerald DA. Recommendations for bariatric surgery in adolescents in Australia and New Zealand. J Paediatr Child Health 46, 704-707 (2010). Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

22. Bariatric interventions in low & middle income nations The situation in low and middle income nations presents special problems because severe obesity is increasing at an alarming rate It is up to each health system to determine whether bariatric surgery with its support services is economically appropriate Health care resources are limited so bariatric surgery should only be performed where: • the health budget can afford it • the expertise is available for both the surgery and the long-term follow up Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

23. Factors to consider when choosing a procedure in obese patients with type 2 diabetes Expertise & experience in the bariatric surgical procedures  Patient’s preference when the range of risks & benefits, the importance of compliance, & the effects on eating choices and behaviours have been fully described  Patient’s general health & risk factors associated with higher peri-operative morbidity & mortality Duration of the diabetes The follow-up regimen for the procedure and the commitment of the patient to adhere to it Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

24. Patient & program factors associated with risk of surgery Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

25. Recommendations on surgical management Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

26. Recommendations on surgical management I Bariatric surgery for type 2 diabetes must be performed within accepted international and national guidelines This requires: - Appropriate assessment for the procedure - Comprehensive and ongoing multidisciplinary care - Patient education - Follow-up and clinical audit, as well as safe and effective surgical procedures - National guidelines for bariatric surgery in people with type 2 diabetes Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

27. Recommendations on surgical management II • Surgery should be considered as complementary to medical therapies to reduce micro-vascular and cardiovascular risk Patients should be assessed and managed by experienced multi-disciplinary teams • A national registry of persons who have undergone bariatric surgery should be established to ensure quality patient care and to monitor both short- and long-term outcomes Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

28. Recommendations on surgical management III The morbidity and mortality associated with bariatric surgery is generally low, and similar to that of well-accepted procedures such as elective gall bladder or gall stone surgery Bariatric surgery in severely obese patients with type 2 diabetes has a range of health benefits, including a reduction in all-cause mortality In order to optimise the future use of bariatric surgery as a therapeutic modality for type 2 diabetes, further research is required Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

29. Recommendations on surgical management IV Apart from conventional procedures now in use new techniques and devices should be explored in research settings only Conventional procedures should be standardised. Other techniques, variations and novel devices can be introduced when supported by an evidence base New bariatric procedures require robust assessment for their efficacy, safety, and durability using similar principles to those for assessing new drug therapies and having regards to the benefits and risks of established therapy Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

30. Recommendations on diabetes management and future research Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

31. Recommendations on diabetes management Surgery should be considered as complementary to medical therapies to reduce micro-vascular and cardiovascular risk Patients should be assessed and managed by experienced multi-disciplinary teams Glycaemic control should be optimised peri-operatively and should be closely monitored after surgery It should be recognised that a prolonged period of normalisation of glycaemic control has benefit for diabetes even if there is eventual relapse Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

32. Recommendations on diabetes management On-going and long-term nutritional supplementation and support must be provided to patients after surgery There should be a minimal accepted data set for pre-surgery and follow-up to allow audit of clinical programmes • Weight, blood glucose control, assessment for diabetes complications, laboratory measures and medications etc. All longitudinal studies should include quality of life as one of the outcomes Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

33. A summary of more common nutritional concerns for each procedure • +Recommended daily intake (allowance) or standard multivitamin preparation likely to be sufficient • ++ Significant risk of deficiency or increased requirements. Specific supplementation is appropriate especially in higher risk groups • +++ High risk of deficiency. Additional specific supplementation is necessary to prevent deficiency. Careful monitoring is recommended. Supplementation well in excess of daily requirements may be necessary. Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

34. Bariatric interventions for type 2 diabetes: research recommendations • Establish better criteria than BMI for predicting benefit from surgery & define which patients benefit most from which procedures   • Studies needed to establish the benefit of surgery for persons with diabetes & BMI less than 35  • Studies are needed to establish the duration of the benefit of surgery Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

35. Bariatric interventions for type 2 diabetes: research recommendations • Studies needed to establish the mechanisms of the success of surgery  • New techniques should be assessed rigorously for efficacy and safety and ideally their mechanisms  • Studies are needed to define the best regimens of diabetes management after bariatric surgery  • It will be important to develop profiles of those who are best candidates for surgery • Randomised controlled trials are needed to evaluate and compare different bariatric procedures for the treatment of diabetes between themselves as well as emerging non-surgical therapies Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

36. Acknowledgments The IDF consensus meeting was supported with unrestricted educational grants from: Allergan Inc, Irvine, CA, USA Ethicon, Ethicon Endo-Surgery, Inc, Cincinnati, Ohio, USA MetaCure Inc, Mount Laurel, NJ, USA None of these companies, or their representatives, had anyinvolvement in the development or preparation of this report Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

37. “These new regulations will fundamentally change the way we get around them.” Source: New Yorker Magazine, 2008