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Dr John B Dixon, MBBS PhD Associate Professor Head of Obesity Research School of Primary Health Care Monash University, Melbourne, Australia NHMRC Senior.

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Presentation on theme: "Dr John B Dixon, MBBS PhD Associate Professor Head of Obesity Research School of Primary Health Care Monash University, Melbourne, Australia NHMRC Senior."— Presentation transcript:

1 Dr John B Dixon, MBBS PhD Associate Professor Head of Obesity Research School of Primary Health Care Monash University, Melbourne, Australia NHMRC Senior research fellow Hypertension and Vascular – Obesity Research Baker Heart Research Institute Melbourne, Australia Diabetes surgery for the non-obese

2 Disclosures: Associate Professor John B Dixon AbbottSpeakers Bureau & Educational Material Allergan IncConsultant, Research Support Bariatric AdvantageConsultant, Speakers Bureau Eli LillySpeakers Bureau Merck Sharp and DohmeSpeakers Bureau Nestle AustraliaMedical Advisory Board, Speakers Bureau, Research Support Novartis AustraliaEducational material ResMedResearch Support Scientific IntakeConsultant & Research Support SP Health CoConsultant Weight WatchersSpeaker and Educational Material Valeant Pharmaceuticals Speaker and Educational Material

3 Diabetes surgery for BMI < 30 Why? Efficacy? Safety? How does it compare with medical therapy?

4 Why?

5 Relationship Between BMI and Risk of Type 2 Diabetes Chan J et al. Diabetes Care 1994;17:961. Colditz G et al. Ann Intern Med 1995;122:481. Age-Adjusted Relative Risk Body Mass Index (kg/m 2 ) <23 24–24.9 25–26.927–28.933–34.9 0 25 50 75 100 1.0 2.9 4.3 5.0 8.1 15.8 27.6 40.3 54.0 93.2 <22 23–23.9 29–30.931–32.9 35+ 1.0 1.5 2.2 4.4 6.7 11.6 21.3 42.1 1.0 Men Women

6 Where is the increase in diabetes occurring? Gregg EW, Cheng YJ, Narayan KM, et al. Prev Med. 2007;45:348-52.

7 There is a burden of diabetes – But also real competition! 43% of those with diabetes are in this weight range There are a range of interventions Weight loss can produce important benefits in an intensive lifestyle program Look AHEAD Dietary interventions Metformin, SU, GLP-1 agonists, and DPP IV inhibitors and even insulin Quenexa ?

8 Efficacy

9 403 gastric cancer patients with T2DM underwent gastrectomy between May 2003 and September 2009. Information from medical records T2DM: resolution, improvement, same, and worse.

10 Results – mean 10% weigh loss

11 Factors influencing diabetes course

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13 Multivariate analysis: Improvement was influenced most greatly by weight loss and weight gain Little happened with less than 10% weight loss

14 Authors conclusions

15 Studies of “Metabolic Surgery” BMI <35 Fried, M., G. Ribaric, et al. (2010). Obes Surg 20(6): 776-790.

16 Total 29 studies Brazil 12 Italy 5 USA 2 Taiwan 2 Korea 2 Chile 2 Australia 1 Venezuela 1 Data on 675 patients Procedures LII LDJB LRYGB LMGB BPD LAGB Mean BMI change 29.95 – 24.83 17%

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18 BMI < 35 – the whole review Remission HbA1c < 7% no medications

19 Prospective Study of RYGB for Type 2 DM in Asian Indians With BMI < 35 kg/m 2 BMI 22-35 kg/m 2 – “Overweight” to “Obese” by Indian-specific WHO criteria Type 2 DM – Confirmed with Abs, C-peptide, FHx Severe diabetes – Mean duration: 9 years – 80% on insulin (all others or oral DM meds) – HbA1c: 10.1% Other features – Dyslipidemia: 93% – Hypertension: 60% Shah, S. S., J. S. Todkar, et al. (2009). Surg Obes Relat Dis.

20 RYGB in Asian Indians with body mass index <35: baseline and 9 months (n=15) Shah, S. S., J. S. Todkar, et al. (2009). Surg Obes Relat Dis.

21 RYGB in Asian Indians with body mass index <35 (n=15)

22 Source: Surgery for Obesity and Related Diseases (DOI:10.1016/j.soard.2009.08.009 )Surgery for Obesity and Related Diseases Copyright © American Society for Metabolic and Bariatric Surgery Terms and ConditionsTerms and Conditions Shah, S. S., J. S. Todkar, et al. (2009). Surg Obes Relat Dis. RYGB in Asian Indians with body mass index <35 (n=15)

23 Did you calculate the weight loss? 20%

24 Gastric bypass – Taiwan A comparison of BMI 35 BMI<35 n=44 BMI > 35 n=157 Weight loss at 1–year 32% for all HbA1c 35 (p=0.06) While there was a lower response rate in those with BMI <35 results still acceptable Lee, W. J., W. Wang, et al. (2008). J Gastrointest Surg 12(5): 945-952.

25 Mini-gastric bypass – Taiwan A comparison of BMI 35 BMI 30

26

27 20 patients mini DS Duodenal part jejunal exclusion BMI 20-30 Excluded very poor control Selected only patients taking metformin, sulponylurea and glitizones included Ramos, A. C., M. P. Galvao Neto, et al. (2009). Obes Surg 19(3): 307-312.

28 Type 2 diabetes (n=20) Ramos, A. C., M. P. Galvao Neto, et al. (2009). Obes Surg 19(3): 307-312.

29 Laparoscopic Duodenal - jejunal bypass 20 diabetic patients underwent laparoscopic duodenal-jejunal exclusion. There was significant weight loss Mean 10% Only two patients were on oral medication after the sixth months - Only included those on oral hypoglycaemics There were no comments on complications in particular gastric emptying issues Studies with longer follow-up and a larger number of patients are necessary to better define the role of this new and promising procedure. Ramos AC, et al. Obes Surg. Mar 2009;19(3):307-312.

30 Lap Duodenal-Jejunal Bypass (n=7) 12 month prospective observational study Remission 1:7 Most reduced medications for diabetes HbA1c 9.4% to 8.5% FPG 209 to 154 mg/dl BMI 27.5 – 27.3 Authors recommend caution Ferzli, G. S., E. Dominique, et al. (2009). "Clinical improvement after duodenojejunal bypass for nonobese type 2 diabetes despite minimal improvement in glycemic homeostasis." World J Surg 33(5): 972-979.

31 Prospective randomized controlled trial of two versions of laparoscopic ileal interposition with sleeve gastrectomy Type 2 diabetic patients with BMI 21 – 34 Mean follow-up of 25 months HbA1c < 7 without medication in 90.9% of patients

32 Ileal Interposition – Sleeve Gastrectomy Ileal Interposition – Diverted Sleeve Gastrectomy ileum

33 Weight Change = 26% Group comparisons with baseline - p<0.001

34 * * * * p<0.001 vs corresponding group before surgery 82% of patients achieved optimal glycemic control, considered as HbA 1c < 6.5%, without antidiabetic treatment 8.6% 6.1% DePaula AL, Vencio S, Mari A, Muscelli E, Ferranninni E. – Diabetologia 2009;52 HbA 1c before and after surgery

35 At a 3-year follow-up there was a significant improvement in insulin sensitivity, insulin secretion and in the disposition index, as measured by a 3- hour OGTT study in type 2 diabetic patients who underwent laparoscopic ileal interposition with sleeve gastrectomy. Ileal interposition with sleeve gastrectomy

36 Biliopancreatic diversion BMI 25 -35 (n=30) Remission in 30% at 12 months Diabetes remission correlated positively with BMI at 12 months Initial BMI R 2 = 0.25; P = 0.02 All patients with BMI ≥30 kg/m 2 were in control at 12 months, 5 patients with BMI 25-30 HbA1c >7% Mean HbA1c 6.5% - Triglycerides went up Scopinaro, N., G. F. Adami, et al. (2011). Ann Surg 253(4): 699-703.

37 Biliopancreatic diversion BMI 25 -30 (n=15) 30-35 (n=15) BMI 30-35 HbA1c reduced from 9.5 – 5.9 – Triglycerides fell and HDL-C unchanged BMI 25-30 HbA1c reduced from 9.1 – 6.9 – Triglycerides were higher – HDL-C lower It seem BMI may be quite important! Scopinaro, N., G. F. Adami, et al. (2011). Obes Surg 21(7): 880-888. 1 year changes

38 Beta cell defect V Insulin Resistance Hypothesis Age-Adjusted Relative Risk Body Mass Index (kg/m 2 ) <23 24–24.9 25–26.927–28.933–34.9 0 25 50 75 100 1.0 2.9 4.3 5.0 8.1 15.8 27.6 40.3 54.0 93.2 <22 23–23.9 29–30.931–32.9 35+ 1.0 1.5 2.2 4.4 6.7 11.6 21.3 42.1 1.0

39 Safety Safety data is limited and mixed It appears related to the complexity of the procedures Surgery is NOT likely to be safer than in class 1 obese patients No data on nutrition, quality of life, functional capacity, body composition, depression and psychological wellbeing

40 Gaede et al., NEJM, 2008;358:580-91

41 Steno multifactorial intervention 2 groups of 80 with type 2 diabetes and microalbuminuria Gaede et al., NEJM, 2008;358:580-91

42 Treatment of T2 diabetes Blood pressure Cholesterol, triglyceride Smoking Inactivity

43 Treatment of T2 diabetes Blood pressure Cholesterol, triglyceride Smoking Inactivity & Glycemic control

44 My Conclusions Evidence for surgery is very limited The best results come with the best weight loss Surgery is less effective at lower levels of BMI We will need properly conducted RCTs and benefits likely to be less substantial than in the severely obese Surgery specifically designed for GI effects without generating significant weight loss should proceed cautiously The competition at level is considerable and evidence WILL need to be of high quality and compelling


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