MULTI-CENTER, PROSPECTIVE, CONTROLLED TRIAL OF THE DUODENAL JEJUNAL BYPASS LINER FOR THE TREATMENT OF TYPE 2 DIABETES IN OBESE PATIENTS

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1 Bariatric endoscopy MULTI-CENTER, PROSPECTIVE, CONTROLLED TRIAL OF THE DUODENAL JEJUNAL BYPASS LINER FOR THE TREATMENT OF TYPE 2 DIABETES IN OBESE PATIENTS Marek Benes, Tomas Hucl, Pavel Drastich, Julius Spicak Hepatology and Gastroenterology, IKEM, Prague, Czech Republic IIIrd Internal Dpt., 1st FM ChU, Prague, Czech Republic

2 Obesity 2

3 Prevalence of obesity 3

4 Predicted incidency of obesity World 2010 = 285 million 2030 = 438 million Increase 54% % % % % % % % 4

5 Obesity and T2 DM 5

6 Obesity and T2 DM not only Metabolic syndrom Obesity and T2DM + Hypercholesterolemia Hypertriglyceridemia Low HDL Arterial hypertension

7 Therapy of obesity Principes and aims of obesity treatment Effectivity Low periprocedural morbidity and mortality Good tolerance of therapy No complications Treatment modalities Conservative Surgery Endoscopy 7

8 Conservative therapy Education Lifestyle changing Drugs Noncompliance 8

9 Surgery Restrictive Gastric Banding Vertical Banded Gastroplasty Vertical Gastrectomy Malabsorbtive Biliopancreatic Diversion Scopinaro Duodenal-Switch BPD Hybrid Roux-en-Y Gastric Bypass 9

10 Surgery Gastric banding Prázdný 10

11 Surgery Vertical gastroplasty Mason Mac Lean 11

12 Surgery Bilio-pancreatic diversion Sec. Scopinaro Duodenal switch 12

13 Surgery New fenomenon: Metabolic bariatric surgery Roux-en-Y Gastric Bypass 13

14 Surgery Invassiveness Complication Cost Irreversible

15 Endoscopy BIB 15

16 Endoscopy 16

17 Endoscopy Endo-gastroplasty Bard, Apollo 17

18 Endoscopy 18

19 Endoscopy Aspire-assist 19

20 Endoscopy No metabolic bariatric procedures 20

21 EndoBarrier (GI liner) Plastic sleeve Anchor in duodenal bulb, lenght 60 cm Endoskopicaly implant. and explant. Exclusion of duodenum and part of jejunum from digestion More than 1400 pts. from

22 EndoBarrier (GI liner)

23 EndoBarrier implant. 23

24 EndoBarrier implant. 24

25 EndoBarrier - extraction 25

26 EndoBarrier - extraction 26

27 D-J bypass liner EB: AE? Efficiency? Is EB effective enough for all obese T2DM pts? What about SE after implantation? 27

28 Study design G-J BYPASS LINER FOR THE TREATMENT OF OBESE PATIENTS WITH T2DM SAFETY AND EFFECTIVITY Multi-center, prospective, controled trial Target pts. (50 EB. vs. 50 controls) 3Y duration, start 8/2013 Pts. from control group diabetologist and diet specialist in one centrum Pts. from EB group plus EB Aim: Confirm effect of EB and verify principles of effect Supported by grant NT /

29 Sub-study design interim results INTERIM RESULTS OF A MULTI-CENTER, PROSPECTIVE, CONTROLLED TRIAL OF THE DUODENAL - JEJUNAL BYPASS LINER FOR THE TREATMENT OF TYPE 2 DIABETES IN OBESE PATIENTS: ARE THERE ANY FACTORS PREDICTING A SUB-OPTIMAL EFFECT? Aim: To identify clinical factors associated with a possible unscheduled explantation pain and sub-optimal outcome of EB (analysis of available data) QoL questionnaire, VAS pain measurement Database of lab. results from main study protocol Pain classification of pain (in 1/2M, 1M, 6-8M) Effectivity of EB measured in M 1, 3 and 8 29

30 Results 2 study groups 32 EB pts. vs. 25 controls Both groups comparable (age, sex, duration of T2DM, initial BMI 40.7 vs. 38.5, HbA1c level 89 vs. 83) In all cases EB implanted succesfully 4 explanted before 10M (mild bleeding, migration, ERCP), no because of pain!!! Total WL in M10-21% (44% EWL) in EB group vs. 8% in controls No death, no SAE HbA1c drop down by 25 mmol/mol in EB group vs. 11 mmol/l in controls in 10M 30

31 Pain after EB treatment T1-1/2M, T2-1M, T3-8M Pain (VAS) T1 T2 T3 Time 31

32 Pain vs. Initial BMI T1-1/2M, T2-1M, T3-8M Pain (VAS) <39,7 <44,4 <62,5 BMI T1 T2 T3 32

33 Pain vs. Height T1-1/2M, T2-1M, T3-8M Pain (VAS) <170 <180 >180 Height (cm) T1 T2 T3 33

34 Pain vs. Position of anchor of EB T1-1/2M, T2-1M, T3-8M Pain (VAS) upper middle lower Posi on T1 T2 T3 34

35 Effectivity of EB: BMI T1-before, T2-1M, T3-3M, T4-8M BMI T1 T2 T3 T4 Time Treated Control group 35

36 Effectivity of EB: EWL (exces weight loss) 40 T1-before, T2-1M, T3-3M, T4-8M EWL (%) Treated Control group 5 0 T1 T2 T3 T4 Time 36

37 Effectivity of EB: Waist T1-before, T2-1M, T3-3M, T4-8M Waist (cm) Treated Control group T1 T2 T3 T4 Time 37

38 Effectivity of EB: CRP 12 T1-before, T2-1M, T3-3M, T4-8M 10 CRP (mg/l) Treated Control group 0 T1 T2 T3 T4 Time 38

39 Effectivity of EB: HbA1c T1-before, T2-1M, T3-3M, T4-8M HbA1c (mmol/mol) T1 T2 T3 T4 Time Treated Control group 39

40 Effectivity of EB: QoL 50 T1-before, T2-1M, T3-3M, T4-8M QoL (Impr. %) Treated Control group -20 T1 T2 T3 T4 Time 40

41 Predicting factors of effectivity: EWL vs. Height EWL (%) Treated Control group 0 <170 <180 >180 Height (cm) 41

42 Predicting factors of effectivity: EWL vs. Weight EWL (%) Treated Control group 0 <120 <135 >135 Weight (kg) 42

43 Incretins principles of effect 43

44 Incretins Incretins (glukagon-like peptid 1 (GLP-1) a gludependent insulinotropy polypeptid GIP ) GI hormons stimulating of secretion of insulinu after p.o. food intake Secern. by endocrin cells of SB as answ. on nutrients content Regulation of postprandial insulin answ. Incretins incret. effect, ~60% of global insulin secretion after p.o. food intake 44

45 Incretins Glukagon-like peptid 1 (GLP-1) L-cells in ileum and colon GIT, pancreas, CNS, myocard Half-life 2-7 min only 45

46 Incretins study results 150 Plazmatická hladina GLP-1 v prùbì hu GLP1 level during meal test meal testu * 200 Návštì Vizit 1va 1 Návštì Vizit 2va 2 Návštì Vizit 3va 4 * pg/ml * p < 0,05 V1 vs. V2 Bazál (min)

47 Incretins study results mmol/l Glykémie v prùbì hu meal testu Návštì Vizit 1 va 1 Návštì Vizit 2 va 2 Návštì Vizit 3 va 4 * O Glu level during meal test * O * O * O * O * O * O 8 6 * p < 0,001 V1 vs. V2 O p < 0,001 V1 vs. V4 Bazál (min)

48 Future: Endo/SatiSphere 48

49 Summary I. EB is safe EB provides significant weight loss and HbA1c reduction because of GLP1 Lower initial BMI, distal position of the anchor and lower body height could be negative prognostic factor for pain

50 Summary II. Lower initial BMI and lower body height could be positive prognostic factor for EWL EB makes people happy improving QoL