Bariatric surgery In Type 2 diabetes Mellitus. Josep Vidal Endocrinology and Nutrition Department Hospital Clínic, Universitat of Barcelona
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1 Bariatric surgery In Type 2 diabetes Mellitus Josep Vidal Endocrinology and Nutrition Department Hospital Clínic, Universitat of Barcelona
2 Bariatric Surgery (BS) Adjustable Gastric Banding Sleeve gastrectomy Roux en Y Gastric bypass Biliopancreatic Diversion Duodenal Switch R1. BMI 40 kg/m 2 regardless of comorbidities present (Grade A) R2. (Grade A, B, or C) BMI 35 kg/m comorbid condition ( T2DM, hypertension, dyslipidemia, OSA, Obesity hypoventilation Sd, NAFLD or NASH, pseudotumor cerebri, GERD, asthma, venous stasis disease, severe urinary incotinence, debilitating arthritis, or considerably impaired quality of life. BMI kg/m 2 + T2DM or the MetSd (although current evidence is limited by the number of subjects studied and lack of long term data demonstrating benefit)
3 BS is superior to medical therapy for the control of T2D Consistently shown in (at least) 5 RCT Author Rx arms (n) Follow up (years) BMI (Kg/m 2 ) HbA1c On insulin (%) DM duration (years) 1ary aim Main outcome Schauer STAMPEDE 2012, 2014 ILMI ILMI+GBP ILMI+SG 3 (out to 5) % 8.3 A1c<6% with or wo meds ILMI: 5% GBP: 38% SG: 24% Mingrone 2012, 2015 ILMI (15) ILMI+GBP (19) ILMI+BPD (19) 5 (out of 5) % NA A1c<6%+ FPG<100, no meds ILMI: 5% GBP: 38% BPD: 24% Ikkramudin 2013, 2015 ILMI (60) ILMI+GBP (60) 2 (out of 5) % NA A1c<7% + LDL<100 + SBP<130 ILMI: 14% GBP: 43% Courcalas 2014,2015 LSI (23) LSI+GBP (24) LSI+AGB (23) 3 (out of 3) % 6.5 A1c<6%+ FPG<100, no meds ILMI: 0% GBP: 40% AGB: 29% Cummings CROSSROADS 2016 ILMI (17) ILMI+GBP (15) 1 (out to 1) % 9.0 A1c<6% wo 1 y ILMI: 5.9% GBP: 60%
4 The case of the STAMPEDE Trial Primary Aim To compare the efficacy of intensive medical therapy alone or in combination with Roux en Y Gastric Bypass or Sleeve Gastrectomy in the attainment of HbA1c<6% throughout FU Population main characteristics (n=137) Age 48 years BMI 36.5 kg/m 2 (36% BMI<35) Duration T2D 8.3 years Insulin Rx 43% Smokers 31% Nephr/ Reth/CVD 18%/26%/ Schauer et al. N Eng J Med 2014
5 The case of the STAMPEDE Trial STAMPEDE Trial Cleveland Clinic: 3 years FU (n=137, Age 48 y, BMI 36,5 kg/m2, HbA1c preq 9,3%, DM duration 8,3 y, Insulin Rx 43%) Time course of HbA1c Final Nadir 0,6±2,5% 1,9% 2,3% 2,8% 2,5±1,9% 2,5±2,1% Schauer et al. N Eng J Med 2014
6 The case of the STAMPEDE Trial STAMPEDE Trial Cleveland Clinic: 3 years FU (n=137, Age 48 y, BMI 36,5 kg/m2, HbA1c preq 9,3%, DM duration 8,3 y, Insulin Rx 43%) HbA1c<6% w/wo med therapy (1ary aim of the study) HbA1c<6,5% Without med therapy HbA1c<7% w/wo medical therapy % patients IMT: vs GBP p<0.001; vs SG p<0.001 GBP vs SG p=0.1 5% 38% 24% IMT: vs GBP p<0.001; vs SGp<0.001 GBP vs SG p=0.08 0% 46% 29% IMT: vs GBP p=0.02; vs SG p=0.02 GBPvs SG p= % 65% 65% Schauer et al. N Eng J Med 2014
7 The case of the STAMPEDE Trial STAMPEDE Trial Cleveland Clinic: 3 years FU (n=137, Age 48 y, BMI 36,5 kg/m2, HbA1c preq 9,3%, DM duration 8,3 y, Insulin Rx 43%) Time course of body weight 4,3 kg ( 4,2%) 21,3 kg ( 21,1%) 26,2 kg ( 24,5%) In the whole population: Change in BMI was the only predictor for 1 ary aim [OR 1.41 (95%CI )] In the surgical groups: Change in BMI and T2D duration <8 years Schauer et al. N Eng J Med 2014
8 The case of the STAMPEDE Trial STAMPEDE Trial Cleveland Clinic: 5 years FU Highlights presented at the American College Cardiologists April Attainment of A1C levels (6.0% or less) 5 years: ILMI+ GBP 29% ILMI+ SG 23% ILMI 5% 2. Those who had surgery GBP>SG sustained weight loss more than patients who controlled diabetes with medication 3. Weight loss was the primary reason their blood glucose remained in control. in cardiology/articles/2016/03/23/18/25/mon 2pm stampede bariatric surgery vs intensive medical therapy for long term glycemic control and complications of diabetes acc 2016
9 Bariatric Surgery (BS) Adjustable Gastric Banding Sleeve gastrectomy Roux en Y Gastric bypass Biliopancreatic Diversion Duodenal Switch Bariatric surgery may be considered for adults with BMI 35 kg/m 2 and T2D, especially if the diabetes or associated comorbidities are difficult to control with lifestyle and pharmacological therapy. (Grade B) Although small trials have shown glycemic benefit of bariatric surgery in patients with type 2 diabetes and BMI kg/m2, there is currently insufficient evidence to generally recommend surgery in patients with BMI<35 kg/m 2 outside of a research protocol. (Grade E)
10 What s missing? Expectations too high from the surgical side! Although surgeons expectations proved incorrect, the value of BS should not be dismissed!!!
11 Who benefits Who benefits the most? the Remission most? of T2DM The importance of patient characteristics Diabetes Remission following RYGB The DiaRem Score Remission Rate According to DiaRem Score Still CD et al, Lancet Diabetes Endocrinology 2013
12 Who benefits Who benefits the most? the Remission most? of T2DM The case of patients on insulin therapy Bariatric Outcomes Longitudinal Database (BOLD) N=5225 Insulin treated T2D subjects (pre op BMI 45 kg/m 2 ) Percentage of subjects off insulin in the 1st year after surgery 62% 34% Ardestani A et al. Diabetes Care 2015
13 Who benefits Who benefits the most? the Remission most? of T2DM The case of patients on insulin therapy Hospital Clinic of Barcelona cohort N=74 Insulin treated T2D subjects (SG or GBP) 12 m FU Mean FU 4.9±1.9 years Vidal J et al. Unpublished data
14 Who benefits Who benefits the most? the Remission most? of T2DM The case of patients on insulin therapy Hospital Clinic of Barcelona cohort N=74 Insulin treated T2D subjects (SG or GBP) Time course of HbA1c of I T2D not in remission at final visit (70 out of 74) HbA1c (%) Nadir: HbA1c 6.2±0.9 Nadir: 75.9% HbA1c<7% Final: HbA1c 7.8±1.2% Final: 29.6% HbA1c<7% Time after surgery (meses) Vidal J et al. Unpublished data
15 Who benefits Who benefits the most? the Remission most? of T2DM The case of patients on insulin therapy Hospital Clinic of Barcelona cohort N=74 Insulin treated T2D subjects (SG or GBP) Time course of drug therapy in I T2D not in remission at final visit (70 out of 74) No drug therapy Oral agents IT other than basal bolus IT basal bolus Vidal J et al. Unpublished data
16 Who benefits Who benefits the most? the Remission most? of T2DM Importance of duration of T2D prior to surgery Impact on diabetes complications SWEDISH OBESE SUBJECTS STUDY T2DM COHORT N=607 (Bariatric surgery, n=345 Control, n= 262) Follow up: median 13.3 years (IQ range y) Sjostrom L et al, JAMA 2014
17 Who benefits Who benefits the most? the Remission most? of T2DM Importance of duration of T2D prior to surgery Impact on diabetes complications SWEDISH OBESE SUBJECTS STUDY T2DM COHORT N=607 (Bariatric surgery, n=345 Control, n= 262) Follow up: median 13.3 years (IQ range y) DM duration <1y DM duration 1 3y DM duration >4y Sjostrom L et al, JAMA 2014
18 Who benefits Who benefits the most? the Remission most? of T2DM Best T2D candidates DM PCOS Male infertility SAHS Hypertens. Dyslipidemia Arthropaty Other NAFLD Cancer
19 Summary 1. Current evidence support BS as part of the T2D therapeutic algorithm. 2. Benefits of BS in the obese patient with T2D expand beyond glycemic control. 3. Selection of best candidates should be based on a sound evaluation of the T2D stage and presence of comorbidities. More advanced T2DM stage (duration, Insulin Rx) Less advanced Less comorbidities Number of comorbidities More comorbidities Failure to oral therapy T2Duration < 10 y Additional comorbidities present
20 Thank you for your attention
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