Metabolic Surgery for Type 2 Diabetes Robin Blackstone, MD, FACS, FASMBS President, ASMBS

STAMPEDE Trial 150 patients with type 2 diabetes BMI 27-43kg/m2, 1/3 BMI <35 Duration of Diabetes 8 years average, mean baseline HgA1C 8.9-9.5%, on 3 diabetic agents including 44% on insulin Randomized Prospective Trial Intensive Medical Therapy vs. Sleeve Gastrectomy vs. Gastric Bypass Schauer PR et al. N Engl J Med 2012. DOI: 10.1056/NEJMoa1200225

Characteristics of the Patients at Baseline. Schauer PR et al. N Engl J Med 2012. DOI: 10.1056/NEJMoa1200225

Changes in Measures of Diabetes Control from Baseline. Figure 1. Changes in Measures of Diabetes Control from Baseline. Values for change in glycated hemoglobin (Panel A), change in fasting plasma glucose (Panel B), the average number of diabetes medications (Panel C), and change in body-mass index (BMI) (Panel D) were plotted at 3, 6, 9, and 12 months. Least-square means and standard errors from a repeated measures model are plotted for glycated hemoglobin, average number of medications, and BMI; medians and interquartile ranges are plotted for fasting plasma glucose. P values are for the comparison between each surgical group and the medical-therapy group and were calculated from a repeated-measures model that considers data over time. Schauer PR et al. N Engl J Med 2012. DOI: 10.1056/NEJMoa1200225

Primary Endpoints After one year……… Patients achieving HgA1c of 6.0 or less, whether one or off medications 12% of intensive medical treatment group 37% in sleeve gastrectomy 42% in gastric bypass Schauer PR et al. N Engl J Med 2012. DOI: 10.1056/NEJMoa1200225

Enrollment and Outcomes. Figure 1. Enrollment and Outcomes. Mingrone G et al. N Engl J Med 2012. DOI: 10.1056/NEJMoa1200111

Glycated Hemoglobin Levels during 2 Years of Follow-up. Figure 2. Glycated Hemoglobin Levels during 2 Years of Follow-up. Mingrone G et al. N Engl J Med 2012. DOI: 10.1056/NEJMoa1200111

Primary Endpoints After two years (93% follow up) No patient on medical therapy achieved remission Rates of complete remission of diabetes (FBG </=100mg/dl, HGA1c </=6.0% for at least one year without medications) CR 75% Gastric Bypass and 95% for BPD Surgical procedures achieved diabetes control independent of preoperative BMI and post operative weight loss Mingrone G et al. N Engl J Med 2012. DOI: 10.1056/NEJMoa1200111

Safety of Surgery Mortality Rate HCUP5 LABS1 Hernia6 Buchwald4 DeMaria3 Lap Cholecystectomy9 Appendectomy7 GI Obstruction8 CABG w/ cath10 Carotid Stent12 Drug Eluding Stent11 1) LABS Reporting Group N Engl J Med 2009;361:445-54 2) DeMaria et al Surg Obes and Relat Dis 2010 ;6:347-355 3)DeMaria et al Ann Surg. 2007;246(4):578-82 4)Buchwald et al JAMA. 2004;292:1724-1737 5) AHRQ, Healthcare Cost and Utilization Project (HCUP), http://hcupnet.ahrq.gov/ accessed 01/13/10, 2007 data DRG 288 6) Ibid 2007 data DRG’s 161 and162 7 )Ibid 2007 data DRG’s 166 and167 8) Ibid 2007 data DRG’s 180 and181 9) Ibid 2007 data DRG’s 493 and 494 10) Ibid 2007 data DRG’s 547 and 548 11) Ibid 2007 data DRG’s 557 and 558 12 Ibid 2007 data DRG 577