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.

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.

Mingrone G et al. N Engl J Med 2012. DOI: 10.1056/NEJMoa1200111

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

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1) LABS Reporting Group N Engl J Med 2009;361:445-542) DeMaria et al Surg Obes and Relat Dis 2010 ;6:347-3553)DeMaria et al Ann Surg. 2007;246(4):578-824)Buchwald et al JAMA. 2004;292:1724-17375) AHRQ, Healthcare Cost and Utilization Project (HCUP), http://hcupnet.ahrq.gov/ accessed 01/13/10, 2007 data DRG 2886) Ibid 2007 data DRG’s 161 and162 7 )Ibid 2007 data DRG’s 166 and1678) Ibid 2007 data DRG’s 180 and181 9) Ibid 2007 data DRG’s 493 and 49410) Ibid 2007 data DRG’s 547 and 548 11) Ibid 2007 data DRG’s 557 and 55812 Ibid 2007 data DRG 577