Bariatric Surgery for T2DM The STAMPEDE Trial

A.R. BMI 36.5 T2DM diagnosed age 24 On Metformin, glyburide  insulin Parents with T2DM, father on dialysis Otherwise negative PMH

A.R. 29 yo F with type 2 DM presents to the ED with nausea and vomiting x 2 weeks. Underwent gastric bypass 2 weeks ago 2 nd admission for IVF in 4 days

Hmm… In obese patients with T2DM, how significant is the benefit to bariatric surgery plus medical management when compared to medical management alone?

STAMPEDE Trial Bariatric Surgery versus Intensive Medical Therapy in Obese Patients Philip R Schauer, Et al NEJM 2012

Design Single-center, non-blinded, randomized, controlled trial ▫Cleveland Clinic, ▫Single surgeon N = 150 ▫3 groups: Intensive medical tx (n=41), intensive medical tx + Roux-en-Y (n=50), intensive medical tx + gastric sleeve (n=49)

Participants Inclusion Criteria ▫T2DM: A1c>7% ▫20-60 years, male and female ▫BMI kg/m 3 Exclusion Criteria ▫Previous bariatric surgery ▫Poorly controlled psych history or other medical comorbidities

Demographics N Engl J Med 2012;366:

Interventions Randomized into 3 groups All received diabetic education, encouraged to participate in weight watchers HTN, HLD treated per ADA guidelines Patients in surgery groups evaluated by psych, nutrition ▫Specific supplements for Roux-en-Y and gastric sleeve patients

Intensive Medical Tx of T2DM ADA Guidelines ▫Lifestyle counseling ▫Weight management ▫Home glucose monitoring ▫BP control ▫Treatment of hyperlipidemia ▫Oral diabetes medications ▫Insulin

Outcomes – 12 months Primary ▫A1c <6  IMT vs IMT + Roux-en-Y: 12% vs 42% (P =.002)  IMT vs IMT + gastric sleeve: 12% vs 37% (P=.008)

N Engl J Med 2012;366:

Medication Use at 12 months N Engl J Med 2012;366:

Adverse Outcomes N Engl J Med 2012;366:

Limitations Single center trial, single surgeon performed all surgeries ▫Trial sponsored by instrument manufacturer No long term outcomes Low power ▫140 patients completed study HgbA1c is not an adequate endpoint ▫Long-term survival ▫Long-term diabetes control

Bariatric Surgery versus intensive medical therapy for diabetes – 3 year outcomes. Schauer, PR et al. NEJM 2014

Outcomes – 3 years Primary outcomes ▫A1c <6%  IMT vs Roux-en-Y: 5% vs 38% (P = <.001)  IMT vs Gastric Sleeve: 5% vs 24% (P =.01)

Conclusions Bariatric surgery can be helpful for management of T2DM in obese patients with poor control IMT remains first line Unclear if bariatric surgeries improves survival in these patients, further studies needed

ADA Standards of Care 2015 Bariatric surgery may be considered for adults with BMI >35 and T2DM ▫Especially in the setting of comorbidities, end organ damage or difficult to control disease Insufficient evidence for recommendations regarding bariatric surgery for BMI <35

References 1. PR Schauer, et al. Bariatric Surgery versus Intensive Medical Therapy for Obese Patients with Diabetes. N Engl J Med 366(17): April PR Schauer, et al. Bariatric Surgery versus Intensive Medical Therapy for Obese Patients with Diabetes – 3 year outcomes. N Engl J Med 370 (21): May American Diabetes Association. Standards of Medical Care in Diabetes – J of Clinical and Applied Research and Ed 35(S11-S63) 2012 January. 4. American Diabetes Association. Standards of Medical Care in Diabetes – J of Clinical and Applied Research and Ed 38(S1-S90) January.