Bariatric surgery versus intensive medical therapy in obese patients with diabetes

Schauer PR, Kashyap SR, Wolski K, et al.
N Engl J Med. 2012;366(17):1567-1576. 

This overview was created under the auspices of KnowledgePoint360 Group, LLC, and was not associated with funding via an educational grant or a promotional interest. 

The Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently (STAMPEDE) study, conducted by Schauer and colleagues, was a randomized, controlled trial comparing intensive medical therapy with surgical treatment to improve glycemic control in 150 obese subjects with type 2 diabetes.  

Subjects were randomized in a 1:1:1 ratio to one of three interventions: intensive medical therapy, intensive medical therapy + Roux-en-Y gastric bypass, or intensive medical therapy + sleeve gastrectomy, stratified by the patients’ use of insulin at baseline. Intensive medical therapy (as defined by the American Diabetes Association [ADA] guidelines), included lifestyle counseling, weight management, frequent home glucose monitoring and FDA-approved pharmacologic therapy for diabetes. All subjects were also treated with antihypertensive and lipid-lowering therapy (per ADA guidelines).  

Eligible subjects were aged 20–60 years, had A1C >7.0%, and BMI 27–43 mg/k2. Exclusion criteria included previous bariatric surgery, other complex abdominal surgery, or poorly controlled medical or psychiatric disorders.  

Baseline data were collected for all subjects, with follow-up assessments at 3, 6, 9, and 12 months. Subjects were also assessed after 4 years for an extension study to examine the durability of glycemic control and diabetes-related complications. The study’s primary end point was the proportion of patients with A1C ≤6% (with or without diabetes medications) 12 months after randomization.  

Results at 12 months  

  • A1C ≤6.0%
    • Medical-therapy group: 5 of 41 subjects (12%)  
    • Medical-therapy + gastric-bypass group: 21 of 50 (42%; all subjects in this group achieved target A1C without medication) (P=0.002)  
    • Medical-therapy + sleeve-gastrectomy group: 18 of 49 (37%) (P=0.008)  
     
  • Mean levels of A1C and fasting plasma glucose (FPG) were significantly lower in the two surgical groups vs the medical therapy group (P<0.01 for both comparisons).
    • Large and rapid (by 3 months) improvement observed in A1C and FPG levels after each of the surgical procedures.  
    • Improvement was sustained over the year of observation with reduced hypoglycemic medication use.  
     
  • Patients receiving medical therapy alone had a smaller and more gradual improvement in glycemic control.  

 

 

Don’t miss slides on STAMPEDE in our Slide Library: 

STAMPEDE: Design   
STAMPEDE Results: Primary Endpoint (A1C ≤6%) at 12 Months
  
 

 

 This overview was created under the auspices of KnowledgePoint360 Group, LLC, and was not associated with funding via an educational grant or a promotional interest. 

 

Last Modified: 11/15/2013