STAMPEDE (sleeve gastrectomy)
Trial question
What is the role of sleeve gastrectom in patients with T2DM?
Study design
Single center
Open label
RCT
Population
Characteristics of study participants
70.0% female
30.0% male
N = 100
100 patients (70 female, 30 male).
Inclusion criteria: patients with obesity and uncontrolled T2DM.
Key exclusion criteria: previous bariatric surgery or other complex abdominal surgery; poorly controlled medical or psychiatric disorders.
Interventions
N=50 bariatric surgery (medical therapy plus sleeve gastrectomy).
N=50 medical therapy (intensive medical therapy alone).
Primary outcome
Percentage of patients achieving glycated hemoglobin level ≤ 6.0% at 12 months
37%
12%
37.0 %
27.8 %
18.5 %
9.3 %
0.0 %
Bariatric
surgery
Medical
therapy
Significant
increase ▲
NNT = 4
Significant increase in the percentage of patients achieving glycated hemoglobin level ≤ 6.0% at 12 months (37% vs. 12%; RR 3.08, 95% CI 0.8 to 5.36).
Secondary outcomes
Significantly greater improvement in glycated hemoglobin level (2.9% vs. 1.4%; AD 1.5%, 95% CI 0.61 to 2.39).
Significantly greater improvement in body weight (25.1 kg vs. 5.4 kg; AD 19.7 kg, 95% CI 8.01 to 31.39).
Conclusion
In patients with obesity and uncontrolled T2DM, bariatric surgery was superior to medical therapy with respect to the percentage of patients achieving glycated hemoglobin level ≤ 6.0% at 12 months.
Reference
Schauer PR, Kashyap SR, Wolski K et al. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012 Apr 26;366(17):1567-76.
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