STAMPEDE (gastric bypass)
Trial question
What is the role of gastric bypass in patients with T2DM?
Study design
Single center
Open label
RCT
Population
Characteristics of study participants
60.0% female
40.0% male
N = 100
100 patients (60 female, 40 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 gastric bypass (medical therapy plus Roux-en-Y gastric bypass).
N=50 medical therapy (intensive medical therapy alone).
Primary outcome
Percentage of patients achieving glycated hemoglobin level ≤ 6.0% at 12 months
42%
12%
42.0 %
31.5 %
21.0 %
10.5 %
0.0 %
Gastric
bypass
Medical
therapy
Significant
increase ▲
NNT = 3
Significant increase in the percentage of patients achieving glycated hemoglobin level ≤ 6.0% at 12 months (42% vs. 12%; RR 3.5, 95% CI 1.29 to 5.71).
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 (29.4 kg vs. 5.4 kg; AD 24 kg, 95% CI 9.76 to 38.24).
Significant increase in change in HDL-C level (28.5% vs. 11.3%; AD 17.2%, 95% CI 6.99 to 27.41).
Conclusion
In patients with obesity and uncontrolled T2DM, gastric bypass 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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