The STAMPEDE (Surgical Therapy and Medications Potentially Eradicate Diabetes Efficiently) trial was the largest randomized trial comparing diabetes control between intensive medical therapy alone and surgery with medical therapy. Diabetes control was defined as HbA1c < 6.0%. Published in 2012, its results favoring surgical treatment over intensive medical therapy were the start of a change in the treatment of metabolic syndrome.
In this lecture, Dr. Schauer discusses the long-term results of the STAMPEDE trial. The 5-year results confirm that diabetes control is better achieved with surgery and that the addition of antidiabetic medication increases the percentage of patients who achieve DM control. These results also show a significant increase in HDL in the surgery group compared to the intensive medical therapy group.
Despite a significant reduction in HbA1c levels for all the groups in the first 6 months, the medical therapy group’s Hb1Ac level steadily increased until it reaches the baseline at 5 months compared with the surgical therapy group in which the HbA1c decrease is maintained over time. This result also applies to weight loss, in which there is a significant BMI decrease maintained over time in the surgical therapy group compared to the medical therapy group. The fact that there are no differences between BMI < 35 and BMI ≥ 35 suggests that the lower BMI group has similar benefits to the higher BMI group.
Also, patients with medical therapy are more dependent on insulin than patients with a sleeve gastrectomy and these are more dependent on insulin than those with a gastric bypass, and these results are similar in reduction in cardiovascular medication.
Concerning quality of life (QoL), there are statistically significant differences favoring surgical treatment, mainly in physical functioning, role limitations, bodily pain and general health.
Dr. Schauer also discusses the clinical impact of the STAMPEDE trail, with changes in the guidelines of International Diabetes Organization which recommended metabolic surgery for:
- Patients with BMI ≥ 40 regardless of glycemic control.
- Patients with BMI ≥ 35 with inadequately controlled hyperglycemia.
For the first time, surgery may be considered for patients with a BMI ranging between 30 and 34.9 with inadequately controlled hyperglycemia and Asians with a BMI as low as 27.5 with inadequately controlled hyperglycemia.