Bariatric surgery is more beneficial than intensive medical therapy alone for patients with type 2 diabetes mellitus (T2DM) and a body mass index (BMI) of 27 to 43 after five years, according to featured clinical research presented April 4 as part of ACC.16 in Chicago.

The STAMPEDE trial, led by Philip R. Schauer, MD, et al, found that both gastric bypass and sleeve gastrectomy—two of the most-performed bariatric surgeries—were more effective than intensive medical therapy alone for achieving long-term biochemical control and remission of  T2DM, reduction of cardiovascular risk factors, positive effects on diabetes-related end-organ disease, and quality of life.

The trial's primary endpoint was a hemoglobin A1c (HbA1c) test result of ≤6.0 percent. Secondary endpoints included change in fasting plasma glucose, change in lipids, blood pressure and BMI, change in medications, change in ophthalmic and renal endpoints, and quality of life.

One-third of participants (50) were randomly assigned to intensive medical therapy that consisted of diet and lifestyle counseling for weight management; scheduled visits with nutrition, endocrinology, and psychology; insulin sensitizers, GLP-1 agonists, sulfonylureas and multiple insulin injections utilized to target HbA1c ≤6.0 percent; and follow-up visits every three months through year two and every six months for the remaining trial timeline.

Two-thirds of the patients were randomly assigned to either roux-en-Y gastric bypass with medical therapy (50 patients) or sleeve gastrectomy with medical therapy (50 patients). The trial had a 90 percent retention rate overall.

At the end of the five-year period, five percent of the patients who received medical therapy alone achieved the primary endpoint of HbA1c ≤6.0 percent. Of the patients who received surgery, 29 percent of the gastric bypass group and 23 percent of the sleeve gastrectomy group achieved the primary endpoint. Patients in the surgery group sustained reduction in the need for cardiovascular and glucose lowering medications. Cardiovascular and metabolic syndrome components showed favorable results five years after surgery compared with intensive medical therapy. No significant ophthalmic changes occurred in any of the groups.

Quality of life measures, such as general health, energy and fatigue levels, and physical limitations improved significantly for the surgery group but showed little, if any, change in the medical therapy group.

The researchers acknowledged that multicenter studies with larger sample sizes are needed to determine if the STAMPEDE trial's results can be generalized. However, they concluded that metabolic surgery (gastric bypass or sleeve gastrectomy) should be considered as a treatment option for patients with uncontrolled T2DM and moderate to severe obesity with results durable through five years of follow up.

Keywords: ACC Annual Scientific Session, Bariatric Surgery, Blood Glucose, Diabetes Mellitus, Secondary Prevention, Primary Prevention

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