STAMPEDE: Bariatric Surgery vs. Intensive Medical Therapy for Diabetes
Gastric bypass and sleeve gastrectomy are each more effective than intensive medical therapy alone in managing uncontrolled type 2 diabetes in obese patients after three years, according to research presented March 31 at ACC.14 and published simultaneously in the New England Journal of Medicine.
A total of 150 patients were randomized into three groups: intensive medical therapy only, intensive medical therapy plus Roux-en-Y gastric bypass, or intensive medical therapy plus sleeve gastrectomy. Medical therapy included counseling, lifestyle changes and insulin sensitizers, GLP-1 agonists, sulfonylureas and multiple insulin injections. The average patient had a baseline glycated hemoglobin level (HbA1c) of 9.3 percent, was living with uncontrolled diabetes for eight or more years, and was taking three or more anti-diabetic medications and three or more cardiovascular medications. The patients were ages 41 to 57, mildly to moderately obese, and 68 percent female.
The primary endpoint was achieving HbA1c ≤6 percent — lower than the American Diabetes Association recommended 7 percent. At three years, 5 percent of patients in the medical therapy group met this criterion, compared with 37.5 percent of the gastric bypass group (P<0.001) and 24.5 percent of sleeve gastrectomy group (P=0.01). The surgical groups also showed greater improvement in metabolic syndrome components including BMI, waist circumference, triglycerides and HDL cholesterol, compared to those receiving medical therapy alone.
Patients in the two surgical groups also had significant reduction in the use of antihypertensive and lipid-lowering agents; at three years, 5 percent to 10 percent of these patients were using insulin compared to 55 percent of those in the medical therapy group.
Further, the trial data also considered kidney function as measured by urinary albumin levels. Researchers noted improvement in albuminuria in the surgical groups, despite a reduction in the use of renin-angiotensin system blockers, suggesting that bariatric surgery may play a role in preventing further renal parenchymal damage.
"Both surgical options maintain their supremacy over standard intensive medical therapy at the three-year mark," said Philip Schauer, MD, professor of surgery, director of the Bariatric and Metabolic Institute, Cleveland Clinic, and lead investigator of the study. While the medical group showed an initial improvement in glycemic control within the first year, they were almost back to baseline by year three. "Their [blood glucose level] went from 9.5 at the start of the study and dropped as low as 7.5 and then back up to 8.4 percent," he said. In contrast, the surgical groups were able to maintain a lower glucose level with an average 2.5 percent reduction (9.3 at baseline and 6.7 and 7.0 for gastric bypass and sleeve gastrectomy at year three).
< Back to Listings