Recent research indicates that bariatric or “metabolic” surgery may prove more effective than intensive medical management alone in managing uncontrolled type 2 diabetes in overweight or obese patients after a year. A news release reports that the research was presented at the American College of Cardiology’s Annual Scientific Session.
The randomized trial, STAMPEDE, reportedly sought to compare the effect of laparoscopic gastric bypass and sleeve gastrectomy to intensive medical therapy in assisting patients to achieve target goals. The trial encompassed 150 patients who were randomly assigned to one of three treatment groups. The first group consisted of intensive medical therapy only, which researchers say included a combination of counseling, lifestyle changes, and medications. The second group included medical therapy in addition to Roux-en-Y gastric bypass. Finally, the third group encompassed the use of medical therapy in combination with sleeve gastrectomy.
Researchers note that during the trial they set an HbA1c of less than 6% target as a primary endpoint. According to the results, this target was achieved in 12% of the medical treatment group, compared to 42% for the gastric bypass group and 37% for the sleeve gastrectomy group. Researchers add that patients in surgical groups exhibited a greater reduction in their HbA1c, greater weigh loss, and reduced reliance on medications compared to the medical treatment group.
The study suggests that at 12 months post-randomization, all three groups exhibited an improvement in glycemic control, with a mean HbA1c of 8% for medical therapy, 6% gastric bypass, and 7% for sleeve gastrectomy. Researchers report that patients exhibited no major differences in blood pressure and chloestrol control between the groups. The results also indicate that patients in the surgical groups saw a significant improvement in glycemic control and were able to dramatically reduce the number of glucose, cholesterol, and blood pressure-lowering medications. Medication use, researchers explain, generally increased in patients in the medical treatment group.
Phillip Schauer, MD, professor of surgery, director of the Bariatric and Metabolic Institute, Cleveland Clinic, led the study. “Even though patients were given very intensive treatment, including new drugs, the surgical therapies were still superior,” Schauer says.
The trial’s results also note that weight loss was five times greater for patients who received gastric bypass or sleeve gastrectomy compared to medical therapy. Schauer emphasizes that the surgeries are not without risk; the most common issues during the trial included short-term dehydration, bleeding, and one leak. Schauer adds that four out of 100 surgical patients also required operative intervention to manage complications occurring within the 12-month follow up period.
Researchers conclude that further studies are needed to determine whether the results are sustained and investigate endpoints such as heart attack, stroke, renal failure, and blindness. Further researcher is also needed to pinpoint the mechanism by which gastric surgery has an immediate and significant effect on glycemic control.
Source: American College of Cardiology