Monday, March 26, 2012, Cleveland, OH -- Overweight, diabetic patients who underwent bariatric surgery achieved significant improvement or remission of their diabetes, according to new research from Cleveland Clinic.
In a randomized, controlled trial, some weight loss surgery patients achieved normal blood sugar levels without use of any diabetes medications. In others, the need for insulin to control blood sugar was eliminated. Recent observational studies had demonstrated that bariatric surgical procedures reduce the incidence of type 2 diabetes and lead to substantial improvement for many patients with pre-existing disease.
"After one year, patients who underwent gastric bypass or sleeve gastrectomy lost more weight and were significantly more successful at controlling their diabetes, compared to those who simply took medications," said lead investigator Philip Schauer, M.D., Director of the Cleveland Clinic Bariatric and Metabolic Institute. "We believe that bariatric surgery represents a potentially valuable strategy for control of diabetes that should be considered in more patients who do not respond to conventional treatment."
Results of the STAMPEDE (Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently) trial were published today in The New England Journal of Medicine and presented today at the Annual Scientific Sessions of the American College of Cardiology in Chicago.
The STAMPEDE trial involved 150 patients with obesity and poorly controlled diabetes. The patients were divided into three groups of 50: those who received intensive medical therapy of their diabetes, those who received intensive medical therapy plus gastric bypass surgery, and those who received intensive medical therapy plus sleeve gastrectomy.
"This trial demonstrates that bariatric surgery can eliminate the need for diabetes medications in many obese patients whose diabetes is poorly controlled," Schauer said. "Furthermore, the surgical patients showed major improvements in other measures of heart health, including reduced need for high blood pressure and cholesterol medications, while significantly boosting HDL – the so-called 'good' – cholesterol."
Effectiveness was gauged by the percentage of patients who achieved an average blood sugar within the normal range 12 months after treatment (measured using the hemoglobin A1c – HbA1c – a standard laboratory test that reflects average blood sugar over three months).
After 12 months, a normal HbA1c (less than 6.0) was achieved in 42.6 percent of patients who underwent gastric bypass and 36.7 percent of patients who underwent sleeve surgery, but just 12.2 percent of medically treated patients. The HbA1c of less than six is a more aggressive target than the American Diabetes Association guidelines.
Participants entered the study taking an average of three medications each for diabetes. In all of the gastric bypass patients who achieved the target level, the normal blood sugar was attained without use of any diabetic medications. Seventy-two percent of sleeve patients who reached normal blood sugar also did so without the use of any diabetic medications. In surgically-treated patients who continued to require drugs, researchers observed a substantial reduction in the need for diabetic medications.
As expected, the patients who received bariatric surgery lost more weight during the 12-month study, averaging 64.7 pounds for patients who received gastric bypass, 55.2 pounds for patients who had stomach reduction surgery, and 11.9 pounds for patients treated with medications.
The study authors reported some complications of surgery, but most were not serious. However, four patients did require a second operation. The study authors caution that the favorable results were observed after a relatively short follow-up period (12 months) and that long-term studies are needed to determine the durability of the findings. The authors will continue to follow these patients for four years to attempt to answer these questions.
More information on the clinical trial can be found at http://www.clevelandclinic.org/stampede.
This study was funded by Ethicon Endo-Surgery, Inc., a subsidiary of Johnson & Johnson, which is a company that designs and manufactures medical devices and surgical instruments. Dr. Schauer is a paid advisory board member of Ethicon, and is in complete compliance with all Cleveland Clinic COI policies.
About Cleveland Clinic
Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. U.S.News & World Report consistently names Cleveland Clinic as one of the nation's best hospitals in its annual "America's Best Hospitals" survey. About 2,800 full-time salaried physicians and researchers and 11,000 nurses represent 120 medical specialties and subspecialties. Cleveland Clinic Health System includes a main campus near downtown Cleveland, eight community hospitals and 18 Family Health Centers in Northeast Ohio, Cleveland Clinic Florida, the Lou Ruvo Center for Brain Health in Las Vegas, Cleveland Clinic Canada, and opening in 2013, Cleveland Clinic Abu Dhabi. In 2010, there were 4 million visits throughout the Cleveland Clinic health system and 167,000 hospital admissions. Patients came for treatment from every state and from more than 100 countries. Visit us at http://www.clevelandclinic.org/. Follow us at http://www.twitter.com/ClevelandClinic.
New England Journal of Medicine