Two studies that recently appeared in the New England Journal of Medicine (NEJM) suggest that some bariatric surgical procedures, either alone or in combination with medical therapy, can be more effective in achieving key treatment goals in specific patients with type 2 diabetes than medical therapy alone.
Laparoscopic placement of an adjustable gastric band is considered the least invasive bariatric surgical procedure.
According to a study(www.nejm.org) published March 26 in NEJM, bariatric surgery in conjunction with 12 months of medical therapy achieved glycemic control in significantly more patients with obesity and uncontrolled type 2 diabetes than did medical therapy alone.
Of 218 potential participants screened for the Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently (STAMPEDE) trial, 150 eligible patients were randomized to undergo intensive medical therapy (i.e., lifestyle counseling, weight management, frequent home glucose monitoring and the use of newer drug therapies) alone or intensive medical therapy plus either Roux-en-Y gastric bypass or sleeve gastrectomy.
The study's primary end point was the proportion of patients with a glycated hemoglobin level of 6 percent or less (with or without diabetes medications) 12 months after randomization. The STAMPEDE researchers also tracked various secondary end points, such as levels of fasting plasma glucose, fasting insulin, lipids, and high-sensitivity C-reactive protein; weight loss; blood pressure; adverse events; and changes in medications.
- Two recently published studies suggest that some bariatric surgical procedures, either alone or in combination with medical therapy, can be more effective in achieving key treatment goals in specific patients with type 2 diabetes than medical therapy alone.
- One study randomized patients to undergo intensive medical therapy alone or intensive medical therapy plus either Roux-en-Y gastric bypass or sleeve gastrectomy. The other randomized patients to receive conventional medical therapy or to undergo either gastric bypass or biliopancreatic diversion.
- Findings in both studies indicated that bariatric surgery, whether with or without concurrent medical therapy, helped ameliorate hyperglycemia and permitted some patients to discontinue pharmacologic treatment.
The report's authors acknowledged that the study had some limitations, including the "relatively short duration of follow-up (12 months) and the single-center, open-label nature of the study." In addition, a number of adverse events occurred in the bariatric surgery group, and four participants required reoperation.
Overall, the durability of trial results and long-term safety profile remain uncertain, said the authors, although four more years of scheduled follow-up of all patients should permit assessment of long-term efficacy and safety results.
Despite these limitations, however, the STAMPEDE researchers concluded that bariatric surgery represents a potentially useful strategy for managing uncontrolled diabetes.
"It has been shown to eliminate the need for diabetes medications in some patients and to markedly reduce the need for drug treatment in others," the authors noted. "In addition, among patients undergoing surgery, cardiovascular risk factors improved, allowing reductions in lipid-lowering and antihypertensive therapies."
Another NEJM study(www.nejm.org) found that bariatric surgery resulted in better glucose control than did medical therapy for severely obese patients with type 2 diabetes.
In this single-center, nonblinded trial, 60 patients ages 30-60 years with a body mass index of 35 or more, a history of at least five years of diabetes, and a glycated hemoglobin level of 7 percent or more were randomized to receive conventional medical therapy or to undergo either gastric bypass or biliopancreatic diversion.
The primary end point was the rate of diabetes remission at two years (defined as a fasting glucose level of less than 100 mg per deciliter [5.6 mmol per liter] and a glycated hemoglobin level of less than 6.5 percent in the absence of pharmacologic therapy). Secondary end points included changes from baseline in levels of fasting plasma glucose and glycated hemoglobin; the average glycated hemoglobin level; body weight; and levels of plasma cholesterol, HDL cholesterol, and triglycerides at two years.
All patients in the surgical groups were able to discontinue pharmacologic treatment (oral hypoglycemic agents and insulin) within 15 days after the operation. At two years, none of the patients randomized to receive medical therapy had achieved diabetes remission, compared with 15 of 20 patients (75 percent) who underwent gastric bypass and 19 of 20 patients (95 percent) who underwent biliopancreatic diversion.
Among other findings were that average percentage changes in glycated hemoglobin levels from baseline were smaller in the medical therapy group than in the gastric bypass group and the biliopancreatic diversion group. In addition, patients in the two surgical groups saw greater reductions in average body weight from baseline than did patients who received medical therapy.
"Our findings indicate that bariatric surgery, specifically gastric bypass and biliopancreatic diversion, may be more effective than conventional medical therapy in controlling hyperglycemia in severely obese patients with type 2 diabetes," the authors wrote.
It's worth noting that in comments on the STAMPEDE article, one physician questioned the wisdom of opting for a surgical solution to ameliorate hyperglycemia, which, he noted, "is not diabetes even though that is what we measure and treat in diabetes. … Are we trading glucose control by bariatric surgery with another lifelong postsurgery syndrome/disease with all other associated problems that come with it? We should use judicious restraint and caution not to replace our present epidemic of type 2 diabetes with obesity with another epidemic of postgastric bypass syndrome."