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Diabetes Surgery Study

Surgical benefits should be weighed against risks

Superior results for patients who had surgery plus lifestyle and medical management

The benefits of Roux-en-Y gastric bypass surgery should be weighed against the possible risk of serious adverse events, according to the results of a randomised clinical trial (Roux-en-Y gastric bypass versus intensive medical management for the control of type 2 diabetes, hypertension, and hyperlipidemia) published in the Journal of the American Medical Association.

The results revealed that mild-to-moderately obese patients with type 2 diabetes benefited more from Roux-en-Y gastric bypass surgery plus lifestyle and medical management, compared to patients who only received lifestyle and medical management treatment.

However, the authors caution that; “Potential benefits of adding gastric bypass surgery to the best lifestyle and medical management strategies of diabetes must be weighed against the risk.”

Study

There are a limited number of randomised clinical trials that have investigated the benefits of bariatric surgery in moderately obese patients with diabetes.

"The foundation of treatment for type 2 diabetes mellitus is weight loss, achieved through reduction of energy intake and increased physical activity via lifestyle modification,” write the authors. “Controlling glycaemia, blood pressure and cholesterol is important for patients with diabetes. How best to achieve this goal is unknown."

As a result, researchers lead by Dr Sayeed Ikramuddin, from the University of Minnesota, Minneapolis, established the Diabetes Surgery Study, a prospective, randomised clinical trial comparing Roux-en-Y gastric bypass with intensive medical management in a cohort of 120 patients with poorly controlled type 2 diabetes and BMIs 30-39.9. Patients were enrolled at three centres in the US and one in Taiwan.

All patients received intensive behavioural intervention to modify their lifestyles and medications, to treat hyperglycaemia, hypertension, and dyslipidemia. Half of the patients were randomsed to also undergo Roux-en-Y gastric-bypass surgery.

The study's primary endpoints afterone-year outcome were: HbA1c below 7%, LDL cholesterol below 100mg/dL, and systolic blood pressure below 130mm Hg.

Results

After one year, 28 patients (49%) in the gastric bypass group and 11 (19%) in the lifestyle-medical management group achieved the primary end points (odds ratio [OR], 4.8; 95% CI, 1.9-11.7).

Patients in the gastric bypass group required 3.0 fewer medications (mean, 1.7 vs 4.8; 95% CI for the difference, 2.3-3.6) and lost 26.1% vs 7.9% of their initial body weight, compared with the lifestyle-medical management group.

Regression analyses indicated that achieving the composite end point was primarily attributable to weight loss.

There were 22 serious adverse events in the gastric bypass group (including one cardiovascular event) and 15 in the lifestyle-medical management group. There were four peri-operative complications and six late post-operative complications. The gastric bypass group experienced more nutritional deficiency than the lifestyle-medical management group.

The researcher also said that the trial should be repeated in a larger sample with longer follow-up, although they note that it was difficult enough to recruit sufficient patients for this trial, with 22 candidates screened to enrol each patient.

"Bariatric surgery can result in dramatic improvements in weight loss and diabetes control in moderately obese patients with type 2 diabetes who are not successful with lifestyle changes or medical management," the authors write. “The merit of gastric bypass treatment of moderately obese patients with type 2 diabetes depends on whether potential benefits make risks acceptable."

The study was supported by Covidien and the NIH.

Editorial

In an accompanying editorial (Wolfe BM, et al "Treating diabetes with surgery" JAMA 2013; 309(21): 2274-2275), Dr Bruce M Wolfe, of Oregon Health and Science University, Portland, said, "Recent large scale trials of intensive medical management for obesity and diabetes have been disappointing. Substantial resources are required to cause modest weight loss and diabetes control. Bariatric surgery does result in substantial weight loss with excellent diabetes control but is offset by initial high cost and risks for surgical complications.”

“The optimal approach for treatment of obesity and diabetes remains unknown. The answer will only come from more well designed, randomized trials such as that performed by Ikramuddin et al. that provide definitive answers."

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