Bariatric surgery is associated with greater weight loss, improved glycemic control, blood pressure and cholesterol, according to data from two studies published in JAMA. However, risks associated with Roux-en-Y gastric bypass surgery are still a concern, researchers wrote.
In one study, Sayeed Ikramuddin, MD, of the department of surgery at the University of Minnesota, and colleagues designed a 12-month randomized clinical trial to compare outcomes of Roux-en-Y gastric bypass with lifestyle and intensive medical management strategies to curb comorbidities associated with diabetes.
All patients were administered the lifestyle-intensive medical management intervention (n=120) and half were randomly assigned to Roux-en-Y gastric bypass surgery (n=60).
“The merit of gastric bypass treatment of moderately obese patients with type 2 diabetes depends on whether potential benefits make risks acceptable,” researchers wrote.
At 12 months, researchers wrote that 28 patients (49%; 95% CI, 36-63) in the gastric bypass group and 11 (19%; 95% CI, 10-32) in the lifestyle-medical management group met the primary end points (OR=4.8; 95% CI, 1.9-11.7), such as HbA1c reductions (8% to <7%), decreased LDL (<100 mg/dL) and lowered systolic BP (<130 mm Hg).
Those who underwent gastric bypass surgery required fewer medications (mean amount: 1.7 vs. 4.8; 95% CI, 2.3-3.6), the researchers wrote. Moreover, they lost 26.1% vs. 7.9% of their baseline body weight compared with the lifestyle-medical management group (difference: 17.5%; 95% CI, 14.2-20.7), according to data.
The researchers wrote that there were 22 serious adverse events among patients in the gastric bypass group and 15 in the lifestyle-medical management group.
In a second report, Melinda Maggard-Gibbons, MD, MSHS, of the department of surgery at the David Geffen School of Medicine at the University of California, Los Angeles, and colleagues wrote that there is not enough evidence to support an appropriate use of bariatric surgery for weight loss and glycemic control among patients with diabetes who are not morbidly obese.
They conducted a systemic review by searching PubMed, Embase and Cochrane Library databases from January 1985 to September 2012. Their investigations led to the analysis of 32 surgical studies, 11 systemic reviews on nonsurgical treatments and 11 large nonsurgical studies published after those reviews, the researchers wrote.
Ultimately, researchers said they were unable to find any robust surgical data beyond 5 years of follow-up on outcomes of diabetes, glucose control, macrovascular and microvascular outcomes.
“There are limited data from randomized clinical trials to directly address the clinically important question of whether bariatric surgery is associated with greater weight loss and better glycemic control than nonsurgical therapy in patients with diabetes and a BMI of 30 to 35,” they wrote.
In an editorial accompanying both studies, Bruce M. Wolfe, MD, of Oregon Health and Science University, and colleagues said the benefits of bariatric surgery are often offset by risks for surgical complications.
Bruce M. Wolfe
“The report by Ikramuddin et al adds to the bariatric surgery literature in important ways,” Wolfe and colleagues wrote.
However, after reviewing the report by Maggard-Gibbons and colleagues, the editorial highlights complications associated with systemic reviews.
“Too limited inclusion criteria result in no guidance for clinicians caring for certain patients and criteria that are too broad lead to recommendations that represent expert opinion,” Wolfe and colleagues wrote. “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.”
For more information:
Ikramuddin S. JAMA. 2013; 309:2240-2249.
Maggard-Gibbons M. JAMA. 2013; 309:2250-2261.
Wolfe BM. JAMA. 2013; 309:2274-2275.
Disclosure: See the studies for full lists of disclosures.