A major study published in New England Journal of Medicine in February 2017 shows that bariatric surgery, either RY bypass or sleeve gastrectomy, is superior to medications alone in lowering A1c, body weight, triglycerides, HDL, insulin use and improving quality of life in adults with type 2 diabetes.
A group of 150 patients with baseline A1c 9.2% were randomized to receive surgery plus medications or medications alone. Participants were followed for 5 years. No major surgical adverse events were seen.
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N E J M
Randomized Trial
February 2017
BACKGROUND: Long-term results from randomized, controlled trials that compare medical therapy with surgical therapy in patients with type 2 diabetes are limited.
METHODS: We assessed outcomes 5 years after 150 patients who had type 2 diabetes and a body-mass index, BMI 27-43 were randomly assigned to receive intensive medical therapy alone or intensive medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy. The primary outcome was a A1c of <6.0% with or without the use of diabetes medications.
RESULTS: Of the 150 patients who underwent randomization, 1 patient died during the 5-year follow-up period; 134 of the remaining 149 patients (90%) completed 5 years of follow-up. At baseline, the mean age of the 134 patients was 49±8 years, 66% were women, the mean A1c was 9.2%, and the mean BMI was 37.
At 5 years, the criterion for the primary endpoint was met by 2 of 38 patients (5%) who received medical therapy alone, as compared with 14 of 49 patients (29%) who underwent gastric bypass (unadjusted P=0.01, adjusted P=0.03, P=0.08 in the intention-to-treat analysis) and 11 of 47 patients (23%) who underwent sleeve gastrectomy (unadjusted P=0.03, adjusted P=0.07, P=0.17 in the intention-to-treat analysis).
Patients who underwent surgical procedures had a greater mean percentage reduction from baseline in A1c than did patients who received medical therapy alone (2.1% vs. 0.3%, P=0.003). At 5 years, changes from baseline observed in the gastric-bypass and sleeve-gastrectomy groups were superior to the changes seen in the medical-therapy group with respect to body weight (−23%, −19%, and −5% in the gastric-bypass, sleeve-gastrectomy, and medical-therapy groups, respectively), triglyceride level (−40%, −29%, and −8%), HDLc level (32%, 30%, and 7%), insulin use (−35%, −34%, and −13%), and quality-of-life measures (general health score increases of 17, 16, and 0.3; scores on the RAND 36-Item Health Survey ranged from 0 to 100, with higher scores indicating better health) (P<0.05 for all comparisons). No major late surgical complications were reported except for one reoperation.
CONCLUSIONS: Five-year outcome data showed that, among patients with type 2 diabetes and a BMI of 27-43, bariatric surgery plus intensive medical therapy was more effective than intensive medical therapy alone in decreasing, or in some cases resolving, hyperglycemia.