A study from Pennington Biomedical Research Center has reported that remission of type 2 diabetes is achieved more effectively and has longer-lasting results with bariatric surgery compared to medications and lifestyle changes. The study included assessed 316 patients with type 2 diabetes to determine the effectiveness and long-term results of metabolic surgery. The Alliance of Randomized Trials of Medicine Versus Metabolic Surgery in Type 2 Diabetes (ARMMS-T2D) study is the largest study to date to evaluate bariatric and metabolic surgery, as a treatment for type 2 diabetes. The findings were featured in the paper, ‘Diabetes Remission in the Alliance of Randomized Trials of Medicine Versus Metabolic Surgery in Type 2 Diabetes (ARMMS-T2D), published Diabetes Care.
"Treatment guidelines from the American Medical Association, American Diabetes Association, and many other leading medical organizations, are that metabolic surgery is an effective treatment for type 2 diabetes," said Pennington Biomedical Executive Director, Dr John Kirwan, who led the study. "Despite growing consensus, many health insurers do not provide coverage for metabolic surgery because we haven't had a sufficiently large, randomised controlled trial that considered how long the results of surgery last relative to medications and lifestyle changes."
The study authors noted that less than one percent of individuals eligible for bariatric surgery receive the treatment, likely due to both patients' and their providers' concerns about long-term safety and lasting results.
In the ARMMS-T2D consortium, 316 patients with type 2 diabetes previously were randomly assigned to surgery (n=195) or medical/lifestyle therapy (n=121) in the STAMPEDE, TRIABETES, SLIMM-T2D, and CROSSROADS trials were enrolled into this prospective observational cohort. The primary outcome was the rate of diabetes remission (haemoglobin A1c [HbA1c] ≤6.5% for three months without usual glucose-lowering therapy) at three years. Secondary outcomes included glycaemic control, body weight, biomarkers, and comorbidity reduction.
Of the patients randomly assigned to surgery, 55% underwent RYGB, 25% SG, and 20% adjustable gastric banding (AGB). Surgical and medical/lifestyle patients had a comparable duration of diabetes (9±6 vs. 9±6 years), although more surgical patients were using insulin (52 vs. 41%).
Outcomes
Three years after randomization, substantially more surgical patients achieved diabetes remission, defined as HbA1c ≤6.5% off diabetes medications, vs. patients in the medical/lifestyle group (60 of 160 [37.5%] vs. 2 of 76 [2.6%], respectively; p<0.001). Patient who achieved glycaemic targets of HbA1c ≤6.5% or ≤7.0%, with or without diabetes medications, were also greater following surgical than medical/lifestyle intervention (Figure 1).
When adjusted for treatment allocation, annual visit, baseline HbA1c, diabetes duration, insulin use, and sex, the predicted probability of remission at three years with surgery was 41.6% vs. 1.0% in the medical/lifestyle group (p<0.001). Surgical patients had greater reductions in HbA1c (p<0.001) and fasting plasma glucose (p<0.001) vs medical/lifestyle patients. Procedurally, RYGB and SG achieved a more effective reduction in HbA1c (−2.1% and −2.5%, respectively) vs. AGB (−0.9%), but all surgical procedures were more effective in improving HbA1c than the medical/lifestyle intervention.
"Even when patients are provided with education in nutrition, exercise, self-monitoring and the newest diabetes medications on the market, only 2.6 percent of patients were able to achieve diabetes remission during the study," Kirwan noted. "When we looked at patients who underwent metabolic surgery, even three years later, 37.5 percent had achieved lasting remission of their diabetes.”
Surgery yielded greater reductions in BMI (p <0.001), body weight (p<0.001) and waist circumference (p<0.001) vs. medical/lifestyle intervention. Surgical patients also achieved greater increases in HDL cholesterol (p<0.001) and reductions in triglycerides (p<0.004). The number of patients with metabolic syndrome was lower three years after the surgical intervention (56 of 144 [38.9%] vs. 46 of 67 [68.7%]; p<0.001).
There were 16 cardiovascular-related SAEs (including one death and six angioplasty/stent procedures) in the medical/lifestyle intervention and eight in the surgical intervention (four in RYGB, two in SG, and two in AGB).
“In summary, prospective randomized interventional data from the largest cohort of patients to date demonstrates that metabolic surgery improves glycaemic control, diabetes-related comorbidities, and weight loss to a greater extent than medical/lifestyle intervention for up to three years after treatment, with minimal and generally tolerable AEs,” the authors concluded.
"It is our hope that physicians will have greater confidence in recommending bariatric surgery to their patients, and that health insurers will see the health benefits and ultimately, cost-savings that can be achieved by covering metabolic surgery," Kirwan added.
Further information
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