New guidelines cite effectiveness, cost efficiency, and safety as reasons to consider procedure.
The International Diabetes Federation Taskforce on Epidemiology and Prevention of Diabetes convened a consensus working group of diabetologists, endocrinologists, surgeons and public health experts to review the appropriate role of surgery and other gastrointestinal interventions in the treatment and prevention of type 2 diabetes. The specific goals were: to develop practical recommendations for clinicians on patient selection; to identify barriers to surgical access and suggest interventions for health policy changes that ensure equitable access to surgery when indicated; and to identify priorities for research. Bariatric surgery can significantly improve glycemic control in severely obese patients with type 2 diabetes. It is an effective, safe and cost-effective therapy for these patients. Surgery can be considered an appropriate treatment for people with type 2 diabetes and obesity who have not achieved the recommended treatment targets with medical therapies, especially in the presence of other major comorbidities. The procedures must be performed within accepted guidelines and require appropriate multidisciplinary assessment, comprehensive patient education and ongoing care, as well as safe and standardized surgical procedures.
Metabolic, or weight-loss, surgery quickly and dramatically improves blood glucose control. Until now, however, it has not been included in clinical practice guidelines as a treatment option for people with diabetes. The Statement and Clinical Guidelines were published in the June 2016 issue of Diabetes Care, available in print and online on May 24, 2016.
The new guidelines emerged from the Second Diabetes Surgery Summit (DSS-II), an international consensus conference held September 28–30, 2015, in London, and jointly organized with the American Diabetes Association (ADA), International Diabetes Federation (IDF), Diabetes UK (DUK), Chinese Diabetes Society (CDS), and Diabetes India (DI). The goal of the summit was to develop global guidelines to inform clinicians and policymakers about the benefits and limitations of metabolic surgery for type 2 diabetes.
In the report, metabolic surgery is defined as the use of gastrointestinal operations, originally designed to induce weight loss (“bariatric surgery”), with the primary intent to treat type 2 diabetes and obesity. These procedures remove parts of the stomach or reroute the small intestine. Many people who undergo metabolic surgery experience major improvements in glycemia, as well as a reduction in cardiovascular risk factors, making it a highly effective treatment for type 2 and a highly effective means of diabetes prevention.
“Despite continuing advances in diabetes pharmacotherapy, fewer than half of adults with type 2 diabetes attain therapeutic goals designed to reduce long-term risks of complications, especially for glycemic control, and lifestyle interventions are disappointing in the long term,” wrote the guideline authors in the commentary. Metabolic surgery, on the other hand, has been shown to “improve glucose homeostasis more effectively than any known pharmaceutical or behavioral approach,” they wrote. Despite such evidence, to date, metabolic surgery had not been included in clinical guidelines for diabetes care as a recommended intervention.
According to the new guidelines, metabolic surgery should be recommended to treat type 2 diabetes in patients with Class III obesity (BMI greater than or equal to 40 kg/m2), as well as in those with Class II obesity (BMI between 35 and 39.9 kg/m2) when hyperglycemia is inadequately controlled by lifestyle and medical therapy. It should also be considered for patients with type 2 diabetes who have a BMI between 30 and 34.9 kg/m2 if hyperglycemia is inadequately controlled, the authors agreed. The Consensus Statement also recognizes that BMI thresholds in Asian patients, who develop type 2 at lower BMI than other populations, should be lowered 2.5 kg/m2 for each of these categories.
These conclusions are based on a large body of evidence, including 11 randomized clinical trials showing that in most cases surgery can either reduce blood glucose levels below diabetic thresholds (“diabetes remission”) or maintain adequate glycemic control despite major reduction in medication usage. While relapse of hyperglycemia may occur in up to 50% of patients with initial remission, most patients maintain substantial improvement of A1C long term, the authors noted.
Economic studies also show that metabolic surgery is cost-effective. The authors of the new guidelines recommend that healthcare regulators introduce appropriate reimbursement policies for metabolic surgery for people with type 2.
Although metabolic surgery is similarly safe compared to commonly performed operations such as gallbladder surgery, there are still risks of complications and long-term nutritional deficiencies, which require lifelong vitamin/nutritional supplementation and rigorous long-term follow up by a multidisciplinary team with appropriate expertise. The report also identifies current gaps in knowledge and indicates priorities for research. In particular, long-term studies looking at cardiovascular endpoints and other diabetes complications in less obese people and adolescents are necessary to better refine the role of surgery in management algorithms.
- Studies show that metabolic surgery is cost-effective.
- Fewer than half of adults with type 2 diabetes attain therapeutic goals designed to reduce long-term risks of complications, especially for glycemic control.
- According to the new guidelines, metabolic surgery should be recommended to treat type 2 diabetes in patients with Class II obesity (BMI between 35 and 39.9 kg/m2) when hyperglycemia is inadequately controlled by lifestyle and medical therapy.
- It should also be considered for patients with type 2 diabetes who have a BMI between 30 and 34.9 kg/m2 if hyperglycemia is inadequately controlled.
- The Consensus Statement also recognizes that BMI thresholds in Asian patients, who develop type 2 at lower BMI than other populations, should be lowered 2.5 kg/m2 for each of these categories.
The full articles, consensus statement and commentary published online at http://care.diabetesjournals.org/content/current on May 24, 2016.
News Release from ADA May 2016.