Surgery guidelines show paradigm shift
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Experts endorse metabolic surgery for diabetes intervention

Metabolic surgery should be recommended for obese patients with type 2 diabetes mellitus, according to an international consensus statement from 48 clinicians and scholars issued after the Second Diabetes Surgery Summit held as part of the World Congress on Interventional Therapies for Type 2 Diabetes in London in 2015.

Current treatment plans for patients with type 2 diabetes do no include bariatric/metabolic surgery, despite increasing evidence of improved glycemic control and reduced cardiovascular risk factors in surgically treated patients, wrote Dr. Francesco Rubino and colleagues on behalf of members of the Second Diabetes Surgery Summit (DSS-II). The guidelines were endorsed by 45 global medical and scientific societies at the time of publication. The statement was published in a special edition of Diabetes Care (Diabetes Care. 2016;39:861-77. doi:10.2337/dc16-0236).

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The guidelines recommend metabolic surgery for patients with type 2 diabetes who have class III obesity (defined as a body mass index of at least 40 kg/m2) or class II obesity (defined as a BMI of 35 kg/m2-39.9 kg/m2). In addition, metabolic surgery should be considered as a option for those patients with type 2 diabetes whose BMI falls within the 30 kg/m2-34.9 kg/m2 range if hyperglycemia remains uncontrolled after treatment attempts with oral or injectable medications. For Asian patients, the BMI thresholds for surgery should be reduced by 2.5 kg/m2, the researchers noted.

The conclusions are based on a review of published evidence on metabolic surgery and type 2 diabetes from January 1, 2005, through September 30, 2015.

The researchers assessed the evidence based on factors including long-term effects of surgery on glycemic control, effectiveness of surgery compared with nonsurgical interventions, comparisons of surgical procedures, and effects of surgery on diabetes complications, cardiovascular risk factors, and mortality. They also considered the short- and long-term safety of different procedures. The recommendations offer guidance on patient selection, pre- and postoperative workups, choice of procedure, and defining goals and success of surgery.

“The success of metabolic surgery needs to be defined in the larger context of comprehensive diabetes care plans,” the researchers noted. “Metabolic surgery should be considered a means to achieve the glycemic control necessary to reduce risk of microvascular complications and CVD.”

The researchers acknowledged that complications from metabolic surgery may require reoperations and rehospitalizations. Other limitations include a lack of evidence in several areas including: cost-effectiveness, optimal nutrition management after surgery, postoperative lifestyle interventions, and long-term effects of surgery, and further research is needed.

However, “there is now sufficient clinical and mechanistic evidence to support inclusion of GI surgery among antidiabetes interventions for people with type 2 diabetes and obesity,” the researchers said. They called for collaboration between clinicians and regulators to recognize the potential value of metabolic surgery for type 2 diabetes and develop appropriate reimbursement plans.

The DSS-II and WCITD 2015 were sponsored by the International Diabetes Society Task Force, King’s College London, King’s College Hospital, Johnson & Johnson, Medtronic, Medimmune, Fractyl, DIAMOND MetaCure, Gore, Novo Nordisk, and NGM Biopharmaceuticals. The researchers reported no relevant conflicts.

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“The new guidelines provide much needed guidance for general practitioners, endocrinologists, and diabetes specialists about the use of metabolic surgery in the treatment of obese patients with type 2 diabetes,” wrote Dr. William T. Cefalu and colleagues in an accompanying editorial.

However, “one of the many issues that remains unanswered for metabolic surgery pertains to the exact mechanism of action. Specifically, we now recognize that postoperative improvements in metabolic control occur rapidly and out of proportion to weight loss, yet the physiological and molecular mechanisms underlying these beneficial glycemic effects remain incompletely elucidated,” they wrote. In addition, “before we can fully appreciate the role of metabolic surgery in becoming a readily available, viable option in our treatment algorithm and expand the appropriate candidate pool, we need to fully understand the efficacy, complications, long-term clinical outcomes, and costs. In particular, it will be important to clarify the financial implications to patients, providers, and insurers (both private and government sectors) and to appreciate that these barriers may be hard to overcome in resource poor areas of the world,” they said.

“It is an exciting time for those of us in diabetes research, and the ability to be part of a paradigm change in the understanding, approach, and management of the disease will keep us focused on the next steps to address the larger issue of prevention,” they noted (Diabetes Care. 2016;39:857-60. doi:10.2337/dc16-0686) .

Dr. Cefalu is affiliated with the Pennington Biomedical Research Center at Louisiana State University in Baton Rouge, La. He disclosed financial relationships with multiple companies including AstraZeneca, Janssen, MannKind Corp., Intarcia Therapeutics, and Sanofi.

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“The new guidelines provide much needed guidance for general practitioners, endocrinologists, and diabetes specialists about the use of metabolic surgery in the treatment of obese patients with type 2 diabetes,” wrote Dr. William T. Cefalu and colleagues in an accompanying editorial.

However, “one of the many issues that remains unanswered for metabolic surgery pertains to the exact mechanism of action. Specifically, we now recognize that postoperative improvements in metabolic control occur rapidly and out of proportion to weight loss, yet the physiological and molecular mechanisms underlying these beneficial glycemic effects remain incompletely elucidated,” they wrote. In addition, “before we can fully appreciate the role of metabolic surgery in becoming a readily available, viable option in our treatment algorithm and expand the appropriate candidate pool, we need to fully understand the efficacy, complications, long-term clinical outcomes, and costs. In particular, it will be important to clarify the financial implications to patients, providers, and insurers (both private and government sectors) and to appreciate that these barriers may be hard to overcome in resource poor areas of the world,” they said.

“It is an exciting time for those of us in diabetes research, and the ability to be part of a paradigm change in the understanding, approach, and management of the disease will keep us focused on the next steps to address the larger issue of prevention,” they noted (Diabetes Care. 2016;39:857-60. doi:10.2337/dc16-0686) .

Dr. Cefalu is affiliated with the Pennington Biomedical Research Center at Louisiana State University in Baton Rouge, La. He disclosed financial relationships with multiple companies including AstraZeneca, Janssen, MannKind Corp., Intarcia Therapeutics, and Sanofi.

Body

“The new guidelines provide much needed guidance for general practitioners, endocrinologists, and diabetes specialists about the use of metabolic surgery in the treatment of obese patients with type 2 diabetes,” wrote Dr. William T. Cefalu and colleagues in an accompanying editorial.

However, “one of the many issues that remains unanswered for metabolic surgery pertains to the exact mechanism of action. Specifically, we now recognize that postoperative improvements in metabolic control occur rapidly and out of proportion to weight loss, yet the physiological and molecular mechanisms underlying these beneficial glycemic effects remain incompletely elucidated,” they wrote. In addition, “before we can fully appreciate the role of metabolic surgery in becoming a readily available, viable option in our treatment algorithm and expand the appropriate candidate pool, we need to fully understand the efficacy, complications, long-term clinical outcomes, and costs. In particular, it will be important to clarify the financial implications to patients, providers, and insurers (both private and government sectors) and to appreciate that these barriers may be hard to overcome in resource poor areas of the world,” they said.

“It is an exciting time for those of us in diabetes research, and the ability to be part of a paradigm change in the understanding, approach, and management of the disease will keep us focused on the next steps to address the larger issue of prevention,” they noted (Diabetes Care. 2016;39:857-60. doi:10.2337/dc16-0686) .

Dr. Cefalu is affiliated with the Pennington Biomedical Research Center at Louisiana State University in Baton Rouge, La. He disclosed financial relationships with multiple companies including AstraZeneca, Janssen, MannKind Corp., Intarcia Therapeutics, and Sanofi.

Title
Surgery guidelines show paradigm shift
Surgery guidelines show paradigm shift

Metabolic surgery should be recommended for obese patients with type 2 diabetes mellitus, according to an international consensus statement from 48 clinicians and scholars issued after the Second Diabetes Surgery Summit held as part of the World Congress on Interventional Therapies for Type 2 Diabetes in London in 2015.

Current treatment plans for patients with type 2 diabetes do no include bariatric/metabolic surgery, despite increasing evidence of improved glycemic control and reduced cardiovascular risk factors in surgically treated patients, wrote Dr. Francesco Rubino and colleagues on behalf of members of the Second Diabetes Surgery Summit (DSS-II). The guidelines were endorsed by 45 global medical and scientific societies at the time of publication. The statement was published in a special edition of Diabetes Care (Diabetes Care. 2016;39:861-77. doi:10.2337/dc16-0236).

©SandraMatic/Thinkstock

The guidelines recommend metabolic surgery for patients with type 2 diabetes who have class III obesity (defined as a body mass index of at least 40 kg/m2) or class II obesity (defined as a BMI of 35 kg/m2-39.9 kg/m2). In addition, metabolic surgery should be considered as a option for those patients with type 2 diabetes whose BMI falls within the 30 kg/m2-34.9 kg/m2 range if hyperglycemia remains uncontrolled after treatment attempts with oral or injectable medications. For Asian patients, the BMI thresholds for surgery should be reduced by 2.5 kg/m2, the researchers noted.

The conclusions are based on a review of published evidence on metabolic surgery and type 2 diabetes from January 1, 2005, through September 30, 2015.

The researchers assessed the evidence based on factors including long-term effects of surgery on glycemic control, effectiveness of surgery compared with nonsurgical interventions, comparisons of surgical procedures, and effects of surgery on diabetes complications, cardiovascular risk factors, and mortality. They also considered the short- and long-term safety of different procedures. The recommendations offer guidance on patient selection, pre- and postoperative workups, choice of procedure, and defining goals and success of surgery.

“The success of metabolic surgery needs to be defined in the larger context of comprehensive diabetes care plans,” the researchers noted. “Metabolic surgery should be considered a means to achieve the glycemic control necessary to reduce risk of microvascular complications and CVD.”

The researchers acknowledged that complications from metabolic surgery may require reoperations and rehospitalizations. Other limitations include a lack of evidence in several areas including: cost-effectiveness, optimal nutrition management after surgery, postoperative lifestyle interventions, and long-term effects of surgery, and further research is needed.

However, “there is now sufficient clinical and mechanistic evidence to support inclusion of GI surgery among antidiabetes interventions for people with type 2 diabetes and obesity,” the researchers said. They called for collaboration between clinicians and regulators to recognize the potential value of metabolic surgery for type 2 diabetes and develop appropriate reimbursement plans.

The DSS-II and WCITD 2015 were sponsored by the International Diabetes Society Task Force, King’s College London, King’s College Hospital, Johnson & Johnson, Medtronic, Medimmune, Fractyl, DIAMOND MetaCure, Gore, Novo Nordisk, and NGM Biopharmaceuticals. The researchers reported no relevant conflicts.

Metabolic surgery should be recommended for obese patients with type 2 diabetes mellitus, according to an international consensus statement from 48 clinicians and scholars issued after the Second Diabetes Surgery Summit held as part of the World Congress on Interventional Therapies for Type 2 Diabetes in London in 2015.

Current treatment plans for patients with type 2 diabetes do no include bariatric/metabolic surgery, despite increasing evidence of improved glycemic control and reduced cardiovascular risk factors in surgically treated patients, wrote Dr. Francesco Rubino and colleagues on behalf of members of the Second Diabetes Surgery Summit (DSS-II). The guidelines were endorsed by 45 global medical and scientific societies at the time of publication. The statement was published in a special edition of Diabetes Care (Diabetes Care. 2016;39:861-77. doi:10.2337/dc16-0236).

©SandraMatic/Thinkstock

The guidelines recommend metabolic surgery for patients with type 2 diabetes who have class III obesity (defined as a body mass index of at least 40 kg/m2) or class II obesity (defined as a BMI of 35 kg/m2-39.9 kg/m2). In addition, metabolic surgery should be considered as a option for those patients with type 2 diabetes whose BMI falls within the 30 kg/m2-34.9 kg/m2 range if hyperglycemia remains uncontrolled after treatment attempts with oral or injectable medications. For Asian patients, the BMI thresholds for surgery should be reduced by 2.5 kg/m2, the researchers noted.

The conclusions are based on a review of published evidence on metabolic surgery and type 2 diabetes from January 1, 2005, through September 30, 2015.

The researchers assessed the evidence based on factors including long-term effects of surgery on glycemic control, effectiveness of surgery compared with nonsurgical interventions, comparisons of surgical procedures, and effects of surgery on diabetes complications, cardiovascular risk factors, and mortality. They also considered the short- and long-term safety of different procedures. The recommendations offer guidance on patient selection, pre- and postoperative workups, choice of procedure, and defining goals and success of surgery.

“The success of metabolic surgery needs to be defined in the larger context of comprehensive diabetes care plans,” the researchers noted. “Metabolic surgery should be considered a means to achieve the glycemic control necessary to reduce risk of microvascular complications and CVD.”

The researchers acknowledged that complications from metabolic surgery may require reoperations and rehospitalizations. Other limitations include a lack of evidence in several areas including: cost-effectiveness, optimal nutrition management after surgery, postoperative lifestyle interventions, and long-term effects of surgery, and further research is needed.

However, “there is now sufficient clinical and mechanistic evidence to support inclusion of GI surgery among antidiabetes interventions for people with type 2 diabetes and obesity,” the researchers said. They called for collaboration between clinicians and regulators to recognize the potential value of metabolic surgery for type 2 diabetes and develop appropriate reimbursement plans.

The DSS-II and WCITD 2015 were sponsored by the International Diabetes Society Task Force, King’s College London, King’s College Hospital, Johnson & Johnson, Medtronic, Medimmune, Fractyl, DIAMOND MetaCure, Gore, Novo Nordisk, and NGM Biopharmaceuticals. The researchers reported no relevant conflicts.

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Key clinical point: Metabolic surgery should be recommended for obese patients with type 2 diabetes mellitus.

Major finding: Surgery is recommended for patients with type 2 diabetes who have a BMI of 35 kg/m2 or higher and should be considered for patients with a BMI of 30 kg/m2-34.9 kg/m2 with uncontrolled hyperglycemia.

Data source: Published evidence on metabolic surgery and type 2 diabetes identified on Medline between January 1, 2005 and September 30, 2015.

Disclosures: The DSS-II and WCITD 2015 were sponsored by the International Diabetes Society Task Force, King’s College London, King’s College Hospital, Johnson & Johnson, Medtronic, Medimmune, Fractyl, DIAMOND MetaCure, Gore, Novo Nordisk, and NGM Biopharmaceuticals. The researchers reported no relevant conflicts.