IDF Endorses Early Bariatric Surgery

Return on Investment Make Gastric Bypass Cost-Effective, Claims Position Statement Issued at 2nd World Congress on Interventional Therapies for Type 2 Diabetes

The International Diabetes Federation (IDF) has issued a "radical statement" at an international conference today saying gastric banding and similar surgeries should no longer be a last resort for severely obese people with type 2 diabetes, it is recommending that surgery be considered at a much earlier stage.

"The statement highlights that there is increasing evidence that the health of obese people with type 2 diabetes, including their glucose control and other obesity related comorbidities (conditions), can benefit substantially from bariatric surgery under certain circumstances," says the IDF press release.

The IDF says gastric banding and other surgeries to alter stomach anatomy should now be considered much earlier in the treatment of type 2 diabetes.
Gastric bypass surgery works by reducing the size of the stomach so a person can't eat as much and shortening the length of the intestine so that the body doesn't absorb too many calories. But it might also have the side effect of normalizing blood sugar.

Summary of the 39-Page Statement

• Obesity and type 2 diabetes are serious chronic diseases associated with complex metabolic dysfunctions that increase the risk for morbidity and mortality.
• The dramatic rise in the prevalence of obesity and diabetes has become a major global public health issue and demands urgent attention from governments, health care systems and the medical community.
• Continuing population-based efforts are essential to prevent the onset of obesity and type 2 diabetes. At the same time, effective treatment must also be available for people who have developed type 2 diabetes
• Faced with the escalating global diabetes crisis, health care providers require as potent an armamentarium of therapeutic interventions as possible.
• In addition to behavioral and medical approaches, various types of surgery on the gastrointestinal tract, originally developed to treat morbid obesity (“bariatric surgery”), constitute powerful options to ameliorate diabetes in severely obese patients, often normalizing blood glucose levels, reducing or avoiding the need for medications and providing a potentially cost-effective approach to treating the disease.
• Bariatric surgery is an appropriate treatment for people with type 2 diabetes and obesity not achieving recommended treatment targets with medical therapies, especially when there are other major co-morbidities.
• Surgery should be an accepted option in people who have type 2 diabetes and a BMI of 35 or more
• Surgery should be considered as an alternative treatment option in patients with a BMI between 30 and 35 when diabetes cannot be adequately controlled by optimal medical regimen, especially in the presence of other major cardiovascular disease risk factors.2
• In Asian, and some other ethnicities of increased risk, BMI action points may be reduced by 2.5 kg/m
• Clinically severe obesity is a complex and chronic medical condition. Societal prejudices about severe obesity, which also exist within the health care system, should not act as a barrier to the provision of clinically effective and cost-effective treatment options.
• Strategies to prioritize access to surgery may be required to ensure that the procedures are available to those most likely to benefit.
• Available evidence indicates that bariatric surgery for obese patients with type 2 diabetes is cost-effective.
• Bariatric surgery for type 2 diabetes must be performed within accepted international and national guidelines. This requires appropriate assessment for the procedure and comprehensive and ongoing multidisciplinary care, patient education, follow-up and clinical audit, as well as safe and effective surgical procedures. National guidelines for bariatric surgery in people with type 2 diabetes and a BMI of 35 or more need to be developed and promulgated.
• The morbidity and mortality associated with bariatric surgery is generally low, and similar to that of well-accepted procedures such as elective gall bladder or gall stone surgery.
• Bariatric surgery in severely obese patients with type 2 diabetes has a range of health benefits, including a reduction in all-cause mortality.
• A national registry of persons who have undergone bariatric surgery should be established in order to ensure quality patient care and to monitor both short and long-term outcomes. 1.17 In order to optimize the future use of bariatric surgery as a therapeutic modality for type 2 diabetes further research is required.

Although such operations cost anywhere from $20,000 to $30,000, they will reduce healthcare expenditures in the long run, according to a new IDF position paper on the subject. The surgery, the IDF explains, often normalizes blood glucose levels and reduces or avoids the need for medication.

In addition, curbing diabetes can stave off costly complications such as blindness, limb amputations, and dialysis, says Francesco Rubino, MD, director of the IDF's 2nd World Congress on Interventional Therapies for Type 2 Diabetes.

"When we talk about whether we can afford bariatric surgery, we have to ask what will be the cost if we don't treat the patient. Studies have shown the surgery to be cost-effective. So there is a return on investment," says Francesco Rubino, MD, director of the IDF's 2nd World Congress on Interventional Therapies for Type 2 Diabetes

The IDF puts the lifetime cost of diabetes in the United States at $172,000 for a person diagnosed at age 50 years and $305,000 at age 30 years. More than 60% of this amount is incurred in the first 10 years after diagnosis.

The new recommended indications for performing bariatric surgery on patients who are both diabetic and obese match those announced last month by the US Food and Drug Administration for expanded use of the Lap-Band Adjustable Gastric Banding System (Allergan) to treat obesity.

The IDF recommendations dovetail with Dr Rubino’s previous research on how bariatric surgery alleviates diabetes. He showed that the effect on diabetes is not entirely explained by a person’s weight loss. In fact, the gastrointestinal tract serves as an endocrine organ and a key player in the regulation of insulin secretion, body weight and appetite, which is why altering the GI tract has such profound metabolic effects.

However, the use of bariatric surgery to treat diabetes has sparked controversy in healthcare circles. Critics question the wisdom of wielding a scalpel to solve a medical problem, especially when clinicians have more drugs at their disposal to deal with diabetes.

A study published online last week in the Archives of Surgery has raised doubts about the efficacy of LAGB. Researchers following 151 patients who underwent LAGB for obesity concluded that the procedure yielded "relatively poor long-term outcomes," with nearly half the patients needing their bands removed and 60% overall requiring some kind of reoperation. The authors, who performed the surgeries in question during the mid-1990s, added a caveat: they had used an older dissection technique.

Indeed, the biggest danger is that new weight-loss options likeEndoBarrier (developed in the UK), Lap-Band, Roux-en-Y gastric bypass and sleeve gastrectomy surgery have the potential to encourage overweight people to abandon traditional diet and exercise for procedures that carry some serious risks. That should be a big worry for all diabetes educators and activists.

Clinical Trial Will Test Whether Surgery Is the Best Option for Type 2 Diabetes, Even for Patients Who Aren't Obese

A new clinical trial at NewYork-Presbyterian Hospital/Weill Cornell Medical Center is among the first to test surgery specifically for Type 2 diabetes. The aim of the study is to understand whether surgery can control diabetes, as well or even better than the best medical treatment available today. This is the first study of its kind open to patients who are overweight or mildly obese.

Under current guidelines, bariatric surgery is only indicated for the treatment of severe or morbid obesity, defined as having a body mass index (BMI) of 35 or greater. By contrast, the new study is open to patients with a BMI as low as 26. Normal-weight individuals have BMI ranging between 19 and 25 and overweight individuals have BMI between 26 and 29, whereas a BMI above 30 defines obesity. Patients with a BMI below 26 and above 35 will not be considered for enrollment in the trial.

Previous research has shown that in severely obese patients (BMI greater than 35) gastric bypass surgery is a safe and effective way to treat Type 2 diabetes. It has been shown to improve or normalize blood glucose levels, reduce or even eliminate the need for medication, and lower the risk for diabetes-related death.

"There is preliminary evidence suggesting that that these results are attainable even in overweight or mildly-obese patients," says Dr.Francesco Rubino, chief of the gastrointestinal metabolic surgery program at NewYork-Presbyterian Hospital/Weill Cornell Medical Center and associate professor of surgery at Weill Cornell Medical College.

In support of this belief, recommendations from the American Diabetes Association's January 2009 issue of Standards of Care: Diabetes Care, and from the Diabetes Surgery Summit Consensus Conference, published in the March 2010 issue Annals of Surgery, suggest that randomized clinical trials for the study of surgery in patients with BMI below 35 are priority for diabetes research.

"Having a potentially effective surgical option against diabetes does not mean that surgery is the best choice for every diabetic patient," Dr. Rubino adds. "We need rigorous, comparative clinical trials, like this one, in order to better understand when to prioritize surgery and when to recommend traditional medical treatment."

The new study is enrolling 50 patients with Type 2 diabetes who will be randomized to receive surgery -- specifically, Roux-en-Y Gastric Bypass -- or traditional medical therapy and intensive lifestyle modification. All patients will be counseled in lifestyle modification techniques like diet and exercise.

Dr. Rubino expects that there will be medical advantages for patients in both arms of the trial since those assigned to the medical arm will receive the most rigorous medical diabetes therapy available. A multidisciplinary team of diabetes and nutrition experts will take care of patients using the most current, approved drugs for diabetes as well as an intensive approach to lifestyle changes. Patients in the medical arm will also be offered the chance to switch study arms and have surgery free of charge after the study is complete, or earlier should their diabetes remain poorly controlled after medical and lifestyle therapy.

Beyond BMI

Dr. Rubino and his co-investigators believe their study may also help identify better criteria than BMI for selection of surgical candidates. "Using strictly BMI-based criteria may be practical, but it is medically inappropriate because, on its own. BMI does not accurately define the severity of diabetes or identify patients who are best suited to benefit from a surgical approach," says Dr. Rubino. "New criteria would not only help patients and clinicians, but also payers."

Because insurers use BMI-based criteria, bariatric surgery is currently not covered for patients with a BMI less than 35, regardless of the severity of their disease. Consequently, the study at NewYork-Presbyterian/Weill Cornell is supported by a research grant from Covidien covering the cost of surgery for patients enrolled in the study.

A Look at How Diabetes Surgery Works

Previous research by Dr. Rubino studied how bariatric surgery alleviates diabetes, showing that the effect on diabetes is not entirely explained by a person's weight loss. In fact, the gastrointestinal tract serves as an endocrine organ and a key player in the regulation of insulin secretion, body weight and appetite, which is why altering the GI tract has such profound metabolic effects.

The current study aims to shed more light on the mechanisms of action of gastric bypass on diabetes. To do this, Dr. Rubino and his co-investigators will measure gut hormone responses to meal stimulation when an equivalent amount of weight loss has been achieved in both surgically and conventionally treated patients. This design may help uncover endocrine effects specific to gastric bypass surgery beyond those associated with non-surgical weight loss.

"Understanding how gastric bypass surgery functions may help us learn how diabetes works," Dr. Rubino says. "This knowledge has the potential to lead to the development of new minimally invasive procedures, devices interventions and better pharmaceutical treatments."

Toward an International Consortium

Dr. Rubino hopes that the current study will be a template for larger, international studies. "We intend this study to serve as a core protocol for similar randomized clinical trials independently run at other institutions as part of a worldwide consortium coordinated through the Diabetes Surgery Center at NewYork-Presbyterian/Weill Cornell," he says. "The consortium will provide a larger pool of patients allowing researchers to better evaluate the impact of surgery on various health measures, including cardiovascular risk and life expectancy."

The global prevalence of Type 2 diabetes is rising dramatically. "If proven successful, diabetes surgery has the potential to help millions of patients in the U.S. and worldwide," Dr Rubino says.

According to International Diabetes Federation (IDF), there are currently 285 million people with the disease around the world, a number that is expected to rise to 438 million by 2030. Diabetes is one of the greatest public health threats in the 21st century and a risk factor for vascular damage and eye, kidney and cardiovascular diseases, as well as death. Type 2 diabetes results from inadequate insulin production and action, and is associated with metabolic dysfunctions involving lipid metabolism and blood pressure regulation.

Interested patients with Type 2 diabetes may contact the Diabetes Surgery Center at NewYork-Presbyterian/Weill Cornell at (212) 746-5925 or ant2026@med.cornell.edu.

For more information, visit www.nyp.org and weill.cornell.edu.