A new clinical trial at NewYork-Presbyterian Hospital/Weill Cornell Medical Center is among the first to test whether surgery is best option 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.
"There is preliminary evidence suggesting that that these results are attainable even in overweight or mildly-obese patients," said 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.
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.
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.
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," said Rubino.
The current study aims to shed more light on the mechanisms of action of gastric bypass on diabetes. To do this, 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.
"Understanding how gastric bypass surgery functions may help us learn how diabetes works. This knowledge has the potential to lead to the development of new minimally invasive procedures, devices interventions and better pharmaceutical treatments," said Rubino.