Implantable Device Designed For Type-2 Diabetes Patients Who Are Overweight

[T_Dia]

New York-Presbyterian Hospital/Weill Cornell Medical Center is recruiting patients for a national clinical research study of an investigational implantable device designed to help those with type-2 diabetes who are overweight and do not respond to current oral anti-diabetic treatments.

The Tantalus? System is designed to sense naturally occurring electrical activity of the stomach in real time and automatically apply electrical stimulation when a person eats. The device is implanted though a minimally invasive laparoscopic procedure that can be performed in an outpatient setting.

NewYork-Presbyterian/Weill Cornell is the first New York metro area medical center to recruit and actively enroll patients in this study. Diabetes affects more than one million New Yorkers.

"Even with current medications and lifestyle changes, controlling type-2 diabetes in patients who are overweight can be difficult. This new treatment potentially offers new hope for patients who have been unsuccessful in managing their diabetes and weight," says Dr. Louis Aronne, clinical site principal investigator, director of the Comprehensive Weight Control Program at NewYork-Presbyterian/Weill Cornell and clinical professor of medicine at Weill Cornell Medical College.

An earlier, smaller study published in the Journal of Obesity Surgery found that the device reduced hunger and body weight in morbidly obese patients. Improvements in blood pressure were also seen.

"The primary objective of the current study is to evaluate the safety and efficacy of the Tantalus in treating overweight patients with type-2 diabetes. The device's impact on weight loss, blood pressure and other clinical and metabolic parameters will also be studied," says Dr. Gregory F. Dakin, the study's co-principal investigator, bariatric and laparoscopic surgeon at NewYork-Presbyterian/Weill Cornell and assistant professor of surgery at Weill Cornell Medical College.

To be considered for the trial, patients must meet certain inclusion criteria, including a diagnosis of type-2 diabetes (treated with oral medications, only), a body mass index (BMI) between 28 and 45 kg/m2 and an age between 18 and 70 years. BMI can be determined by using an online calculator and entering weight and height information.

NewYork-Presbyterian/Weill Cornell is one of thirty sites in the U.S. participating in the study, which is funded by MetaCure, the manufacturer of Tantalus. The device is currently CE-marked in Europe.

The national epidemic of type-2 diabetes, most often associated with being overweight, continues to accelerate and affects more than 20 million Americans. About one million new people are diagnosed with the disease annually. The most common form of diabetes, type-2 diabetes, left untreated, may result in damage to the eyes, kidneys, nerves or heart and lead to major health complications later in life, or to death.
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