Vanderbilt Medical Center is seeking local residents with type 2 diabetes who are overweight to participate in a national clinical study evaluating an investigational device, the TANTALUSSystem. Diabetes affects more than 400,000 individuals in Tennessee.
The TANTALUS System is an implantable device that delivers electrical pulses to the stomach when a person eats. The primary objective of the randomized, double-blind controlled study is to evaluate the safety and efficacy of the TANTALUS System in treating patients who have type 2 diabetes and are overweight. Impact on weight loss, blood pressure and other clinical and metabolic parameters will also be studied.
TANTALUS includes a pulse generator and leads that are implanted through a minimally invasive laparoscopic procedure that can be performed in an outpatient setting. The leads are implanted in the gastric muscle and the device is implanted in a subcutaneous pocket. The system is based on new technology called Gastric Contractility Modulation (GCM) that is designed to sense naturally occurring electrical activity of the stomach in real time and automatically apply electrical stimulation treatment during meal times.
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, and be between 18 and 70.
“Even with current medications and lifestyle changes, controlling blood glucose levels in type 2 diabetes patients who are overweight can be difficult, ” explained study investigator William Richards, M.D. “We are excited to be participating in this clinical trial of an alternative treatment for patients where we have been unsuccessful in managing their type 2 diabetes and weight.”
The national epidemic of type 2 diabetes, most often associated with being overweight, continues to accelerate and affects more than 20 million Americans. About 1 million new people are diagnosed with the disease annually. Each year, it costs the nation more than $130 billion in hospitalizations, co-morbidities and loss of productivity.
For more information on and to be considered for the study, please call Joan Kaiser at (615) 343-5821.