Vanderbilt Medical Center announced yesterday that it is seeking participants for a clinical study aimed at evaluating the Tantalus System, an investigational device designed to combat Type 2 diabetes.
Vanderbilt is one of three sites in the U.S. participating in the study, which is funded by Bermuda-based MetaCure, the manufacturer of Tantalus. Eventually the study will be expanded to 30 sites around the country and involve 300 patients. Tantalus is currently CE marked and available to patients in Europe.
Tantalus is designed to sense naturally occurring electrical activity of the stomach in real time and automatically apply electrical stimulation treatment when a person eats. MetaCure calls the new technology Gastric Contractility Modulation.
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; the cell-phone-size device is implanted in a subcutaneous pocket.
The primary objective of the current study is to evaluate the safety and efficacy of 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.
A previous study published in the Journal of Obesity Surgery hypothesized that enhancement of gastric contractions by electrical stimulation at an early stage of the meal would reduce food intake and body weight in morbidly obese subjects.
In the study, 12 subjects underwent laparoscopic implantation with Tantalus. Following activation of the device, a reduction in hunger and an increase in cognitive control as assessed by an eating questionnaire were observed. Body weight decreased from 128.8 ± 5.2 to 119.9 ± 5.9 after 14 weeks of treatment. In the 9 subjects continuing for 46 weeks of treatment, body weight decreased to 112.4 ± 3.8 kg. Improvements in blood pressure were also seen.
Those familiar with classical Greek culture, will recall tale of Tantalus, a son of Zeus and the nymph Plouto. In the myth, Tantalus offers his son, Pelops, as a sacrifice to the gods. The gods were said to be aware of his plan for their feast, so they didn’t touch the offering.
Tantalus’ punishment was to stand in a pool of water beneath a fruit tree with low branches. Whenever he reached for the fruit, the branches would raise beyond his grasp. Whenever he bent down to get a drink of water, the water receded before he could get a sip.