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Obese Diabetics Who Fail Oral Therapy Can Benefit from Gastric Electrical Stimulation

Gastric electrical stimulation is a reasonable alternative to insulin and oral hypoglycemic agents in obese Type 2 diabetics who are poorly controlled by oral agents and who are not candidates for gastric bypass surgery.

The study, conducted in 73 American patients by Dr. Harold Lebovitz of the State University of New York Downstate Medical Center in Brooklyn, NY, involved the Tantalus system (MetaCure Ltd.), which is already in use in Europe. Tantalus comprises a rechargeable pulse generator connected to three pairs of bipolar electrodes. The pulse generator is implanted laparoscopically in subcutaneous abdominal fat and the electrodes are inserted into the gastric muscle.

The device increases the normal regulatory activities mediated by the stomach and possibly the duodenum, Dr. Lebovitz explained.

In 60 patients who have completed 6 months of treatment, mean HbA1c decreased from 8.4% at baseline to 7.4%, and mean weight decreased from 111.4 kg to 106.6 kg, Dr. Lebovitz reported.

“The vast majority of this improvement was related to glucose metabolism and was not attributable to weight loss. In fact, there are some people who do not lose weight,” Dr. Lebovitz noted.

At 6 months, 73% of patients had weight loss and improved HbA1c; 10% had HbA1c improvements without weight loss; 12% had weight loss with no improvement in HbA1c; and 5% had no improvements.

In 44 patients for whom 12 months’ follow-up is available, the beneficial effects on HbA1c and weight loss were sustained. Improvements in waist circumference, blood pressure and lipid profiles also persisted at 12 months.

“Initially we started on very obese patients, as they were the easiest to convince that they should have a device. But now we are treating a significant number of patients with body mass indices of 28 to 35″ and seeing beneficial effects, said Dr. Lebovitz.

There are some preliminary data suggesting that insulin secretion is increased and glucagon suppressed in patients who use the device, Dr. Lebovitz added.

“After gastric bypass surgery, patients have an improvement in glucose metabolism before they leave the hospital. This improvement is not due to weight loss, but hormonal changes secondary to gastric bypass surgery.”

“I am fascinated by the hypoglycemia that people find after gastric bypass,” he continued. “What it means is, there must be some cocktail of hormonal changes that can actually make new beta cells, and if we know what that is we can cure diabetes.”

Presented at the 11th Hong Kong Diabetes and Cardiovascular Risk Factors East meets West Symposium. Oct. 2009