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Gastric stimulator induces weight loss in diabetics

NEW YORK - Gastric electrical stimulation using the Tantalus system (MetaCure Ltd) can potentially improve glucose control and induce weight loss in obese type 2 diabetic patients who are poorly controlled with oral antidiabetic medication, according to preliminary study results reported at the European Association for the Study of Diabetes in Rome.

The Tantalus system is a device that induces stomach contractility and consists of three pairs of bipolar electrodes connected to an implantable pulse generator. The device automatically detects food intake and applies gastric contractility modulation signals to the stomach to induce early satiety.

"The patient needs only 1 hour per week to recharge the implantable pulse generator battery using an external charger and the sensing and stimulation parameters can be adjusted per subject using an external programmer," Dr. Bruno Guerci from Hopital Jeanne-d'Arc, Nancy, France, told meeting attendees.

The Tantalus system is approved in Europe to treat obesity and to treat type 2 diabetics who are obese, so they can delay or avoid insulin treatment. It is currently in clinical trials in the United States.

As part of a European multicenter pilot study, 19 obese type 2 diabetic adults with HbA1c above 7.5 percent, despite oral antidiabetic medication, had the Tantalus system surgically implanted. HbA1c determines blood glucose levels by measuring glycated hemoglobin, a substance in red blood cells that forms when glucose attaches to hemoglobin. A HbA1c of 6.0 percent or lower is normal.

"Body weight and body mass index decreased significantly at 3 months and then remained stable at 6 months. The weight loss was around 5 kilograms (11 pounds), and the waist circumference reduction around 6 centimeters (2.5 inches)," Guerci told the conference. "It is important to emphasize that the patients were not put on a specific diet. They just continued their normal life activity," Guerci noted.

At 6 months, blood pressure was also significantly improved, with a reduction of more than 10 points for both systolic and diastolic values, the researcher noted.

HbA1c decreased from the start of the trial to 3 months and remained stable at 6 months. The average decrease after 6 months was around 1.0 percent. The percentage of patients who reached the target HbA1c below 7 percent was 61 percent at 3 months and 56 percent at 6 months.

The HbA1c reduction was "essentially explained" by lower fasting blood glucose levels, but not in glucose level after meals," Guerci said.

However, it should be kept in mind, added the researcher, that fasting blood glucose was directly measured by blood samples, whereas post-meal time values were recorded by self-monitored blood glucose.

Three study subjects (16 percent) decreased their oral antidiabetes medication at 3 months of therapy and all of them were able to sustain stable glycemic control afterward.

About half of the change in HbA1c could be explained by weight changes. "More weight loss, more HbA1c reduction," Guerci noted. "This also suggests that there are additional mechanisms involved in the improvement in the glycemic control other than the contribution of the weight loss," the researcher added.

Adverse events were consistent with other similar laparoscopic procedures, Guerci noted, and were "primarily related to the procedure and not to the device."