Gastric electrical stimulation treatment of XXXX 2 @entity6 : effects of implantation versus meal-mediated stimulation. A randomized blinded cross-over trial.

@entity1 @entity164 @entity6 @entity4051
Gastric electrical stimulation with the implanted DIAMOND device has been shown to improve glycemic control and decrease weight and systolic blood pressure in @entity1 with @entity164 2 @entity6 inadequately controlled with oral antidiabetic agents. The objective of this study was to determine if device implantation alone (placebo effect) contributes to the long-term metabolic benefits of DIAMOND(  ) meal-mediated gastric electrical stimulation in @entity1 with @entity164 2 @entity6 . The study was a 48  week randomized, blinded, cross-over trial in university centers comparing glycemic improvement of DIAMOND(  ) implanted @entity1 with @entity164 2 @entity6 with no activation of the electrical stimulation (placebo) versus meal-mediated activation of the electrical signal. The endpoint was improvement in glycemic control (HbA1c) from baseline to 24 and 48  weeks. In period 1 (0-24  weeks), equal improvement in HbA1c occurred independent of whether the meal-mediated electrical stimulation was turned on or left off (HbA1c -0.80% and -0.85% [-8.8 and -9.0  mmol/mol]). The device placebo improvement proved to be transient as it was lost in period 2 (25-48  weeks). With electrical stimulation turned off, HbA1c returned toward baseline values (8.06 compared to 8.32%; 64.2 to 67.4  mmol/mol, P  =  0.465). In contrast, turning the electrical stimulation on in period 2 sustained the decrease in @entity4051 c from baseline (-0.93%, -10.1mmol/mol, P  =  0.001) observed in period 1. The results indicate that implantation of the DIAMOND device causes a transient improvement in HbA1c which is not sustained beyond 24  weeks. Meal-mediated electrical stimulation accounts for the significant improvement in @entity4051 c beyond 24  weeks.
