Open AccessGastric electrical stimulation treatment of type 2 diabetes: effects of implantation versus meal‐mediated stimulation. A randomized blinded cross‐over trial
Author(s) -
Lebovitz Harold E.,
Ludvik Bernhard,
Kozakowski Jaroslaw,
Tarnowski Wieslaw,
Zelewski Mateusz,
Yaniv Irit,
Schwartz Tse'ela
Publication year - 2015
Publication title -
physiological reports
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 39
ISSN - 2051-817X
DOI - 10.14814/phy2.12456
Subject(s) - glycemic , medicine , stimulation , type 2 diabetes , placebo , meal , randomized controlled trial , crossover study , diabetes mellitus , metformin , endocrinology , pathology , alternative medicine
Gastric electrical stimulation with the implanted DIAMOND device has been shown to improve glycemic control and decrease weight and systolic blood pressure in patients with type 2 diabetes 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 patients with type 2 diabetes. The study was a 48 week randomized, blinded, cross‐over trial in university centers comparing glycemic improvement of DIAMOND ® implanted patients with type 2 diabetic 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 HbA1c 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 HbA1c beyond 24 weeks.