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DOI: 10.1055/s-0036-1580763
Duodenal electric stimulation. Feasibility, safety, and effects on glycemic control and body weight Results of first human study
Objective: Aim of this study was to demonstrate feasibility and safety of a new Electric Duodenal Stimulation System (EDS, BALANCE) in humans and to evaluate the effect on glycemic control and weight loss in patients with obesity and type 2 diabetes mellitus (T2DM).
Methods: In an open labeled, prospective, single-arm, non-randomized multicenter study 12 obese T2DM patients with a mean HbA1c of 8.0% received a laparoscopic implantation of the BALANCE duodenal stimulating device. Adverse events, changes in glycemic control, cardiovascular parameters, and weight were collected. Due to the individual response, adjustments of the device in order to optimize stimulation were made. The follow up period after implantation was 12 months.
Results: Device related severe adverse events did not occur. Mean HbA1c decreased by 0.8% (p = 0.02) and mean fasting blood glucose level (FBG) was reduced by 19% (p = 0.038) after the 12 months. Mean HDL level increased from 44 mg/dl to 48 mg/dl (p = 0.033).
Conclusions: EDS is a feasible and safe approach with positive effects on T2DM and some cardiovascular parameters. Further studies are needed in order to evaluate the potential of this new promising minimally-invasive method.