Duodenal Electric Stimulation

• DOI: 10.1007/s11695-015-1774-8
• Publication Date: 2015-06-25T02:43:54Z
• Authors: Jens Aberle; Philipp Busch; Jochen Veigel; Anna Duprée; Thomas Roesch; Christine zu Eule...; Björn Paschen; Bernd M. Scholz; Stefan Wolter; Nina Sauer; Kaja Ludwig; Jakob Izbicki; Oliver Mann
• Keywords: Adult; Blood Glucose; Male; 2. Zero hunger; Duodenum; Electric Stimulation Therapy; Middle Aged; 3. Good health; Prosthesis Implantation; 03 medical and health sciences; 0302 clinical medicine; Diabetes Mellitus, Type 2; Humans; Female; Laparoscopy; Obesity; Prospective Studies; Aged

The aim of this study was to demonstrate feasibility and safety of a new electric duodenal stimulation system (EDS, BALANCE) in humans. Secondary objectives were to evaluate the effect on glycemic control and weight loss in patients with obesity and type 2 diabetes mellitus (T2DM).In an open-labeled, prospective, single-arm, non-randomized multicenter study, 12 obese T2DM patients with a mean HbA1c of 8.0% received laparoscopic implantation of the BALANCE duodenal stimulating device. Adverse events, changes in glycemic control, cardiovascular parameters, and weight were collected. The follow-up period after implantation was 12 months.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 to 48 mg/dl (p = 0.033).EDS is a feasible and safe procedure. Positive effects on T2DM and some cardiovascular parameters (HDL, weight) were seen. However, further prospective randomized blinded studies are needed in order to evaluate the potential of this new minimally invasive method.