Duodenal electric stimulation. Feasibility, safety, and effects on glycemic control and body weight Results of first human study
J Veigel, J Aberle, P Busch, A Duprée, T Roesch, C zu Eulenburg, B Paschen, B Scholz, S Wolter, J Izbicki, O Mann · Diabetologie und Stoffwechsel · 2016 · Heft 04
Bibliografische Angaben
Zusammenfassung
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, adju…