Duodenal Electric Stimulation: Results of a First-in-Man Study
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Duodenal Electric Stimulation: Results of a First-in-Man Study. / Aberle, Jens; Busch, Christoph Philipp; Veigel, Jochen; Duprée, Anna; Roesch, Thomas; Zu Eulenburg, Christine; Paschen, Björn; Scholz, Bernd M; Wolter, Stefan; Sauer, Nina; Ludwig, Kaja; Izbicki, Jakob; Mann, Oliver.
in: OBES SURG, Jahrgang 26, Nr. 2, 02.2016, S. 369-75.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Duodenal Electric Stimulation: Results of a First-in-Man Study
AU - Aberle, Jens
AU - Busch, Christoph Philipp
AU - Veigel, Jochen
AU - Duprée, Anna
AU - Roesch, Thomas
AU - Zu Eulenburg, Christine
AU - Paschen, Björn
AU - Scholz, Bernd M
AU - Wolter, Stefan
AU - Sauer, Nina
AU - Ludwig, Kaja
AU - Izbicki, Jakob
AU - Mann, Oliver
PY - 2016/2
Y1 - 2016/2
N2 - BACKGROUND: 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).METHODS: 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.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 to 48 mg/dl (p = 0.033).CONCLUSIONS: 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.
AB - BACKGROUND: 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).METHODS: 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.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 to 48 mg/dl (p = 0.033).CONCLUSIONS: 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.
U2 - 10.1007/s11695-015-1774-8
DO - 10.1007/s11695-015-1774-8
M3 - SCORING: Journal article
C2 - 26112135
VL - 26
SP - 369
EP - 375
JO - OBES SURG
JF - OBES SURG
SN - 0960-8923
IS - 2
ER -
