Jens Aberle1, Philipp Busch2, Jochen Veigel3, Anna Duprée2, Thomas Roesch4, Christine zu Eulenburg5, Björn Paschen6, Bernd M Scholz6, Stefan Wolter2, Nina Sauer3, Kaja Ludwig7, Jakob Izbicki2, Oliver Mann2. 1. Department of Diabetology and Endocrinology, Interdisciplinary Obesity Center, Universitätsklinikum Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany. aberle@uke.de. 2. Clinic of General-, Visceral and Thoracic-Surgery, Martinistraße 52, 20246, Hamburg, Germany. 3. Department of Diabetology and Endocrinology, Interdisciplinary Obesity Center, Universitätsklinikum Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany. 4. Clinic of Interdisciplinary Endoscopy, Universitätsklinikum Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany. 5. Institute of Medical Biometrics and Epidemiology, Universitätsklinikum Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany. 6. Diabetologische Schwerpunktpraxis, Am Wall 1, 21073, Hamburg, Germany. 7. Clinic of General-, Visceral-, and Thoracic Surgery, Klinikum Südstadt, Südring 81, 18056, Rostock, Germany.
Abstract
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.
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.
Entities:
Keywords:
Duodenal pacer; Electric duodenal stimulation; Obesity; Type 2 diabetes mellitus
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