title: Duodenal Electric Stimulation: Results of a First-in-Man Study.
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.
authors.affiliation: Department of Diabetology and Endocrinology, Interdisciplinary Obesity Center, Universitätsklinikum Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany. aberle@uke.de.
authors.forename: Jens
authors.initials: J
authors.lastname: Aberle
authors.affiliation: Clinic of General-, Visceral and Thoracic-Surgery, Martinistraße 52, 20246, Hamburg, Germany.
authors.forename: Philipp
authors.initials: P
authors.lastname: Busch
authors.affiliation: Department of Diabetology and Endocrinology, Interdisciplinary Obesity Center, Universitätsklinikum Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.
authors.forename: Jochen
authors.initials: J
authors.lastname: Veigel
authors.affiliation: Clinic of General-, Visceral and Thoracic-Surgery, Martinistraße 52, 20246, Hamburg, Germany.
authors.forename: Anna
authors.initials: A
authors.lastname: Duprée
authors.affiliation: Clinic of Interdisciplinary Endoscopy, Universitätsklinikum Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Roesch
authors.affiliation: Institute of Medical Biometrics and Epidemiology, Universitätsklinikum Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.
authors.forename: Christine
authors.initials: C
authors.lastname: zu Eulenburg
authors.affiliation: Diabetologische Schwerpunktpraxis, Am Wall 1, 21073, Hamburg, Germany.
authors.forename: Björn
authors.initials: B
authors.lastname: Paschen
authors.affiliation: Diabetologische Schwerpunktpraxis, Am Wall 1, 21073, Hamburg, Germany.
authors.forename: Bernd M
authors.initials: BM
authors.lastname: Scholz
authors.affiliation: Clinic of General-, Visceral and Thoracic-Surgery, Martinistraße 52, 20246, Hamburg, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Wolter
authors.affiliation: Department of Diabetology and Endocrinology, Interdisciplinary Obesity Center, Universitätsklinikum Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.
authors.forename: Nina
authors.initials: N
authors.lastname: Sauer
authors.affiliation: Clinic of General-, Visceral-, and Thoracic Surgery, Klinikum Südstadt, Südring 81, 18056, Rostock, Germany.
authors.forename: Kaja
authors.initials: K
authors.lastname: Ludwig
authors.affiliation: Clinic of General-, Visceral and Thoracic-Surgery, Martinistraße 52, 20246, Hamburg, Germany.
authors.forename: Jakob
authors.initials: J
authors.lastname: Izbicki
authors.affiliation: Clinic of General-, Visceral and Thoracic-Surgery, Martinistraße 52, 20246, Hamburg, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Mann
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D003924:Diabetes Mellitus, Type 2 / Q000601:surgery / Q000628:therapy*; D004386:Duodenum / Q000503:physiopathology / Q000601:surgery*; D004599:Electric Stimulation Therapy; D005260:Female; D006801:Humans; D010535:Laparoscopy; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000601:surgery / Q000628:therapy*; D011446:Prospective Studies; D019919:Prosthesis Implantation
chemical_list: D001786:Blood Glucose
keywords: Duodenal pacer; Electric duodenal stimulation; Obesity; Type 2 diabetes mellitus