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Journal of Obesity
Volume 2013 (2013), Article ID 245683, 8 pages
http://dx.doi.org/10.1155/2013/245683
Clinical Study

Vagal Blocking Improves Glycemic Control and Elevated Blood Pressure in Obese Subjects with Type 2 Diabetes Mellitus

1Brigham and Women’s Hospital, 75 Francis Street, Boston, MA 02115, USA
2Adelaide Bariatric Center, Flinders Private Hospital, Suite 502/Level 5, Bedford Park, SA, 5041, Australia
3Instituto Nacional de la Nutricion, Salvador Zubiran (INNSZ), Vasco de Quiroga 15, Tlalpan, 1400 Mexico City, DF, Mexico
4Center for Obesity, St. Olavs Hospital, Olav Kyrres Gate 6, 7006 Trondheim, Norway
5Division of Gastroenterology, University Hospital Basel, 4031 Basel, Switzerland
6Institute of Weight Control, 495 Windsor Road, Baulkham Hills, NSW 2153, Australia
7EnteroMedics Inc., 2800 Patton Road, St. Paul, MN 55113, USA
8University of Minnesota, Minneapolis, Minnesota Veterans’ Administration Medical Center, One Veterans’ Drive, Minneapolis, MN 55417, USA

Received 21 March 2013; Accepted 15 May 2013

Academic Editor: Francesco Saverio Papadia

Copyright © 2013 S. Shikora et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background. An active device that downregulates abdominal vagal signalling has resulted in significant weight loss in feasibility studies. Objective. To prospectively evaluate the effect of intermittent vagal blocking (VBLOC) on weight loss, glycemic control, and blood pressure (BP) in obese subjects with DM2. Methods. Twenty-eight subjects were implanted with a VBLOC device (Maestro Rechargeable System) at 5 centers in an open-label study. Effects on weight loss, HbA1c, fasting blood glucose, and BP were evaluated at 1 week to 12 months. Results. 26 subjects (17 females/9 males, years, BMI  kg/m2, mean ± SEM) completed 12 months followup. One serious adverse event (pain at implant site) was easily resolved. At 1 week and 12 months, mean excess weight loss percentages (% EWL) were % and % ( ), and HbA1c declined by % and % ( , baseline %). In DM2 subjects with elevated BP ( ), mean arterial pressure reduced by  mmHg and  mmHg ( , baseline  mmHg) at 1 week and 12 months. All subjects MAP decreased by  mmHg (baseline  mmHg) at 12 months. Conclusions. VBLOC was safe in obese DM2 subjects and associated with meaningful weight loss, early and sustained improvements in HbA1c, and reductions in BP in hypertensive DM2 subjects. This trial is registered with ClinicalTrials.gov NCT00555958.