Vagal Nerve Block for Improvements in Glycemic Control in Obese Patients with Type 2 Diabetes Mellitus: Three-Year Results of the VBLOC DM2 Study
Miguel F Herrera1, James Toouli2, BÃ¥rd Kulseng3, Roy Brancatisano4, Lilian Kow2, Juan P Pantoja1, Gjermund Johnsen3, Anthony Brancatisano4, Katherine S Tweden5*, Jonathan J Waataja6, Charles J Billington7, Scott A Shikora8
Affiliation
- 1Instituto Nacional de al Nutricion, Salvador Zubrian (INNSZ), Vasco de Quiroga 15, Tlalpan, 1400 Mexico City, DF, Mexico
- 2Adelaide Bariatric Center, Flinders Private Hospital, Suite 502/Level 5, Bedford Park, SA, 5041, Australia
- 3Center for Obesity, St. Olavs Hospital, Olav Kyrres Gate 6, 7006, Trondheim, Norway
- 4Institute of Weight Control, 17-19 Solent Circuit, Norwest Business Park, Baulkham Hills, NSW 2153, Australia
- 5EnteroMedics Inc, 2800 Patton Road, St. Paul, MN 55113, USA
- 6University of Minnesota, 321 Church Street SE, Minneapolis, Minnesota, 55455, USA
- 7University of Minnesota, Minneapolis, Minnesota Veterans’ Administration Medical Center, One Veterans’ Drive, Minneapolis, MN 55417, USA
- 8Brigham and Women’s Hospital, 75 Francis Street, Boston MA 02115, USA
Corresponding Author
Katherine Tweden, PhD. Entero Medics Inc, 2800 Patton Road, St. Paul, MN 55113, E-mail: ktweden@enteromedics.com
Citation
Tweden, K.S., et al. Vagal Nerve Block for Improvements in Glycemic Control in Obese Patients with Type 2 Diabetes Mellitus: Three-Year Results of the VBLOC DM2 Study. (2017) J Diab Obes 4(1): 1- 6.
Copy rights
© 2017 Tweden, K.S. This is an Open access article distributed under the terms of Creative Commons Attribution 4.0 International License.
Keywords
Abstract
Background: The VBLOC DM2 study demonstrated that intermittent electrical vagal blocking (vBloc therapy) was safe among subjects with obesity and type 2 diabetes mellitus (DM2) and led to clinically meaningful improvement in weight loss and glycemic parameters at 2 years. Sustainability of these responses at three years is reported here.
Methods: VBLOC DM2 is a prospective, observational study of 28 subjects with DM2 and body mass index (BMI) between 30 and 40 kg/m². Safety and changes in weight, glycemic parameters and other risk factors with vBloc therapy are assessed. Mixed models are used to report continuous outcome variables.
Results: After three years of therapy, mean percentage of excess weight loss was 21% (95% CI, 14 to 28) or 7% total body weight loss (95% CI, 5 to 9). Hemoglobin A1c decreased by a mean of 0.6 percentage points (95% CI, 0.2 to 1.0) from a baseline of 7.8%. Fasting plasma glucose declined by a mean of 18 mg/dL (95% CI, 2 to 34) from a baseline of 151 mg/dL. The most common adverse events continued to be heartburn, constipation and neuroregulator site pain which were mostly mild to moderate in severity as noted in earlier reports.
Conclusions: Three years of treatment with vBloc therapy resulted in durable improvements in weight loss and glycemic control. vBloc was shown to have favorable safety through 3 years.
