Vagal Nerve Block for Improvements in Glycemic Control in Obese Patients with Type 2 Diabetes Mellitus: Three-Year Results of the VBLOC DM2 Study

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. *Corresponding author: Katherine Tweden, PhD. Entero Medics Inc, 2800 Patton Road, St. Paul, MN 55113, E-mail: [email protected]