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

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, HbA 1c , fasting blood glucose, and BP were evaluated at 1 week to 12 months. Results . 26 subjects (17 females/9 males, 51 ± 2 years, BMI 37 ± 1 kg/m 2 , 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 9 ± 1% and 25 ± 4% ( P < 0.0001), and HbA 1c declined by 0.3 ± 0.1% and 1.0 ± 0.2% ( P = 0.02, baseline 7.8 ± 0.2%). In DM2 subjects with elevated BP ( n = 15), mean arterial pressure reduced by 7 ± 3 mmHg and 8 ± 3 mmHg ( P = 0.04, baseline 100 ± 2 mmHg) at 1 week and 12 months. All subjects MAP decreased by 3 ± 2 mmHg (baseline 95 ± 2 mmHg) at 12 months. Conclusions . VBLOC was safe in obese DM2 subjects and associated with meaningful weight loss, early and sustained improvements in HbA 1c , and reductions in BP in hypertensive DM2 subjects. This trial is registered with ClinicalTrials.gov NCT00555958 .