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

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, HbA_1c, fasting blood glucose, and BP were evaluated at 1 week to 12 months.Results. 26 subjects (17 females/9 males,51±2years, BMI37±1 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) were9±1% and25±4% (P<0.0001), and HbA_1cdeclined by0.3±0.1% and1.0±0.2% (P=0.02, baseline7.8±0.2%). In DM2 subjects with elevated BP (n=15), mean arterial pressure reduced by7±3 mmHg and8±3 mmHg (P=0.04, baseline100 ± 2 mmHg) at 1 week and 12 months. All subjects MAP decreased by3 ± 2 mmHg (baseline95 ± 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.govNCT00555958.