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. 1. Introduction It has been estimated that approximately 20 million adults in the USA have type 2 diabetes mellitus [1]. Worldwide, the incidence of type 2 diabetes mellitus is now thought to be over 347 million [2]. In the USA alone, it is estimated that it will cost 147 billion dollars to take care of diabetes and its complications [1]. The majority of these individuals are obese. Obesity and type 2 diabetes mellitus (DM2) are closely linked [3]—as body mass index (BMI) increases, there is a weight-dependent increased risk of developing type 2 diabetes [4]. Body weight reduction of just 5% can improve glycemic control in obese type 2 diabetics [5]. Current medical treatments are limited by many factors including subject’s compliance and high costs as well as by the inexorable progression of the disease and its complications. Current bariatric surgical procedures such as gastric bypass, biliopancreatic diversion or sleeve gastrectomy have demonstrated a significant beneficial impact on the glucose control even before significant weight loss occurs [6, 7]. However these procedures are invasive with the potential for serious complications and considerable professional and patient aversion. Given the severity of the problem, there is a societal need for a less invasive,
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