clinicaltrials.gov Identifier: NCT01327976.

VBLOC® therapy to treat morbid obesity was safe, but weight loss was not greater in treated compared to controls; clinically important weight loss, however, was related to hours of device use. Post-study analysis suggested that the system electrical safety checks (low charge delivered via the system for electrical impedance, safety, and diagnostic checks) may have contributed to weight loss in the control group.

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, 51 ± 2 years, BMI 37 ± 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) were 9 ± 1% and 25 ± 4% (P < 0.0001), and HbA1c 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 HbA1c, and reductions in BP in hypertensive DM2 subjects. This trial is registered with ClinicalTrials.gov NCT00555958.

Improvements in obesity and glycemic control were largely sustained after 2 years of treatment with VBLOC therapy with a well-tolerated risk profile.

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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/m 2. 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 A 1c 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.

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