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Vagal nerve-blocking therapy safe, effective in type 2 diabetes, obesity

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February 16, 2017

Treatment with intermittent electrical vagal blocking was safe and effective for reducing weight, HbA1c and other glycemic parameters at 3 years in adults with type 2 diabetes and obesity, according to data published in the Journal of Diabetes and Obesity.

Charles Billington, MD, professor in the department of medicine at the University of Minnesota, evaluated data from the VBLOC DM2 study, a prospective, open-label, observational study, on 28 adults (mean age, 51 years) with type 2 diabetes and obesity (mean BMI, 37 kg/m2) who received intermittent electrical vagal blocking (vBloc therapy, EnteroMedics), delivered via the Maestro rechargeable system. The system delivered 5,000 Hz for at least 12 hours each day; therapy did not require a specific diet or exercise program. Researchers sought to determine the therapy’s safety and efficacy for weight loss and glycemic control.

Weight loss at 3 years was comparable to that at 1 and 2 years for an estimated mean weight loss of 21% from baseline among participants. Among 18 participants who attended the 3-year visit, mean estimated percent weight loss was 24%.

Baseline HbA1c was 7.8% and was significantly reduced by 1 percentage point at 1 year after vBloc initiation; by 2 years, the reduction was 0.6 percentage points, and it remained unchanged at 3 years. At 3 years, 71% of participants had HbA1c less than 7% compared with 25% of participants at baseline. Mean estimated fasting plasma glucose also decreased from a baseline of 151 mg/dL to 133 mg/dL.

The most frequently reported adverse events were mild to moderate heartburn, constipation and neuroregulatory site pain.

“In addition to maintaining weight loss over time, successful management of comorbid conditions, such as diabetes, is critical,” Billington said in a press release. “The 3-year data from the VBLC DM2 study continue to demonstrate that vBloc therapy not only provides durable improvements in weight loss through 3 years, but also improved glycemic control in obese patients with type 2 diabetes who do not wish to undergo anatomy-altering weight-loss procedures.” – by Amber Cox

Disclosure: Billington reports receiving grant support from Covidien and being a consultant for Novo Nordisk. Please see the full study for a list of all other authors’ relevant financial disclosures.

itj+ Perspective

PERSPECTIVE
Caroline Apovian
Caroline M. Apovian
The vBloc surgically placed device is a tool that uses electrical signaling technology to temporarily and reversibly block conduction through the anterior and posterior trunks of the vagal nerve. A randomized, sham-controlled, double blind trial of vBloc therapy for moderate to severe obesity in 239 patients showed significant weight loss compared with sham control with a very low rate of complications at 1 year, and these results were durable to 2 years (Apovian CM, et al. Obes Surg. 2017; doi:10.1007/s11695-016-2325-7).
The VBLOC DM2 study investigated the use of the device in 28 subjects with obesity and type 2 diabetes, and 2-year results were reported recently and included significant weight loss and decreases in glycemic parameters.
The study herein reports the 3-year results of the VBLOC DM2 trial in which participants sustained a 7% total body weight loss and an average HbA1c reduction of 0.6 percentage points. This study confirms the durability, safety and efficacy of the vBloc device in those with type 2 diabetes and moderate to severe obesity in 3 years of follow-up. Future studies are needed to combine vBloc therapy with other modalities of treatment that can enhance weight loss and glycemic parameters, such as GLP-1 agonists, SGLT2 inhibitors and metformin therapy.
Caroline M. Apovian, MD
Professor of Medicine, Boston University School of Medicine, Director, Nutrition and Weight Management Center, Boston Medical Center
Disclosure: Apovian reports being a paid consultant of EnteroMedics.