Effect of Vagal Nerve Blockade on Moderate Obesity with an Obesity-Related Comorbid Condition: the ReCharge Study

Background Vagal nerve blockade (vBloc) therapy was shown to be a safe and effective treatment for moderate to severe obesity. This report summarizes the safety and efficacy of vBloc therapy in the prespecified subgroup of patients with moderate obesity. Methods The ReCharge Trial is a double-blind,...

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Bibliographic Details
Published in:Obesity surgery 2016-05, Vol.26 (5), p.983-989
Main Authors: Morton, John M., Shah, Sajani N., Wolfe, Bruce M., Apovian, Caroline M., Miller, Christopher J., Tweden, Katherine S., Billington, Charles J., Shikora, Scott A.
Format: Article
Language:English
Subjects:
Adult
Body Mass Index
Comorbidity
Diabetes Mellitus, Type 2 - complications
Double-Blind Method
Dyslipidemias - complications
Female
Gastrointestinal surgery
Humans
Hypertension - complications
Male
Medicine
Medicine & Public Health
Middle Aged
Nerve Block - methods
Obesity
Obesity - complications
Obesity - therapy
Original Contributions
Surgery
Surgical outcomes
Treatment Outcome
Vagus Nerve
Weight control
Weight Loss - physiology
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Summary:Background Vagal nerve blockade (vBloc) therapy was shown to be a safe and effective treatment for moderate to severe obesity. This report summarizes the safety and efficacy of vBloc therapy in the prespecified subgroup of patients with moderate obesity. Methods The ReCharge Trial is a double-blind, randomized controlled clinical trial of participants with body mass index (BMI) of 40–45 or 35–40 kg/m 2 with at least one obesity-related comorbid condition. Participants were randomized 2:1 to implantation with either a vBloc or sham device with weight management counseling. Eighty-four subjects had moderate obesity (BMI 35–40 kg/m 2 ) at randomization. Results Fifty-three participants were randomized to vBloc and 31 to sham. Qualifying obesity-related comorbidities included dyslipidemia (73 %), hypertension (58 %), sleep apnea (33 %), and type 2 diabetes (8 %). The vBloc group achieved a percentage excess weight loss (%EWL) of 33 % (11 % total weight loss (%TWL)) compared to 19 % EWL (6 % TWL) with sham at 12 months (treatment difference 14 percentage points, 95 % CI, 7–22; p  
ISSN:0960-8923
1708-0428
DOI:10.1007/s11695-016-2143-y