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

John M. Morton, Sajani N. Shah, Bruce Wolfe, Caroline M. Apovian, Christopher J. Miller, Katherine S. Tweden, Charles J. Billington, Scott A. Shikora

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

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/m2 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/m2) 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 <0.0001). Common adverse events of vBloc through 12 months were heartburn/dyspepsia and implant site pain; the majority of events were reported as mild or moderate. Conclusions: vBloc therapy resulted in significantly greater weight loss than the sham control among participants with moderate obesity and comorbidities with a well-tolerated safety profile.

Original languageEnglish (US)
Pages (from-to)983-989
Number of pages7
JournalObesity Surgery
Volume26
Issue number5
DOIs
StatePublished - May 1 2016

Fingerprint

Nerve Block
Obesity
Weight Loss
Comorbidity
Body Mass Index
Therapeutics
Safety
Heartburn
Morbid Obesity
Dyspepsia
Sleep Apnea Syndromes
Dyslipidemias
Random Allocation
Type 2 Diabetes Mellitus
Counseling
Randomized Controlled Trials
Hypertension
Weights and Measures
Pain
Equipment and Supplies

Keywords

  • Active implantable medical device
  • Bariatric surgery
  • Laparoscopic surgery
  • Moderate obesity
  • Obesity
  • Randomized controlled trial
  • Vagal nerve blocking

ASJC Scopus subject areas

  • Surgery
  • Endocrinology, Diabetes and Metabolism
  • Nutrition and Dietetics

Cite this

Morton, J. M., Shah, S. N., Wolfe, B., Apovian, C. M., Miller, C. J., Tweden, K. S., ... Shikora, S. A. (2016). Effect of Vagal Nerve Blockade on Moderate Obesity with an Obesity-Related Comorbid Condition: the ReCharge Study. Obesity Surgery, 26(5), 983-989. https://doi.org/10.1007/s11695-016-2143-y

Effect of Vagal Nerve Blockade on Moderate Obesity with an Obesity-Related Comorbid Condition : the ReCharge Study. / Morton, John M.; Shah, Sajani N.; Wolfe, Bruce; Apovian, Caroline M.; Miller, Christopher J.; Tweden, Katherine S.; Billington, Charles J.; Shikora, Scott A.

In: Obesity Surgery, Vol. 26, No. 5, 01.05.2016, p. 983-989.

Research output: Contribution to journalArticle

Morton, JM, Shah, SN, Wolfe, B, Apovian, CM, Miller, CJ, Tweden, KS, Billington, CJ & Shikora, SA 2016, 'Effect of Vagal Nerve Blockade on Moderate Obesity with an Obesity-Related Comorbid Condition: the ReCharge Study', Obesity Surgery, vol. 26, no. 5, pp. 983-989. https://doi.org/10.1007/s11695-016-2143-y
Morton, John M. ; Shah, Sajani N. ; Wolfe, Bruce ; Apovian, Caroline M. ; Miller, Christopher J. ; Tweden, Katherine S. ; Billington, Charles J. ; Shikora, Scott A. / Effect of Vagal Nerve Blockade on Moderate Obesity with an Obesity-Related Comorbid Condition : the ReCharge Study. In: Obesity Surgery. 2016 ; Vol. 26, No. 5. pp. 983-989.
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