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 < 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.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4831996 | PMC |
| http://dx.doi.org/10.1007/s11695-016-2143-y | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Spatio-temporal segregation between sensory relay and swallowing pre-motor population activities by optical imaging in the rat nucleus of the solitary tract.
Pflugers Arch
January 2025
Division of Neurophysiology, Department of Physiology, Hyogo Medical University, Hyogo, 663 8501, Japan.
The nucleus tractus solitarius (NTS) contains neurons that relay sensory swallowing commands information from the oropharyngeal cavity and swallowing premotor neurons of the dorsal swallowing group (DSG). However, the spatio-temporal dynamics of the interplay between the sensory relay and the DSG is not well understood. Here, we employed fluorescence imaging after microinjection of the calcium indicator into the NTS in an arterially perfused brainstem preparation of rat (n = 8) to investigate neuronal population activity in the NTS in response to superior laryngeal nerve (SLN) stimulation.
View Article and Find Full Text PDFIntroducing the Index of Response to Stimulation (IRES): A Novel Metric for Assessing Vagus Nerve Stimulation Outcomes in Drug-Resistant Epilepsy.
Medicina (Kaunas)
January 2025
Department of Neurosurgery, University of Medicine and Pharmacy "Carol Davila", 030147 Bucharest, Romania.
: The Index of Response to Stimulation (IRES) is a new index that we introduce in this study to grade the effectiveness of vagus nerve stimulation in the treatment of drug-resistant epilepsy. We assessed 76 patients at 6, 12, and 18 months after VNS evaluating improvement with the IRES in four key dimensions: seizure duration decrease, seizure intensity decrease, improvement in quality of life, and seizure frequency decrease. This scale goes from 0, meaning no improvement, to 8, meaning maximal improvement, making the scale a really good measure of clinical utility.
View Article and Find Full Text PDFUnderstanding Patterns of the Gut Microbiome May Contribute to the Early Detection and Prevention of Type 2 Diabetes Mellitus: A Systematic Review.
Microorganisms
January 2025
Department Neuromed & Movement Science, Norwegian University of Science & Technology (NTNU), 7034 Trondheim, Norway.
The rising burden of type 2 diabetes mellitus (T2DM) is a growing global public health problem, particularly prominent in developing countries. The early detection of T2DM and prediabetes is vital for reversing the outcome of disease, allowing early intervention. In the past decade, various microbiome-metabolome studies have attempted to address the question of whether there are any common microbial patterns that indicate either prediabetic or diabetic gut microbial signatures.
View Article and Find Full Text PDFLiver-innervating vagal sensory neurons are indispensable for the development of hepatic steatosis and anxiety-like behavior in diet-induced obese mice.
Nat Commun
January 2025
The Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine, New York, USA.
The visceral organ-brain axis, mediated by vagal sensory neurons, is essential for maintaining various physiological functions. Here, we investigate the impact of liver-projecting vagal sensory neurons on energy balance, hepatic steatosis, and anxiety-like behavior in mice under obesogenic conditions. A small subset of vagal sensory neurons innervate the liver and project centrally to the nucleus of the tractus solitarius, area postrema, and dorsal motor nucleus of the vagus, and peripherally to the periportal areas in the liver.
View Article and Find Full Text PDFRspo3-mediated metabolic liver zonation regulates systemic glucose metabolism and body mass in mice.
PLoS Biol
January 2025
Department of Internal Medicine, Teikyo University School of Medicine, Tokyo, Japan.
The unique architecture of the liver consists of hepatic lobules, dividing the hepatic features of metabolism into 2 distinct zones, namely the pericentral and periportal zones, the spatial characteristics of which are broadly defined as metabolic zonation. R-spondin3 (Rspo3), a bioactive protein promoting the Wnt signaling pathway, regulates metabolic features especially around hepatic central veins. However, the functional impact of hepatic metabolic zonation, regulated by the Rspo3/Wnt signaling pathway, on whole-body metabolism homeostasis remains poorly understood.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!