Jaime Ruiz-Tovar1, Carolina Llavero2, Irene Ortega3, María Diez4, Lorea Zubiaga4, Rafael Calpena4. 1. Unidad de Cirugía Bariátrica, Servicio de Cirugía General y Digestiva, Hospital General Universitario de Elche, Alicante, España; Unidad de Neuroestimulación para el Tratamiento de la Obesidad, Clínica Garcilaso, Madrid, España; Unidad de Neuroestimulación para el Tratamiento de la Obesidad, Clínica Maisonnave, Alicante, España. Electronic address: jruiztovar@gmail.com. 2. Unidad de Neuroestimulación para el Tratamiento de la Obesidad, Clínica Garcilaso, Madrid, España; Unidad de Neuroestimulación para el Tratamiento de la Obesidad, Clínica Maisonnave, Alicante, España. 3. Servicio de Cirugía General y Digestiva, Hospital Severo Ochoa, Leganés, Madrid, España. 4. Unidad de Cirugía Bariátrica, Servicio de Cirugía General y Digestiva, Hospital General Universitario de Elche, Alicante, España.
Abstract
INTRODUCTION: Endocrine pancreatic segregation is regulated by the autonomic nervous system. The parasympathetic system stimulates insulin production by the beta cells and inhibits the adrenergic discharge by the sympathetic nervous system. The aim of this study was to evaluate the effect of percutaneous neurostimulation (PENS) of dermatome T7, generating a somato-autonomic reflex, whose efferent pathway are the vagal branches that specifically stimulate the pancreas. The effect of this treatment on glycemia, insulin secretion and insulin resistance was investigated. METHODS: A prospective randomized clinical trial was performed. Patients with Body Mass Index>30kg/m(2) and diagnosis of diabetes mellitus treated withMetformin were included. Patients were divided into 2 groups: Patients undergoing PENS of dermatome T7 (12 sessions of 30minutes weekly) associated with a 1,200 Kcal/day diet (Group 1) and patients following only a 1,200Kcal/day diet (Group 2). All the patients underwent a blood sample extraction before the treatment and 7 days after finishing it. RESULTS:60 patients were included: 30 in each group. After finishing the treatment, in Group 1 a significant decrease in glycemia (Mean decrease of 62,1mg/dl; P=.024) and HOMA (Mean decrease 1.37; P=.014) was observed. In Group 2, no significant differences between pre and post-treatment values were observed. CONCLUSION: PENS of dermatome T7 associated with a 1,200Kcal/day diet achieves a greater reduction in glycemia and insulin resistance than with diet exclusively after 3 months of treatment.
RCT Entities:
INTRODUCTION: Endocrine pancreatic segregation is regulated by the autonomic nervous system. The parasympathetic system stimulates insulin production by the beta cells and inhibits the adrenergic discharge by the sympathetic nervous system. The aim of this study was to evaluate the effect of percutaneous neurostimulation (PENS) of dermatome T7, generating a somato-autonomic reflex, whose efferent pathway are the vagal branches that specifically stimulate the pancreas. The effect of this treatment on glycemia, insulin secretion and insulin resistance was investigated. METHODS: A prospective randomized clinical trial was performed. Patients with Body Mass Index>30kg/m(2) and diagnosis of diabetes mellitus treated with Metformin were included. Patients were divided into 2 groups: Patients undergoing PENS of dermatome T7 (12 sessions of 30minutes weekly) associated with a 1,200 Kcal/day diet (Group 1) and patients following only a 1,200Kcal/day diet (Group 2). All the patients underwent a blood sample extraction before the treatment and 7 days after finishing it. RESULTS: 60 patients were included: 30 in each group. After finishing the treatment, in Group 1 a significant decrease in glycemia (Mean decrease of 62,1mg/dl; P=.024) and HOMA (Mean decrease 1.37; P=.014) was observed. In Group 2, no significant differences between pre and post-treatment values were observed. CONCLUSION: PENS of dermatome T7 associated with a 1,200Kcal/day diet achieves a greater reduction in glycemia and insulin resistance than with diet exclusively after 3 months of treatment.