“Metformin decreased the BMI z score and improved inflammatory and cardiovascular-related obesity parameters only in prepubertal children, but a differential effect of metformin was not observed in prepubertal compared to pubertal children. Nevertheless, the doses per kilogram of weight administrated may have had an impact on the metformin effect. Further investigations are necessary.”

BackgroundOverweight and obesity are considered to be serious public health problems. In pediatric populations, insulin resistance, dyslipidemia, and hypertension associated with obesity occur with increased frequencies. Metformin is an oral anti-hyperglycemic agent that has been demonstrated to be efficacious in the treatment of diabetic and non-diabetic obese adults. A considerable amount of pharmacogenetic research has demonstrated that genetic variation is one of the major factors affecting metformin response. Additionally, potential microbiota-mediated mechanisms of metformin effect have been recently described. However, scant work has been conducted in children, with no attention being paid to the potential effects of pubertal development. Thus, the main objective of the present study is to evaluate the effect of metformin treatment together with lifestyle recommendations in a randomized control trial (RCT) of obese children according to pubertal stage, genetic variants and signature of gut microbiota.Methods/designThis is a randomized, prospective, double-blind, placebo-controlled, multicenter trial, which is stratified by puberty and sex. Eighty pre-pubertal (40 boys and 40 girls) and 80 pubertal non-diabetic obese children (40 boys and 40 girls) are being recruited in four Spanish Clinical Hospitals. The inclusion criteria to participate in the RCT include a Body Mass Index (BMI) above the 95th percentile and age 7–14 years. The pubertal stage is determined based on the Tanner criteria. Participants are assigned to two groups in accordance with a randomization schedule and receive 1 g of metformin or placebo for six months in combination with healthy lifestyle recommendations in both groups. The primary outcomes include changes in the BMI Z score and the biomarkers associated with the early appearance of insulin resistance syndrome, inflammation, cardiovascular risk according of the presence of genetic determinants of metformin response, as well as possible modifications in microbiota.DiscussionThis study will assess the differential response of metformin treatment at six months in pre-pubertal and pubertal obese children.Trial registrationRegistered by European Clinical Trials Database (EudraCT, ID: 2010-023061-21) on 14 November 2011.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1403-4) contains supplementary material, which is available to authorized users.

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INTRODUCCIÓN: En México 2,1% de casos con SIDA son adolescentes. Los casos de 20 a 29 años alcanzan a 30,5% y una proporción importante pudo infectarse VIH en la adolescencia. El nivel de conocimientos de los adolescentes sobre VIH/SIDA es variable. En contextos urbanos poseen conceptos errados y mitos que podrían orientarlos a prácticas riesgosas. Los medios masivos e interpersonales son fuentes importantes de información en la construcción social del VIH/SIDA en los adolescentes. El objetivo es relacionar el grado de conocimientos sobre VIH/SIDA con la exposición a fuentes informativas masivas e interpersonales en los adolescentes de Guadalajara, México. MATERIAL Y MÉTODO: Encuesta a 1.410 adolescentes, varones y mujeres de 15 a 19 años, en diferentes estratos socio-económicos. Se aplicaron pruebas de significación Ji Cuadrada y BTukey, Intervalos de Confianza del 95% para proporciones y medias y ANOVA factorial simple. RESULTADO: Hay un nivel regular de conocimientos con medias favorables a los estratos alto y medio. La información de periódicos y profesores tuvo relación directa con el nivel de conocimientos controlada por la exposición a la televisión y variables socio-demográficas. CONCLUSIONES: Hay desigualdades por estratos socio-económicos en la relación de las fuentes informativas y los niveles de conocimientos sobre VIH/SIDA. Es necesario fortalecer y desarrollar acciones educativas por fuentes masivas e interpersonales, con énfasis en estratos bajo y marginado.