RT Journal Article T1 Metformin for Obesity in Prepubertal and Pubertal Children: A Randomized Controlled Trial. A1 Pastor-Villaescusa, Belen A1 Cañete, M Dolores A1 Caballero-Villarraso, Javier A1 Hoyos, Raul A1 Latorre, Miriam A1 Vazquez-Cobela, Rocio A1 Plaza-Diaz, Julio A1 Maldonado, Jose A1 Bueno, Gloria A1 Leis, Rosaura A1 Gil, Angel A1 Cañete, Ramon A1 Aguilera, Concepcion M K1 Adolescent K1 Biomarkers K1 Body mass index K1 Cardiovascular diseases AB Metformin has shown its effectiveness in treating obesity in adults. However, little research has been conducted in children, with a lack of attention on pubertal status. The objectives were to determine whether oral metformin treatment reduces BMI z score, cardiovascular risk, and inflammation biomarkers in children who are obese depending on pubertal stage and sex. This was a randomized, prospective, double-blind, placebo-controlled, multicenter trial, stratified according to pubertal stage and sex, conducted at 4 Spanish clinical hospitals. Eighty prepubertal and 80 pubertal nondiabetic children who were obese aged 7 to 14 years with a BMI >95th percentiles were recruited. The intervention included 1 g/d of metformin versus placebo for 6 months. The primary outcome was a reduction in BMI z score. Secondary outcomes comprised insulin resistance, cardiovascular risk, and inflammation biomarkers. A total of 140 children completed the study (72 boys). Metformin decreased the BMI z score versus placebo in the prepubertal group (-0.8 and -0.6, respectively; difference, 0.2; P = .04). Significant increments were observed in prepubertal children treated with metformin versus placebo recipients in the quantitative insulin sensitivity check index (0.010 and -0.007; difference, 0.017; P = .01) and the adiponectin-leptin ratio (0.96 and 0.15; difference, 0.81; P = .01) and declines in interferon-γ (-5.6 and 0; difference, 5.6; P = .02) and total plasminogen activator inhibitor-1 (-1.7 and 2.4; difference, 4.1; P = .04). No serious adverse effects were reported. “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.” PB American Academy of Pediatrics YR 2017 FD 2017-03-21 LK http://hdl.handle.net/10668/11457 UL http://hdl.handle.net/10668/11457 LA en NO Pastor-Villaescusa B, Cañete MD, Caballero-Villarraso J, Hoyos R, Latorre M, Vázquez-Cobela R, et al. Metformin for Obesity in Prepubertal and Pubertal Children: A Randomized Controlled Trial. Pediatrics. 2017 Jul;140(1):e20164285. doi: 10.1542/peds.2016-4285. Epub 2017 Jun 12. Erratum in: Pediatrics. 2017 Nov;140(5):e20172555 DS RISalud RD Apr 17, 2025