RT Journal Article
T1 Metformin for Obesity in Prepubertal and Pubertal Children: A Randomized Controlled Trial
A1 Pastor-Villaescusa, Belen
A1 Canete, M. Dolores
A1 Caballero-Villarraso, Javier
A1 Hoyos, Rayal
A1 Latorre, Miriam
A1 Vazquez-Cobela, Rocio
A1 Plaza-Diaz, Julio
A1 Maldonado, Jose
A1 Bueno, Gloria
A1 Leis, Rosaura
A1 Gil, Angel
A1 Canete, Ramon
A1 Aguilera, Concepcion M.
K1 Insulin-resistant adolescents
K1 Metabolic syndrome
K1 Endothelial function
K1 Glucose-tolerance
K1 Oxidative stress
K1 Term treatment
K1 Hyperinsulinemia
K1 Overweight
K1 Markers
K1 Weight
AB OBJECTIVES: 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.METHODS: 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.RESULTS: 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 -gamma (-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.CONCLUSIONS: Metformin decreased the BMI z score and improved inflammatory and cardiovascular-related obesity parameters in prepubertal children but not in pubertal children. Ilence, the differential response according to puberty might be related to the dose of metformin per kilogram of weight. Further investigations are necessary.
PB Amer acad pediatrics
SN 0031-4005
YR 2017
FD 2017-07-01
LK https://hdl.handle.net/10668/25879
UL https://hdl.handle.net/10668/25879
LA en
DS RISalud
RD Apr 18, 2025