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Pediatrics. 2017 Jul;140(1). pii: e20164285. doi: 10.1542/peds.2016-4285. Epub 2017 Jun 12.

Metformin for Obesity in Prepubertal and Pubertal Children: A Randomized Controlled Trial.

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Department of Biochemistry and Molecular Biology II, Institute of Nutrition and Food Technology, Center for Biomedical Research, University of Granada, Granada. Spain.
CIBER Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Madrid, Spain.
PAIDI CTS-329, Maimonides Institute of Biomedical Research of Córdoba (IMIBIC), Córdoba, Spain.
Clinical Analysis Services, IMIBIC/Reina Sofía Hospital, Córdoba University, Córdoba, Spain.
Pediatric Department and.
Health Sciences Institute in Aragon, Zaragoza, Spain.
Pediatric Department, Lozano Blesa University Clinical Hospital, University of Zaragoza, Zaragoza, Spain.
Unit of Investigation in Nutrition, Growth and Human Development of Galicia, Pediatric Department, Clinic University Hospital of Santiago, University of Santiago de Compostela, Santiago de Compostela, Spain.
Pediatric Gastroenterology and Nutrition Unit, Virgen de las Nieves University Hospital, Andalusian Health Service, Granada, Spain.
Instituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain; and.
Unit of Pediatric Endocrinology, Reina Sofia University Hospital, Córdoba, Spain.
Department of Biochemistry and Molecular Biology II, Institute of Nutrition and Food Technology, Center for Biomedical Research, University of Granada, Granada. Spain;



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.

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