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Evaluation of the gut microbiota after metformin intervention in children with obesity: A metagenomic study of a randomized controlled trial.

Institute for Nutritional Medicine, Else Kröner-Fresenius-Center for Nutritional Medicine, School of Life Sciences, Technical University of Munich, 85354, Freising, Germany; Department of Biochemistry and Molecular Biology II, School of Pharmacy, University of Granada, 18071, Granada, Spain; Institute of Nutrition and Food Technology "José Mataix", Centre of Biomedical Research, University of Granada, Avda. Del Conocimiento s/n, 18016 Armilla, Granada, Spain. Electronic address: belen.pastor@tum.de. Department of Biochemistry and Molecular Biology II, School of Pharmacy, University of Granada, 18071, Granada, Spain; Institute of Nutrition and Food Technology "José Mataix", Centre of Biomedical Research, University of Granada, Avda. Del Conocimiento s/n, 18016 Armilla, Granada, Spain; Instituto de Investigación Biosanitaria IBS.GRANADA, Complejo Hospitalario Universitario de Granada, Granada, 18014, Spain. Electronic address: jrplaza@ugr.es. Institute of Nutrition and Food Technology "José Mataix", Centre of Biomedical Research, University of Granada, Avda. Del Conocimiento s/n, 18016 Armilla, Granada, Spain. CIBEROBN (CIBER Physiopathology of Obesity and Nutrition), Instituto de Salud Carlos III, 28029, Madrid, Spain; Unit of Investigation in Nutrition, Growth and Human Development of Galicia, Paediatric Department, Clinic University Hospital of Santiago, University of Santiago de Compostela, Santiago de Compostela, 15706, Spain. CIBEROBN (CIBER Physiopathology of Obesity and Nutrition), Instituto de Salud Carlos III, 28029, Madrid, Spain; Pediatric Department, Lozano Blesa University Clinical Hospital, University of Zaragoza, Zaragoza, 50009, Spain. Pediatric Department, Virgen de Las Nieves University Hospital, Andalusian Health Service, Granada, 18014, Spain. Unit of Investigation in Nutrition, Growth and Human Development of Galicia, Paediatric Department, Clinic University Hospital of Santiago, University of Santiago de Compostela, Santiago de Compostela, 15706, Spain. Pediatric Department, Lozano Blesa University Clinical Hospital, University of Zaragoza, Zaragoza, 50009, Spain; Pediatric Department and Health Sciences Institute in Aragon, Zaragoza, 50009, Spain. PAIDI CTS-329, Maimonides Institute of Biomedical Research of Córdoba (IMIBIC), Córdoba, 14004, Spain. Clinical Analysis Services, IMIBIC/Reina Sofía Hospital, Córdoba University, Córdoba, 14004, Spain. Department of Biochemistry and Molecular Biology II, School of Pharmacy, University of Granada, 18071, Granada, Spain; Institute of Nutrition and Food Technology "José Mataix", Centre of Biomedical Research, University of Granada, Avda. Del Conocimiento s/n, 18016 Armilla, Granada, Spain; Instituto de Investigación Biosanitaria IBS.GRANADA, Complejo Hospitalario Universitario de Granada, Granada, 18014, Spain; CIBEROBN (CIBER Physiopathology of Obesity and Nutrition), Instituto de Salud Carlos III, 28029, Madrid, Spain. PAIDI CTS-329, Maimonides Institute of Biomedical Research of Córdoba (IMIBIC), Córdoba, 14004, Spain; Unit of Paediatric Endocrinology, Reina Sofia University Hospital, Córdoba, 14004, Spain.

Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie. 2021;:111117
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Abstract

BACKGROUND Metformin, a first-line oral antidiabetic agent that has shown promising results in terms of treating childhood and adolescent obesity, might influence the composition of the gut microbiota. We aimed to evaluate whether the gut microbiota of non-diabetic children with obesity changes after a metformin intervention. METHODS The study was a multicenter and double-blind randomized controlled trial in 160 children with obesity. Children were randomly assigned to receive either metformin (1 g/day) or placebo for 6 months in combination with healthy lifestyle recommendations in both groups. Then, we conducted a metagenomic analysis in a subsample obtained from 33 children (15 metformin, 18 placebo). A linear mixed-effects model (LMM) was used to determine the abundance changes from baseline to six months according to treatment. To analyze the data by clusters, a principal component analysis was performed to understand whether lifestyle habits have a different influence on the microbiota depending on the treatment group. RESULTS Actinobacteria abundance was higher after placebo treatment compared with metformin. However, the interaction time x treatment just showed a trend to be significant (4.6% to 8.1% after placebo vs. 3.8 % to 2.6 % after metformin treatment, p = 0.055). At genus level, only the abundance of Bacillus was significantly higher after the placebo intervention compared with metformin (2.5% to 5.7% after placebo vs. 1.5 % to 0.8 % after metformin treatment, p = 0.044). Furthermore, different ensembles formed by Firmicutes, Bacteroidetes, and Verrucomicrobia were found according to the interventions under a similar food consumption. CONCLUSION Further studies with a large sample size controlled by lifestyle patterns are required in obese children and adolescents to clarify whether metformin might trigger gut microbiota alterations. TRIAL REGISTRATION Registered on the European Clinical Trials Database (EudraCT, ID: 2010-023061-21) on 14 November 2011.

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