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Institute of Endocrinology and Diabetes (S.S., G.R.A., S.P.G., M.T., C.T.C.), The Children’s Hospital at Westmead, Westmead, New South Wales 2145, Australia; Discipline of Paediatrics and Child Health (S.S., L.A.B., S.P.G., C.T.C.), University of Sydney, Sydney 2006, Australia; Department of Paediatrics (F.Y.), KK Women’s and Children’s Hospital Singapore, Singapore 229899; and Department of Endocrinology (G.M.W.), St. Vincent’s Hospital Melbourne, Fitzroy, Victoria 3065, Australia
Address all correspondence and requests for reprints to: Dr. Shubha Srinivasan, Institute of Endocrinology and Diabetes, The Children’s Hospital at Westmead, Locked Bag 4001 Westmead, New South Wales 2145, Australia. E-mail: shubhas{at}chw.edu.au.
Context: Metformin therapy for adults and children with type 2 diabetes is well established. However, its role in the treatment of insulin resistance and obesity in children and adolescents is less clearly defined.
Objective: We assessed the effect of metformin on body composition and insulin sensitivity in pediatric subjects with exogenous obesity.
Design and Setting: Patients referred to a pediatric endocrine clinic were enrolled in a randomized, double-blind, crossover trial.
Patients: Twenty-eight patients (13 males) aged 9–18 yr participated in the study.
Intervention: Patients received metformin (1 g twice daily) and placebo for 6 months, each with a 2-wk washout period.
Main Outcome Measures: Body composition (anthropometry, dual-energy x-ray absorptiometry, and abdominal magnetic resonance imaging), and insulin sensitivity (Si; minimal model, fasting insulin and glucose) were measured at baseline and 6 and 12 months.
Results: Mean age of subjects at baseline was 12.5 ± 2.2 yr, median body mass index z-score 2.54 (range, 1.93–2.85). Metformin had a greater treatment effect over placebo for weight (–4.35 kg, P = 0.02), body mass index (–1.26 kg/m2, P = 0.002), waist circumference (–2.8 cm, P = 0.003), sc abdominal adipose tissue (–52.5 cm2, P = 0.002), and fasting insulin (–2.2 mU/liter, P = 0.011). Si improved in 45% of subjects while on metformin and 27% of subjects while on placebo (P = 0.21).
Conclusions: Metformin therapy for obese insulin-resistant pediatric patients results in significant improvement in body composition and fasting insulin. Although improvement in Si was noted in many individuals, Si was a less useful parameter for analysis of group data, possibly because of effects of variable compliance and changing Si during puberty.
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