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Submitted on February 2, 2006
Accepted on March 29, 2006
Institute of Endocrinology and Diabetes, The Children's Hospital at Westmead; Discipline of Paediatrics and Child Health, University of Sydney; Department of Paediatrics, KK Women's and Children's Hospital Singapore, Department of Endocrinology, St Vincent's Hospital Melbourne
* To whom correspondence should be addressed. 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: 28 patients (13 males) aged nine to 18 yr participated in the study.
Intervention: Patients received metformin (1 g bd) and placebo for 6 months each with a 2 week washout period.
Main outcome measures: Body composition (anthropometry, DXA and abdominal MRI), insulin sensitivity (Si; minimal model, fasting insulin and glucose) were measured at baseline, six and 12 months.
Results: Mean age of subjects at baseline was 12.5 ± 2.2 yr, median BMI z-score 2.54 (range 1.93-2.85). Metformin had a greater treatment effect over placebo for weight (-4.35kg, P = 0.02), BMI (-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 (-2.2mU/L, 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. While improvement in insulin sensitivity 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 insulin sensitivity during puberty.
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