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J Clin Endocrinol Metab. 2006 Jun;91(6):2074-80. Epub 2006 Apr 4.

Randomized, controlled trial of metformin for obesity and insulin resistance in children and adolescents: improvement in body composition and fasting insulin.

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1
Institute of Endocrinology and Diabetes, The Children's Hospital at Westmead, Locked Bag 4001 Westmead, New South Wales 2145, Australia. shubhas@chw.edu.au

Abstract

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/m(2), P = 0.002), waist circumference (-2.8 cm, P = 0.003), sc abdominal adipose tissue (-52.5 cm(2), 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.

PMID:
16595599
DOI:
10.1210/jc.2006-0241
[Indexed for MEDLINE]
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