Abstract
Background:As adolescents with obesity and insulin resistance may be refractory to lifestyle intervention therapy alone, additional off-label metformin therapy is often used. In this study, the long-term efficacy and safety of metformin versus placebo in adolescents with obesity and insulin resistance is studied.Methods:In a randomized placebo-controlled double-blinded trial, 62 adolescents with obesity aged 10–16 years old with insulin resistance received 2000 mg of metformin or placebo daily and physical training twice weekly over 18 months. Primary end points were change in body mass index (BMI) and insulin resistance measured by the Homeostasis Model Assessment for Insulin Resistance (HOMA-IR). Secondary end points were safety and tolerability of metformin. Other end points were body fat percentage and HbA1c.Results:Forty-two participants completed the 18-month study (66% girls, median age 13 (12–15) years, BMI 30.0 (28.3 to 35.0) kg m−2 and HOMA-IR 4.08 (2.40 to 5.88)). Median ΔBMI was +0.2 (−2.9 to 1.3) kg m−2 (metformin) versus +1.2 (−0.3 to 2.4) kg m−2 (placebo) (P=0.015). No significant difference was observed for HOMA-IR. No serious adverse events were reported. Median change in fat percentage was −3.1 (−4.8 to 0.3) versus −0.8 (−3.2 to 1.6)% (P=0.150), in fat mass −0.2 (−5.2 to 2.1) versus +2.0 (1.2–6.4) kg (P=0.007), in fat-free mass +2.0 (−0.1 to 4.0) versus +4.5 (1.3 to 11.6) kg (P=0.047) and in ΔHbA1c +1.0 (−1.0 to 2.3) versus +3.0 (0.0 to 5.0) mmol mol−1 (P=0.020) (metformin versus placebo).Conclusions:Long-term treatment with metformin in adolescents with obesity and insulin resistance results in stabilization of BMI and improved body composition compared with placebo. Therefore, metformin may be useful as an additional therapy in combination with lifestyle intervention in adolescents with obesity and insulin resistance.
Highlights
Childhood obesity is an important pediatric health issue, with rising prevalence rates in almost all European countries, the United States and Canada.[1]
Participants In all, 127 participants were assessed for eligibility (Figure 1)
One patient in the placebo group was excluded from the analysis, because this patient was an outlier with a change in body mass index (BMI)-SDS of − 4.47
Summary
Childhood obesity is an important pediatric health issue, with rising prevalence rates in almost all European countries, the United States and Canada.[1]. Reduction of body mass index (BMI) is known to reduce the risk of developing these diseases.[7,8,9] IR might be a limiting factor in losing weight in children and adolescents with obesity. Children without IR achieved a reduction in BMI-s.d. As adolescents with obesity and insulin resistance may be refractory to lifestyle intervention therapy alone, additional off-label metformin therapy is often used. The long-term efficacy and safety of metformin versus placebo in adolescents with obesity and insulin resistance is studied. RESULTS: Forty-two participants completed the 18-month study (66% girls, median age 13 (12–15) years, BMI 30.0 (28.3 to 35.0) kg m − 2 and HOMA-IR 4.08 (2.40 to 5.88)). CONCLUSIONS: Long-term treatment with metformin in adolescents with obesity and insulin resistance results in stabilization of BMI and improved body composition compared with placebo. Metformin may be useful as an additional therapy in combination with lifestyle intervention in adolescents with obesity and insulin resistance
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