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Metformin and placebo therapy in adjunct with lifestyle intervention both improve weight loss and insulin resistance in obese adolescents

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Study design

Design

Randomised, double-blind placebo-controlled trial.

Allocation

Patients were stratified for age, sex and pubertal age.

Blinding

Metformin or placebo was dispensed by local pharmacy.

Study question

Setting

Paediatric Obesity Clinic in Germany

Patients

Adolescents aged 10 to 17years at risk of developing type 2 diabetes according to American Diabetes Association criteria who had enrolled in an individualised ‘lifestyle intervention’ weight loss programme (Phase 1). Candidates for the trial (phase 2) were those whose outcome in phase 1 at 6 months was classified unsuccessful; a reduction in body mass index (BMI) of <2 kg/m2 and persistent insulin resistance expressed as HOMA-IR (Homeostatic Model Assessment-estimated insulin resistance) > 3 or 95th percentile.

Intervention

Metformin 500 mg twice per day or placebo for 6 months. Multiprofessional individualised lifestyle intervention continued throughout both phases of the study.

Outcomes

Improvement in insulin resistance (IR) measured by HOMA-IR after 6 months of treatment with Metformin/placebo.

HOMA-IR = fasting insulin …

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