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Randomised, double-blind placebo-controlled trial.
Patients were stratified for age, sex and pubertal age.
Metformin or placebo was dispensed by local pharmacy.
Paediatric Obesity Clinic in Germany
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.
Metformin 500 mg twice per day or placebo for 6 months. Multiprofessional individualised lifestyle intervention continued throughout both phases of the study.
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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