Background: The prevalence of childhood obesity and insulin resistance is rising, increasing the risk of diabetes\nmellitus type 2. To prevent these complications, lifestyle intervention is the corner stone in treatment. However,\nlong-term efficacy of lifestyle intervention is questionable. In addition to lifestyle intervention, pharmacological\ntreatments have been explored. Metformin has been shown to be moderately effective to reduce BMI in obese\nadolescents with hyperinsulinemia. However, data on pharmacokinetics and long-term efficacy and safety are\nlacking as well as an evidence-based dosing regimen for this age group. The primary objective of the METFORMIN\nstudy is to determine the effect of adding metformin treatment to lifestyle intervention in reducing BMI in obese\nadolescents with insulin resistance. In addition, the pharmacokinetics of metformin in obese adolescents will be studied.\nMethods/design: The METFORMIN study is a multi-centre prospective study that consists of two 18-month phases: a\ndouble-blind randomized placebo-controlled trial (part 1) and an open-label follow-up study (part 2). During part 1, the\nparticipants will be given metformin 1,000 mg or placebo twice daily and will be offered a lifestyle intervention\nprogramme; 144 participants will be included, 72 in each arm. Primary endpoints are reduction in body mass index,\ninsulin resistance, and percentage body fat.\nDiscussion: This study will provide data on short- a
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