Objective. To assess the effectiveness of metformin and therapeutic lifestyle changes (TLCs) in a clinical setting, compared to TLC alone in adolescents with metabolic syndrome (MS). Methodology. This study was a retrospective trial consisting of 60 patients, aged 8–18 years, who were treated for MS at an outpatient clinic. Two groups were formed: the metformin group (M group) and the control group (C group). The M group had been given metformin along with TLC, and the C group had been given TLC alone. Several outcome measures were obtained; the main outcome measure was measuring the change in percentile and z-score of weight and BMI. Results. There were no significant differences between the two groups at the conclusion of the study, except for height percentile ( ) and z-score ( ). Both groups showed promising significant intragroup decreases in weight z-score but BMI percentile and z-score were only significantly decreased in the M group. Conclusion. Metformin at an average dose of 1033？mg, when added to TLC, did not show any clinically important efficacy compared to TLC alone in a pediatric population with MS. However, both groups made significant changes in a positive direction, which may be solely due to TLC. 1. Introduction During the last 30 years, childhood obesity rates have more than tripled in the United States [1]. The National Health and Nutrition Examination Survey (NHANES) from 2007-2008 estimated that 16.9% of children from ages of 2- to 19-years old were obese [1]. In 12–19 year olds the obesity rate has increased from 5.0% in the 1976–1980 NHANES survey to 18.1% in 2007-2008 [1]. Further, a strong correlation between childhood obesity and adult obesity has been found and an increasing need to intervene at a younger age may be important [2]. Despite available data in this field, no FDA approved medications that specifically target weight loss, are available for pediatric patients. The most predictive factors for obesity, cardiovascular disease, and diabetes have been defined in the criteria for metabolic syndrome (MS) [3]. These risk factors include: hypertension, glucose intolerance, high triglycerides, low HDL-cholesterol concentrations, and elevated waist circumference [3]. Outcome measures based on these criteria constitute a way to assess the effectiveness of a treatment plan. MS is possibly reversible and early intervention might prevent progression to a more serious illness. One therapy of particular interest is the medication metformin, which is currently approved for use in type 2 diabetes mellitus. Metformin increases insulin
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