![]() Informed consent was obtained from all participants' parents and assent was obtained from all children and young people who took part in the trial. In the MOCA trial, compensatory hyperinsulinemia was defined using local data and data from previous studies that determined insulin ranges in nonobese children and young people ( 29, 30). Standards for insulin resistance in children have not been established, and measurement of insulin levels is not optimal for the assessment of peripheral insulin sensitivity but may provide information regarding the associated compensatory hyperinsulinemia ( 28). fasting insulin greater than 26 mIU/liter or 120-min insulin greater than 89 mIU/liter (pubertal/postpubertal children) fasting insulin greater than 15 mIU/liter or 120-min insulin greater than 89 mIU/liter (prepubertal children). OGTT 2-h plasma glucose value 7.8 or greater to 11.1 mmol/liter or less (with or without impaired fasting glucose ≥ 6.1 to ≤ 7.0 mmol/liter) or hyperinsulinemia, i.e. BMI centile charts and impaired glucose tolerance, i.e. Participants were invited to enter the trial according to the following inclusion criteria: BMI greater than the 98th centile on U.K. These children and young people were screened with a standard 120-min oral glucose tolerance test (OGTT). The participants for the trial were identified from a cohort of obese children and young people who were referred to the centers for obesity. It was a double-blind, placebo controlled, parallel-group trial conducted in the United Kingdom. ![]() MOCA was a multicenter trial, stratified by gender and age (8–13 yr and 14–18 yr with balanced randomization). The secondary objectives were to determine the effect of metformin on BMI and waist to hip ratio, fasting and postprandial insulin and glucose levels, metabolic risk factors, and adipokines (secondary outcomes). The primary objective of the Metformin in Obese Children and Adolescents (MOCA) trial was to determine whether metformin (1.5 g/d for 6 months) in obese children and young people (8–18 yr) with hyperinsulinemia and/or impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) is more effective than placebo in the reduction of BMI sd scores (BMI-SDS) (primary outcome). Some randomized trials in children and young people have demonstrated that metformin treatment is associated with small reductions in body mass index (BMI), weight, fasting insulin and glucose, 120-min insulin, and homeostasis model of insulin resistance ( 19– 27) however, study limitations include small sample size and presentation of unadjusted outcomes without intention-to-treat analyses. In adults robust evidence exists for reduced progression from IR to T2D with lifestyle intervention or metformin treatment ( 15– 18). The treatment of T2D is well established however, the clinical relevance of IR and IRS in children and young people and the rationale for treatment remains controversial because the evidence to support treatment, other than for T2D, is deficient. ![]() Intervention at this early stage may therefore prevent further deterioration in cardiovascular and metabolic status. A study in 151 overweight youths found that increasing quartiles of fasting and 2-h insulin were associated with increasing cardiovascular risk factors, leading to the theory that hyperinsulinemia may well be the first abnormality that presents in obese children and young people ( 14). Development of IR, IRS, and T2D in childhood can be associated with both current and future health problems, including increased risk of developing metabolic and cardiovascular complications, and an increased risk of premature death ( 13). Both these conditions are predicated by the development of obesity related insulin resistance (IR) ( 12), and both conditions were previously uncommon in pediatrics. ![]() ![]() The rise in the global prevalence of childhood obesity over the last 2 decades ( 1, 2) has led to increased diagnosis of type 2 diabetes (T2D) ( 3– 7) and insulin resistance syndrome (IRS) ( 8– 11) in children and young people. ![]()
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