Lifestyle intervention vs. metformin in the maintenance of normoglycemia in prediabetic adolescents
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INTRODUCTION: Type 2 diabetes mellitus (T2DM), once thought to be an adult disease, now affects large numbers of children. The prevalence of T2DM in children increased 35% between 2001 and 20091 and while it appears to now be leveling off, it is clear that much of the burden of disease falls disproportionately on ethnic minorities. It is well known that there are changes occurring in the microvasculature well before diabetes is diagnosed, and these changes are thought to contribute to micro- and macrovascular complications. Therefore, prediabetes, which is a time of mild hyperglycemia that exists between normal glucose metabolism and overt diabetes, provides a target for behavior modification and potentially the prevention of complications. The mainstay of treatment for diabetes has been lifestyle intervention and treatment with metformin. Research has shown that both intensive lifestyle interventions and metformin are effective for the treatment of T2DM. However, much of this knowledge comes from studies on adults and is simply inferred to youth. Thus, at this time it is still unknown to what extent treatments including lifestyle intervention and metformin should be used, or how they should be utilized, in youth. This is especially true for youth with prediabetes, as this is likely where prevention of the disease needs to occur to have the greatest overall benefit. PROPOSED STUDY: Thus, the proposed study will directly compare two groups treated with standard of care and either metformin daily or intensive lifestyle intervention with a CrossFit™ training modality. The primary outcome is treatment failure and development of diabetes. A secondary outcome is achievement of normoglycemia and its durability. CONCLUSIONS: This study will be the first to examine the longer term outcomes of the use of metformin in youth as well as the effects of high intensity functional training (HIFT) using the CrossFit™ modality. While there is accumulating evidence about the safety of the use of metformin in youth, most studies are of short duration and this study will provide longer term results. Additionally, CrossFit™, a relatively new exercise modality, has not been tested in the literature on youth and as a form of combined aerobic and resistance training, it may provide and effective and interesting means of lifestyle intervention and reversion to normoglycemia in adolescents. In conclusion the results from this study will provide significant clinical relevance.