Puberty Related Intervention to Improve Metabolic Outcomes (The PRIMO Study)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Puberty represents a critical period in terms of metabolic health. Racial differences in insulin dynamics, reproductive maturation, and the associated endocrine changes may affect a female's health later in life. Further, the peripubertal period is likely the period of racial divergence in adiposity noted between European American (EA) and African American (AA) girls. Diet is a major modifiable risk factor. The identification of simple, cost-effective dietary strategies for prevention and management of metabolic disease and excess fat mass accrual during the peripubertal period is a priority. Modification of the diet to affect metabolic and endocrine outcomes with and without weight loss during the pubertal transition represents a novel approach to the pediatric obesity epidemic. It is likely that the two diets used in this project will have different metabolic effects, including effects on postprandial glycemia, triglyceride concentration, free fatty acid concentration, and satiety. These factors may in turn, affect development of metabolic perturbations, especially in susceptible individuals (e.g. AA peripubertal girls).The role of carbohydrates on metabolic outcomes, particularly among children, has received little attention. It has been hypothesized that higher postprandial glycemia may be a mechanism for disease progression. Development of a diet that reduces insulin secretion and optimizes metabolic-endocrine health among peripubertal girls will likely reduce obesity and related co-morbidities and future reliance on pharmacologic treatments, even in the absence of weight loss. However, in light of the current trends in pediatric obesity, a safe and effective regimen that also promotes weight loss is needed for the pediatric population. This proposal is significant in that it will shed light on whether diet composition, as a part of a eucaloric (weight-stable) or hypocaloric diet (weight-loss) can influence the hyperinsulinemic characteristic of AA peripubertal girls. Existing data suggest that elevated concentrations of insulin and/or reproductive hormones may contribute to the fat mass accrual in AA and could elevate risks for development of chronic diseases in adulthood. The results of this study will lead to the development of dietary means for the reduction of insulin, and thereby to the prevention of both pediatric obesity and type 2 diabetes.

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Last update posted Nov 24, 2019 · Synced Sep 5, 2026

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