Trials (Aug 2017)

Prevention of diabetes in overweight/obese children through a family based intervention program including supervised exercise (PREDIKID project): study protocol for a randomized controlled trial

  • Lide Arenaza,
  • María Medrano,
  • María Amasene,
  • Beatriz Rodríguez-Vigil,
  • Ignacio Díez,
  • Manuel Graña,
  • Ignacio Tobalina,
  • Edurne Maiz,
  • Edurne Arteche,
  • Eider Larrarte,
  • Inge Huybrechts,
  • Catherine L. Davis,
  • Jonatan R. Ruiz,
  • Francisco B. Ortega,
  • Javier Margareto,
  • Idoia Labayen

DOI
https://doi.org/10.1186/s13063-017-2117-y
Journal volume & issue
Vol. 18, no. 1
pp. 1 – 12

Abstract

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Abstract Background The global pandemic of obesity has led to an increased risk for prediabetes and type-2 diabetes (T2D). The aims of the current project are: (1) to evaluate the effect of a 22-week family based intervention program, including supervised exercise, on insulin resistance syndrome (IRS) risk in children with a high risk of developing T2D and (2) to identify the profile of microRNA in circulating exosomes and in peripheral blood mononuclear cells in children with a high risk of developing T2D and its response to a multidisciplinary intervention program including exercise. Methods A total of 84 children, aged 8–12 years, with a high risk of T2D will be included and randomly assigned to control (N = 42) or intervention (N = 42) groups. The control group will receive a family based lifestyle education and psycho-educational program (2 days/month), while the intervention group will attend the same lifestyle education and psycho-educational program plus the exercise program (3 days/week, 90 min per session including warm-up, moderate to vigorous aerobic activities, and strength exercises). The following measurements will be evaluated at baseline prior to randomization and after the intervention: fasting insulin, glucose and hemoglobin A1c; body composition (dual-energy X-ray absorptiometry); ectopic fat (magnetic resonance imaging); microRNA expression in circulating exosomes and in peripheral blood mononuclear cells (MiSeq; Illumina); cardiorespiratory fitness (cardiopulmonary exercise testing); dietary habits and physical activity (accelerometry). Discussion Prevention and identification of children with a high risk of developing T2D could help to improve their cardiovascular health and to reduce the comorbidities associated with obesity. Trial registration ClinicalTrials.gov, ID: NCT03027726 . Registered on 16 January 2017.

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