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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

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

Authors: 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

Published in: Trials | Issue 1/2017

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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.
Appendix
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Metadata
Title
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
Authors
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
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2117-y

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