TY - JOUR
T1 - Prevention of diabetes in overweight/obese children through a family based intervention program including supervised exercise (PREDIKID project)
T2 - Study protocol for a randomized controlled trial
AU - Arenaza, Lide
AU - Medrano, María
AU - Amasene, María
AU - Rodríguez-Vigil, Beatriz
AU - Díez, Ignacio
AU - Graña, Manuel
AU - Tobalina, Ignacio
AU - Maiz, Edurne
AU - Arteche, Edurne
AU - Larrarte, Eider
AU - Huybrechts, Inge
AU - Davis, Catherine L.
AU - Ruiz, Jonatan R.
AU - Ortega, Francisco B.
AU - Margareto, Javier
AU - Labayen, Idoia
N1 - Funding Information:
The current project was supported by the Spanish Ministry of Industry and Competitiveness (DEP2016-78377-R), by “Fondos Estructurales de la Unión Europea (FEDER), Una manera de hacer Europa.” and by the University of the Basque Country (GIU14/21). This work was also supported by grants from Spanish Ministry of Economy and Competitiveness (RYC-2010-05957; RYC-2011-09011), Spanish Ministry of Education, Culture and Sports (FPU14/ 03329) and by the Education, Linguistic Policy and Culture Department of the Government of the Basque Country (PRE_2016_1_0057).
Publisher Copyright:
© 2017 The Author(s).
PY - 2017/8/10
Y1 - 2017/8/10
N2 - 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.
AB - 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.
KW - Children
KW - Ectopic fat
KW - Exercise
KW - Family based lifestyle intervention program
KW - MiRNA
KW - Type-2 diabetes
UR - http://www.scopus.com/inward/record.url?scp=85027098526&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85027098526&partnerID=8YFLogxK
U2 - 10.1186/s13063-017-2117-y
DO - 10.1186/s13063-017-2117-y
M3 - Article
C2 - 28793919
AN - SCOPUS:85027098526
SN - 1745-6215
VL - 18
JO - Trials
JF - Trials
IS - 1
M1 - 372
ER -
