通过包括监督锻炼在内的家庭干预计划预防超重/肥胖儿童患糖尿病（PREDIKID项目）：一项随机对照试验的研究方案
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.
作者信息
Arenaza Lide, Medrano María, Amasene María, Rodríguez-Vigil Beatriz, Díez Ignacio, Graña Manuel, Tobalina Ignacio, Maiz Edurne, Arteche Edurne, Larrarte Eider, Huybrechts Inge, Davis Catherine L, Ruiz Jonatan R, Ortega Francisco B, Margareto Javier, Labayen Idoia
机构信息
Nutrition, Exercise and Health Research group, Elikadura, Ariketa Fisikoa eta Osasuna, ELIKOS group, Department of Nutrition and Food Science, University of the Basque Country, UPV/EHU, Vitoria-Gasteiz, Spain.
Department of Magnetic Resonance Imaging, Osatek, University Hospital of Alava (HUA), Vitoria-Gasteiz, Spain.
出版信息
Trials. 2017 Aug 10;18(1):372. doi: 10.1186/s13063-017-2117-y.
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.
背景
肥胖症的全球流行导致前驱糖尿病和2型糖尿病（T2D）的风险增加。本项目的目标是：（1）评估一项为期22周的基于家庭的干预计划（包括监督运动）对有发展为T2D高风险儿童的胰岛素抵抗综合征（IRS）风险的影响；（2）确定有发展为T2D高风险儿童循环外泌体和外周血单核细胞中的微小RNA谱及其对包括运动在内的多学科干预计划的反应。
方法
总共将纳入84名8至12岁有T2D高风险的儿童，并随机分为对照组（N = 42）或干预组（N = 42）。对照组将接受基于家庭的生活方式教育和心理教育计划（每月2天），而干预组将参加相同的生活方式教育和心理教育计划以及运动计划（每周3天，每次90分钟，包括热身、中度至剧烈有氧运动和力量训练）。在随机分组前的基线和干预后将评估以下指标：空腹胰岛素、血糖和糖化血红蛋白A1c；身体成分（双能X线吸收法）；异位脂肪（磁共振成像）；循环外泌体和外周血单核细胞中的微小RNA表达（MiSeq；Illumina）；心肺适能（心肺运动测试）；饮食习惯和身体活动（加速度计）。
讨论
预防和识别有发展为T2D高风险的儿童有助于改善他们的心血管健康并减少与肥胖相关的合并症。
试验注册
ClinicalTrials.gov，ID：NCT03027726。于2017年1月16日注册。
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