Prevention of Diabetes in Overweight/Obese Preadolescent Children
- Conditions
- Overweight Children With Type 2 Diabetes Risk
- Interventions
- Behavioral: lifestyle and psycho-educational programOther: Exercise plus lifestyle and psycho-educational program
- Registration Number
- NCT03027726
- Lead Sponsor
- University of the Basque Country (UPV/EHU)
- Brief Summary
Background: The global pandemic obesity has led to increased risk for prediabetes and type 2 diabetes (T2D).
Objectives: (i) To evaluate the effect of a 22 weeks multidisciplinary intervention program including exercise on T2D risk in pre-adolescents with high risk to develop T2D, and (ii) To identify the profile of microRNA in circulating exosomes and in blood peripheral mononuclear cells in pre-adolescents with high risk to develop T2D and its response to a multidisciplinary intervention program including exercise.
- Detailed Description
Background: The global pandemic obesity has led to increased risk for prediabetes and type 2 diabetes (T2D).
Objectives: (i) To evaluate the effect of a 22 weeks multidisciplinary intervention program including exercise on T2D risk in pre-adolescents with high risk to develop T2D, and (ii) To identify the profile of microRNA in circulating exosomes and in blood peripheral mononuclear cells in pre-adolescents with high risk to develop T2D and its response to a multidisciplinary intervention program including exercise.
Design, participants and methods: A total of 84 children with high risk of type 2 diabetes mellitus aged 8-12 years 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). The duration of training sessions will be 90 min of exercise, 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; total and abdominal fat (dual X-ray absorptiometry); pancreatic, hepatic and visceral fat (magnetic resonance imaging); systolic and diastolic blood pressure; fasting leptin, adiponectin, fibroblast growth factor-21, fetuin-A, hs-C-reactive protein, tumor necrosis factor-alfa, interleukin (IL)-1beta and IL-6 and lipid profile; carotid intima-media thickness (ultrasonography), microRNA expression in circulating exosomes and in blood peripheral mononuclear cells (MiSeq-Illumina); functional peak aerobic capacity (cardiopulmonary exercise testing and 20m shuttle run test). Changes in dietary habits (food frequency questionnaire and two non-consecutive 24h recalls), physical activity and sleep (accelerometry); sex, age, socioeconomic status and pubertal status will be used as potential confounders.
Discussion/Conclusions: Early prevention and identification of children with high risk to develop T2D could help to reduce the morbidity and mortality associated with the disease.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
- Overweight/obese children aged between 8 and 12 years, meeting the international criteria for classification for T2D risk and having at least one parent or caregiver willing to participate in the program sessions will be included
- Children with any medical condition that could affect the results of the study or that limits physical activity will be excluded
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group lifestyle and psycho-educational program Family-based lifestyle education and psycho-educational program Exercise group Exercise plus lifestyle and psycho-educational program Supervised exercise plus family-based lifestyle education and psycho-educational program Exercise group lifestyle and psycho-educational program Supervised exercise plus family-based lifestyle education and psycho-educational program
- Primary Outcome Measures
Name Time Method microRNA expression in circulating exosomes and in blood peripheral mononuclear cells Baseline and at the end of the 22 weeks of intervention The expression of miRNAs will be measured in circulating exosomes and in white blood cells (MiSeq-Ilumina)
Insulin resistance Baseline and at the end of the 22 weeks of intervention The Homeostasis model assessment index will be calculated as fasting insulin concentration (microU/mL) x fasting glucose concentration (mmol/L)/22.5.
- Secondary Outcome Measures
Name Time Method Inflammation and biochemical cardiovascular disease risk factors Baseline and at the end of the 22 weeks of intervention Fasting lipid profile (total-, HDL- and LDL-cholesterol, and triglycerides), glucose, insulin, and hemoglobin A1c, cytokines (e.g. tumor necrosis factor alpha and IL-6) adipokines (e.g leptin and adiponectin), hepatokines (fetuin-A and fibroblast growth factor-21), liver enzymes (alanine aminotransferase, aspartate aminotransferase and gamma-glutamyl transferase), C-reactive protein, thyroid hormones (thyroid stimulating hormone, triiodothyronine and free thyroxine), urea, bilirubin and uric acid
Ectopic fat: pancreatic and liver fat accumulation Baseline and at the end of the 22 weeks of intervention Hepatic and pancreatic fat will be measured by magnetic resonance
Total, abdominal and visceral adiposity Baseline and at the end of the 22 weeks of intervention Total and abdominal adiposity will be measured by dual energy X-ray absorptiometry. Visceral adiposity will be measured by magnetic resonance imaging
Anthropometry and blood pressure Baseline and at the end of the 22 weeks of intervention Body mass, height and waist circumference will be measured following standard protocols at least twice until consistent measures will be obtained and thereafter, body mass index (BMI) and waist to height ratio will be calculated. Systolic and diastolic blood pressure measurements will be performed following the recommendations for children using an arm blood pressure oscillometric monitor device
Cardiorespiratory fitness Baseline and at the end of the 22 weeks of intervention Cardiorespiratory fitness will be assessed by two different tests: (i) The 20m shuttle run test in which the equation reported by Léger et al. will be used to estimate the maximum oxygen consumption (VO2max, ml/kg/min) from the 20m shuttle run test scores, and (ii) Direct cardiopulmonary exercise progressive incremental treadmill test using the modified American College of Sports Medicine protocol with respiratory gas analysis to exhaustion
Carotid intima-media thickness Baseline and at the end of the 22 weeks of intervention carotid intima-media thickness will be measured by ultrasound according to international recommendations.
Trial Locations
- Locations (1)
Pediatric Endocrinology Unit of the University Hospital of Araba (HUA)
🇪🇸Vitoria-Gasteiz, Araba, Spain