Prevention of Diabetes in Overweight/Obese Preadolescent Children Through a Family-based Intervention Program Including Supervised Exercise; the PREDIKID Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Overweight Children With Type 2 Diabetes Risk
- Sponsor
- University of the Basque Country (UPV/EHU)
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- microRNA expression in circulating exosomes and in blood peripheral mononuclear cells
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
IDOIA LABAYEN
Professor
University of the Basque Country (UPV/EHU)
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Children with any medical condition that could affect the results of the study or that limits physical activity will be excluded
Outcomes
Primary Outcomes
microRNA expression in circulating exosomes and in blood peripheral mononuclear cells
Time Frame: 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
Time Frame: 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 Outcomes
- Inflammation and biochemical cardiovascular disease risk factors(Baseline and at the end of the 22 weeks of intervention)
- Ectopic fat: pancreatic and liver fat accumulation(Baseline and at the end of the 22 weeks of intervention)
- Total, abdominal and visceral adiposity(Baseline and at the end of the 22 weeks of intervention)
- Anthropometry and blood pressure(Baseline and at the end of the 22 weeks of intervention)
- Cardiorespiratory fitness(Baseline and at the end of the 22 weeks of intervention)
- Carotid intima-media thickness(Baseline and at the end of the 22 weeks of intervention)