Clinical trial NCT03027726: Prevention of Diabetes in Overweight/Obese Preadolescent Children
Official title: Prevention of Diabetes in Overweight/Obese Preadolescent Children Through a Family-based Intervention Program Including Supervised Exercise; the PREDIKID Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight Children With Type 2 Diabetes Risk
Lead sponsor: University of the Basque Country (UPV/EHU)
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
name: Universidad Pública de Navarra
First posted: 2017-01-23
Enrollment: 84
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Insulin resistance
timeFrame: Baseline and at the end of the 22 weeks of intervention
measure: microRNA expression in circulating exosomes and in blood peripheral mononuclear cells
timeFrame: Baseline and at the end of the 22 weeks of intervention
Secondary outcomes:
measure: Ectopic fat: pancreatic and liver fat accumulation
timeFrame: Baseline and at the end of the 22 weeks of intervention
measure: Total, abdominal and visceral adiposity
timeFrame: Baseline and at the end of the 22 weeks of intervention
measure: Anthropometry and blood pressure
timeFrame: Baseline and at the end of the 22 weeks of intervention
measure: Cardiorespiratory fitness
timeFrame: Baseline and at the end of the 22 weeks of intervention
measure: Carotid intima-media thickness
timeFrame: Baseline and at the end of the 22 weeks of intervention
measure: Inflammation and biochemical cardiovascular disease risk factors
timeFrame: Baseline and at the end of the 22 weeks of intervention
Other outcomes:
measure: Confounding variable: puberty stage
timeFrame: Baseline
measure: Confounding variable:physical activity and sleep
timeFrame: Baseline and at the end of the 22 weeks of intervention
measure: Confounding variable: dietary habits
timeFrame: Baseline and at the end of the 22 weeks of intervention
measure: Confounding variable: sedentary behaviors
timeFrame: Baseline and at the end of the 22 weeks of intervention
measure: Confounding variable: Socio-demographic variables:
timeFrame: Baseline
Locations:
city: Vitoria-Gasteiz
country: Spain
facility: Pediatric Endocrinology Unit of the University Hospital of Araba (HUA)
state: Araba
Study officials:
References:
citation: Medrano M, Maiz E, Maldonado-Martin S, Arenaza L, Rodriguez-Vigil B, Ortega FB, Ruiz JR, Larrarte E, Diez-Lopez I, Sarasua-Miranda A, Tobalina I, Barrenechea L, Perez-Asenjo J, Kannengiesser S, Manhaes-Savio A, Echaniz O, Labayen I. The effect of a multidisciplinary intervention program on hepatic adiposity in overweight-obese children: protocol of the EFIGRO study. Contemp Clin Trials. 2015 Nov;45(Pt B):346-355. doi: 10.1016/j.cct.2015.09.017. Epub 2015 Sep 25.
citation: Arenaza L, Medrano M, Amasene M, Rodriguez-Vigil B, Diez I, Grana M, Tobalina I, Maiz E, Arteche E, Larrarte E, Huybrechts I, Davis CL, Ruiz JR, Ortega FB, Margareto J, Labayen I. 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. Trials. 2017 Aug 10;18(1):372. doi: 10.1186/s13063-017-2117-y.