Prevention of Diabetes in Overweight/Obese Preadolescent Children (PREDIKID)
Prevention of Diabetes in Overweight/Obese Preadolescent Children Through a Family-based Intervention Program Including Supervised Exercise; the PREDIKID Study
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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Araba
-
Vitoria-Gasteiz, Araba, Spanien, 01009
- Pediatric Endocrinology Unit of the University Hospital of Araba (HUA)
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Control group
Family-based lifestyle education and psycho-educational program
|
The family-based healthy lifestyle education and psychological education program will be followed once every two weeks (11 sessions over 22 weeks) for 90 minutes (45 minutes in the healthy lifestyle education program and 45 minutes in the psycho-educational intervention).
The sessions of the healthy lifestyle education and psycho-educational interventions will be developed simultaneously and delivered to both parents (or caregivers) and children, separately.
The family-based healthy lifestyle education program will be conducted by experienced nutritionists and the psycho-educational program by experienced psychologists in behavior changes
|
|
Experimentell: Exercise group
Supervised exercise plus family-based lifestyle education and psycho-educational program
|
The family-based healthy lifestyle education and psychological education program will be followed once every two weeks (11 sessions over 22 weeks) for 90 minutes (45 minutes in the healthy lifestyle education program and 45 minutes in the psycho-educational intervention).
The sessions of the healthy lifestyle education and psycho-educational interventions will be developed simultaneously and delivered to both parents (or caregivers) and children, separately.
The family-based healthy lifestyle education program will be conducted by experienced nutritionists and the psycho-educational program by experienced psychologists in behavior changes
The intervention group will attend the same lifestyle education and psycho-educational program plus the exercise program.
The exercise group will do exercise 3 days/week, 90 minutes per session, over a 22-week period.
The program will be offered to the families five days per week to choose a total of three days/week.
Sessions will be designed and supervised by exercise specialists.
The duration of training sessions will be 90 minutes of exercise, including warm-up, moderate to vigorous aerobic activities, and strength exercises
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Insulin resistance
Tidsram: 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.
|
Baseline and at the end of the 22 weeks of intervention
|
|
microRNA expression in circulating exosomes and in blood peripheral mononuclear cells
Tidsram: 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)
|
Baseline and at the end of the 22 weeks of intervention
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Ectopic fat: pancreatic and liver fat accumulation
Tidsram: Baseline and at the end of the 22 weeks of intervention
|
Hepatic and pancreatic fat will be measured by magnetic resonance
|
Baseline and at the end of the 22 weeks of intervention
|
|
Total, abdominal and visceral adiposity
Tidsram: 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
|
Baseline and at the end of the 22 weeks of intervention
|
|
Anthropometry and blood pressure
Tidsram: 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
|
Baseline and at the end of the 22 weeks of intervention
|
|
Cardiorespiratory fitness
Tidsram: 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
|
Baseline and at the end of the 22 weeks of intervention
|
|
Carotid intima-media thickness
Tidsram: Baseline and at the end of the 22 weeks of intervention
|
carotid intima-media thickness will be measured by ultrasound according to international recommendations.
|
Baseline and at the end of the 22 weeks of intervention
|
|
Inflammation and biochemical cardiovascular disease risk factors
Tidsram: 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
|
Baseline and at the end of the 22 weeks of intervention
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Confounding variable: puberty stage
Tidsram: Baseline
|
The pediatrician will evaluate Tanner staging by direct examination with breast palpation in girls and testicular measurement by orchidometer in boys.
|
Baseline
|
|
Confounding variable:physical activity and sleep
Tidsram: Baseline and at the end of the 22 weeks of intervention
|
Children will wear an activity monitor on the wrist for 7 consecutive days for 24 hours to record physical activity intensity levels and patterns, as well as sleeping habits and participants will also complete a diary log
|
Baseline and at the end of the 22 weeks of intervention
|
|
Confounding variable: dietary habits
Tidsram: Baseline and at the end of the 22 weeks of intervention
|
Dietary intake will be evaluated by two non-consecutive 24h recalls within a period of seven days by nutritionists and a validated food frequency questionnaire
|
Baseline and at the end of the 22 weeks of intervention
|
|
Confounding variable: sedentary behaviors
Tidsram: Baseline and at the end of the 22 weeks of intervention
|
Sedentary behaviors such as watching television, playing computer games, playing video games or phone games, and surfing the Internet will be self-reported by the children using validated questionnaires
|
Baseline and at the end of the 22 weeks of intervention
|
|
Confounding variable: Socio-demographic variables:
Tidsram: Baseline
|
Information about socioeconomic status, demographic characteristics and family medical history of obesity, diabetes, dyslipidemia and hypertension will be collected.
Socioeconomic status will be evaluated using The Family Affluence Scale (74) and parental education level and parental occupation.
As demographic characteristics date of birth, sex, ethnicity and family structure will be recorded.
|
Baseline
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- DEP2016-78377-R
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .