Overweight Children With Type 2 Diabetes Risk Clinical Trial
— PREDIKIDOfficial title:
Prevention of Diabetes in Overweight/Obese Preadolescent Children Through a Family-based Intervention Program Including Supervised Exercise; the PREDIKID Study
| Verified date | November 2020 |
| Source | Basque Country University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 84 |
| Est. completion date | September 15, 2018 |
| Est. primary completion date | September 15, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 8 Years to 12 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Pediatric Endocrinology Unit of the University Hospital of Araba (HUA) | Vitoria-Gasteiz | Araba |
| Lead Sponsor | Collaborator |
|---|---|
| Basque Country University | Ministerio de Economía y Competitividad, Spain, Universidad Pública de Navarra |
Spain,
Medrano M, Maiz E, Maldonado-Martín S, Arenaza L, Rodríguez-Vigil B, Ortega FB, Ruiz JR, Larrarte E, Diez-López I, Sarasúa-Miranda A, Tobalina I, Barrenechea L, Pérez-Asenjo J, Kannengiesser S, Manhães-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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Confounding variable: puberty stage | The pediatrician will evaluate Tanner staging by direct examination with breast palpation in girls and testicular measurement by orchidometer in boys. | Baseline | |
| Other | Confounding variable:physical activity and sleep | 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 | |
| Other | Confounding variable: dietary habits | 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 | |
| Other | Confounding variable: sedentary behaviors | 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 | |
| Other | Confounding variable: Socio-demographic variables: | 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 | |
| Primary | Insulin resistance | 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 | |
| Primary | microRNA expression in circulating exosomes and in blood peripheral mononuclear cells | 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 | |
| Secondary | Ectopic fat: pancreatic and liver fat accumulation | Hepatic and pancreatic fat will be measured by magnetic resonance | Baseline and at the end of the 22 weeks of intervention | |
| Secondary | Total, abdominal and visceral adiposity | 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 | |
| Secondary | Anthropometry and blood pressure | 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 | |
| Secondary | Cardiorespiratory fitness | 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 | |
| Secondary | Carotid intima-media thickness | carotid intima-media thickness will be measured by ultrasound according to international recommendations. | Baseline and at the end of the 22 weeks of intervention | |
| Secondary | Inflammation and biochemical cardiovascular disease risk factors | 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 |