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Prevention of Diabetes in Overweight/Obese Preadolescent Children (PREDIKID)

19. november 2020 oppdatert av: IDOIA LABAYEN, University of the Basque Country (UPV/EHU)

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

84

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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Studiesteder

  • Spania
    • Araba
      • Vitoria-Gasteiz, Araba, Spania, 01009
        • Pediatric Endocrinology Unit of the University Hospital of Araba (HUA)

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

8 år til 12 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Control group
Family-based lifestyle education and psycho-educational program
Atferdsmessig: lifestyle 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
Eksperimentell: Exercise group
Supervised exercise plus family-based lifestyle education and psycho-educational program
Atferdsmessig: lifestyle 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
Annen: Exercise plus lifestyle and psycho-educational program
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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Insulin resistance
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Ectopic fat: pancreatic and liver fat accumulation
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Confounding variable: puberty stage
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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:
Tidsramme: 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

Samarbeidspartnere og etterforskere

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Sponsor

University of the Basque Country (UPV/EHU)

Samarbeidspartnere

Universidad Pública de Navarra
Ministerio de Economía y Competitividad, Spain

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

7. mars 2017

Primær fullføring (Faktiske)

15. september 2018

Studiet fullført (Faktiske)

15. september 2018

Datoer for studieregistrering

Først innsendt

16. januar 2017

Først innsendt som oppfylte QC-kriteriene

18. januar 2017

Først lagt ut (Anslag)

23. januar 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. november 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. november 2020

Sist bekreftet

1. november 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • DEP2016-78377-R

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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