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Trial record 48 of 134 for:    exosomes

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

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ClinicalTrials.gov Identifier: NCT03027726
Recruitment Status : Completed
First Posted : January 23, 2017
Last Update Posted : November 15, 2018
Sponsor:
Collaborator:
Ministerio de Economía y Competitividad, Spain
Information provided by (Responsible Party):
IDOIA LABAYEN, Basque Country University

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.


Condition or disease Intervention/treatment Phase
Overweight Children With Type 2 Diabetes Risk Behavioral: lifestyle and psycho-educational program Other: Exercise plus lifestyle and psycho-educational program Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prevention of Diabetes in Overweight/Obese Preadolescent Children Through a Family-based Intervention Program Including Supervised Exercise; the PREDIKID Study
Actual Study Start Date : March 7, 2017
Actual Primary Completion Date : September 15, 2018
Actual Study Completion Date : September 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control group
Family-based lifestyle education and psycho-educational program
Behavioral: 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

Experimental: Exercise group
Supervised exercise plus family-based lifestyle education and psycho-educational program
Behavioral: 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

Other: 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




Primary Outcome Measures :
  1. 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.

  2. 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)


Secondary Outcome Measures :
  1. Ectopic fat: pancreatic and liver fat accumulation [ Time Frame: Baseline and at the end of the 22 weeks of intervention ]
    Hepatic and pancreatic fat will be measured by magnetic resonance

  2. Total, abdominal and visceral adiposity [ Time Frame: 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

  3. Anthropometry and blood pressure [ Time Frame: 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

  4. Cardiorespiratory fitness [ Time Frame: 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

  5. Carotid intima-media thickness [ Time Frame: Baseline and at the end of the 22 weeks of intervention ]
    carotid intima-media thickness will be measured by ultrasound according to international recommendations.

  6. Inflammation and biochemical cardiovascular disease risk factors [ Time Frame: 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


Other Outcome Measures:
  1. Confounding variable: puberty stage [ Time Frame: Baseline ]
    The pediatrician will evaluate Tanner staging by direct examination with breast palpation in girls and testicular measurement by orchidometer in boys.

  2. Confounding variable:physical activity and sleep [ Time Frame: 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

  3. Confounding variable: dietary habits [ Time Frame: 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

  4. Confounding variable: sedentary behaviors [ Time Frame: 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

  5. Confounding variable: Socio-demographic variables: [ Time Frame: 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.



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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03027726


Locations
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Spain
Pediatric Endocrinology Unit of the University Hospital of Araba (HUA)
Vitoria-Gasteiz, Araba, Spain, 01009
Sponsors and Collaborators
Basque Country University
Ministerio de Economía y Competitividad, Spain

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: IDOIA LABAYEN, Professor, Basque Country University
ClinicalTrials.gov Identifier: NCT03027726     History of Changes
Other Study ID Numbers: DEP2016-78377-R
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms