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Completed

NCT Number: NCT03003754

Supervised Exercise-training in Children With Insulin Resistance or Healthy Metabolic Profile

Despite exercise training decrease blood fasting glycemia in 'average' terms, there is a wide interindividual variability after exercise training explored mainly in adults but not in children. Thus, is yet unknown what baseline health status as well as the influence of what health variable may produce more/less non-responder (NR) prevalence (i.e., percentage of subjects who experienced a non-change/worsened response after training in some metabolic outcomes) after exercise training in school children.

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Key information

Conditions

Metabolism Disorder Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Insulin Sensitivity Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Pediatric Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

9 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Robinson Ramírez-Vélez

Bogota Distrito Especial, Cundinamarca, 000000000, Colombia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed of insulin resistance by one of three plasmatic glucose control: HOMA-IR ≥3.0,
  • Fasting insulin levels ≥15 µUI/dL or fasting glucose ≥100 and ≤126 mg/dL within the enrolment stage applied at school (i.e., ≤3 months),
  • Physical inactivity (volume of ≤60 min/day of moderate physical activity),
  • To be participating of regular practical physical education classes at school (i.e., 90 min/week),
  • Living only in urban areas.

Exclusion criteria

  • Potential medical, musculoskeletal problems or a familial history of T2DM,
  • Ischemic disease,
  • Arrhythmia,
  • Asthma,
  • Utilization of drugs that modulate the metabolic and respiratory control.

Treatment and study plan

High Intensity Training (HIT) + Resistance Training (RT)

Behavioral

Exercise will be performed at three sessions per week. Post statistical analyses will be including analyses by the 3 sub-groups proposed. All sessions will be supervised by an exercise physiologist during 6 weeks.

Control Group

Behavioral

Post statistical analyses will be including analyses by the 3 sub-groups proposed Exercise will be performed at three sessions per week. All sessions will be supervised by an exercise physiologist during 6 weeks.

Primary outcomes

  1. Change from Baseline in plasma homeostasis model assessment (HOMA-IR)

    Time frame: Baseline and 6 weeks immediately after the interventions ends

Secondary outcomes

  1. Change from Baseline in body mass

    Time frame: Baseline and 6 weeks immediately after the interventions ends

  2. Change from Baseline in body mass index

    Time frame: Baseline and 6 weeks immediately after the interventions ends

  3. Change from Baseline in waist circumference

    Time frame: Baseline and 6 weeks immediately after the interventions ends

  4. Change from Baseline in fat mass

    Time frame: Baseline and 6 weeks immediately after the interventions ends

  5. Change from Baseline in blood pressure

    Time frame: Baseline and 6 weeks immediately after the interventions ends

  6. Change from Baseline in fasting glucose

    Time frame: Baseline and 6 weeks immediately after the interventions ends

  7. Change from Baseline in fasting insulin

    Time frame: Baseline and 6 weeks immediately after the interventions ends

  8. Change from Baseline in one maximum repetition strength test of leg-extension exercise

    Time frame: Baseline and 6 weeks immediately after the interventions ends

  9. Change from Baseline in one maximum repetition strength test of shoulder press exercise

    Time frame: Baseline and 6 weeks immediately after the interventions ends

  10. Change from Baseline in one maximum repetition strength test of upper-row exercise

    Time frame: Baseline and 6 weeks immediately after the interventions ends

  11. Change from Baseline in one maximum repetition strength test of biceps curl exercise

    Time frame: Baseline and 6 weeks immediately after the interventions ends

Sponsors and collaborators

Lead sponsor

Universidad Santo Tomas

Other

Collaborators

  • Health Service of Los Ríos by the Health promotion program
  • Healthcare Center Tomas Rojas
  • Universidad Pública de Navarra
  • Universidad del Rosario

Registry information

Official study title

Supervised Exercise-training in Children With Insulin Resistance or Healthy Metabolic Profile: Cardiometabolic Risk Factors and Muscular Strength Changes in Responders and Non Responders

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Dec 28, 2016
Registry last updated
Oct 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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