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CompletedNCT03003754Updated Oct 15, 2018

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

An interventional study of High Intensity Training (HIT) + Resistance Training (RT) and Control group in Metabolism Disorder, Insulin Sensitivity and Obesity, Pediatric, sponsored by Universidad Santo Tomas. Completed at 1 site in Colombia. Open to participants aged 9 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-15.

Sponsored by Universidad Santo Tomas · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Jun 2015, registered Dec 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
9 Years to 13 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Metabolism Disorder
  • Insulin Sensitivity
  • Obesity, Pediatric
03

In context

Insulin Resistance

1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.

This study's enrollment of 60 is above the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

Universidad Santo Tomas is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
9 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

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

    To HIT program will be use cycle ergometers adapted for children (OXFORDTM, model BE2601, OXOFORD Inc, Santiago, Chile) were used. Each participant performed a range of 8 to 14 cycling intervals during the intervention period. The time of each work interval cycling will be increased progressively weekly, and ranged between 40-60 s (40 s weeks 1-2; 50 s weeks 3-5; 60 s week 6), with 120 s of passive rest (over the bicycle without movement) between each interval of work. The RT will consist in voluntary concentric/eccentric exercise during 1 minute until to get a high subjective effort perception (i.e., between 8-10 points based on the modified and subjective Borg scale of 1 to 10 points. Subjects will perform 4 exercises (biceps curl, leg-extension, shoulders press, and upper row exercise) during 6-weeks.

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

  • Active comparator
    Control group

    We will compare within each group (G)-1, G-2, and G-3 sub-group according to both RT and HIT intervention both pre-post changes as well as if are there some anthropometric, cardiovascular, and performance variable predicting changes in homeostasis model assessment (HOMA-IR).

    Behavioral: Control group

Interventions

  • BehavioralHigh Intensity Training (HIT) + Resistance Training (RT)

    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.

  • BehavioralControl group

    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.

06

What researchers measure

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

07

Study locations

1 site
  • Robinson Ramírez-Vélez
    Bogota Distrito Especial, Cundinamarca 000000000, Colombia
08

References and documents

Publications

  • Alvarez C, Ramirez-Campillo R, Ramirez-Velez R, Martinez C, Castro-Sepulveda M, Alonso-Martinez A, Izquierdo M. Metabolic effects of resistance or high-intensity interval training among glycemic control-nonresponsive children with insulin resistance. Int J Obes (Lond). 2018 Jan;42(1):79-87. doi: 10.1038/ijo.2017.177. Epub 2017 Jul 31. PubMed 28757639 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03003754
Lead sponsor
Universidad Santo Tomas
Collaborators
Healthcare Center Tomas Rojas, Health Service of Los Ríos by the Health promotion program, Universidad Pública de Navarra, Universidad del Rosario
Responsible party
Sponsor
First posted
Dec 28, 2016
Start date
Jun 2015
Primary completion
Dec 2016
Completion
Feb 2017
Last update
Oct 15, 2018

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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