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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03003754
Enrollment
60
Registered
2016-12-28
Start date
2015-06-30
Completion date
2017-02-28
Last updated
2018-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Sensitivity, Metabolism Disorder, Obesity, Pediatric

Brief 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.

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.

Sponsors

Healthcare Center Tomas Rojas
CollaboratorOTHER
Health Service of Los Ríos by the Health promotion program
CollaboratorUNKNOWN
Universidad Pública de Navarra
CollaboratorOTHER
Universidad del Rosario
CollaboratorOTHER
Universidad Santo Tomas
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
9 Years to 13 Years
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

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

Design outcomes

Primary

MeasureTime frame
Change from Baseline in plasma homeostasis model assessment (HOMA-IR)Baseline and 6 weeks immediately after the interventions ends

Secondary

MeasureTime frame
Change from Baseline in body mass indexBaseline and 6 weeks immediately after the interventions ends
Change from Baseline in waist circumferenceBaseline and 6 weeks immediately after the interventions ends
Change from Baseline in fat massBaseline and 6 weeks immediately after the interventions ends
Change from Baseline in blood pressureBaseline and 6 weeks immediately after the interventions ends
Change from Baseline in fasting glucoseBaseline and 6 weeks immediately after the interventions ends
Change from Baseline in body massBaseline and 6 weeks immediately after the interventions ends
Change from Baseline in one maximum repetition strength test of leg-extension exerciseBaseline and 6 weeks immediately after the interventions ends
Change from Baseline in one maximum repetition strength test of shoulder press exerciseBaseline and 6 weeks immediately after the interventions ends
Change from Baseline in one maximum repetition strength test of upper-row exerciseBaseline and 6 weeks immediately after the interventions ends
Change from Baseline in one maximum repetition strength test of biceps curl exerciseBaseline and 6 weeks immediately after the interventions ends
Change from Baseline in fasting insulinBaseline and 6 weeks immediately after the interventions ends

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026