Clinical trial NCT03003754: Supervised Exercise-training in Children With Insulin Resistance or Healthy Metabolic Profile
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolism Disorder
Insulin Sensitivity
Obesity, Pediatric
Lead sponsor: Universidad Santo Tomas
Sponsor class: OTHER
Collaborators: name: Healthcare Center Tomas Rojas
name: Health Service of Los Ríos by the Health promotion program
name: Universidad Pública de Navarra
name: Universidad del Rosario
First posted: 2016-12-28
Enrollment: 60
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in plasma homeostasis model assessment (HOMA-IR)
timeFrame: Baseline and 6 weeks immediately after the interventions ends
Secondary outcomes:
measure: Change from Baseline in body mass
timeFrame: Baseline and 6 weeks immediately after the interventions ends
measure: Change from Baseline in body mass index
timeFrame: Baseline and 6 weeks immediately after the interventions ends
measure: Change from Baseline in waist circumference
timeFrame: Baseline and 6 weeks immediately after the interventions ends
measure: Change from Baseline in fat mass
timeFrame: Baseline and 6 weeks immediately after the interventions ends
measure: Change from Baseline in blood pressure
timeFrame: Baseline and 6 weeks immediately after the interventions ends
measure: Change from Baseline in fasting glucose
timeFrame: Baseline and 6 weeks immediately after the interventions ends
measure: Change from Baseline in fasting insulin
timeFrame: Baseline and 6 weeks immediately after the interventions ends
measure: Change from Baseline in one maximum repetition strength test of leg-extension exercise
timeFrame: Baseline and 6 weeks immediately after the interventions ends
measure: Change from Baseline in one maximum repetition strength test of shoulder press exercise
timeFrame: Baseline and 6 weeks immediately after the interventions ends
measure: Change from Baseline in one maximum repetition strength test of upper-row exercise
timeFrame: Baseline and 6 weeks immediately after the interventions ends
measure: Change from Baseline in one maximum repetition strength test of biceps curl exercise
timeFrame: Baseline and 6 weeks immediately after the interventions ends
Other outcomes:
Locations:
city: Bogota Distrito Especial
country: Colombia
facility: Robinson Ramírez-Vélez
state: Cundinamarca
Study officials:
References:
citation: 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.