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

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.

Study Overview

• Status: Completed
• Conditions: Insulin Sensitivity; Obesity, Pediatric; Metabolism Disorder
• Intervention / Treatment: Behavioral: High Intensity Training (HIT) + Resistance Training (RT); Behavioral: Control group

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 13 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in plasma homeostasis model assessment (HOMA-IR)	Baseline and 6 weeks immediately after the interventions ends

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in body mass	Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in body mass index	Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in waist circumference	Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in fat mass	Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in blood pressure	Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in fasting glucose	Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in fasting insulin	Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in one maximum repetition strength test of leg-extension exercise	Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in one maximum repetition strength test of shoulder press exercise	Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in one maximum repetition strength test of upper-row exercise	Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in one maximum repetition strength test of biceps curl exercise	Baseline and 6 weeks immediately after the interventions ends

Collaborators and Investigators

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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: December 22, 2016
• First Submitted That Met QC Criteria: December 22, 2016
• First Posted (Estimate): December 28, 2016

Study Record Updates

• Last Update Posted (Actual): October 15, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Hyperinsulinism; Obesity; Pediatric Obesity; Insulin Resistance; Metabolic Diseases
• Other Study ID Numbers: 2016-12-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO