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

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ClinicalTrials.gov Identifier: NCT03003754
Recruitment Status : Completed
First Posted : December 28, 2016
Last Update Posted : October 15, 2018
Sponsor:
Collaborators:
Healthcare Center Tomas Rojas
Health Service of Los Ríos by the Health promotion program
Universidad Pública de Navarra
Universidad del Rosario
Information provided by (Responsible Party):
Universidad Santo Tomas

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.

Condition or disease Intervention/treatment Phase
Metabolism Disorder Insulin Sensitivity Obesity, Pediatric Behavioral: High Intensity Training (HIT) + Resistance Training (RT) Behavioral: Control group Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : June 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change from Baseline in plasma homeostasis model assessment (HOMA-IR) [ Time Frame: Baseline and 6 weeks immediately after the interventions ends ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   9 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03003754


Locations
Colombia
Robinson Ramírez-Vélez
Bogota Distrito Especial, Cundinamarca, Colombia, 000000000
Sponsors and Collaborators
Universidad Santo Tomas
Healthcare Center Tomas Rojas
Health Service of Los Ríos by the Health promotion program
Universidad Pública de Navarra
Universidad del Rosario

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Universidad Santo Tomas
ClinicalTrials.gov Identifier: NCT03003754     History of Changes
Other Study ID Numbers: 2016-12-22
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Insulin Resistance
Metabolic Diseases
Pediatric Obesity
Hyperinsulinism
Glucose Metabolism Disorders
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms