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

Insulin Sensitivity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03003754
• Other study ID #: 2016-12-22
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: February 2017

Study information

• Verified date: October 2018
• Source: Universidad Santo Tomas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insulin Resistance
• Insulin Sensitivity
• Metabolic Diseases
• Metabolism Disorder
• Obesity, Pediatric
• Pediatric Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
Colombia	Robinson Ramírez-Vélez	Bogota Distrito Especial	Cundinamarca

Sponsors (5)

Lead Sponsor	Collaborator
Universidad Santo Tomas	Health Service of Los Ríos by the Health promotion program, Healthcare Center Tomas Rojas, Universidad del Rosario, Universidad Pública de Navarra

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in plasma homeostasis model assessment (HOMA-IR)		Baseline and 6 weeks immediately after the interventions ends
Secondary	Change from Baseline in body mass		Baseline and 6 weeks immediately after the interventions ends
Secondary	Change from Baseline in body mass index		Baseline and 6 weeks immediately after the interventions ends
Secondary	Change from Baseline in waist circumference		Baseline and 6 weeks immediately after the interventions ends
Secondary	Change from Baseline in fat mass		Baseline and 6 weeks immediately after the interventions ends
Secondary	Change from Baseline in blood pressure		Baseline and 6 weeks immediately after the interventions ends
Secondary	Change from Baseline in fasting glucose		Baseline and 6 weeks immediately after the interventions ends
Secondary	Change from Baseline in fasting insulin		Baseline and 6 weeks immediately after the interventions ends
Secondary	Change from Baseline in one maximum repetition strength test of leg-extension exercise		Baseline and 6 weeks immediately after the interventions ends
Secondary	Change from Baseline in one maximum repetition strength test of shoulder press exercise		Baseline and 6 weeks immediately after the interventions ends
Secondary	Change from Baseline in one maximum repetition strength test of upper-row exercise		Baseline and 6 weeks immediately after the interventions ends
Secondary	Change from Baseline in one maximum repetition strength test of biceps curl exercise		Baseline and 6 weeks immediately after the interventions ends