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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03003754
• Date of registration: 22/12/2016
• Prospective Registration: No
• Primary sponsor: Universidad Santo Tomas
• Public title: Supervised Exercise-training in Children With Insulin Resistance or Healthy Metabolic Profile
• Scientific 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
• Date of first enrolment: June 2015
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03003754
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Colombia

Key inclusion & exclusion 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.



Age minimum: 9 Years
Age maximum: 13 Years
Gender: All

Health Condition(s) or Problem(s) studied

Metabolism Disorder

Obesity, Pediatric

Insulin Sensitivity

Intervention(s)

Behavioral: Control group

Behavioral: High Intensity Training (HIT) + Resistance Training (RT)

Primary Outcome(s)

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

Secondary Outcome(s)

Change from Baseline in blood pressure [Time Frame: Baseline and 6 weeks immediately after the interventions ends]

Change from Baseline in one maximum repetition strength test of leg-extension exercise [Time Frame: Baseline and 6 weeks immediately after the interventions ends]

Change from Baseline in body mass [Time Frame: Baseline and 6 weeks immediately after the interventions ends]

Change from Baseline in one maximum repetition strength test of biceps curl exercise [Time Frame: Baseline and 6 weeks immediately after the interventions ends]

Change from Baseline in body mass index [Time Frame: Baseline and 6 weeks immediately after the interventions ends]

Change from Baseline in fat mass [Time Frame: Baseline and 6 weeks immediately after the interventions ends]

Change from Baseline in fasting glucose [Time Frame: Baseline and 6 weeks immediately after the interventions ends]

Change from Baseline in fasting insulin [Time Frame: Baseline and 6 weeks immediately after the interventions ends]

Change from Baseline in one maximum repetition strength test of shoulder press exercise [Time Frame: Baseline and 6 weeks immediately after the interventions ends]

Change from Baseline in one maximum repetition strength test of upper-row exercise [Time Frame: Baseline and 6 weeks immediately after the interventions ends]

Change from Baseline in waist circumference [Time Frame: Baseline and 6 weeks immediately after the interventions ends]

Secondary ID(s)

2016-12-22

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Health Service of Los Ríos by the Health promotion program

Universidad Pública de Navarra

Healthcare Center Tomas Rojas

Universidad del Rosario