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Completed

NCT Number: NCT02753231

Exercise Training and Hepatic Metabolism in Overweight/Obese Adolescent

The HEPAFIT Study aims to examine whether a 6-months physical education program has benefits on hepatic metabolism and cardiovascular health as well as on selected physical fitness and mental health outcomes among adolescent overweight/obese from Bogota, Colombia.

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Key information

Conditions

Obesity Body Composition, Beneficial Body Weight Glucocorticoid Receptor Deficiency Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Lipid Metabolism Disorders Mental Health Wellness 1 Metabolic Diseases Metabolic Syndrome Metabolic Syndrome X Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Overweight or obesity status
  • 11-17 years old
  • Written informed consent
  • Interested in improving health and fitness

Exclusion criteria

  • Any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial.
  • Clinical diagnosis of diabetes
  • Pregnancy
  • Drugs/alcohol abuse

Treatment and study plan

Low physical activity program

Behavioral

Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.

High physical activity program

Behavioral

Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.

Low and High physical activity program

Behavioral

Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.

Conventional physical activity program

Behavioral

One Physical Education sessions / week

Primary outcomes

  1. Change from Baseline in hepatic fat measured by controlled attenuation parameter values (FibroScan®)

    Time frame: Baseline and 6 months

    Changes in hepatic fat fraction measured by controlled attenuation parameter after the 6 months intervention program

Secondary outcomes

  1. Changes in liver enzymes

    Time frame: Baseline and 6 months

    Changes in total alanine transaminase (ALT) after the 6 months intervention program

  2. Changes in serum lipid profile

    Time frame: Baseline and 6 months

    Changes in cholesterol total, LDL cholesterol, HDL cholesterol and triglycerides after the 6 months intervention program

  3. Changes in Insulin sensitivity measured by homeostasis model assessment (HOMA)

    Time frame: Baseline and 6 months

    Changes in insulin sensitivity measured by homeostasis model assessment (HOMA) after the 6 months intervention program

  4. Change from Baseline in Aerobic fitness measured on a maximum effort test

    Time frame: Baseline and 6 months

    Change from Baseline in Cardiorespiratory fitness measured on a maximum effort test

  5. Change from Baseline in Muscular Fitness assessed using handgrip test (maximum handgrip strength assessment)

    Time frame: Baseline and 6 months

    Muscular fitness will be assessed using handgrip test (maximum handgrip strength assessment) using a standard adjustable handle analogue handgrip dynamometer T-18 TKK SMEDLY III®

  6. Change from Baseline in Body composition

    Time frame: Baseline and 6 months

    Fat mass as measured by Dual Energy X-ray Absorptiometry

  7. Changes in physical activity using accelerometry

    Time frame: Baseline and 6 months

    Changes in physical activity estimated by accelerometry after the 6 months intervention program

  8. Change from Baseline in Quality & satisfaction with life by SF Community - short-form survey (SF-12™) Colombian version

    Time frame: Baseline and 6 months

  9. Changes in blood pressure

    Time frame: Baseline and 6 months

    Changes in blood pressure after the 6 months intervention program

  10. Changes in liver enzymes

    Time frame: Baseline and 6 months

    Changes in total gamma-GT after the 6 months intervention program

  11. Changes in liver enzymes

    Time frame: Baseline and 6 months

    Changes in total aspartate transaminase (AST) after the 6 months intervention program

  12. Changes in inflammatory markers after the 6 months intervention program

    Time frame: Baseline and 6 months

    Changes in TNF-alpha after the 6 months intervention program

  13. Changes in inflammatory markers after the 6 months intervention program

    Time frame: Baseline and 6 months

    Changes in IL-6 and IL-10 after the 6 months intervention program

  14. Changes in inflammatory markers after the 6 months intervention program

    Time frame: Baseline and 6 months

    Changes in C-reactive protein (CRP) after the 6 months intervention program

  15. Change from Baseline in Body composition

    Time frame: Baseline and 6 months

    Lean body mass as measured by Dual Energy X-ray Absorptiometry

Sponsors and collaborators

Lead sponsor

Universidad Santo Tomas

Other

Collaborators

  • Emory University
  • Universidad Pública de Navarra
  • Universidad de Granada
  • Universidad de Santiago de Chile
  • University of Castilla-La Mancha

Registry information

Official study title

Effects of an Exercise Program on Hepatic Metabolism and Cardiovascular Health in Overweight/Obese Adolescent From Bogota, Colombia (HEPAFIT Study)

Acronym: HEPAFIT

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 27, 2016
Registry last updated
Nov 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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