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ObesityHEPAFITNCT02753231

Exercise Training and Hepatic Metabolism in Overweight/Obese Adolescent

A study testing Low physical activity program, High physical activity program and Low and High physical activity program in people with Obesity and Metabolic Syndrome X, run by Universidad Santo Tomas.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 11 to 17 yearsHealthy volunteers can take part
What is being tested?
Low physical activity program, High physical activity program and Low and High physical activity program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
No sites listed yet
Study dates
Jan 2017to Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

  • 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

About this study

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

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.

Being tested
Low physical activity program, High physical activity program, Low and High physical activity program, Conventional physical activity program
Medical subject headings
Obesity, Metabolic Syndrome, Lipid Metabolism Disorders, Glucocorticoid Receptor Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low physical activity programBehavioural

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

  • High physical activity programBehavioural

    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 programBehavioural

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

  • Conventional physical activity programBehavioural

    One Physical Education sessions / week

Study groups in NCT02753231
Study groupRoleWhat they receive
Low physical activity programExperimentalThree Physical Education sessions / week
Receives: Behavioral: Low physical activity program
High physical activity programExperimentalThree Physical Education sessions / week (increased volume)
Receives: Behavioral: High physical activity program
Low and High physical activity programExperimentalThree Physical Education sessions / week (increased volume and intensity)
Receives: Behavioral: Low and High physical activity program
Conventional physical activity programActive comparatorOne Physical Education sessions / week
Receives: Behavioral: Conventional physical activity program

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Baseline and 6 months

Secondary outcomes (15)

  1. Changes in liver enzymes

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

    Measured: Baseline and 6 months

  2. Changes in serum lipid profile

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

    Measured: Baseline and 6 months

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

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

    Measured: Baseline and 6 months

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

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

    Measured: Baseline and 6 months

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

    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®

    Measured: Baseline and 6 months

  6. Change from Baseline in Body composition

    Fat mass as measured by Dual Energy X-ray Absorptiometry

    Measured: Baseline and 6 months

  7. Changes in physical activity using accelerometry

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

    Measured: Baseline and 6 months

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

    Measured: Baseline and 6 months

  9. Changes in blood pressure

    Changes in blood pressure after the 6 months intervention program

    Measured: Baseline and 6 months

  10. Changes in liver enzymes

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

    Measured: Baseline and 6 months

  11. Changes in liver enzymes

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

    Measured: Baseline and 6 months

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

    Changes in TNF-alpha after the 6 months intervention program

    Measured: Baseline and 6 months

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

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

    Measured: Baseline and 6 months

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

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

    Measured: Baseline and 6 months

  15. Change from Baseline in Body composition

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

    Measured: Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2016 (estimated)
  2. Study startJan 2017
  3. Primary completionDec 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Investigator
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02753231
Sponsor's protocol ID
UR-21042016
Acronym
HEPAFIT
Status last verified
Nov 2018
First submitted
21 Apr 2016
Last updated
29 Nov 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ramirez-Velez R, Garcia-Hermoso A, Correa-Rodriguez M, Fernandez-Irigoyen J, Palomino-Echeverria S, Santamaria E, Correa-Bautista JE, Gonzalez-Ruiz K, Izquierdo M. Effects of Different Doses of Exercise on Inflammation Markers Among Adolescents With Overweight/Obesity: HEPAFIT Study. J Clin Endocrinol Metab. 2022 May 17;107(6):e2619-e2627. doi: 10.1210/clinem/dgac021.

    PubMed 35038337

  • Gonzalez-Ruiz K, Correa-Bautista JE, Izquierdo M, Garcia-Hermoso A, Martinez-Vizcaino V, Lobelo F, Gonzalez-Jimenez E, Schmidt-RioValle J, Correa-Rodriguez M, Fernandez-Irigoyen J, Palomino-Echeverria S, Santamaria E, Ramirez-Velez R. Exercise dose on hepatic fat and cardiovascular health in adolescents with excess of adiposity. Pediatr Obes. 2022 Apr;17(4):e12869. doi: 10.1111/ijpo.12869. Epub 2021 Nov 4.

    PubMed 34734674

  • Gonzalez-Ruiz K, Correa-Bautista JE, Izquierdo M, Garcia-Hermoso A, Dominguez-Sanchez MA, Bustos-Cruz RH, Garcia-Prieto JC, Martinez-Vizcaino V, Lobelo F, Gonzalez-Jimenez E, Prieto-Benavides DH, Tordecilla-Sanders A, Schmidt-RioValle J, Perez G, Ramirez-Velez R. Effects of an exercise program on hepatic metabolism, hepatic fat, and cardiovascular health in overweight/obese adolescents from Bogota, Colombia (the HEPAFIT study): study protocol for a randomized controlled trial. Trials. 2018 Jun 25;19(1):330. doi: 10.1186/s13063-018-2721-5.

    PubMed 29941024

Questions about this trial

What is this clinical trial studying?

A study testing Low physical activity program, High physical activity program and Low and High physical activity program in people with Obesity and Metabolic Syndrome X, run by Universidad Santo Tomas.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in hepatic fat measured by controlled attenuation parameter values (FibroScan®) (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02753231, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.

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