Clinical trial NCT02753231: Exercise Training and Hepatic Metabolism in Overweight/Obese Adolescent
Official title: Effects of an Exercise Program on Hepatic Metabolism and Cardiovascular Health in Overweight/Obese Adolescent From Bogota, Colombia (HEPAFIT Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Metabolic Syndrome X
Lipid Metabolism Disorders
Body Composition, Beneficial
Mental Health Wellness 1
Lead sponsor: Universidad Santo Tomas
Sponsor class: OTHER
Collaborators: name: Universidad de Santiago de Chile
name: Universidad de Granada
name: Universidad Pública de Navarra
name: Emory University
name: University of Castilla-La Mancha
First posted: 2016-04-27
Enrollment: 120
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in hepatic fat measured by controlled attenuation parameter values (FibroScan®)
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Changes in liver enzymes
timeFrame: Baseline and 6 months
measure: Changes in serum lipid profile
timeFrame: Baseline and 6 months
measure: Changes in Insulin sensitivity measured by homeostasis model assessment (HOMA)
timeFrame: Baseline and 6 months
measure: Change from Baseline in Aerobic fitness measured on a maximum effort test
timeFrame: Baseline and 6 months
measure: Change from Baseline in Muscular Fitness assessed using handgrip test (maximum handgrip strength assessment)
timeFrame: Baseline and 6 months
measure: Change from Baseline in Body composition
timeFrame: Baseline and 6 months
measure: Changes in physical activity using accelerometry
timeFrame: Baseline and 6 months
measure: Change from Baseline in Quality & satisfaction with life by SF Community - short-form survey (SF-12™) Colombian version
timeFrame: Baseline and 6 months
measure: Changes in blood pressure
timeFrame: Baseline and 6 months
measure: Changes in liver enzymes
timeFrame: Baseline and 6 months
measure: Changes in liver enzymes
timeFrame: Baseline and 6 months
measure: Changes in inflammatory markers after the 6 months intervention program
timeFrame: Baseline and 6 months
measure: Changes in inflammatory markers after the 6 months intervention program
timeFrame: Baseline and 6 months
measure: Changes in inflammatory markers after the 6 months intervention program
timeFrame: Baseline and 6 months
measure: Change from Baseline in Body composition
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Universidad del Rosario
name: Robinson Ramirez Velez, Ph.D
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.