Exercise Training and Hepatic Metabolism in Overweight/Obese Adolescent

Obesity Clinical Trial

— HEPAFIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02753231
• Other study ID #: UR-21042016
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 2017

Study information

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

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Composition, Beneficial
• Lipid Metabolism Disorders
• Mental Health Wellness 1
• Metabolic Diseases
• Metabolic Syndrome X
• Obesity
• Overweight

Intervention

Behavioral:
• Low physical activity program
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
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
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
One Physical Education sessions / week

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Universidad Santo Tomas	Emory University, Universidad de Granada, Universidad de Santiago de Chile, Universidad Pública de Navarra, University of Castilla-La Mancha

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline and 6 months
Secondary	Changes in liver enzymes	Changes in total alanine transaminase (ALT) after the 6 months intervention program	Baseline and 6 months
Secondary	Changes in serum lipid profile	Changes in cholesterol total, LDL cholesterol, HDL cholesterol and triglycerides after the 6 months intervention program	Baseline and 6 months
Secondary	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	Baseline and 6 months
Secondary	Change from Baseline in Aerobic fitness measured on a maximum effort test	Change from Baseline in Cardiorespiratory fitness measured on a maximum effort test	Baseline and 6 months
Secondary	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®	Baseline and 6 months
Secondary	Change from Baseline in Body composition	Fat mass as measured by Dual Energy X-ray Absorptiometry	Baseline and 6 months
Secondary	Changes in physical activity using accelerometry	Changes in physical activity estimated by accelerometry after the 6 months intervention program	Baseline and 6 months
Secondary	Change from Baseline in Quality & satisfaction with life by SF Community - short-form survey (SF-12™) Colombian version		Baseline and 6 months
Secondary	Changes in blood pressure	Changes in blood pressure after the 6 months intervention program	Baseline and 6 months
Secondary	Changes in liver enzymes	Changes in total gamma-GT after the 6 months intervention program	Baseline and 6 months
Secondary	Changes in liver enzymes	Changes in total aspartate transaminase (AST) after the 6 months intervention program	Baseline and 6 months
Secondary	Changes in inflammatory markers after the 6 months intervention program	Changes in TNF-alpha after the 6 months intervention program	Baseline and 6 months
Secondary	Changes in inflammatory markers after the 6 months intervention program	Changes in IL-6 and IL-10 after the 6 months intervention program	Baseline and 6 months
Secondary	Changes in inflammatory markers after the 6 months intervention program	Changes in C-reactive protein (CRP) after the 6 months intervention program	Baseline and 6 months
Secondary	Change from Baseline in Body composition	Lean body mass as measured by Dual Energy X-ray Absorptiometry	Baseline and 6 months