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Exercise Training and Hepatic Metabolism in Overweight/Obese Adolescent (HEPAFIT)

Primary Purpose

Obesity, Metabolic Syndrome X, Lipid Metabolism Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low physical activity program
High physical activity program
Low and High physical activity program
Conventional physical activity program
Sponsored by
Universidad Santo Tomas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

11 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Low physical activity program

    High physical activity program

    Low and High physical activity program

    Conventional physical activity program

    Arm Description

    Three Physical Education sessions / week

    Three Physical Education sessions / week (increased volume)

    Three Physical Education sessions / week (increased volume and intensity)

    One Physical Education sessions / week

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    April 21, 2016
    Last Updated
    November 27, 2018
    Sponsor
    Universidad Santo Tomas
    Collaborators
    Universidad de Santiago de Chile, Universidad de Granada, Universidad Pública de Navarra, Emory University, University of Castilla-La Mancha
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02753231
    Brief Title
    Exercise Training and Hepatic Metabolism in Overweight/Obese Adolescent
    Acronym
    HEPAFIT
    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

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (Actual)
    Primary Completion Date
    December 2017 (Actual)
    Study Completion Date
    December 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Santo Tomas
    Collaborators
    Universidad de Santiago de Chile, Universidad de Granada, Universidad Pública de Navarra, Emory University, University of Castilla-La Mancha

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Metabolic Syndrome X, Lipid Metabolism Disorders, Body Composition, Beneficial, Mental Health Wellness 1

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Low physical activity program
    Arm Type
    Experimental
    Arm Description
    Three Physical Education sessions / week
    Arm Title
    High physical activity program
    Arm Type
    Experimental
    Arm Description
    Three Physical Education sessions / week (increased volume)
    Arm Title
    Low and High physical activity program
    Arm Type
    Experimental
    Arm Description
    Three Physical Education sessions / week (increased volume and intensity)
    Arm Title
    Conventional physical activity program
    Arm Type
    Active Comparator
    Arm Description
    One Physical Education sessions / week
    Intervention Type
    Behavioral
    Intervention Name(s)
    Low physical activity program
    Intervention Description
    Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
    Intervention Type
    Behavioral
    Intervention Name(s)
    High physical activity program
    Intervention Description
    Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Low and High physical activity program
    Intervention Description
    Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Conventional physical activity program
    Intervention Description
    One Physical Education sessions / week
    Primary Outcome Measure Information:
    Title
    Change from Baseline in hepatic fat measured by controlled attenuation parameter values (FibroScan®)
    Description
    Changes in hepatic fat fraction measured by controlled attenuation parameter after the 6 months intervention program
    Time Frame
    Baseline and 6 months
    Secondary Outcome Measure Information:
    Title
    Changes in liver enzymes
    Description
    Changes in total alanine transaminase (ALT) after the 6 months intervention program
    Time Frame
    Baseline and 6 months
    Title
    Changes in serum lipid profile
    Description
    Changes in cholesterol total, LDL cholesterol, HDL cholesterol and triglycerides after the 6 months intervention program
    Time Frame
    Baseline and 6 months
    Title
    Changes in Insulin sensitivity measured by homeostasis model assessment (HOMA)
    Description
    Changes in insulin sensitivity measured by homeostasis model assessment (HOMA) after the 6 months intervention program
    Time Frame
    Baseline and 6 months
    Title
    Change from Baseline in Aerobic fitness measured on a maximum effort test
    Description
    Change from Baseline in Cardiorespiratory fitness measured on a maximum effort test
    Time Frame
    Baseline and 6 months
    Title
    Change from Baseline in Muscular Fitness assessed using handgrip test (maximum handgrip strength assessment)
    Description
    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®
    Time Frame
    Baseline and 6 months
    Title
    Change from Baseline in Body composition
    Description
    Fat mass as measured by Dual Energy X-ray Absorptiometry
    Time Frame
    Baseline and 6 months
    Title
    Changes in physical activity using accelerometry
    Description
    Changes in physical activity estimated by accelerometry after the 6 months intervention program
    Time Frame
    Baseline and 6 months
    Title
    Change from Baseline in Quality & satisfaction with life by SF Community - short-form survey (SF-12™) Colombian version
    Time Frame
    Baseline and 6 months
    Title
    Changes in blood pressure
    Description
    Changes in blood pressure after the 6 months intervention program
    Time Frame
    Baseline and 6 months
    Title
    Changes in liver enzymes
    Description
    Changes in total gamma-GT after the 6 months intervention program
    Time Frame
    Baseline and 6 months
    Title
    Changes in liver enzymes
    Description
    Changes in total aspartate transaminase (AST) after the 6 months intervention program
    Time Frame
    Baseline and 6 months
    Title
    Changes in inflammatory markers after the 6 months intervention program
    Description
    Changes in TNF-alpha after the 6 months intervention program
    Time Frame
    Baseline and 6 months
    Title
    Changes in inflammatory markers after the 6 months intervention program
    Description
    Changes in IL-6 and IL-10 after the 6 months intervention program
    Time Frame
    Baseline and 6 months
    Title
    Changes in inflammatory markers after the 6 months intervention program
    Description
    Changes in C-reactive protein (CRP) after the 6 months intervention program
    Time Frame
    Baseline and 6 months
    Title
    Change from Baseline in Body composition
    Description
    Lean body mass as measured by Dual Energy X-ray Absorptiometry
    Time Frame
    Baseline and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    11 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robinson Ramirez Velez, Ph.D
    Organizational Affiliation
    Universidad del Rosario
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    35038337
    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.
    Results Reference
    derived
    PubMed Identifier
    34734674
    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.
    Results Reference
    derived
    PubMed Identifier
    29941024
    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.
    Results Reference
    derived

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    Exercise Training and Hepatic Metabolism in Overweight/Obese Adolescent

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