Effects of High-Intensity Interval Training Exercise in Adolescents With Hepatosteatosis

July 30, 2024 updated by: Arkansas Children's Hospital Research Institute
This is a research study about how short-term exercise intervention affects adolescents with a disease called non-alcoholic fatty liver disease (NAFLD).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study investigators want to learn more about the effect of a type of exercise on non-alcoholic fatty liver disease (NAFLD), and on markers of health (for example, liver, heart, and overall health) and how the body uses energy in teenagers. The exercise we are studying is called high-intensity interval training, or HIIT. Some participants in this study will receive a 4-week exercise program, and the others will not.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Nutrition Center
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Pediatric Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria: Initial Enrollment

  • Ages 13-18 years (inclusive) for both sexes
  • Any ethnic/racial background
  • English speaking competence
  • Teenagers ages 13-15 weighing more than 145 pounds OR teenagers ages 16-18 weighing more than 170 pounds
  • Low risk to participate in an exercise program as determined by "The Physical Activity Readiness Questionnaire for Everyone"
  • Late stages of puberty (i.e., Tanner stage IV or V) based on Tanner Staging.

Inclusion Criteria: Control or Exercise Group

  • Presence of Non-Alcoholic Fatty Liver Disease (NAFLD) as determined by FibroScan Controlled Attenuated Parameter (CAP) score
  • Confirmed lack of diabetes as determined by Oral Glucose Tolerance Test (OGTT)
  • Confirmed eligibility per medical history

Exclusion criteria:

  • Pre-pubertal or early stages of puberty
  • Pregnancy
  • Confirmed lack of NAFLD in the past 6 months via biopsy or MRI
  • Presence of an implantable medical device or metal objects in the body (a contraindication for FibroScan and/or MRI)
  • High-risk to participate in an exercise program as determined by "The Physical Activity Readiness Questionnaire for Everyone"
  • Unable to cooperate with study procedures and tests including genetic or physical conditions impacting mobility over the past year
  • Having known chronic illnesses/disorders that may independently affect study outcome measures: type 1 diabetes mellitus, type 2 diabetes, neurologic (e.g., epilepsy), developmental (developmental delay, autism spectrum disorder), endocrine (Cushing's, growth hormone deficiency), hepatic (other than NAFLD), autoimmune, cardiac and renal disorders
  • Current history of poorly-controlled asthma.
  • Taking any of the following medications that can affect study outcome at the time of enrollment: insulin, metformin, or any other anti-diabetics, antipsychotics, oral steroids, and anabolic drugs (growth hormone replacement therapy, testosterone, and oxandrolone).
  • Adolescents who have a history of claustrophobia.
  • Adolescents who need sedation in order to complete MRI.
  • Adolescents determined ineligible by the study investigator or delegated staff.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise Group
Study participants in this group will be asked to complete 4 weeks of high-intensity interval training (HIIT).
Other: High-Intensity Interval Training (HIIT)
The exercise we are studying is called high-intensity interval training, or HIIT. Participants in the exercise group will participate in the exercise program. Each exercise session will last up to 1 hour. All exercise sessions will be directed and monitored by an experienced exercise trainer or exercise physiologist.
No Intervention: Control Group
Study participants in this group will not undergo HIIT exercise training during this study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intrahepatic Triglyceride (IHTG)
Time Frame: 4 weeks
Intrahepatic triglyceride (IHTG) percent (%) will be measured via Magnetic Resonance Imaging (MRI). IHTG percent can theoretically range between 0 and 100. By definition, an individual has Non-Alcoholic Fatty Liver Disease (NAFLD) when the IHTG percent is at or above 5 percent.
4 weeks
Cardiovascular Fitness
Time Frame: 4 weeks
Cardiovascular fitness will be assessed via "peak oxygen uptake" (VO2 max). VO2 max is expressed as milliliters per body weight per minute in kilograms of lean body mass (mL/min/kg per LBM). There is no established normative data for VO2 max in pediatric population; however, higher values indicate better cardiovascular fitness.
4 weeks
HOMA-IR
Time Frame: 4 weeks
The Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) will be calculated using the fasting glucose and insulin levels. Higher HOMA-IR values indicate greater insulin resistance. HOMA-IR is calculated as "fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5". HOMA-IR has an arbitrary unit. Higher numbers suggest worse outcomes.
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Alanine Aminotransferase
Time Frame: 4 weeks
Serum alanine aminotransferase (ALT) level will be measured. ALT level is reported in international unit/liter or IU/L. Higher ALT levels suggest presence of hepatocellular damage.
4 weeks
FibroScan - Controlled Attenuated Parameter
Time Frame: 4 weeks
Controlled Attenuated Parameter (CAP) score will be measured using FibroScan. CAP score is reported in decibel/meter (dB/m) and ranges between 100-400. A score of 241 dB/m or greater is consistent with non-alcoholic fatty liver disease.
4 weeks
FibroScan - Transient Elastogram
Time Frame: 4 weeks
Transient Elastogram (TE) score will be measured using FibroScan. TE score is reported in kilopascals (kPa) and ranges between 0-75. A score of 8.5 kPa or greater is consistent with fibrotic liver disease.
4 weeks
Body Composition - Total Body Fat
Time Frame: 4 weeks
Body composition will be measured using Dual X-Ray Absorptiometry (DXA) scan. Normative data for total body fat is not established; however, larger total body fat percentage (percentage of total body weight) is linked to higher intrahepatic triglyceride content and insulin resistant state.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arkansas Children's Hospital Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of General Medical Sciences (NIGMS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emir Tas, MD, Arkansas Children's Hospital Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 2, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 260671
  • P20GM109096 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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