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

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

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

Interventional

Enrollment (Actual)

40

Phase

  • 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

    • 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

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
Intervention / Treatment
Experimental: Exercise Group
Study participants in this group will be asked to complete 4 weeks of 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

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

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.

Investigators

  • 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)

April 2, 2021

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

November 1, 2022

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

April 8, 2020

First Posted (Actual)

April 13, 2020

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

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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