- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04342390
Effects of High-Intensity Interval Training Exercise in Adolescents With Hepatosteatosis
February 19, 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
Completed
Conditions
Intervention / Treatment
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.
Collaborators
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
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on High Intensity Interval Training
-
University of MiamiCompletedResistance Training | High-Intensity Interval TrainingUnited States
-
University of Central LancashireUniversity of HullCompletedHigh Intensity Interval TrainingUnited Kingdom
-
Riphah International UniversityRecruiting
-
University of NottinghamCompletedHigh-Intensity Interval TrainingUnited Kingdom
-
Teesside UniversityCompleted
-
University of North Carolina, Chapel HillNational Institute for Occupational Safety and Health (NIOSH/CDC)Enrolling by invitationHigh Intensity Interval Training | FirefighterUnited States
-
University of BathCompletedHigh-Intensity Interval TrainingUnited Kingdom
-
Teesside UniversityLiverpool John Moores UniversityCompletedHigh-intensity Interval Training
-
Ankara UniversityCompletedHigh Intensity Interval Training | CreatineTurkey
-
Superior UniversityEnrolling by invitationHigh Intensity Interval Training | Aerobic ExercisePakistan
Clinical Trials on High-Intensity Interval Training (HIIT)
-
Université de SherbrookeRecruiting
-
Mayo ClinicRecruitingCardiac RehabilitationUnited States
-
Karolinska University HospitalKarolinska InstitutetUnknownDermatomyositis | PolymyositisSweden
-
Chang Gung Memorial HospitalCompletedHeart Failure | Morality | Remodeling, VentricularTaiwan
-
Brock UniversityCompletedCardiovascular Diseases | Metabolic SyndromeCanada
-
McMaster UniversityUnknown
-
University of North Carolina, Chapel HillEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedKnee OsteoarthritisUnited States
-
Amsterdam UMC, location VUmcRecruitingExercise | Brain Tumor, PrimaryNetherlands
-
VA Office of Research and DevelopmentAtlanta VA Medical CenterNot yet recruitingStroke | Stroke Rehabilitation | Walking, Difficulty | Lower Extremity Weakness, SpasticUnited States
-
Karolinska InstitutetRecruitingOverweight | Type 1 DiabetesSweden