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NCT04342390

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

Completed NA Results posted Last updated 22 August 2024
What this trial tests

NA trial testing High-Intensity Interval Training (HIIT) in Non-Alcoholic Fatty Liver Disease in 40 participants. Completed in 1 November 2022.

Timeline
2 April 2021
Primary endpoint
1 July 2022
1 November 2022

Quick facts

Lead sponsorArkansas Children's Hospital Research Institute
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment40
Start date2 April 2021
Primary completion1 July 2022
Estimated completion1 November 2022
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Arkansas Children's Hospital Research Institute

Who can join

Adults 13 to 18, any sex, with Non-Alcoholic Fatty Liver Disease or Insulin Resistance. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Intrahepatic Triglyceride (IHTG) Primary · 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.

GroupValue95% CI
Exercise Group5.26± 3.01
Control Group8.97± 6.61
Cardiovascular Fitness Primary · 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.

GroupValue95% CI
Exercise Group40.8± 7.3
Control Group43.2± 7.2
HOMA-IR Primary · 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.

GroupValue95% CI
Exercise Group8.69± 5.5
Control Group6.4± 5.5
Alanine Aminotransferase Secondary · 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.

GroupValue95% CI
Exercise Group20.1± 17.6
Control Group29.7± 17.6
FibroScan - Controlled Attenuated Parameter Secondary · 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.

GroupValue95% CI
Exercise Group279± 35
Control Group280± 35
FibroScan - Transient Elastogram Secondary · 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.

GroupValue95% CI
Exercise Group5± 1
Control Group5± 3
Body Composition - Total Body Fat Secondary · 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.

GroupValue95% CI
Exercise Group45.35± 6.18
Control Group44.05± 6.18

Adverse events — posted to ClinicalTrials.gov

Time frame: 4 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Exercise Group
Serious: 0/34 (0%)
Deaths: 0/34
Control Group
Serious: 0/6 (0%)
Deaths: 0/6
Other adverse events (1 terms — click to expand)

ReactionSystemExercise GroupControl Group
muscle sprainMusculoskeletal and connective tissue disorders

Data from ClinicalTrials.gov NCT04342390 adverse events section.

Sponsor's own description

This is a research study about how short-term exercise intervention affects adolescents with a disease called non-alcoholic fatty liver disease (NAFLD).

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Effects of short-term supervised exercise training on liver fat in adolescents with obesity: a randomized controlled trial.
    Tas E, Landes RD, Diaz EC, Bai S, et al · · 2023 · cited 13× · PMID 37731271 · DOI 10.1002/oby.23887
  2. Associations Between Serum Gut-Derived Tryptophan Metabolites and Cardiovascular Health Markers in Adolescents with Obesity.
    Rivera JE, Lan R, Ferruzzi MG, Børsheim E, et al · · 2025 · cited 3× · PMID 40806015 · DOI 10.3390/nu17152430
  3. Diagnostic Accuracy of Transient Elastography in Hepatosteatosis in Youth With Obesity.
    Tas E, Sundararajan D, Lo JS, Morelli N, et al · · 2024 · cited 3× · PMID 38895640 · DOI 10.1210/jendso/bvae110
  4. Liver Fat Is Associated With Elevated FGF21 in Youth With Obesity but Without MASLD.
    Tas E, Diaz EC, Ou X, Børsheim E, et al · · 2026 · PMID 41665252 · DOI 10.1111/ijpo.70092
  5. OR15-06 Measuring Hepatic Steatosis With Transient Elastography In Adolescents With Obesity
    · 2023

Verify or expand the search:

Other trials of High-Intensity Interval Training (HIIT)

Trials testing the same drug.

Other recruiting trials for Non-Alcoholic Fatty Liver Disease

Currently open trials in the same condition.

Other Arkansas Children's Hospital Research Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing