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.
Group
Value
95% CI
Exercise Group
5.26
± 3.01
Control Group
8.97
± 6.61
Cardiovascular FitnessPrimary· 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.
Group
Value
95% CI
Exercise Group
40.8
± 7.3
Control Group
43.2
± 7.2
HOMA-IRPrimary· 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.
Group
Value
95% CI
Exercise Group
8.69
± 5.5
Control Group
6.4
± 5.5
Alanine AminotransferaseSecondary· 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.
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.
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.
Group
Value
95% CI
Exercise Group
5
± 1
Control Group
5
± 3
Body Composition - Total Body FatSecondary· 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.
Group
Value
95% CI
Exercise Group
45.35
± 6.18
Control Group
44.05
± 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.
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):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Arkansas Children's Hospital Research Institute
Last refreshed: 22 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04342390.