N/A
N=40
Effects of High-Intensity Interval Training Exercise in Adolescents With Hepatosteatosis
Non-Alcoholic Fatty Liver Disease · Insulin Resistance · High Intensity Interval Training · Childhood Obesity
Bottom Line
View on ClinicalTrials.gov: NCT04342390 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Intrahepatic Triglyceride (IHTG) — 5.26; 8.97 percentage of IHTG — p=0.363
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High-Intensity Interval Training (HIIT) (Other)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- Arkansas Children's Hospital Research Institute
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intrahepatic Triglyceride (IHTG) |
5.26; 8.97 | 0.363 |
| PRIMARY Cardiovascular Fitness |
40.8; 43.2 | 0.633 |
| PRIMARY HOMA-IR |
8.69; 6.4 | 0.433 |
| SECONDARY Alanine Aminotransferase |
20.1; 29.7 | 0.822 |
| SECONDARY FibroScan - Controlled Attenuated Parameter |
279; 280 | 0.554 |
| SECONDARY FibroScan - Transient Elastogram |
5; 5 | 0.186 |
| SECONDARY Body Composition - Total Body Fat |
45.35; 44.05 | 0.921 |
Summary
This is a research study about how short-term exercise intervention affects adolescents with a disease called non-alcoholic fatty liver disease (NAFLD).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04342390). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.