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Clinical Trials/NCT04342390
NCT04342390
Completed
Not Applicable

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

Arkansas Children's Hospital Research Institute2 sites in 1 country40 target enrollmentApril 2, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Non-Alcoholic Fatty Liver Disease
Sponsor
Arkansas Children's Hospital Research Institute
Enrollment
40
Locations
2
Primary Endpoint
Cardiovascular Fitness
Status
Completed
Last Updated
last year

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
April 2, 2021
End Date
November 1, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

  • FibroScan - Controlled Attenuated Parameter(4 weeks)
  • FibroScan - Transient Elastogram(4 weeks)
  • Body Composition - Total Body Fat(4 weeks)
  • Alanine Aminotransferase(4 weeks)

Study Sites (2)

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