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

Not Applicable

Completed

Conditions: Childhood Obesity
Non-Alcoholic Fatty Liver Disease
High Intensity Interval Training
Insulin Resistance

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.

Recruitment & Eligibility

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.

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Exercise Group	High-Intensity Interval Training (HIIT)	Study participants in this group will be asked to complete 4 weeks of high-intensity interval training (HIIT).

Primary Outcome Measures

Name	Time	Method
Cardiovascular Fitness	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	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)	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 Outcome Measures

Name	Time	Method
FibroScan - Controlled Attenuated Parameter	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.
FibroScan - Transient Elastogram	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.
Body Composition - Total Body Fat	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.
Alanine Aminotransferase	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.

Locations (2): Arkansas Children's Pediatric Clinical Research Unit
🇺🇸
Little Rock, Arkansas, United States
Arkansas Children's Nutrition Center
🇺🇸
Little Rock, Arkansas, United States