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

Sponsor

Arkansas Children's Hospital Research Institute (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04342390

Collaborator

(none)

150

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

3.8

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Non-Alcoholic Fatty Liver Disease Insulin Resistance High Intensity Interval Training Childhood Obesity	Other: High-Intensity Interval Training (HIIT)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 2, 2021

Actual Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise Group Study participants in this group will be asked to complete 4 weeks of high-intensity interval training (HIIT).	Other: High-Intensity Interval Training (HIIT) The exercise we are studying is called high-intensity interval training, or HIIT. Participants in the exercise group will participate in the exercise program. Each exercise session will last up to 1 hour. All exercise sessions will be directed and monitored by an experienced exercise trainer or exercise physiologist.
No Intervention: Control Group Study participants in this group will not undergo HIIT exercise training during this study.

Arm

Intervention/Treatment

Experimental: Exercise Group

Study participants in this group will be asked to complete 4 weeks of high-intensity interval training (HIIT).

Other: High-Intensity Interval Training (HIIT)

The exercise we are studying is called high-intensity interval training, or HIIT. Participants in the exercise group will participate in the exercise program. Each exercise session will last up to 1 hour. All exercise sessions will be directed and monitored by an experienced exercise trainer or exercise physiologist.

No Intervention: Control Group

Study participants in this group will not undergo HIIT exercise training during this study.

Outcome Measures

Primary Outcome Measures

Intrahepatic triglyceride (IHTG) [24 months]
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.
Cardiovascular fitness [24 months]
Cardiovascular fitness will be assessed via "peak oxygen uptake" (VO2 max). VO2 max is expressed as milliliters per body weight in kilograms per minutes. There is no established normative data for VO2 max in pediatric population; however, higher values indicate better cardiovascular fitness.
HOMA-IR [24 months]
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.

Secondary Outcome Measures

Alanine Aminotransferase [24 months]
Serum alanine aminotransferase (ALT) level will be measured. Higher ALT levels suggest presence of hepatocellular damage.
FibroScan - Controlled Attenuated Parameter [24 months]
Controlled Attenuated Parameter (CAP) score will be measured using FibroScan. CAP score is reported in decibel/second (dB/s) and ranges between 100-400. A score of 241 dB/s or greater is consistent with non-alcoholic fatty liver disease.
FibroScan - Transient Elastogram [24 months]
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 and Visceral Fat [24 months]
Body composition will be measured using Dual X-Ray Absorptiometry (DXA) scan. Normative data for total body fat and visceral fat are not established; however, larger visceral fat volume is linked to higher intrahepatic triglyceride content and insulin resistant state; similarly, larger total body fat volume is linked to higher intrahepatic triglyceride content and insulin resistant state.

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arkansas Children's Nutrition Center	Little Rock	Arkansas	United States	72202
2	Arkansas Children's Pediatric Clinical Research Unit	Little Rock	Arkansas	United States	72202