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

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04342390
• Other study ID #: 260671
• Secondary ID: P20GM109096
• Status: Completed
• Phase: N/A
• Start date: April 2, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: July 2023
• Source: Arkansas Children's Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 18 Years

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.

Related Conditions & MeSH terms

• Childhood Obesity
• Fatty Liver
• High Intensity Interval Training
• Insulin Resistance
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	Arkansas Children's Nutrition Center	Little Rock	Arkansas
United States	Arkansas Children's Pediatric Clinical Research Unit	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intrahepatic Triglyceride (IHTG)	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.	4 weeks
Primary	Cardiovascular Fitness	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.	4 weeks
Primary	HOMA-IR	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.	4 weeks
Secondary	Alanine Aminotransferase	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.	4 weeks
Secondary	FibroScan - Controlled Attenuated Parameter	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.	4 weeks
Secondary	FibroScan - Transient Elastogram	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.	4 weeks
Secondary	Body Composition - Total Body Fat	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.	4 weeks