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

NCT04342390 | Completed Results

• 2 other identifiers: 260671P20GM109096
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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).

Conditions

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

Keywords

NAFLD; HIIT; Insulin; Fitness; Controlled Attenuated Parameter; Steatosis; Peak oxygen uptake

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (4)

• Alanine Aminotransferase

  4 weeks

• FibroScan - Controlled Attenuated Parameter

  4 weeks

• FibroScan - Transient Elastogram

  4 weeks

• Body Composition - Total Body Fat

  4 weeks

Study Arms (2)

Exercise Group

EXPERIMENTAL

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

Other: High-Intensity Interval Training (HIIT)

Control Group

NO INTERVENTION

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

Interventions

High-Intensity Interval Training (HIIT) OTHER

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.

Exercise Group

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (2)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

Location

Arkansas Children's Pediatric Clinical Research Unit

Little Rock, Arkansas, 72202, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Insulin Resistance; Pediatric Obesity; Fatty Liver

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Emir Tas
• Organization: Arkansas Children's Research Insitute

tase2@upmc.edu

4126928688

Study Officials

• Emir Tas, MD

  Arkansas Children's Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 13, 2020
• Study Start: April 2, 2021
• Primary Completion: July 1, 2022
• Study Completion: November 1, 2022
• Last Updated: August 22, 2024
• Results First Posted: February 20, 2024

Record last verified: 2023-07

Locations

US (2)