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

NCT ID: NCT04342390

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-02
• Study Completion Date: 2022-11-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise Group

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

Group Type: EXPERIMENTAL

High-Intensity Interval Training (HIIT)

Intervention Type: 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.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role: collaborator

Arkansas Children's Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emir Tas, MD

Role: PRINCIPAL_INVESTIGATOR

Arkansas Children's Hospital Research Institute

Locations

Arkansas Children's Nutrition Center

Little Rock, Arkansas, United States

Arkansas Children's Pediatric Clinical Research Unit

Little Rock, Arkansas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

P20GM109096

Identifier Type: NIH

Identifier Source: secondary_id

View Link

260671

Identifier Type: -

Identifier Source: org_study_id