Status:
COMPLETED
Effects of High-Intensity Interval Training Exercise in Adolescents With Hepatosteatosis
Lead Sponsor:
Arkansas Children's Hospital Research Institute
Collaborating Sponsors:
National Institute of General Medical Sciences (NIGMS)
Conditions:
Non-Alcoholic Fatty Liver Disease
Insulin Resistance
Eligibility:
All Genders
13-18 years
Phase:
NA
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)...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
April 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04342390
Start Date
April 2 2021
End Date
November 1 2022
Last Update
August 22 2024
Active Locations (2)
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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