Clinical trial NCT04342390: Effects of High-Intensity Interval Training Exercise in Adolescents With Hepatosteatosis
Official title: Effects of High-Intensity Interval Training Exercise in Adolescents With Hepatosteatosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2020-04-13
Enrollment: 40
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intrahepatic Triglyceride (IHTG)
timeFrame: 4 weeks
measure: Cardiovascular Fitness
timeFrame: 4 weeks
measure: HOMA-IR
timeFrame: 4 weeks
Secondary outcomes:
measure: Alanine Aminotransferase
timeFrame: 4 weeks
measure: FibroScan - Controlled Attenuated Parameter
timeFrame: 4 weeks
measure: FibroScan - Transient Elastogram
timeFrame: 4 weeks
measure: Body Composition - Total Body Fat
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Children's Pediatric Clinical Research Unit
state: Arkansas
Study officials:
affiliation: Arkansas Children's Hospital Research Institute
name: Emir Tas, MD
role: PRINCIPAL_INVESTIGATOR
References: