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

Primary Purpose

Non-Alcoholic Fatty Liver Disease, Insulin Resistance, High Intensity Interval Training

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High-Intensity Interval Training (HIIT)
Sponsored by
Arkansas Children's Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring NAFLD, HIIT, Insulin, Fitness, Controlled Attenuated Parameter, Steatosis, Peak oxygen uptake

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Arkansas Children's Nutrition Center
  • Arkansas Children's Pediatric Clinical Research Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
Cardiovascular fitness
Cardiovascular fitness will be assessed via "peak oxygen uptake" (VO2 max). VO2 max is expressed as milliliters per body weight in kilograms per minutes. There is no established normative data for VO2 max in pediatric population; however, higher values indicate better cardiovascular fitness.
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.

Secondary Outcome Measures

Alanine Aminotransferase
Serum alanine aminotransferase (ALT) level will be measured. Higher ALT levels suggest presence of hepatocellular damage.
FibroScan - Controlled Attenuated Parameter
Controlled Attenuated Parameter (CAP) score will be measured using FibroScan. CAP score is reported in decibel/second (dB/s) and ranges between 100-400. A score of 241 dB/s or greater is consistent with non-alcoholic fatty liver disease.
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.
Body Composition - Total Body Fat and Visceral Fat
Body composition will be measured using Dual X-Ray Absorptiometry (DXA) scan. Normative data for total body fat and visceral fat are not established; however, larger visceral fat volume is linked to higher intrahepatic triglyceride content and insulin resistant state; similarly, larger total body fat volume is linked to higher intrahepatic triglyceride content and insulin resistant state.

Full Information

First Posted
April 8, 2020
Last Updated
August 17, 2022
Sponsor
Arkansas Children's Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04342390
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arkansas Children's Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
Study participants in this group will be asked to complete 4 weeks of high-intensity interval training (HIIT).
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Study participants in this group will not undergo HIIT exercise training during this study.
Intervention Type
Other
Intervention Name(s)
High-Intensity Interval Training (HIIT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intrahepatic triglyceride (IHTG)
Description
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.
Time Frame
24 months
Title
Cardiovascular fitness
Description
Cardiovascular fitness will be assessed via "peak oxygen uptake" (VO2 max). VO2 max is expressed as milliliters per body weight in kilograms per minutes. There is no established normative data for VO2 max in pediatric population; however, higher values indicate better cardiovascular fitness.
Time Frame
24 months
Title
HOMA-IR
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Alanine Aminotransferase
Description
Serum alanine aminotransferase (ALT) level will be measured. Higher ALT levels suggest presence of hepatocellular damage.
Time Frame
24 months
Title
FibroScan - Controlled Attenuated Parameter
Description
Controlled Attenuated Parameter (CAP) score will be measured using FibroScan. CAP score is reported in decibel/second (dB/s) and ranges between 100-400. A score of 241 dB/s or greater is consistent with non-alcoholic fatty liver disease.
Time Frame
24 months
Title
FibroScan - Transient Elastogram
Description
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.
Time Frame
24 months
Title
Body Composition - Total Body Fat and Visceral Fat
Description
Body composition will be measured using Dual X-Ray Absorptiometry (DXA) scan. Normative data for total body fat and visceral fat are not established; however, larger visceral fat volume is linked to higher intrahepatic triglyceride content and insulin resistant state; similarly, larger total body fat volume is linked to higher intrahepatic triglyceride content and insulin resistant state.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emir Tas, MD
Organizational Affiliation
Arkansas Children's Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Children's Nutrition Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Arkansas Children's Pediatric Clinical Research Unit
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States

12. IPD Sharing Statement

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

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