Non-Alcoholic Fatty Liver DiseaseNCT04342390
Effects of High-Intensity Interval Training Exercise in Adolescents With Hepatosteatosis
A study testing High-Intensity Interval Training (HIIT) in people with Non-Alcoholic Fatty Liver Disease and Insulin Resistance, run by Arkansas Children's Hospital Research Institute at 2 sites in United States.
Trial summary
This is a research study about how short-term exercise intervention affects adolescents with a disease called non-alcoholic fatty liver disease (NAFLD). Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Insulin Resistance, High Intensity Interval Training
- What is being tested?
- High-Intensity Interval Training (HIIT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Apr 2021to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202
Arkansas Children's Pediatric Clinical Research Unit
Little Rock, Arkansas, 72202
About this study
This is a research study about how short-term exercise intervention affects adolescents with a disease called non-alcoholic fatty liver disease (NAFLD).
Read the 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
- Being tested
- High-Intensity Interval Training (HIIT)
- Keywords
- NAFLD, HIIT, Insulin, Fitness, Controlled Attenuated Parameter, Steatosis, Peak oxygen uptake
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Insulin Resistance, Pediatric Obesity, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Study participants in this group will be asked to complete 4 weeks of high-intensity interval training (HIIT). Receives: Other: High-Intensity Interval Training (HIIT) |
| Control Group | No intervention | Study participants in this group will not undergo HIIT exercise training during this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (4)
Alanine Aminotransferase
Serum alanine aminotransferase (ALT) level will be measured. ALT level is reported in international unit/liter or IU/L. Higher ALT levels suggest presence of hepatocellular damage.
Measured: 4 weeks
FibroScan - Controlled Attenuated Parameter
Controlled Attenuated Parameter (CAP) score will be measured using FibroScan. CAP score is reported in decibel/meter (dB/m) and ranges between 100-400. A score of 241 dB/m or greater is consistent with non-alcoholic fatty liver disease.
Measured: 4 weeks
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.
Measured: 4 weeks
Body Composition - Total Body Fat
Body composition will be measured using Dual X-Ray Absorptiometry (DXA) scan. Normative data for total body fat is not established; however, larger total body fat percentage (percentage of total body weight) is linked to higher intrahepatic triglyceride content and insulin resistant state.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start2 Apr 2021
- Primary completion1 Jul 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Emir Tas, MD, Principal investigator, Arkansas Children's Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342390
- Sponsor's protocol ID
- 260671
- Other IDs
- P20GM109096
- Status last verified
- Jul 2023
- First submitted
- 8 Apr 2020
- Last updated
- 22 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-Intensity Interval Training Exercise in Adolescents With Hepatosteatosis
- ClinicalTrials.gov ID
- NCT04342390
- Acronym / sponsor ID
- 260671
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 13 Apr 2020 (actual)
- Results
- Posted 20 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: High-Intensity Interval Training (HIIT)Study participants in this group will be asked to complete 4 weeks of high-intensity interval training (HIIT). |
| Control Group | No intervention | –Study participants in this group will not undergo HIIT exercise training during this study. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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"
Key exclusion criteria (12 listed)
- 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"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Exercise Group |
Primary outcome
Intrahepatic Triglyceride (IHTG)
Time frame: 4 weeks
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
Time frame: 4 weeks
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.
HOMA-IR
Time frame: 4 weeks
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 secondary outcomes
Alanine Aminotransferase
Time frame: 4 weeks
FibroScan - Controlled Attenuated Parameter
Time frame: 4 weeks
FibroScan - Transient Elastogram
Time frame: 4 weeks
Body Composition - Total Body Fat
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emir Tas, MD principal investigator
Arkansas Children's Hospital Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Interval Training (HIIT) in people with Non-Alcoholic Fatty Liver Disease and Insulin Resistance, run by Arkansas Children's Hospital Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrahepatic Triglyceride (IHTG) (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.