NAFLDAMPEDNCT04987879
NASH AMPK Exercise Dosing (AMPED) Trial
A study testing Exercise in people with NAFLD, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
There is no known cure or regulatory agency approved drug therapy for nonalcoholic fatty liver disease (NAFLD), the leading cause of liver disease worldwide, and its progressive type, NASH. This places increased importance on using exercise to treat NAFLD. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- NAFLD
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2022to 10 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-69 years
- Sedentary [<90 min/wk of exercise identified by the Get Active Questionnaire (GAQ)
- BMI >25kg/m2
- Liver biopsy within six months prior to enrollment showing:
- NASH defined by NASH Clinical Research Network (CRN) histology scoring system (NAS) >4 and MRI-PDFF >5% and;
- Liver fibrosis stage 1-3
Who cannot join
- Active cardiac symptoms
- Body mass index (BMI) >45kg/m2
- Cancer that is active
- Inability to walk >2 blocks
- Institutionalized/prisoner
- Other liver disease
Show all 13Show fewer
- Pregnancy
- Secondary hepatic steatosis
- Severe comorbidities
- AUDIT-C questionnaire identified significant alcohol use
- Substance abuse/active smoking
- Uncontrolled diabetes (changes in drug dosing over previous three months or A1c >9%)
- GAQ response indicates exercise may be unsafe.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
There is no known cure or regulatory agency approved drug therapy for nonalcoholic fatty liver disease (NAFLD), the leading cause of liver disease worldwide, and its progressive type, NASH. This places increased importance on using exercise to treat NAFLD.
While physical activity is recommended for all with NAFLD, how to best prescribe exercise as a specific treatment remains unknown, including what dose of exercise is most effective.
Read the detailed description
The mechanism explaining how exercise training benefits patients with NAFLD and NASH is unclear. The AMPK pathway may be responsible for the benefits seen with exercise training because: 1) AMPK has a liver-specific role in hepatic de novo lipogenesis and fatty acid oxidation, 2) AMPK activity is abnormally low in NAFLD and 3) NAFLD animal models demonstrate exercise changes the liver-specific AMPK pathway, leading to less liver fat accumulation by reducing lipogenesis and increasing fatty acid oxidation (This has not been studied in patients). Importantly, exercise-induced AMPK activation appears to be dose dependent.
- Conditions
- NAFLD
- Being tested
- Exercise
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called Physical activity
Aerobic exercise can be completed by walking, jogging or running or by using cardio equipment (e.g., recumbent bike). Each session will begin with a warm-up with walking (30-40% target HR for 5-min) and dynamic exercises (knee-to-chest, 10-yd lateral shuffle, bent over twist, calf sweeps, leg swings). A 5-min walking cool down will end the session (30-40% target HR).
| Study group | Role | What they receive |
|---|---|---|
| Exercise Arm 1 | Experimental | Aerobic exercise will be completed by walking, jogging or running or by using cardio equipment (e.g., recumbent bike). Each session will begin with a warm-up with walking and dynamic exercises. A 5-min walking cool down will end the session. The training dose for this arm is 750 MET-min/wk for 3-5 days per week, 22-45 minutes per session at a moderate to vigorous intensity. The exercise can be completed in person or virtually. Receives: Behavioral: Exercise |
| Exercise Arm 2 | Experimental | Aerobic exercise will be completed by walking, jogging or running or by using cardio equipment (e.g., recumbent bike). Each session will begin with a warm-up with walking and dynamic exercises. A 5-min walking cool down will end the session. The training dose for this arm is 1,000 MET-min/wk for 3-5 days per week, 30-60 minutes per session at a moderate to vigorous intensity. The exercise can be completed in person or virtually. Receives: Behavioral: Exercise |
| Standard of Care | No intervention | This group will receive best NASH clinical practices counseling at baseline and end-of-trial in accordance with NAFLD clinical practice guidelines and be reinforced by handouts from the American Liver Foundation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in liver fat
Degree of liver fat change as measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF) across different doses of exercise in patients with NASH.
Measured: 16 weeks
Secondary outcomes (16)
Hip/waist circumference
change in Hip/waist circumference
Measured: 16 weeks
Body mass index
change in body mass index
Measured: 16 weeks
change in body composition
change in body composition as measured by Dual-energy X-ray absorptiometry (DXA scan) across different doses of exercise in patients with NASH.
Measured: 16 weeks
Insulin
change in insulin
Measured: 16 weeks
Hemoglobin A1c
change in Hemoglobin A1c
Measured: 16 weeks
change in cholesterol and triglycerides levels (dyslipidemia)
change in cholesterol and triglycerides levels (dyslipidemia) as measured by clinical labs.
Measured: 16 weeks
Interleukin-6
change in Interleukin-6
Measured: 16 weeks
c-reactive protein
change in c-reactive protein
Measured: 16 weeks
Non-Alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score
change in NAFLD Fibrosis Score which estimates amount of scarring in the liver based on several laboratory tests.
NAFLD Score Correlated Fibrosis Severity < -1.455 F0-F2
-1.455 - 0.675 Indeterminant score > 0.675 F3-F4 Fibrosis Severity Scale
F0 = no fibrosis F1 = mild fibrosis F2 = moderate fibrosis F3 = severe fibrosis F4 = cirrhosis
Measured: 16 weeks
Enhance liver fibrosis (ELF) test
change in Enhance liver fibrosis (ELF) test
Measured: 16 weeks
TIMP-1
change in TIMP-1
Measured: 16 weeks
ProC3
change in ProC3
Measured: 16 weeks
Adiponectin
change in Adiponectin
Measured: 16 weeks
Fibroblast Growth Factor (FGF) 21
change in Fibroblast Growth Factor (FGF) 21
Measured: 16 weeks
Change in stiffness of the liver
Change in stiffness of the liver as measured by the technique of transient elastography, a non-invasive test to stage the severity of liver disease.
Measured: 16 weeks
Liver glycogen
change in liver glycogen
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start30 Aug 2022
- Primary completion10 Feb 2026
- Study completion10 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Sciamanna, MD, MPH, Penn State Health Milton S Hershey Medical Center
- Investigators
- Christopher Sciamanna, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987879
- Sponsor's protocol ID
- STUDY00018280
- Other IDs
- K23DK131290
- Acronym
- AMPED
- Status last verified
- Aug 2026
- First submitted
- 13 Jul 2021
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NASH AMPK Exercise Dosing (AMPED) Trial
- ClinicalTrials.gov ID
- NCT04987879
- Acronym / sponsor ID
- AMPED / STUDY00018280
- Conditions
- NAFLD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 10 Feb 2026 (actual)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is no known cure or regulatory agency approved drug therapy for nonalcoholic fatty liver disease (NAFLD), the leading cause of liver disease worldwide, and its progressive type, NASH. This places increased importance on using exercise to treat NAFLD.
While physical activity is recommended for all with NAFLD, how to best prescribe exercise as a specific treatment remains unknown, including what dose of exercise is most effective.
Detailed description
The mechanism explaining how exercise training benefits patients with NAFLD and NASH is unclear. The AMPK pathway may be responsible for the benefits seen with exercise training because: 1) AMPK has a liver-specific role in hepatic de novo lipogenesis and fatty acid oxidation, 2) AMPK activity is abnormally low in NAFLD and 3) NAFLD animal models demonstrate exercise changes the liver-specific AMPK pathway, leading to less liver fat accumulation by reducing lipogenesis and increasing fatty acid oxidation (This has not been studied in patients). Importantly, exercise-induced AMPK activation appears to be dose dependent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise Arm 1 | Experimental | Behavioral: ExerciseAerobic exercise will be completed by walking, jogging or running or by using cardio equipment (e.g., recumbent bike). Each session will begin with a warm-up with walking and dynamic exercises. A 5-min walking cool down will end the session. The training dose for this arm is 750 MET-min/wk for 3-5 days per week, 22-45 minutes per session at a moderate to vigorous intensity. The exercise can be completed in person or virtually. |
| Exercise Arm 2 | Experimental | Behavioral: ExerciseAerobic exercise will be completed by walking, jogging or running or by using cardio equipment (e.g., recumbent bike). Each session will begin with a warm-up with walking and dynamic exercises. A 5-min walking cool down will end the session. The training dose for this arm is 1,000 MET-min/wk for 3-5 days per week, 30-60 minutes per session at a moderate to vigorous intensity. The exercise can be completed in person or virtually. |
| Standard of Care | No intervention | –This group will receive best NASH clinical practices counseling at baseline and end-of-trial in accordance with NAFLD clinical practice guidelines and be reinforced by handouts from the American Liver Foundation. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-69 years
- Sedentary [<90 min/wk of exercise identified by the Get Active Questionnaire (GAQ)
- BMI >25kg/m2
- Liver biopsy within six months prior to enrollment showing:
Key exclusion criteria (13 listed)
- Active cardiac symptoms
- Body mass index (BMI) >45kg/m2
- Cancer that is active
- Inability to walk >2 blocks
- Institutionalized/prisoner
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 |
|---|---|---|
| ExerciseAlso: Physical activityAerobic exercise can be completed by walking, jogging or running or by using cardio equipment (e.g., recumbent bike). Each session will begin with a warm-up with walking (30-40% target HR for 5-min) and dynamic exercises (knee-to-chest, 10-yd lateral shuffle, bent over twist, calf sweeps, leg swings). A 5-min walking cool down will end the session (30-40% target HR). | Behavioural | Exercise Arm 1, Exercise Arm 2 |
Primary outcome
Change in liver fat
Time frame: 16 weeks
Degree of liver fat change as measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF) across different doses of exercise in patients with NASH.
16 secondary outcomes
Hip/waist circumference
Time frame: 16 weeks
Body mass index
Time frame: 16 weeks
change in body composition
Time frame: 16 weeks
Insulin
Time frame: 16 weeks
Hemoglobin A1c
Time frame: 16 weeks
change in cholesterol and triglycerides levels (dyslipidemia)
Time frame: 16 weeks
Interleukin-6
Time frame: 16 weeks
c-reactive protein
Time frame: 16 weeks
Non-Alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score
Time frame: 16 weeks
Enhance liver fibrosis (ELF) test
Time frame: 16 weeks
TIMP-1
Time frame: 16 weeks
ProC3
Time frame: 16 weeks
Adiponectin
Time frame: 16 weeks
Fibroblast Growth Factor (FGF) 21
Time frame: 16 weeks
Change in stiffness of the liver
Time frame: 16 weeks
Liver glycogen
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Christopher Sciamanna, MD principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with NAFLD, run by Milton S. Hershey Medical Center at 1 site 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 6 inclusion and 13 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 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in liver fat (time frame: 16 weeks). 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 12 Aug 2026.