Health TrialsbyHealthPanel

NASH AMPK Exercise Dosing (AMPED) Trial

ConditionNAFLD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-69
SponsorMilton S. Hershey Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-69 years

Sedentary [<90 min/wk of exercise identified by the Get Active Questionnaire (GAQ)

BMI >25kg/m2

NASH defined by NASH Clinical Research Network (CRN) histology scoring system (NAS) >4 and MRI-PDFF >5% and;

Disqualifiers

Active cardiac symptoms

Body mass index (BMI) >45kg/m2

Cancer that is active

Inability to walk >2 blocks

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise

    Behavioral

    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).

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Exercise Arm 1Experimental treatment 1 intervention
Group B: Exercise Arm 2Experimental treatment 1 intervention
Group C: Standard of CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
16 weeks

Secondary outcomes

1

Hip/waist circumference

change in Hip/waist circumference

Time frame
16 weeks
2

Body mass index

change in body mass index

Time frame
16 weeks
3

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.

Time frame
16 weeks
4

Insulin

change in insulin

Time frame
16 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Milton S. Hershey Medical Center

Lead sponsor

Penn State Health Milton S Hershey Medical Center

Sponsor institution

Source ClinicalTrials.gov
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