Exercise dosing for treating nonalcoholic fatty liver disease

NASH AMPK Exercise Dosing (AMPED) Trial

This study tests how different amounts of exercise can help people with nonalcoholic fatty liver disease feel better and improve their liver health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years to 69 Years
• Sex: All
• Sponsor: Milton S. Hershey Medical Center (Academic / other)
• Locations: 1 site (Hershey, Pennsylvania)
• Trial ID: NCT04987879 on ClinicalTrials.gov

What this trial studies

This trial investigates the optimal exercise prescription for patients with nonalcoholic fatty liver disease (NAFLD) and its progressive form, NASH. It aims to understand how exercise affects the AMPK pathway, which may play a crucial role in reducing liver fat accumulation. Participants will engage in a structured exercise program, and the study will assess the effectiveness of different exercise doses on liver health. The trial is particularly focused on sedentary individuals with specific liver biopsy results indicating NASH.

Who should consider this trial

Good fit: Ideal candidates are sedentary adults aged 18-69 with a BMI over 25 and diagnosed with NASH.

Not a fit: Patients with severe comorbidities, active cancer, or other liver diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a tailored exercise regimen that significantly improves liver health in patients with NAFLD.

How similar studies have performed: While exercise is commonly recommended for NAFLD, this specific approach targeting the AMPK pathway has not been extensively studied in patients, making it a novel investigation.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* Active cardiac symptoms
* Body mass index (BMI) \>45kg/m2
* Cancer that is active
* Inability to walk \>2 blocks
* Institutionalized/prisoner
* Other liver disease
* 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.

Where this trial is running

Hershey, Pennsylvania

• Penn State Hershey Medical Center — Hershey, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Christopher Sciamanna, MD — Milton S. Hershey Medical Center
• Study coordinator: Breianna L Hummer, MS

Conditions NAFLD