NASH AMPK Exercise Dosing (AMPED) 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. 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

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.

Conditions2

Locations1 site

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