NASH AMPK Exercise Dosing (AMPED) Trial

Last updated: December 10, 2024
Sponsor: Milton S. Hershey Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Exercise

Clinical Study ID

NCT04987879
STUDY00018280
  • Ages 18-69
  • All Genders

Study 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 Criteria

Inclusion

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

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.

Study Design

Total Participants: 45
Treatment Group(s): 1
Primary Treatment: Exercise
Phase:
Study Start date:
August 30, 2022
Estimated Completion Date:
June 01, 2026

Study 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.

Connect with a study center

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

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