RECRUITING

NASH AMPK Exercise Dosing (AMPED) Trial

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

NASH AMPK Exercise Dosing (AMPED) Trial

Quick Facts

Study Start:2022-08-30
Study Completion:2026-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04987879

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 69 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-69 years
  2. * Sedentary \[\<90 min/wk of exercise identified by the Get Active Questionnaire (GAQ)
  3. * BMI \>25kg/m2
  4. * Liver biopsy within six months prior to enrollment showing:
  5. * NASH defined by NASH Clinical Research Network (CRN) histology scoring system (NAS) \>4 and MRI-PDFF \>5% and;
  6. * Liver fibrosis stage 1-3
  1. * Active cardiac symptoms
  2. * Body mass index (BMI) \>45kg/m2
  3. * Cancer that is active
  4. * Inability to walk \>2 blocks
  5. * Institutionalized/prisoner
  6. * Other liver disease
  7. * Pregnancy
  8. * Secondary hepatic steatosis
  9. * Severe comorbidities
  10. * AUDIT-C questionnaire identified significant alcohol use
  11. * Substance abuse/active smoking
  12. * Uncontrolled diabetes (changes in drug dosing over previous three months or A1c \>9%)
  13. * GAQ response indicates exercise may be unsafe.

Contacts and Locations

Study Contact

Breianna L Hummer, MS
CONTACT
7175310003
bhummer@pennstatehealth.psu.edu

Principal Investigator

Jonathan G Stine
PRINCIPAL_INVESTIGATOR
Milton S. Hershey Medical Center

Study Locations (Sites)

Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
United States

Collaborators and Investigators

Sponsor: Milton S. Hershey Medical Center

  • Jonathan G Stine, PRINCIPAL_INVESTIGATOR, Milton S. Hershey Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-30
Study Completion Date2026-06-01

Study Record Updates

Study Start Date2022-08-30
Study Completion Date2026-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • NAFLD