Non-Alcoholic Fatty Liver Disease Clinical Trials

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NASH AMPK Exercise Dosing (AMPED) Trial

Status: Recruiting

Location: See location...

Intervention Type: Behavioral

Study Type: Interventional

Study Phase: Not Applicable

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

Participation Requirements

Sex: All

Minimum Age: 18

Maximum Age: 69

Healthy Volunteers: f

View:

• 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

Locations

United States

Pennsylvania

Penn State Hershey Medical Center

RECRUITING

Hershey

Contact Information

Primary

Breianna L Hummer, MS

bhummer@pennstatehealth.psu.edu

7175310003

Time Frame

Start Date: 2022-08-30

Estimated Completion Date: 2026-07-15

Participants

Target number of participants: 45

Treatments

Experimental: Exercise Arm 1

Aerobic exercise will 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 and dynamic exercises. A 5-min walking cool down will end the session. The training dose for this arm is 750 MET-min/wk for 3-5 days per week, 22-45 minutes per session at a moderate to vigorous intensity. The exercise can be completed in person or virtually.

Experimental: Exercise Arm 2

Aerobic exercise will 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 and dynamic exercises. A 5-min walking cool down will end the session. The training dose for this arm is 1,000 MET-min/wk for 3-5 days per week, 30-60 minutes per session at a moderate to vigorous intensity. The exercise can be completed in person or virtually.

No_intervention: Standard of Care

This group will receive best NASH clinical practices counseling at baseline and end-of-trial in accordance with NAFLD clinical practice guidelines and be reinforced by handouts from the American Liver Foundation.

Authors

Jonathan G Stine

Related Therapeutic Areas

Non-Alcoholic Fatty Liver Disease

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