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New treatment option for NAFLD
Official title NASH AMPK Exercise Dosing (AMPED) Trial
ClinicalTrials.gov ID: NCT04987879
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 69
You may be able to join if
- 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;
You likely can't join if
- Active cardiac symptoms
- Body mass index (BMI) \>45kg/m2
- Cancer that is active
- Inability to walk \>2 blocks
- Institutionalized/prisoner
- Other liver disease
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hershey, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 69 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hershey, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.