NCT06334666Enrolling by invitation
The Efficacy of Pedometer-motivated Physical Activity for the Management of Patients With MASLD.
The Efficacy of Pedometer-motivated Physical Activity for the Management of Patients With Metabolic-associated Steatotic Liver Disease: a Randomized-controlled Trial
Source: ClinicalTrials.gov · Last updated 15 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The study conducted a health survey among Thai adults in 2022 and found a significant increase in obesity and nonalcoholic fatty liver disease (NAFLD), leading to metabolic-associated steatotic liver disease (MASLD). The prevalence of NAFLD was 19.7%, with higher rates in individuals with metabolic syndrome and diabetes. MASLD is associated with insulin resistance and genetic polymorphisms, particularly the patatin like phospholipase domain containing 3-rs738409 variant. Additionally, physical activity was inversely related to liver disease risk, with higher step counts associated with reduced incidence of NAFLD and liver-related mortality. The study aims to investigate the impact of dietary advice and pedometer use on physical activity levels and health outcomes in MASLD patients over 24 weeks.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 86 (estimated)
- First submitted
- 18 Mar 2024
- Start date
- 1 Aug 2024
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- Mahidol University
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06334666
What you commit to
- Study type: Interventional
- Planned participants: 86
- From 1 Aug 2024 to the primary completion date, 1 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individuals who have regular physical activity with walking exceeding 3000 steps per day before participating in the study.
- Individuals who have previously taken medications known to impact fatty liver disease, including vitamin E, pioglitazone, Glucagon-like peptide-1 agonists, SGLT2 inhibitors.
- Participants intending to join weight loss programs or undergo bariatric surgery for obesity treatment.
- Patients with contraindications for undergoing MRI examinations, such as claustrophobia or having body implants or materials that are incompatible with MRI scanning.
Other illness
- Individuals diagnosed with other chronic liver diseases such as hepatitis B or C, autoimmune hepatitis, Wilson's disease, liver cancer, hemochromatosis, liver cirrhosis, or others.
- Individuals diagnosed with diseases that may affect non-alcoholic fatty liver disease, such as HIV, various chronic inflammatory diseases, or connective tissue disorders.
- Individuals taking medications known to promote fatty liver disease, including amiodarone, steroids, methotrexate, hormonal medications, or immunosuppressants.
- Individuals diagnosed with liver cancer.
- Individuals with severe chronic diseases still exhibiting symptoms during physical activity that may exacerbate the disease, such as coronary artery disease, chronic obstructive pulmonary disease, or severe osteoarthritis.
Other
- Individuals who engage in regular exercise for at least 20 minutes per day, at least 3 days per week.
- Individuals with cirrhosis.
- Women who are pregnant.
- Individuals who do not provide formal consent to participate in the research project.
Who the study is looking for
- Participants must be diagnosed with MASLD according to the diagnostic criteria of the A multi-society Delphi consensus statement on new fatty liver disease nomenclature 2023, with evidence of hepatic steatosis and alcohol consumption of less than 140 grams per week for females or less than 210 grams per week for males, along with at least one of the clinical characteristics of metabolic syndrome.
- Participants must be at least 18 years old at the time of enrollment.
- Patients must consent to blood testing for the identification of the patatin like phospholipase domain containing-3 gene polymorphism.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Medicine Siriraj Hospital Coordinator of this site? Confirm its status | Bangkoknoi | Thailand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.