NCT06826807Enrolling by invitation
Hepatic Elastography-Enhanced Lifestyle Modification in MASLD
Hepatic Elastography-Enhanced Lifestyle Modification in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 13 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The 2022 National Health Survey in Thailand revealed a substantial rise in obesity and metabolic dysfunction-associated steatotic liver disease (MASLD). The prevalence of MASLD was 19.7%, with higher rates observed in individuals with metabolic syndrome and diabetes. Effective management of MASLD primarily involves lifestyle modifications, including dietary adjustments and increased physical activity. Evidence suggests that patients unaware of their liver fibrosis status are less likely to adhere to these interventions. This study aims to evaluate the impact of hepatic elastography monitoring on lifestyle modification adherence and health outcomes in patients with MASLD over 48 weeks.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 92 (estimated)
- First submitted
- 28 Jan 2025
- Start date
- 12 May 2025
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Mahidol University
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06826807
What you commit to
- Study type: Interventional
- Planned participants: 92
- From 12 May 2025 to the primary completion date, 1 Jan 2027
- 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 previously taken medications known to impact fatty liver disease, including vitamin E, pioglitazone, GLP-1 receptor agonists, or SGLT2 inhibitors.
- Participants intending to join weight loss programs or undergo bariatric surgery for obesity treatment.
- Patients with contraindications to undergoing MRI examinations, such as claustrophobia or incompatible body implants or materials.
Other illness
- Individuals diagnosed with other chronic liver diseases, including hepatitis B or C, autoimmune hepatitis, Wilson's disease, liver cancer, hemochromatosis, or liver cirrhosis.
- Individuals diagnosed with conditions that may influence MASLD, such as HIV, chronic inflammatory diseases, or connective tissue disorders.
- Individuals taking medications known to promote fatty liver disease, such as amiodarone, steroids, methotrexate, hormonal medications, or immunosuppressants.
- Individuals with severe chronic diseases presenting symptoms during physical activity, such as coronary artery disease, chronic obstructive pulmonary disease, or severe osteoarthritis, which may exacerbate their condition.
Other
- 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 outlined in the 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 clinical characteristic of metabolic syndrome.
- Participants must be at least 18 years old and less than 80 years old at the time of enrollment.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Medicine Siriraj Hospital, Mahidol University Coordinator of this site? Confirm its status | Bangkoknoi | Thailand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.