Hepatic Elastography-Enhanced Lifestyle Modification in MASLD
Launched by MAHIDOL UNIVERSITY · Feb 13, 2025
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
The 2022 health survey of Thai adults (aged ≥18 years) reported an obesity prevalence of 44.9% (40.3% in males, 49.2% in females), a significant increase over past decades. Obesity is a major contributing factor to the rising incidence of MASLD, previously termed nonalcoholic fatty liver disease (NAFLD). MASLD is defined as fatty liver disease occurring in individuals consuming less than 140 grams of alcohol per week for females or less than 210 grams per week for males, alongside clinical features of metabolic dysfunction.
Among 18,588 surveyed individuals, the prevalence of MASLD was 19....
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. 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.
- • 2. Participants must be at least 18 years old and less than 80 years old at the time of enrollment.
- Exclusion Criteria:
- • 1. Individuals diagnosed with other chronic liver diseases, including hepatitis B or C, autoimmune hepatitis, Wilson's disease, liver cancer, hemochromatosis, or liver cirrhosis.
- • 2. Individuals diagnosed with conditions that may influence MASLD, such as HIV, chronic inflammatory diseases, or connective tissue disorders.
- • 3. Individuals taking medications known to promote fatty liver disease, such as amiodarone, steroids, methotrexate, hormonal medications, or immunosuppressants.
- • 4. Individuals who have previously taken medications known to impact fatty liver disease, including vitamin E, pioglitazone, GLP-1 receptor agonists, or SGLT2 inhibitors.
- • 5. Participants intending to join weight loss programs or undergo bariatric surgery for obesity treatment.
- • 6. 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.
- • 7. Patients with contraindications to undergoing MRI examinations, such as claustrophobia or incompatible body implants or materials.
- • 8. Women who are pregnant.
- • 9. Individuals who do not provide formal consent to participate in the research project.
About Mahidol University
Mahidol University, a premier institution in Thailand, is dedicated to advancing healthcare through innovative research and education. As a leading sponsor of clinical trials, the university leverages its extensive expertise in medical and health sciences to facilitate rigorous scientific investigations aimed at improving patient care and public health outcomes. With a commitment to ethical practices and collaboration, Mahidol University fosters multidisciplinary approaches, engaging a diverse array of researchers and healthcare professionals to drive meaningful advancements in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bangkoknoi, Bangkok, Thailand
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported