Hepatic Elastography-Enhanced Lifestyle Modification in MASLD

Launched by MAHIDOL UNIVERSITY · Feb 13, 2025

Keywords

ClinConnect Summary

This study is checking whether regularly monitoring liver fat with a liver scan (elastography) and giving people feedback to improve diet and exercise helps people with MASLD (metabolic dysfunction-associated steatotic liver disease) do better over 48 weeks than standard lifestyle counseling alone. In other words, they’re asking if tracking liver fat and fibrosis and using that information to guide lifestyle changes leads to bigger improvements in liver fat and other health measures than usual care.

Adults 18–79 with MASLD and metabolic syndrome features can join, as long as they don’t have other liver diseases and can safely have MRI scans. About 92 people will be randomly assigned to either (1) regular elastography monitoring plus lifestyle feedback or (2) standard care with counseling only, and neither participants nor the staff assessing results will know which group a person is in. Over 48 weeks, participants will have MRI tests to measure liver fat and stiffness, blood tests for liver and metabolic health, and body composition tests. The trial is taking place at Siriraj Hospital, Mahidol University in Bangkok, Thailand, and results are not yet available. The study is registered as NCT06826807.

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.