Hepatic Elastography-Enhanced Lifestyle Modification in MASLD
NCT ID: NCT06826807
Last Updated: 2025-05-13
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ENROLLING_BY_INVITATION
Clinical Phase
NA
Total Enrollment
92 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-05-12
Study Completion Date
2027-06-01
Brief Summary
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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.
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Detailed Description
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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 19.7% (20.9% in males, 18.6% in females), with notably higher rates of 43.5% in those with abdominal obesity and 35.6% in individuals with diabetes. Significant associations were observed between MASLD and factors such as age, sex, physical activity, smoking, and metabolic abnormalities, including overweight, abdominal obesity, elevated triglycerides, diabetes, hypertension, and low HDL cholesterol levels.
MASLD is closely linked to insulin resistance, a critical risk factor for cardiovascular disease. Current guidelines emphasize weight loss through dietary control and exercise to reduce hepatic fat accumulation, inflammation, and fibrosis, while improving metabolic parameters such as blood glucose, lipid profiles, and insulin sensitivity. Behavioral and environmental factors, including high-calorie diets and sedentary lifestyles, contribute to the pathogenesis of MASLD by promoting insulin resistance and hepatic fat accumulation, leading to oxidative stress, inflammation, and fibrosis, thereby increasing the risks of cirrhosis and hepatocellular carcinoma.
A recent study highlighted that 59.2% of MASLD patients were unaware of their liver fat and fibrosis status. Lack of awareness was associated with poor adherence to lifestyle modifications, particularly in obese individuals (BMI \> 30 kg/m²). This randomized controlled trial investigates the effect of hepatic elastography monitoring on lifestyle changes, hepatic steatosis, metabolic parameters, and anthropometry, compared to standard care over a 48-week period.
Among 18,588 surveyed individuals, the prevalence of MASLD was 19.7% (20.9% in males, 18.6% in females), with notably higher rates of 43.5% in those with abdominal obesity and 35.6% in individuals with diabetes. Significant associations were observed between MASLD and factors such as age, sex, physical activity, smoking, and metabolic abnormalities, including overweight, abdominal obesity, elevated triglycerides, diabetes, hypertension, and low HDL cholesterol levels.
MASLD is closely linked to insulin resistance, a critical risk factor for cardiovascular disease. Current guidelines emphasize weight loss through dietary control and exercise to reduce hepatic fat accumulation, inflammation, and fibrosis, while improving metabolic parameters such as blood glucose, lipid profiles, and insulin sensitivity. Behavioral and environmental factors, including high-calorie diets and sedentary lifestyles, contribute to the pathogenesis of MASLD by promoting insulin resistance and hepatic fat accumulation, leading to oxidative stress, inflammation, and fibrosis, thereby increasing the risks of cirrhosis and hepatocellular carcinoma.
A recent study highlighted that 59.2% of MASLD patients were unaware of their liver fat and fibrosis status. Lack of awareness was associated with poor adherence to lifestyle modifications, particularly in obese individuals (BMI \> 30 kg/m²). This randomized controlled trial investigates the effect of hepatic elastography monitoring on lifestyle changes, hepatic steatosis, metabolic parameters, and anthropometry, compared to standard care over a 48-week period.
Conditions
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Transient Elastography
MASLD
BMI
Metabolic Syndrome
NAFLD
Insulin Resistance
Cardiovascular Diseases
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
The intervention group will undergo regular hepatic elastography monitoring to assess liver fat composition and receive feedback to encourage dietary modifications and increased physical activity. The control group will receive standard care without elastography monitoring.
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Outcome Assessors
Study Groups
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Experimental: Active Comparator: Regular hepatic elastography monitoring to encourage dietary modifi
• MASLD patient will undergo regular hepatic elastography monitoring to assess liver fat composition and receive feedback to encourage dietary modifications and increased physical activity.
Group Type
EXPERIMENTAL
Regular monitoring with transient elastography
Intervention Type
OTHER
MASLD patients were received their liver fat and fibrosis status regularly using transient elastography
No Intervention: Placebo comparator: standard care (counselling for dietary modifications and increa
The control group will receive standard care (counselling for dietary modifications and increased physical activity) without elastography monitoring.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Regular monitoring with transient elastography
MASLD patients were received their liver fat and fibrosis status regularly using transient elastography
Intervention Type
OTHER
Eligibility Criteria
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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.
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.
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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Mahidol University
OTHER
Sponsor Role
lead
Responsible Party
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Phunchai Charatcharoenwitthaya
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, Thailand
Site Status
Countries
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Thailand
References
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Other Identifiers
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SI 009/2025
Identifier Type: -
Identifier Source: org_study_id
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