NCT06826807

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Transient Elastography
• MASLD
• BMI
• Metabolic Syndrome
• NAFLD
• Insulin Resistance
• Cardiovascular Diseases

Interventions

Type	Name	Description
OTHER	Regular monitoring with transient elastography	MASLD patients were received their liver fat and fibrosis status regularly using transient elastography

Timeline

• Start date: 2025-05-12
• Primary completion: 2027-01-01
• Completion: 2027-06-01
• First posted: 2025-02-14
• Last updated: 2025-05-13

Locations

1 site across 1 country: Thailand