Hepatic Elastography-Enhanced Lifestyle Modification in MASLD

Sponsor
Mahidol University
Study ID
NCT06826807
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Regular monitoring with transient elastography — OTHER
    MASLD patients were received their liver fat and fibrosis status regularly using transient elastography

Study Details

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.

Key Dates

First listed
Feb 14, 2025
Start date
May 12, 2025
Status verified
May 2025
Primary completion
Jan 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
92 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • No Intervention: 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.

Primary Outcome Measure

Change from baseline in non-invasive marker magnetic resonance imaging-estimated proton density fat fraction (MRI-PDFF) (%) [ Time Frame: 48 weeks ]

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