Hepatic Elastography-Enhanced Lifestyle Modification in MASLD

May 12, 2025 updated by: Phunchai Charatcharoenwitthaya, Mahidol University

Hepatic Elastography-Enhanced Lifestyle Modification in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease: A Randomized Controlled Trial

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Regular monitoring with transient elastography
MASLD patients were received their liver fat and fibrosis status regularly using transient elastography
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in non-invasive marker magnetic resonance imaging-estimated proton density fat fraction (MRI-PDFF) (%)
Time Frame: 48 weeks
Hepatic fat content assessed by MRI-PDFF (%)
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in non-invasive liver fibrosis marker
Time Frame: 48 weeks
Liver fibrosis assessed by magnetic resonance elastography (kPa)
48 weeks
Change from baseline in markers of liver injury
Time Frame: 48 weeks
Alanine aminotransferase (ALT) (U/L), aspartate aminotransferase (AST) (U/L), and gamma glutamyl transferase (GGT) (U/L).
48 weeks
Change from baseline in markers of glycemic control
Time Frame: 48 weeks
Fasting blood glucose (mg/dL)
48 weeks
Change from baseline in Hemoglobin A1C (%)
Time Frame: 48 weeks
Hemoglobin A1C (%)
48 weeks
Change from baseline in lipoproteins
Time Frame: 48 weeks
To compare changes in total cholesterol, triglyceride, HDL-cholesterol, and LDL-Total cholesterol (mg/dL), Triglycerides (TG) (mg/dL), high density lipoprotein cholesterol (HDL-C) (mg/dL), Non-HDL-C (mg/dL), and low-density lipoprotein cholesterol (LDL-C) (mg/dL)
48 weeks
Change from baseline in body fat composition assessed by Bioelectrical Impedance Analysis
Time Frame: 48 weeks
Body fat percentage assessed by Bioelectrical Impedance Analysis
48 weeks
Change from baseline in muscle mass assessed by Bioelectrical Impedance Analysis
Time Frame: 48 weeks
Muscle mass in kilograms assessed by Bioelectrical Impedance Analysis
48 weeks
Change from baseline in visceral fat assessed by Bioelectrical Impedance Analysis
Time Frame: 48 weeks
Visceral fat rate assessed by Bioelectrical Impedance Analysis
48 weeks
Change from baseline in wieght in kilograms assessed by Bioelectrical Impedance Analysis
Time Frame: 48 weeks
Body wieght in kilograms assessed by Bioelectrical Impedance Analysis
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

January 28, 2025

First Submitted That Met QC Criteria

February 13, 2025

First Posted (Actual)

February 14, 2025

Study Record Updates

Last Update Posted (Actual)

May 13, 2025

Last Update Submitted That Met QC Criteria

May 12, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SI 009/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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