Transient ElastographyNCT06826807

Hepatic Elastography-Enhanced Lifestyle Modification in MASLD

A study testing Regular monitoring with transient elastography in people with Transient Elastography and MASLD, run by Mahidol University at 1 site in Thailand.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Transient Elastography, MASLD, BMI
What is being tested?: Regular monitoring with transient elastography
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 92 participants
Where: 1 siteThailand
Study dates: 12 May 2025to 1 Jun 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.
Participants must be at least 18 years old and less than 80 years old at the time of enrollment.

Who cannot join

Individuals diagnosed with other chronic liver diseases, including hepatitis B or C, autoimmune hepatitis, Wilson's disease, liver cancer, hemochromatosis, or liver cirrhosis.
Individuals diagnosed with conditions that may influence MASLD, such as HIV, chronic inflammatory diseases, or connective tissue disorders.
Individuals taking medications known to promote fatty liver disease, such as amiodarone, steroids, methotrexate, hormonal medications, or immunosuppressants.
Individuals who have previously taken medications known to impact fatty liver disease, including vitamin E, pioglitazone, GLP-1 receptor agonists, or SGLT2 inhibitors.
Participants intending to join weight loss programs or undergo bariatric surgery for obesity treatment.
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.

Show all 9Show fewer

Patients with contraindications to undergoing MRI examinations, such as claustrophobia or incompatible body implants or materials.
Women who are pregnant.
Individuals who do not provide formal consent to participate in the research project.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Thailand1 site

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

Other trials in Thailand

About this study

Official title: 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.

Read the 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
Being tested: Regular monitoring with transient elastography
Keywords: Lifestyle modification, MASLD, transient elastography
Medical subject headings: Metabolic Syndrome, Non-alcoholic Fatty Liver Disease, Insulin Resistance, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06826807
Study group	Role	What they receive
Experimental: Active Comparator: Regular hepatic elastography monitoring to encourage dietary modifi	Experimental	• MASLD patient will undergo regular hepatic elastography monitoring to assess liver fat composition and receive feedback to encourage dietary modifications and increased physical activity. Receives: Other: Regular monitoring with transient elastography
No Intervention: Placebo comparator: standard care (counselling for dietary modifications and increa	No intervention	The control group will receive standard care (counselling for dietary modifications and increased physical activity) without elastography monitoring.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (9)

Change from baseline in non-invasive liver fibrosis marker
Liver fibrosis assessed by magnetic resonance elastography (kPa)
Measured: 48 weeks
Change from baseline in markers of liver injury
Alanine aminotransferase (ALT) (U/L), aspartate aminotransferase (AST) (U/L), and gamma glutamyl transferase (GGT) (U/L).
Measured: 48 weeks
Change from baseline in markers of glycemic control
Fasting blood glucose (mg/dL)
Measured: 48 weeks
Change from baseline in Hemoglobin A1C (%)
Hemoglobin A1C (%)
Measured: 48 weeks
Change from baseline in lipoproteins
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)
Measured: 48 weeks
Change from baseline in body fat composition assessed by Bioelectrical Impedance Analysis
Body fat percentage assessed by Bioelectrical Impedance Analysis
Measured: 48 weeks
Change from baseline in muscle mass assessed by Bioelectrical Impedance Analysis
Muscle mass in kilograms assessed by Bioelectrical Impedance Analysis
Measured: 48 weeks
Change from baseline in visceral fat assessed by Bioelectrical Impedance Analysis
Visceral fat rate assessed by Bioelectrical Impedance Analysis
Measured: 48 weeks
Change from baseline in wieght in kilograms assessed by Bioelectrical Impedance Analysis
Body wieght in kilograms assessed by Bioelectrical Impedance Analysis
Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 May 20251 Jun 2027

First posted14 Feb 2025
Study start12 May 2025
Primary completion1 Jan 2027 (estimated)
Study completion1 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (39)Papers the sponsor has linked to this study.
Other trials for Transient ElastographyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 92 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06826807
Sponsor's protocol ID: SI 009/2025
Status last verified: May 2025
First submitted: 28 Jan 2025
Last updated: 13 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Sheka AC, Adeyi O, Thompson J, Hameed B, Crawford PA, Ikramuddin S. Nonalcoholic Steatohepatitis: A Review. JAMA. 2020 Mar 24;323(12):1175-1183. doi: 10.1001/jama.2020.2298.
PubMed 32207804
Koolhaas CM, van Rooij FJ, Cepeda M, Tiemeier H, Franco OH, Schoufour JD. Physical activity derived from questionnaires and wrist-worn accelerometers: comparability and the role of demographic, lifestyle, and health factors among a population-based sample of older adults. Clin Epidemiol. 2017 Dec 18;10:1-16. doi: 10.2147/CLEP.S147613. eCollection 2018.
PubMed 29296097
Joo JH, Kim HJ, Park EC, Jang SI. Association between sitting time and non-alcoholic fatty live disease in South Korean population: a cross-sectional study. Lipids Health Dis. 2020 Sep 23;19(1):212. doi: 10.1186/s12944-020-01385-6.
PubMed 32967678
Mansour-Ghanaei R, Mansour-Ghanaei F, Naghipour M, Joukar F. The Lifestyle Characteristics in Non-Alcoholic Fatty Liver Disease in the PERSIAN Guilan Cohort Study. Open Access Maced J Med Sci. 2019 Sep 14;7(19):3313-3318. doi: 10.3889/oamjms.2019.647. eCollection 2019 Oct 15.
PubMed 31949537
Rinella ME, Neuschwander-Tetri BA, Siddiqui MS, Abdelmalek MF, Caldwell S, Barb D, Kleiner DE, Loomba R. AASLD Practice Guidance on the clinical assessment and management of nonalcoholic fatty liver disease. Hepatology. 2023 May 1;77(5):1797-1835. doi: 10.1097/HEP.0000000000000323. Epub 2023 Mar 17. No abstract available.
PubMed 36727674
Akuta N, Kawamura Y, Arase Y, Suzuki F, Sezaki H, Hosaka T, Kobayashi M, Kobayashi M, Saitoh S, Suzuki Y, Ikeda K, Kumada H. Relationships between Genetic Variations of PNPLA3, TM6SF2 and Histological Features of Nonalcoholic Fatty Liver Disease in Japan. Gut Liver. 2016 May 23;10(3):437-45. doi: 10.5009/gnl15163.
PubMed 26610348
Carrieri P, Mourad A, Marcellin F, Trylesinski A, Calleja JL, Protopopescu C, Lazarus JV. Knowledge of liver fibrosis stage among adults with NAFLD/NASH improves adherence to lifestyle changes. Liver Int. 2022 May;42(5):984-994. doi: 10.1111/liv.15209. Epub 2022 Mar 7.
PubMed 35220673
Rinella ME, Lazarus JV, Ratziu V, Francque SM, Sanyal AJ, Kanwal F, Romero D, Abdelmalek MF, Anstee QM, Arab JP, Arrese M, Bataller R, Beuers U, Boursier J, Bugianesi E, Byrne CD, Castro Narro GE, Chowdhury A, Cortez-Pinto H, Cryer DR, Cusi K, El-Kassas M, Klein S, Eskridge W, Fan J, Gawrieh S, Guy CD, Harrison SA, Kim SU, Koot BG, Korenjak M, Kowdley KV, Lacaille F, Loomba R, Mitchell-Thain R, Morgan TR, Powell EE, Roden M, Romero-Gomez M, Silva M, Singh SP, Sookoian SC, Spearman CW, Tiniakos D, Valenti L, Vos MB, Wong VW, Xanthakos S, Yilmaz Y, Younossi Z, Hobbs A, Villota-Rivas M, Newsome PN; NAFLD Nomenclature consensus group. A multisociety Delphi consensus statement on new fatty liver disease nomenclature. Hepatology. 2023 Dec 1;78(6):1966-1986. doi: 10.1097/HEP.0000000000000520. Epub 2023 Jun 24.
PubMed 37363821
Schneider CV, Zandvakili I, Thaiss CA, Schneider KM. Physical activity is associated with reduced risk of liver disease in the prospective UK Biobank cohort. JHEP Rep. 2021 Mar 2;3(3):100263. doi: 10.1016/j.jhepr.2021.100263. eCollection 2021 Jun.
PubMed 33898961
Stens NA, Bakker EA, Manas A, Buffart LM, Ortega FB, Lee DC, Thompson PD, Thijssen DHJ, Eijsvogels TMH. Relationship of Daily Step Counts to All-Cause Mortality and Cardiovascular Events. J Am Coll Cardiol. 2023 Oct 10;82(15):1483-1494. doi: 10.1016/j.jacc.2023.07.029. Epub 2023 Sep 6.
PubMed 37676198
Boeckmans J, Gatzios A, Schattenberg JM, Koek GH, Rodrigues RM, Vanhaecke T. PNPLA3 I148M and response to treatment for hepatic steatosis: A systematic review. Liver Int. 2023 May;43(5):975-988. doi: 10.1111/liv.15533. Epub 2023 Feb 16.
PubMed 36719059
Trepo E, Romeo S, Zucman-Rossi J, Nahon P. PNPLA3 gene in liver diseases. J Hepatol. 2016 Aug;65(2):399-412. doi: 10.1016/j.jhep.2016.03.011. Epub 2016 Mar 30.
PubMed 27038645
Romeo S, Kozlitina J, Xing C, Pertsemlidis A, Cox D, Pennacchio LA, Boerwinkle E, Cohen JC, Hobbs HH. Genetic variation in PNPLA3 confers susceptibility to nonalcoholic fatty liver disease. Nat Genet. 2008 Dec;40(12):1461-5. doi: 10.1038/ng.257. Epub 2008 Sep 25.
PubMed 18820647
Anstee QM, Day CP. The Genetics of Nonalcoholic Fatty Liver Disease: Spotlight on PNPLA3 and TM6SF2. Semin Liver Dis. 2015 Aug;35(3):270-90. doi: 10.1055/s-0035-1562947. Epub 2015 Sep 17.
PubMed 26378644
Maximos M, Bril F, Portillo Sanchez P, Lomonaco R, Orsak B, Biernacki D, Suman A, Weber M, Cusi K. The role of liver fat and insulin resistance as determinants of plasma aminotransferase elevation in nonalcoholic fatty liver disease. Hepatology. 2015 Jan;61(1):153-60. doi: 10.1002/hep.27395. Epub 2014 Nov 25.
PubMed 25145475

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hepatic Elastography-Enhanced Lifestyle Modification in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06826807
Acronym / sponsor ID: SI 009/2025
Conditions: Transient Elastography, MASLD, BMI, Metabolic Syndrome, NAFLD, Insulin Resistance
Keywords: Lifestyle modification, MASLD, transient elastography
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 92 participants (estimated)
Lead sponsor: Mahidol UniversityUniversity, hospital or other
Study start: 12 May 2025 (actual)
Primary completion: 1 Jan 2027 (estimated)
Study completion: 1 Jun 2027 (estimated)
First posted: 14 Feb 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Experimental: Active Comparator: Regular hepatic elastography monitoring to encourage dietary modifi	Experimental	Other: Regular monitoring with transient elastography• 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: Placebo comparator: standard care (counselling for dietary modifications and increa	No intervention	–The control group will receive standard care (counselling for dietary modifications and increased physical activity) without elastography monitoring.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.
Participants must be at least 18 years old and less than 80 years old at the time of enrollment.

Key exclusion criteria (9 listed)

Individuals diagnosed with other chronic liver diseases, including hepatitis B or C, autoimmune hepatitis, Wilson's disease, liver cancer, hemochromatosis, or liver cirrhosis.
Individuals diagnosed with conditions that may influence MASLD, such as HIV, chronic inflammatory diseases, or connective tissue disorders.
Individuals taking medications known to promote fatty liver disease, such as amiodarone, steroids, methotrexate, hormonal medications, or immunosuppressants.
Individuals who have previously taken medications known to impact fatty liver disease, including vitamin E, pioglitazone, GLP-1 receptor agonists, or SGLT2 inhibitors.
Participants intending to join weight loss programs or undergo bariatric surgery for obesity treatment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Regular monitoring with transient elastographyMASLD patients were received their liver fat and fibrosis status regularly using transient elastography	Other	Experimental: Active Comparator: Regular hepatic elastography monitoring to encourage dietary modifi

Primary outcome

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 (%)

9 secondary outcomes

Change from baseline in non-invasive liver fibrosis marker
Time frame: 48 weeks
Change from baseline in markers of liver injury
Time frame: 48 weeks
Change from baseline in markers of glycemic control
Time frame: 48 weeks
Change from baseline in Hemoglobin A1C (%)
Time frame: 48 weeks
Change from baseline in lipoproteins
Time frame: 48 weeks
Change from baseline in body fat composition assessed by Bioelectrical Impedance Analysis
Time frame: 48 weeks
Change from baseline in muscle mass assessed by Bioelectrical Impedance Analysis
Time frame: 48 weeks
Change from baseline in visceral fat assessed by Bioelectrical Impedance Analysis
Time frame: 48 weeks
Change from baseline in wieght in kilograms assessed by Bioelectrical Impedance Analysis
Time frame: 48 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
Background: PubMed 32207804Sheka AC, Adeyi O, Thompson J, Hameed B, Crawford PA, Ikramuddin S. Nonalcoholic Steatohepatitis: A Review. JAMA. 2020 Mar 24;323(12):1175-1183. doi: 10.1001/jama.2020.2298.
Background: PubMed 29296097Koolhaas CM, van Rooij FJ, Cepeda M, Tiemeier H, Franco OH, Schoufour JD. Physical activity derived from questionnaires and wrist-worn accelerometers: comparability and the role of demographic, lifestyle, and health factors among a population-based sample of older adults. Clin Epidemiol. 2017 Dec 18;10:1-16. doi: 10.2147/CLEP.S147613. eCollection 2018.
Background: PubMed 32967678Joo JH, Kim HJ, Park EC, Jang SI. Association between sitting time and non-alcoholic fatty live disease in South Korean population: a cross-sectional study. Lipids Health Dis. 2020 Sep 23;19(1):212. doi: 10.1186/s12944-020-01385-6.
Background: PubMed 31949537Mansour-Ghanaei R, Mansour-Ghanaei F, Naghipour M, Joukar F. The Lifestyle Characteristics in Non-Alcoholic Fatty Liver Disease in the PERSIAN Guilan Cohort Study. Open Access Maced J Med Sci. 2019 Sep 14;7(19):3313-3318. doi: 10.3889/oamjms.2019.647. eCollection 2019 Oct 15.
Background: PubMed 36727674Rinella ME, Neuschwander-Tetri BA, Siddiqui MS, Abdelmalek MF, Caldwell S, Barb D, Kleiner DE, Loomba R. AASLD Practice Guidance on the clinical assessment and management of nonalcoholic fatty liver disease. Hepatology. 2023 May 1;77(5):1797-1835. doi: 10.1097/HEP.0000000000000323. Epub 2023 Mar 17. No abstract available.
Background: PubMed 26610348Akuta N, Kawamura Y, Arase Y, Suzuki F, Sezaki H, Hosaka T, Kobayashi M, Kobayashi M, Saitoh S, Suzuki Y, Ikeda K, Kumada H. Relationships between Genetic Variations of PNPLA3, TM6SF2 and Histological Features of Nonalcoholic Fatty Liver Disease in Japan. Gut Liver. 2016 May 23;10(3):437-45. doi: 10.5009/gnl15163.
Background: PubMed 35220673Carrieri P, Mourad A, Marcellin F, Trylesinski A, Calleja JL, Protopopescu C, Lazarus JV. Knowledge of liver fibrosis stage among adults with NAFLD/NASH improves adherence to lifestyle changes. Liver Int. 2022 May;42(5):984-994. doi: 10.1111/liv.15209. Epub 2022 Mar 7.
Background: PubMed 37363821Rinella ME, Lazarus JV, Ratziu V, Francque SM, Sanyal AJ, Kanwal F, Romero D, Abdelmalek MF, Anstee QM, Arab JP, Arrese M, Bataller R, Beuers U, Boursier J, Bugianesi E, Byrne CD, Castro Narro GE, Chowdhury A, Cortez-Pinto H, Cryer DR, Cusi K, El-Kassas M, Klein S, Eskridge W, Fan J, Gawrieh S, Guy CD, Harrison SA, Kim SU, Koot BG, Korenjak M, Kowdley KV, Lacaille F, Loomba R, Mitchell-Thain R, Morgan TR, Powell EE, Roden M, Romero-Gomez M, Silva M, Singh SP, Sookoian SC, Spearman CW, Tiniakos D, Valenti L, Vos MB, Wong VW, Xanthakos S, Yilmaz Y, Younossi Z, Hobbs A, Villota-Rivas M, Newsome PN; NAFLD Nomenclature consensus group. A multisociety Delphi consensus statement on new fatty liver disease nomenclature. Hepatology. 2023 Dec 1;78(6):1966-1986. doi: 10.1097/HEP.0000000000000520. Epub 2023 Jun 24.
Background: PubMed 33898961Schneider CV, Zandvakili I, Thaiss CA, Schneider KM. Physical activity is associated with reduced risk of liver disease in the prospective UK Biobank cohort. JHEP Rep. 2021 Mar 2;3(3):100263. doi: 10.1016/j.jhepr.2021.100263. eCollection 2021 Jun.
Background: PubMed 37676198Stens NA, Bakker EA, Manas A, Buffart LM, Ortega FB, Lee DC, Thompson PD, Thijssen DHJ, Eijsvogels TMH. Relationship of Daily Step Counts to All-Cause Mortality and Cardiovascular Events. J Am Coll Cardiol. 2023 Oct 10;82(15):1483-1494. doi: 10.1016/j.jacc.2023.07.029. Epub 2023 Sep 6.
Background: PubMed 36719059Boeckmans J, Gatzios A, Schattenberg JM, Koek GH, Rodrigues RM, Vanhaecke T. PNPLA3 I148M and response to treatment for hepatic steatosis: A systematic review. Liver Int. 2023 May;43(5):975-988. doi: 10.1111/liv.15533. Epub 2023 Feb 16.
Background: PubMed 27038645Trepo E, Romeo S, Zucman-Rossi J, Nahon P. PNPLA3 gene in liver diseases. J Hepatol. 2016 Aug;65(2):399-412. doi: 10.1016/j.jhep.2016.03.011. Epub 2016 Mar 30.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Regular monitoring with transient elastography in people with Transient Elastography and MASLD, run by Mahidol University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in non-invasive marker magnetic resonance imaging-estimated proton density fat fraction (MRI-PDFF) (%) (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06826807, which also lists 39 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025; AzTrials last refreshed its copy on 26 Oct 2026.