Metabolic-dysfunction-associated Fatty Liver Disease (MAFLD)NCT06953830
Optimal Measurement of Spleen Stiffness Among Veterans With Metabolic Dysfunction-Associated Steatotic Liver Disease
A study of Metabolic-dysfunction-associated Fatty Liver Disease (MAFLD), run by William Jennings Bryan Dorn VA Medical Center at 1 site in United States.
Trial summary
A growing number of people are being diagnosed with fatty liver disease, also known as metabolic-dysfunction associated liver disease (MASLD). Fatty liver disease can unknowingly progress to serious liver disease and even permanent scarring (cirrhosis).The purpose of this research is to learn the best way to detect… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic-dysfunction-associated Fatty Liver Disease (MAFLD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2025to Jul 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to consent for participation in a clinical study
- Able to read and comprehend English
- Evidence of fatty liver disease on previous liver biopsy, imaging or clinical documentation
Who cannot join
- Pregnant
- Known decompensated cirrhosis or hepatocellular carcinoma
- Absence of spleen
- Documentation of alcohol use disorder or alcohol use greater than 20g/day for women or greater than 30 g/day for men
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
WJB Dorn VA Medical Center 6439 Garners Ferry Road Columbia, South Carolina 29209
Columbia, South Carolina, 29209
About this study
A growing number of people are being diagnosed with fatty liver disease, also known as metabolic-dysfunction associated liver disease (MASLD). Fatty liver disease can unknowingly progress to serious liver disease and even permanent scarring (cirrhosis).The purpose of this research is to learn the best way to detect serious liver disease as early as possible in patients with fatty liver disease by measuring the stiffness of the spleen. Secondarily, the study hopes to understand how the stiffness of the spleen relates to the severity of liver disease.
- Being tested
- Vibration-controlled transient elastography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibration-controlled transient elastographyDevice
Liver and spleen stiffness measurements using vibration-controlled transient elastography
| Study group | Role | What they receive |
|---|---|---|
| Spleen Stiffness Measurements | Experimental | Participants with metabolic-dysfunction associated steatotic liver disease will undergo liver and spleen stiffness measurements using vibration-controlled transient elastography Receives: Device: Vibration-controlled transient elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spleen Stiffness measurement
Percent of participants with valid spleen stiffness measurements using vibration controlled transient elastography
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start8 Apr 2025
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic-dysfunction-associated Fatty Liver Disease (MAFLD)Studies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- William Jennings Bryan Dorn VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Nicholas Hoppmann, William Jennings Bryan Dorn VA Medical Center
- Investigators
- Nicholas Hoppmann, MD, Principal investigator, Columbia VA Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953830
- Sponsor's protocol ID
- 1766537-1
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Measurement of Spleen Stiffness Among Veterans With Metabolic Dysfunction-Associated Steatotic Liver Disease
- ClinicalTrials.gov ID
- NCT06953830
- Acronym / sponsor ID
- 1766537-1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- William Jennings Bryan Dorn VA Medical CenterUS federal agency
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 1 May 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.
A growing number of people are being diagnosed with fatty liver disease, also known as metabolic-dysfunction associated liver disease (MASLD). Fatty liver disease can unknowingly progress to serious liver disease and even permanent scarring (cirrhosis).The purpose of this research is to learn the best way to detect serious liver disease as early as possible in patients with fatty liver disease by measuring the stiffness of the spleen. Secondarily, the study hopes to understand how the stiffness of the spleen relates to the severity of liver disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spleen Stiffness Measurements | Experimental | Device: Vibration-controlled transient elastographyParticipants with metabolic-dysfunction associated steatotic liver disease will undergo liver and spleen stiffness measurements using vibration-controlled transient elastography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to consent for participation in a clinical study
- Able to read and comprehend English
- Evidence of fatty liver disease on previous liver biopsy, imaging or clinical documentation
Key exclusion criteria (5 listed)
- Pregnant
- Known decompensated cirrhosis or hepatocellular carcinoma
- Absence of spleen
- Documentation of alcohol use disorder or alcohol use greater than 20g/day for women or greater than 30 g/day for men
- Unable to provide informed consent
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 |
|---|---|---|
| Vibration-controlled transient elastographyLiver and spleen stiffness measurements using vibration-controlled transient elastography | Device | Spleen Stiffness Measurements |
Primary outcome
Spleen Stiffness measurement
Time frame: 1 year
Percent of participants with valid spleen stiffness measurements using vibration controlled transient elastography
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 1 May 2025.
- Individual participant dataSharing planned: No
Related trials for Metabolic-dysfunction-associated Fatty Liver Disease (MAFLD)
Not yet recruitingObservational study
Liver Stiffness Changes by iLivTouch to Predict Liver-Related Events in MAFLD
MAFLD
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Effect of SGLT2 Inhibitor on Metabolic-Dysfunction-Associated Fatty Liver Disease in Patients With Insulin Resistance
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A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)
Metabolic Dysfunction-Associated Steatotic Liver Disease
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Cardiovascular Risk in T2DM With MAFLD: A Cohort Study
Type 2 Diabetes (T2DM), Metabolic Dysfunction-Associated Steatotic Liver Disease
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Phase II Study Evaluating the Efficacy and Safety of DR10624 Injection in MASLD and MetALD Subjects
MASLD
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.
Nicholas Hoppmann, MD principal investigator
Columbia VA Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Metabolic-dysfunction-associated Fatty Liver Disease (MAFLD), run by William Jennings Bryan Dorn VA Medical Center at 1 site in United States.
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 3 inclusion and 5 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 1 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 United States. 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?
Spleen Stiffness measurement (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2025.