Optimal Measurement of Spleen Stiffness Among Veterans With Metabolic Dysfunction-Associated Steatotic Liver Disease

NCT ID: NCT06953830

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-08
• Study Completion Date: 2026-07-31

Brief 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 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.

Conditions

Metabolic-dysfunction-associated Fatty Liver Disease (MAFLD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Spleen Stiffness Measurements

Participants with metabolic-dysfunction associated steatotic liver disease will undergo liver and spleen stiffness measurements using vibration-controlled transient elastography

Group Type: EXPERIMENTAL

Vibration-controlled transient elastography

Intervention Type: DEVICE

Liver and spleen stiffness measurements using vibration-controlled transient elastography

Interventions

Vibration-controlled transient elastography

Liver and spleen stiffness measurements using vibration-controlled transient elastography

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

William Jennings Bryan Dorn VA Medical Center

FED

Sponsor Role: lead

Responsible Party

Nicholas Hoppmann

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicholas Hoppmann, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia VA Healthcare System

Locations

WJB Dorn VA Medical Center 6439 Garners Ferry Road Columbia, South Carolina 29209

Columbia, South Carolina, United States

Countries

United States

Other Identifiers

1766537-1

Identifier Type: -

Identifier Source: org_study_id