Prevalence of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) in High-Risk Patients Presenting to Primary Care

Investigating Liver Disease Linked to Metabolic Issues in High-Risk Patients

R
Raj Vuppalanchi, MD

Primary Investigator

Enrolling By Invitation
40 years or above
All
Phase N/A
100 participants needed
1 Location

Brief description of study

This study will provide the first comprehensive real-world prevalence data on MASLD in a primary care-based high-risk population, using validated non-invasive imaging. Results will inform evidence-based screening guidelines, support integration of FibroScan into PCP workflows, and facilitate early intervention to reduce progression to advanced liver disease. Identified predictors of significant fibrosis will aid in prioritizing referral pathways and health system resource allocation.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Prospective participants meeting study criteria and presenting to a PCP visit will be approached during their clinic appointment in a private room about participating in the study. 

Detailed description of study

Study Procedures
•    eligible patients will be approached in person during PCP clinic visit
•    FibroScan® will be performed at the point of care
•    participants will be asked to complete a short questionnaire to assess alcohol consumption
•    pertinent variables from the electronic medical record will be collected for research purposes
•    data will be stored in a Red Cap database.
•    participants with significant findings (LSM ≥10 kPa) will be referred to hepatology per standard of care

 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Type 2 Diabetes Mellitus (T2DM)
  • Age: 40 years or above
  • Gender: All

Inclusion — adults presenting to a PCP visit meeting at least 2 of the following 3 criteria:
•    Confirmed diagnosis of Type 2 Diabetes Mellitus (T2DM)
•    BMI >30 kg/m² (documented obesity)
•    Age 40 years or older

Exclusion: 
•    known liver cirrhosis
•    known viral hepatitis (HBV/HCV) 
•    known cholestatic liver disease
•    pregnancy
•    uncontrolled ascites

This study investigates the prevalence of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) in high-risk patients visiting primary care. MASLD is a liver condition linked to metabolic dysfunction, which can lead to liver damage if not managed. The purpose of this study is to gather real-world data to help develop screening guidelines and improve patient care in primary care settings.

Participants will undergo a FibroScan, a non-invasive test to evaluate liver stiffness, during their regular primary care visit. They will also complete a questionnaire about alcohol use and have certain health information collected from their medical records. If significant liver stiffness is found, participants will be referred to a liver specialist for further care.

  • Who can participate: Adults who are visiting their primary care doctor and meet at least two of the following criteria: have Type 2 Diabetes Mellitus, have a BMI over 30, or are 40 years or older. People with known liver cirrhosis, viral hepatitis, cholestatic liver disease, pregnancy, or uncontrolled ascites cannot participate.
  • Study details: Participants will have a FibroScan done during their primary care visit and will complete a short questionnaire about alcohol use. Their medical records will be reviewed for research purposes.
Updated on 10 Jun 2026. Study ID: GI-IIR-PCP-FS, 31587
Please visit our main page to search for other studies you may be interested in. If you need help finding a study or have any questions, please contact us at inhealth@iu.edu

Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only