Development of a Non-invasive Screening Tool to Predict Metabolic Dysfunction-associated Steatotic Liver Disease

Launched by RICHMOND RESEARCH INSTITUTE · Apr 29, 2021

Keywords

ClinConnect Summary

This clinical trial is looking to develop a new, non-invasive tool that can help predict a condition called Non-Alcoholic Fatty Liver Disease (NAFLD). The goal is to establish a baseline understanding of how certain organs work in healthy individuals and those with a known history of NAFLD. If you're between the ages of 18 and 80 and are interested in participating, you would need to provide your consent and be willing to follow the study's guidelines. For part of the study, individuals with a confirmed diagnosis of NAFLD will be included.

As a participant, you can expect to undergo various assessments that do not involve any invasive procedures. It's important to note that some people won't be eligible to take part, such as those with a history of liver diseases from other causes or who consume more than 30 alcoholic drinks per week. This study is currently recruiting participants, and your involvement could contribute to better understanding and management of liver health in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female volunteers aged ≥18 to ≤80 years at the date of signing the informed consent.
• • 2. Willingness and ability to provide written, personally signed, and dated informed consent, in accordance with the latest ICH Good Clinical Practice (GCP) Guidelines and applicable regulations.
• • 3. An understanding, ability and willingness to fully comply with project procedures and restrictions.
• For PART B only:
• 1. With a known history of MASLD as evidenced either of:
• • 1. GP diagnosis on HCF
• • 2. Documented Fibroscan or liver US demonstrating MASLD
• Exclusion Criteria:
• • 1. Known alcoholic liver disease, history of cirrhosis of any other cause (metabolic, viral hepatitis or other)
• • 2. Any other significant previous liver pathology (liver malignancy, portal hypertension, infiltrative liver disease)
• • 3. Alcohol consumption \>30 units per week
• • 4. An Implanted cardiac devices