MedTrace Logo

Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers

NCT07172997 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 163

Last updated 2025-09-15

No results posted yet for this study

Summary

The goal of this observational study is to prospectively develop and validate a non-invasive scoring system based on metabolic markers, proteomic, and transcriptomic profiles to accurately screen, diagnose, stage, and monitor Metabolic dysfunction-associated steatotic liver disease (MASLD) activity and regression as a replacement for the invasive liver biopsy tool in Bahraini bariatric patients. The study also aims to identify biomarkers for predicting type 2 diabetes mellitus remission post-bariatric surgery. The main questions it aims to answer are:

* What proteomic and transcriptomic markers can be used to accurately screen, diagnose, stage, and monitor MASLD activity and regression?
* What transcriptomic markers can predict type 2 diabetes mellitus remission? Researchers will compare the proteomic and transcriptomic profiles of bariatric patients before and after surgery to identify molecular changes associated with weight loss and normalization of metabolic biomarkers. The data will be used to design and validate a scoring system for MASLD diagnosis and monitoring.

Participants will undergo comprehensive assessments, including anthropometric measurements, metabolic biomarker evaluations, proteomic, and transcriptomic profiling at three time points: before surgery, and at 6- and 12-months post-surgery. The data collected will inform the development of the non-invasive scoring system, which will be tested for its reliability and accuracy in replacing liver biopsy as the standard diagnostic tool for MASLD.

Conditions

  • MASLD
  • T2DM (Type 2 Diabetes Mellitus)
  • Non-alcoholic Fatty Liver Disease (NAFLD)
  • Obesity

Interventions

PROCEDURE

Bariatric Surgery

A surgical procedure used to manage obesity and obesity-related conditions.

Sponsors & Collaborators

  • King Hamad University Hospital, Bahrain

    collaborator OTHER

  • King Faisal Specialist Hospital & Research Center

    collaborator OTHER

  • King Fahad Medical City

    collaborator OTHER_GOV

  • Royal College of Surgeons in Ireland - Medical University of Bahrain

    lead OTHER

Principal Investigators

  • John Flood · RCSI-MUB

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • Bahrain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07172997 on ClinicalTrials.gov