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ACTIVE NOT RECRUITING
NCT07172997

Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers

Sponsor: Royal College of Surgeons in Ireland - Medical University of Bahrain

View on ClinicalTrials.gov

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.

Official title: Evaluating Non-Invasive Approaches for Screening, Diagnosis, and Monitoring of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) in Bariatric Patients & Identifying Biomarkers for Predicting Type 2 Diabetes Remission

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

163

Start Date

2025-01-01

Completion Date

2027-06-30

Last Updated

2025-09-15

Healthy Volunteers

No

Interventions

PROCEDURE

Bariatric Surgery

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

Locations (2)

Alhakeem Radiology Center

Manama, Manama, Bahrain

King Hamad University Hospital

Al Muharraq, Muharraq, Bahrain