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Active Not Recruiting NCT07172997

Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers

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

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 163
Sponsor: Royal College of Surgeons in Ireland - Medical University of Bahrain

Location: Alhakeem Radiology Center Manama Manama

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.

Eligibility Criteria

Inclusion Criteria: * Adult obese patients undergoing bariatric surgery in KHUH surgery department consented to be included in the study. Exclusion Criteria: * Patients fail to complete the surgery due to intra-operative complications. * Patients fail to retrieve liver biopsy sample from due to intra-operative difficulties. * Patients with missing data pre-operatively * Body Mass Index less than 30 kg/m2. * Post-liver transplant patients * Patients known to have any liver disease other than MASLD * Patients with history of Alcohol Drinking.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07172997). StuddyBuddy aggregates publicly available trial information.