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Life sciences · Observational Study
ClinicalTrials.gov · October 28, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07172997). This is a study registration, not published results. Lead sponsor: Royal College of Surgeons in Ireland - Medical University of Bahrain. Recruitment status: ACTIVE_NOT_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 163 participants (ESTIMATED). Conditions: MASLD, T2DM (Type 2 Diabetes Mellitus), Non-alcoholic Fatty Liver Disease (NAFLD), Obesity. Interventions: PROCEDURE: Bariatric Surgery. Primary outcome measures: Accuracy of Non-invasive Ultrasonography Tools for MASLD Assessment , At Baseline, at 6-months after the surgery, and at 12 months after the surgery; Proteomic Changes and Their Correlation with MASLD Regression , At Baseline; Accuracy of Available Formulae for MASLD Assessment , At Baseline, at 6-months after the surgery, and at 12 months after the surgery; mi-RNA Changes and Their Correlation with MASLD Regression and Diabetes Remission , At Baseline, at 6-months after the surgery, and at 12 months after the surgery. Brief 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.