Clinical trial
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
Active, not recruiting · Not applicable · 1 countries · Registry ID NCT07172997
What this study is about
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.
Basic eligibility
Full registry criteria
Treatments and study arms
Bariatric Surgery
A surgical procedure used to manage obesity and obesity-related conditions.
Primary outcomes
To assess the diagnostic accuracy of three ultrasonography tools for diagnosing MASLD by calculating their sensitivity (%), specificity(%), positive predictive value (PPV)(%), and negative predictive value (NPV)(%) compared to the liver histopathology diagnosis: * Conventional Ultrasonography: Detects liver steatosis and evaluates liver size (cm), texture, and fibrosis. * Shear-wave elastography (SWE): Measures liver stiffness(kPa), correlating with fibrosis severity (F0-F1: 0.0 - 8.27 kPa = Normal-mild, F2: 8.27 - 9.4 kPa = mild-moderate, F3: 9.4-11.8 kPa = moderate-severe, F4: \>11.8 kPa cirrhosis). * Ultrasound-guided acoustic pulse (UGAP) examination: Combines ultrasound with acoustic pulses to assess liver steatosis by measuring the attenuation of ultrasound waves as they pass through the liver. Higher attenuation values generally correlate with a greater degree of hepatic steatosi…
This outcome measures changes in protein expression between MASLD-positive patients and a control of MASLD- negative patients. Both group will have equal number of participants, and equal male to female ratio. Protein levels will be measured using liquid chromatography tandem mass spectrometry (counts per second (cps), and Changes in protein levels and will be quantified as percent and fold changes. .
To evaluate the diagnostic accuracy of three formulae for diagnosing MASLD by assessing Sensitivity(percentage), Specificity(percentage), Positive Predictive Value (PPV)(percentage), and Negative Predictive Value (NPV)(percentage) compared to the liver histopathology diagnosis. 1. APRI: Uses AST levels (U/L) and platelet count (x10\^9/l) to estimate liver fibrosis risk (\< 0.5 = minimal or no fibrosis, 0.5 - 1.5 = Moderate fibrosis, \> 1.5 = Severe fibrosis or cirrhosis). 2. FIB-4: Combines age(years), AST(U/L), ALT(U/L), and platelet count (x10\^9/l) to assess liver fibrosis risk (\< 1.45 = minimal or no fibrosis, 1.45 - 3.39 = significant fibrosis, ≥ 3.4 = advanced fibrosis or cirrhosis). 3. NAFLD-Fibrosis Score: Uses age (years), BMI (kg/m\^2), diabetes status, liver enzymes (U/l), platelet count (x10\^9/l), and albumin (g/L) to assess fibrosis risk (\< -1.455 = low probability of fi…
This outcome measures changes in circulating microRNA (miRNA) levels, in relation to diabetes remission post-bariatric surgery. Changes in miRNA levels will be quantified as percent and fold changes. miRNA levels will be measured using micro-array technique. Changes will be assessed in the diabetic disease state and after achieving diabetes remission, defined by fasting glucose \<100 mg/dL and HbA1c \<6.5%. miRNA changes will be correlated with diabetes remission at 6 and 12 months.