An observational study in MASLD, T2DM (Type 2 Diabetes Mellitus) and Non-alcoholic Fatty Liver Disease (NAFLD), sponsored by Royal College of Surgeons in Ireland - Medical University of Bahrain. Active, not recruiting at 2 sites in Bahrain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Royal College of Surgeons in Ireland - Medical University of Bahrain · Observational
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:
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.
Metabolic dysfunction Associated Steatotic Liver Disease (MASLD), previously known as NonAlcoholic Fatty Liver Disease (NAFLD), is becoming the most common cause of liver disease in adults with the pandemic of obesity in this century. MASLD is affecting more than quarter of the whole population on earth and the highest prevalence is in the middle east region. A recent retrospective study performed on bariatric patients at the King Hamad University Hospital (KHUH) reported a prevalence of 82.3% of MASLD before the surgery. MASLD progression may lead to liver cirrhosis following which the liver cells become damaged irreversibly. The current gold standard to diagnose MASLD is liver biopsy, however, this method has several limitations due to its invasive nature.
This observational study aims to study MASLD in depth utilizing molecular analysis tools, which can yield more information about disease progression in bariatric patients specific to the Bahraini population.
The total sample size of our study is estimated to be around 163 participants of which 134 subjects would to be positive cases of MASLD. We will include the patients undergoing bariatric surgery from the January to December 2025. An informed consent will be taken from the patients to participate in the research while consenting them for the surgery. The surgeon will inform the participant that radiological and biochemical investigations will be done pre-operatively as well as wedge liver biopsy will be taken during the laparoscopic procedure.
Several data will be collected from the enrolled patients' medical records to study disease progression before the surgery, 6 months and 12 months after the surgery:
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 163 is below the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Royal College of Surgeons in Ireland - Medical University of Bahrain is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Bahraini adult obese patients
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult obese patients (18 years old and above) who underwent bariatric surgery in KHUH surgery department from January 2025 to December2025.
Procedure: Bariatric Surgery
A surgical procedure used to manage obesity and obesity-related conditions.
Also known as: Sleeve Gastrectomy, Roux-en-Y, Metabolic Surgery, One Anastomosis Gastric Bypass, Biliopancreatic Diversion, Gastric Bypass, Mini-Bypass, OAGB, SAGB, SG
Accuracy of Non-invasive Ultrasonography Tools for MASLD Assessment
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 steatosis (attenuation coefficient cutoff value (dB/cm/MHz): ≥S1= 0.65, ≥S2= 0.71, S3= 0.77).
Time frame: At Baseline, at 6-months after the surgery, and at 12 months after the surgery
Proteomic Changes and Their Correlation with MASLD Regression
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. .
Time frame: At Baseline
Accuracy of Available Formulae for MASLD Assessment
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 fibrosis, -1.455- 0.765 = significant fibrosis, \> 0.675 = high probability of fibrosis).
Time frame: 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
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.
Time frame: At Baseline, at 6-months after the surgery, and at 12 months after the surgery
Percentage of MASLD Regression Post-Bariatric Surgery
This outcome aims to assess the regression of Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) after bariatric surgery. MASLD regression will be evaluated through changes in liver stiffness, liver enzymes, inflammatory markers, and MASLD risk scores: 1. Liver Stiffness (kPa): Measured by elastography. A decrease of at least 30% from baseline suggests regression. 2. Liver Enzymes \[AST, ALT, ALP, GGT (U/L)\]: A significant decrease in enzyme levels indicates improved liver function. 3. Inflammatory Markers: A reduction in inflammatory markers (e.g., CRP) signals MASLD improvement. 4. MASLD Risk Scores: 1. FIB-4: A reduction in score suggests decreased fibrosis. 2. APRI: A decrease indicates improved liver function. 3. NAFLD-Fibrosis Score: A reduction suggests MASLD regression. MASLD regression will be assessed at 6- and 12-months post-surgery, focusing on these markers and risk scores.
Time frame: At 6-months after the surgery, and at 12 months after the surgery
Percentage of Type 2 Diabetes Remission Post-Bariatric Surgery
This outcome evaluates the remission of Type 2 Diabetes Mellitus (T2DM) following bariatric surgery. T2DM remission will be determined by changes in fasting glucose and glycated hemoglobin (HbA1c) levels: Fasting Glucose: Fasting glucose levels will be measured after an overnight fast. A fasting glucose level below 100 mg/dL will be considered indicative of T2DM remission. Glycated Hemoglobin (HbA1c): HbA1c levels reflect average blood glucose over the past 2-3 months. T2DM remission is defined as an HbA1c level below 6.5% without the need for diabetes medications. T2DM remission will be assessed at 6 and 12 months following bariatric surgery, with remission defined by meeting the aforementioned glucose and HbA1c thresholds.
Time frame: At 6-months after the surgery, and at 12 months after the surgery
Excess Weight Loss (EWL) Measurement
This outcome assesses the effectiveness of bariatric surgery in terms of Excess Weight Loss (EWL). EWL will be calculated based on individual measurements of weight and ideal body weight. 1. Pre-surgery Weight (kg): Weight will be measured before surgery. 2. Post-surgery Weight (kg): Weight will be measured at 6 and 12 months. 3. Ideal Body Weight (kg): Ideal body weight (IBW) will be calculated using one of the following formulae based on patients' gender: For Men: IBW (kg) = 50 + 0.91 × (height in cm - 152.4) For Women: IBW (kg) = 45.5 + 0.91 × (height in cm - 152.4) 4. Excess Weight Loss (EWL): EWL will be calculated as: EWL (%) = \[(Pre-surgery weight - Ideal body weight) / (Pre-surgery weight - post-surgery weight)\] × 100 5. Statistical Analysis: Paired t-tests will compare pre- and post-surgery weight. Regression models will assess factors affecting EWL and its link to clinical outcomes.
Time frame: At Baseline, at 6-months after the surgery, and at 12 months after the surgery
Body Composition Parameters After Bariatric Surgery
The body composition is measured using Bioelectrical Impedance Analysis (BIA) device to assess the proportions of fat, muscle, bone, and water in the body. The following parameters are measured at baseline, and then at 6 and 12 months after bariatric surgery: Weight (kg), Height (m),BMI (kg/m\^2), Fat Mass (kg), Fat Free Mass (kg), Fat Percentage (%), Bone Mass (kg), Muscle Mass (kg), Total Body Water (kg), Intracellular Water (kg), Extracellular water (kg), Visceral Fat Rating, Metabolic age (years) All parameters are measured using a fully-automated BIA scales.
Time frame: At baseline, and at 6 months and 12 months after bariatric surgery
Identification of Novel Biomarkers through Fold Change Analysis and Regression Models
This outcome measures the identification of novel biomarkers, proteins and microRNAs, through fold change analysis and regression models. Fold change analysis compares biomarker expression between groups (e.g., patients vs. controls or pre-treatment vs. post-treatment), with a threshold of a 1.5-fold change indicating significant differences. Regression models assess the relationship between biomarker levels and clinical factors (e.g., disease progression, treatment response). Biomarker expression was measured using molecular techniques, namelymicro-arrays and tandem mass spectrometry. The goal is to identify biomarkers that could aid in disease diagnosis, prognosis, or treatment monitoring, providing a foundation for personalized medicine.
Time frame: Through study completion, an average of 1 year
Plan to share: Yes — Monitoring, audits, and REC review will be permitted and provide direct access to source data and documents. The Lead PI and the researchers assigned by him will have access to the stored data/specimens. Only the Lead PI and the researchers assigned working on this study will be eligible to obtain the data/specimens from the participants during data collection.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: Data will be collected in the case report form to allow for cross referencing to check validity. Study documents (paper) will be retained in a secure (kept locked when not in use) location during and after the trial has finished. All essential documents including source documents will be retained for a period of 5 years after study completion (last patient, last study point).
Access criteria: Study documents (paper) will be retained in a secure (kept locked when not in use) location during and after the trial has finished.
Started Jan 2025 (actual). Primary completion is estimated for Dec 2026, 23 months after the start.
Of 432 non-industry observational studies under Diabetes Mellitus, Type 2, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 96. This study's planned 23 months is below that.
Counting every sponsor, half of 602 studies reached it within 32 months; a quarter within 17 and three quarters within 62.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Royal College of Surgeons in Ireland - Medical University of Bahrain