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IRCT20260602069614N1 IRCT 2026-06-12 Bagheiat-allah University of Medical Sciences Effects of Liraglutide on Liver Fat and Metabolic Indices in Type 2 Diabetes Patients with MASLD Evaluation of the Effects of Liraglutide on Metabolic Parameters, Liver Function, and Non-Invasive Liver Fibrosis Indices in Patients with Type 2 Diabetes and Metabolic Dysfunction–Associated Steatotic Liver Disease (MASLD): A Randomized Controlled Trial 2026-06-03 anticipated 90 Recruiting https://irct.ir/trial/90584 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: کارآزمایی بالینی موازی. مدت مداخله ۱۲ هفته. پیگیری‌ها شامل معاینات و آزمایش‌های دوره‌ای در هفته‌های ۴، ۸ و ۱۲ است. معیارهای ارزیابی بر اساس فیبرواسکن، آزمایش خون و شاخص‌های محاسباتی است, Randomization description: Random assignment to intervention and control groups using permutation blocks of 4 (Block Size 4) and a ratio of 1:1. Random sequences were generated by a statistician using the online Sealed Envelope tool for two fibrosis classes (less than 8 and greater than or equal to 8 kPa). The independent investigator assigned and notified the group after receiving the patient code, Blinding description: This study is open-label for both the patient and the physician, as the method of administering liraglutide (daily injection with dose titration) is different from the control group. However, the FibroScan machine operator and the biostatistician are completely blinded to the patients' treatment group to avoid bias in the assessment of the primary and secondary outcomes. 2-3 Condition 1: Type 2 diabetes. Condition 2: Metabolic Syndrome-Associated Fatty Liver Disease (MASLD). Intervention 1: Intervention group: Daily subcutaneous Liraglutide. Dose titration: 0.6 mg (Week 1), 1.2 mg (Week 2), and 1.8 mg (Week 3 onwards). Patients continue their previous antidiabetic medications at fixed doses (with prophylactic dose reduction of sulfonylureas/insulin if necessary). Intervention 2: Control group: Standard care (previous medications at fixed doses + lifestyle education). Yes - There is a plan to make this available What will be shared: All data can be shared after un-identification of individuals. When: Access period starts 6 months after the results are published To whom: The data will be available to researchers working in academic centers as well as to industry professionals. Conditions: Statistical analyzes on data are allowed for scientific and research use after obtaining permission from the project manager. Where to obtain: For data and documentation, refer to the Research Center for Gastroenterology and Liver Diseases and Dr. Mohammad Ali Abyazi Herris. How to obtain: After receiving a written request from researchers... by the Baqiyatallah Research Center for Gastroenterology and Liver Disease and reviewing the application in the Research Council of the Research Center, the documents or data files will be delivered to the applicant after about 10 days. Comments:
public Mohammad Ali Abyazi Heris
Baqiyatallah Hospital, Mulla Sadra, Vanak Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1435915381 +98 21 8804 0060 yashar862@gmail.com Bagheiat-allah University of Medical Sciences scientific Mohammad Ali Abyazi Heris
Baqiyatallah Hospital, Mulla Sadra, Vanak Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1435915381 +98 21 8804 0060 yashar862@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Age 35-65 years BMI between 27-40 kg/m² Confirmed diagnosis of Type 2 Diabetes Stable antidiabetic regimen for at least 3 months Confirmed hepatic steatosis (CAP ≥ 245 dB/m) via FibroScan 35 years 65 years Both Significant alcohol consumption (>30g/day for men, >20g/day for women) History of acute pancreatitis Pregnancy or lactation Concomitant use of other GLP-1 receptor agonists Need for changes in antidiabetic medication dosage in the past 12 weeks E11 K75.81 Type 2 diabetes mellitus Nonalcoholic steatohepatitis (NASH) Treatment - Drugs Other Intervention group: Daily subcutaneous Liraglutide. Dose titration: 0.6 mg (Week 1), 1.2 mg (Week 2), and 1.8 mg (Week 3 onwards). Patients continue their previous antidiabetic medications at fixed doses (with prophylactic dose reduction of sulfonylureas/insulin if necessary). Control group: Standard care (previous medications at fixed doses + lifestyle education). Changes in the hepatic steatosis index (CAP). Timepoint: 1. Baseline: Before initiation of Liraglutide.2. End of Intervention: Week 12 (12 weeks) after starting treatment. Method of measurement: Non-invasive measurement using FibroScan® device.The operator must be blinded to the patient's treatment group. Two consecutive measurements are performed for each patient, and the mean is recorded as the final result (if the difference is >10%, a third measurement is taken). Changes in body mass index (BMI). Timepoint: 1. Baseline: Before initiation of Liraglutide.2. End of Intervention: Week 12 (12 weeks) after starting treatment. Method of measurement: Direct measurement of weight and height.Weight is measured using a calibrated digital scale (light clothing, barefoot) and height using a stadiometer (barefoot). BMI is calculated as kg/m². Liver Stiffness Index (LSM). Timepoint: 1. Baseline: Before initiation of Liraglutide.2. End of Intervention: Week 12 (12 weeks) after starting treatment. Method of measurement: Measurement using FibroScan® device.The mean of 10 successful measurements (with success rate ≥60% and IQR <30% of the median) is recorded. Liver enzymes (ALT and AST). Timepoint: 1. Baseline: Before initiation of Liraglutide.2. End of Intervention: Week 12 (12 weeks) after starting treatment. Method of measurement: Biochemical blood test.A venous blood sample is taken after 8-10 hours of fasting and measured in the hospital's reference laboratory (ISO 15189 standard) using standard enzymatic methods. The unit is U/L. Glycosylated hemoglobin (HbA1c). Timepoint: 1. Baseline: Before initiation of Liraglutide.2. End of Intervention: Week 12 (12 weeks) after starting treatment. Method of measurement: Biochemical blood test.Measurement performed via High-Performance Liquid Chromatography (HPLC) or validated immunological methods in the reference laboratory. The unit is percentage (%). Side effects and tolerability. Timepoint: Continuous Follow-up: At weekly/monthly visits during the 12-week period and at the end of the 12-week course. Method of measurement: Clinical interview and standard checklist.The researcher records adverse events by interviewing the patient and observing clinical signs, categorizing them by severity (mild, moderate, severe) and causal relationship to the drug. Bagheiat-allah University of Medical Sciences Approved 2026-05-18 Ethics committee of Baqiatallah University of Medical Sciences Baqiyatallah University of Medical Sciences, Mulla Sadra, Vanak Square, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)