Effect of SGLT2 Inhibitor on Metabolic-Dysfunction-Associated Fatty Liver Disease in Patients With Insulin Resistance
SGLT2
1 other identifier
interventional
66
1 country
1
Brief Summary
Metabolic-dysfunction-associated fatty liver disease (MAFLD) has evolved as a major health problem recently. Discovering ways to prevent or delay the progression of MAFLD has become a global focus. Lifestyle modifications remain the cornerstone of MAFLD treatment, even though various pharmaceutical interventions are currently under clinical trial. Among them, sodium-glucose co-transporter type-2 inhibitors (SGLT-2i) are emerging as promising agents. In this study we aim to evaluate the effect of SGLT2 inhibitors on fatty liver disease in patients with prediabetes and type 2 diabetes
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2026
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
CompletedFirst Posted
Study publicly available on registry
October 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
October 23, 2026
October 1, 2026
1 year
September 26, 2026
October 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Liver fibrosis
Liver fibrosis will be evaluated using vibration-controlled transient elastography (VCTE) with controlled attenuation parameter (CAP) technology. We will measure liver stiffness (LSM) in kilopascals (kPa) using a FibroScan 502 Touch device equipped with both M and XL probes. We will assess these parameter on day 0, then reassess after 3 months and 1 year.
one year
Liver steatosis
Liver steatosis will be evaluated using vibration-controlled transient elastography (VCTE) with controlled attenuation parameter (CAP) technology, using a FibroScan 502 Touch device equipped with both M and XL probes. CAP in decibels per meter (dB/m). We will assess these parameter on day 0, then reassess after 3 months and 1 year.
one year
Fibrosis (FIB-4) score
FIB-4 score = (Age x AST) / (Platelets x √(ALT)) Will be assessed on day 0, then reassessed after 3 months and 1 year.
one year
NAFLD fibrosis score
NAFLD fibrosis score = -1.675 + (0.037 x age \[years\]) + (0.094 x BMI \[kg/m²\]) + (1.13 x IFG/diabetes \[yes = 1, no = 0\]) + (0.99 x AST/ALT ratio) - (0.013 x platelet count \[×109/L\]) - (0.66 x albumin \[g/dl\]). Will be assessed on day 0, then reassessed after 3 months and 1 year.
one year
Secondary Outcomes (5)
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
one year
Glycated hemoglobin (HbA1C)
one year
blood pressure control
one year
lipid profile
one year
Body mass index (BMI)
one year
Study Arms (3)
Prediabetic patients will receive SGLT2 inhibitors
ACTIVE COMPARATORPrediabetic patients with fatty liver disease will receive SGLT2 inhibitors (dapagliflozin)
Prediabetic patients will receive metformin
ACTIVE COMPARATORPrediabetic patients with fatty liver disease will receive metformin
Diabetic patients will receive SGLT2 inhibitors.
ACTIVE COMPARATORDiabetic patients with fatty liver disease will receive SGLT2 inhibitors (dapagliflozin).
Interventions
Dapagliflozin 5 mg per os once daily will be used for the prediabetic group (1)
Metformin 500 mg once daily after lunch will be used for the prediabetes group (2)
Dapagliflozin 10 mg per os once daily will be used for diabetic patients not previously receiving SGLT2
Eligibility Criteria
You may qualify if:
- Patients of both sexes aged≥ 18 years
- Obese and non-obese patients
- Patients with prediabetes or type 2 diabetes
You may not qualify if:
- Patients with liver disease other than NAFLD
- Patients with type 1 diabetes
- pregnant patients
- Patients with malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sherihan AboElyazed Mohamed Khalillead
- Ain Shams Universitycollaborator
Study Sites (1)
Ain Shams University hospital
Cairo, 002, Egypt
Related Publications (3)
Zhu X, Xia L, Yin D, Yang J, Wei R. Evaluating the Safety and Efficacy of Sodium-Glucose Co-transporter 2 Inhibitors in Subjects with Prediabetes: A Protocol for a Randomized Controlled Trial. Diabetes Ther. 2024 May;15(5):1231-1244. doi: 10.1007/s13300-024-01560-3. Epub 2024 Mar 18.
PMID: 38494571BACKGROUNDAndroutsakos T, Nasiri-Ansari N, Bakasis AD, Kyrou I, Efstathopoulos E, Randeva HS, Kassi E. SGLT-2 Inhibitors in NAFLD: Expanding Their Role beyond Diabetes and Cardioprotection. Int J Mol Sci. 2022 Mar 13;23(6):3107. doi: 10.3390/ijms23063107.
PMID: 35328527BACKGROUNDLi L, Li Q, Huang W, Han Y, Tan H, An M, Xiang Q, Zhou R, Yang L, Cheng Y. Dapagliflozin Alleviates Hepatic Steatosis by Restoring Autophagy via the AMPK-mTOR Pathway. Front Pharmacol. 2021 May 17;12:589273. doi: 10.3389/fphar.2021.589273. eCollection 2021.
PMID: 34093169BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- lecturer of endocrinology and internal medicine, faculty of medicine, Ain Shams university
Study Record Dates
First Submitted
September 26, 2026
First Posted
October 23, 2026
Study Start
October 1, 2026
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
October 23, 2026
Record last verified: 2026-10
Data Sharing
- IPD Sharing
- Will not share