The efficiency of sodium-glucose cotransporter-2 (SGLT2) inhibitors on fatty liver mass in patients with type 2 diabetes and associated fatty liver disease diagnosed by magnetic resonance imaging

The effect of SGLT2 inhibitors on hepatic steatosis detected by MRI-PDFF in Patients with type 2 Diabetes Mellitus and metabolic associated steatotic liver disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN85961860

Enrollment

Registered

2024-09-12

Start date

2022-05-01

Completion date

Unknown

Last updated

2025-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes with MASLD Nutritional, Metabolic, Endocrine

Interventions

Our patients received SGLT2 inhibitor in the form of empagliflozin 10 mg daily added to their standard of care treatment and followed up for 6 months with full assessment of hepatic steatosis and fibr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult patients with type 2 diabetes with sonographic evidence of hepatic steatosis with or without elevated liver enzymes diagnosed as MASLD 2. Patients on oral hypoglycemics not including SGLT2 inhibitors in their standard of care treatment

Exclusion criteria

Exclusion criteria: 1. T2DM patients already on SGLT2 inhibitors 2. Type 1 diabetes 3. Patients with estimated GFR<30ml/min 4. Pregnant and lactating females 5. Patients with liver cirrhosis 6. Patients who could not tolerate SGLT2 inhibitors

Design outcomes

Primary

Measure	Time frame
Measured at baseline and after 24 weeks of adding Empagliflozin 10 mg to the standard of care treatment: 1. The hepatic fat content was measured by Magnetic resonance imaging Proton Density Fat Fraction (MRI-PDFF) in every patient 2. Staging of hepatic fibrosis using Fib-4 and NAFLD fibrosis scores was calculated using the formula below: FIB-4 =Age ([yr] x AST [U/L]) / ((PLT [10(9)/L]) x (ALT [U/L])(1/2)). NAFLD fibrosis score = -1.675 + 0.037 × age (year) + 0.094 × BMI (kg/m2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelet count (×109/L) - 0.66 × albumin (g/dL).	—

Measure

Time frame

Measured at baseline and after 24 weeks of adding Empagliflozin 10 mg to the standard of care treatment: 1. The hepatic fat content was measured by Magnetic resonance imaging Proton Density Fat Fraction (MRI-PDFF) in every patient 2. Staging of hepatic fibrosis using Fib-4 and NAFLD fibrosis scores was calculated using the formula below: FIB-4 =Age ([yr] x AST [U/L]) / ((PLT [10(9)/L]) x (ALT [U/L])(1/2)). NAFLD fibrosis score = -1.675 + 0.037 × age (year) + 0.094 × BMI (kg/m2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelet count (×109/L) - 0.66 × albumin (g/dL).

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Secondary

Measure	Time frame
Measured at baseline and after 24 weeks of adding Empagliflozin 10 mg to the standard of care treatment: 1. Serum fasting blood glucose (FBG) measured using glucose oxidase methods 2. Serum 2 hours postprandial blood glucose (2 hrs pp glucose) measured using standard techniques 3. Glycated hemoglobin (HbA1C) measured using high frequency liquid tomography 4. Serum alanine transaminase (ALT) measured using standard biochemical assays 5. Serum aspartate transaminase (AST) measured using standard biochemical assays 6. Serum creatinine measured using standard biochemical assays 7. Total cholesterol (TC) measured using standard biochemical assays 8. Low-density lipoprotein (LDL-C) measured using by Friedwald formula 9. High-density lipoprotein (HDL-C) measured using standard biochemical assays 10. Fasting Triglycerides (TG) measured using standard biochemical assays 11. Estimated glomerular filtration rate (eGFR) calculated using age, sex, and serum creatinine	—

Measure

Time frame

Measured at baseline and after 24 weeks of adding Empagliflozin 10 mg to the standard of care treatment: 1. Serum fasting blood glucose (FBG) measured using glucose oxidase methods 2. Serum 2 hours postprandial blood glucose (2 hrs pp glucose) measured using standard techniques 3. Glycated hemoglobin (HbA1C) measured using high frequency liquid tomography 4. Serum alanine transaminase (ALT) measured using standard biochemical assays 5. Serum aspartate transaminase (AST) measured using standard biochemical assays 6. Serum creatinine measured using standard biochemical assays 7. Total cholesterol (TC) measured using standard biochemical assays 8. Low-density lipoprotein (LDL-C) measured using by Friedwald formula 9. High-density lipoprotein (HDL-C) measured using standard biochemical assays 10. Fasting Triglycerides (TG) measured using standard biochemical assays 11. Estimated glomerular filtration rate (eGFR) calculated using age, sex, and serum creatinine

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Countries

Egypt

Contacts

Public ContactMona Amin

monasleman@kasralainy.edu.eg+20 25729584

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 5, 2026