Effect of SGLT2 Inhibitor on Metabolic-Dysfunction-Associated Fatty Liver Disease in Patients With Insulin Resistance

Condition(s) studied

Investigational drug(s) / intervention(s)

Dapagliflozin 5Mg Tab: Dapagliflozin 5 mg per os once daily will be used for the prediabetic group (1)

Metfomin 500 mg: Metformin 500 mg once daily after lunch will be used for the prediabetes group (2)

Dapagliflozin (10mg Tab): Dapagliflozin 10 mg per os once daily will be used for diabetic patients not previously receiving SGLT2

Study 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

Eligibility

Primary outcome measure(s)

• Liver fibrosis — one year
  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.
• Liver steatosis — one year
  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.
• Fibrosis (FIB-4) score — one year
  FIB-4 score = (Age x AST) / (Platelets x √(ALT)) Will be assessed on day 0, then reassessed after 3 months and 1 year.
• NAFLD fibrosis score — one year
  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.

Trial sites (1)