This randomized clinical trial aims to compare the effect of the pioglitazone and SGLT2 inhibitor combination on liver fat mass, as compared to either drug used alone, with or without background medical therapy of metformin and/or DDP4 inhibitors.
To compare the effect of pioglitazone with or without Metformin and/or DPP4 inhibitor (no SGLT2 inhibitor) on improvement of NAFLD parameters, versus The effect of SGLT inhibitor with or without metformin and/or DPP4 inhibitor (no pioglitazone) on NAFLD parameters and versus Pioglitazone with or without metformin and/or DPP4 inhibitor, plus empagliflozin on improvement of NAFLD parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
123
Pioglitazone with (or without) metformin and/or DPP4 inhibitor (no SGLT2 inhibitor). The maximum dose for metformin would be 2.5 g/day, while for pioglitazone would be 45mg/day. The maximum dose for DPP4 inhibitor would be 100mg/day.
Empagliflozin with (or without) metformin and/or DPP4 inhibitor (no pioglitazone). The maximum dose for metformin would be 2.5g/day, while for empagliflozin would be 25mg/day depending on follow up blood sugar levels and tolerability. The maximum dose 100mg daily.
Pioglitazone with (or without) metformin and/or DPP4 inhibitor, plus empagliflozin. The maximum dose for metformin would be 2.5g/day; for pioglitazone would be 45mg/day and 25mg/day for empagliflozin, and 100mg daily for DPP4 inhibitors (depending on follow up blood sugar levels and tolerability).
Aga Khan University Hospital
Karachi, Sindh, Pakistan
RECRUITINGChange in radiologic liver parameters
Number of participants reported change in liver fat content from baseline, as quantified by fibroscan
Time frame: 12 months
Change in liver enzymes
Number of participants reported change in liver enzymes levels including ALT, AST and GGT
Time frame: 12 months
Change in Fibrosis-4 (FIB-4) Score and NAFLD Fibrosis Score
Number of participants reported change in FIB-4 Score and NAFLD Fibrosis Score. Fibrosis-4 scores range from 0 to 4, where \<1.45 indicates absence of cirrhosis; score between 1.45 - 3.25 are deemed inconclusive and score \>3.25 indicates cirrhosis.
Time frame: 12 months
Change in body weight
Number of participants reported change in body weight from baseline (treat to target response of at least 5% of baseline at 6 months, 10% baseline over 12 months).
Time frame: 12 months
Change in waist circumference (WC)
Number of participants reported change in waist circumference (WC)
Time frame: 12 months
Change in liver fat mass with total body fat (TBF)
Comparison of baseline and end of treatment liver fat mass with total body fat (TBF) using a Body Composition Monitor
Time frame: 12 months
Change in HbA1C levels (< 7.0%)
Number of participants reported change in HbA1C levels from baseline to end of treatment
Time frame: 12 months
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Change in Fasting Blood Sugar (FBS)
Number of participants reported change in Fasting Blood Sugar (FBS) from baseline to end of treatment
Time frame: 12 months
Change in Lipid profile
Number of participants reported change in Fasting triglycerides (TG), Low-Density Lipoprotein (LDL), High-Density Lipoprotein (HDL) from baseline to end of treatment
Time frame: 12 months