A Phase 4 interventional study of Dapagliflozin 5Mg Tab and Metfomin 500 mg in MAFLD in Prediabetes and Diabetes, sponsored by Sherihan AboElyazed Mohamed Khalil. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Sherihan AboElyazed Mohamed Khalil · Phase 4, Interventional, and Treatment
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
11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 66 is below the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Sherihan AboElyazed Mohamed Khalil is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Prediabetic patients with fatty liver disease will receive SGLT2 inhibitors (dapagliflozin)
Drug: Dapagliflozin 5Mg Tab
Prediabetic patients with fatty liver disease will receive metformin
Drug: Metfomin 500 mg
Diabetic patients with fatty liver disease will receive SGLT2 inhibitors (dapagliflozin).
Drug: Dapagliflozin (10mg Tab)
Dapagliflozin 5 mg per os once daily will be used for the prediabetic group (1)
Also known as: PreDM/Dapa
Metformin 500 mg once daily after lunch will be used for the prediabetes group (2)
Also known as: PreDM/Met
Dapagliflozin 10 mg per os once daily will be used for diabetic patients not previously receiving SGLT2
Also known as: DM/Dapa
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: one year
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
HOMA-IR: \[fasting insulin (microU/L) x fasting glucose (mg/dL) / 405\]. Will be assessed on day 0, then reassessed after 3 months and 1 year
Time frame: one year
Glycated hemoglobin (HbA1C)
Glycated hemoglobin (HbA1c) will be measured on day 0, then followed up after 3 months and 1 year
Time frame: one year
blood pressure control
Measurements of systolic and diastolic blood pressure (mmHg). Will be measured on day 0, then reassessed after 3 months and 1 year.
Time frame: one year
lipid profile
Lipid profile (total cholesterol, LDL, triglycerides, HDL, and non-HDL). Will be assessed on day 0, then reassessed after 3 months and 1 year.
Time frame: one year
Body mass index (BMI)
BMI = weight in kilograms/height in square meters. Will be assessed on day 0, then reassessed after 3 months and 1 year.
Time frame: one year
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.
Of 264 non-industry phase 4 interventional studies under Diabetes Mellitus, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 46. This study's planned 12 months is below that.
Counting every sponsor, half of 374 studies reached it within 23 months; a quarter within 12 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dapagliflozin
Sherihan AboElyazed Mohamed Khalil