MAFLD in Prediabetes and Diabetes
Conditions
Keywords
MAFLD, SGLT2 inhibitors, prediabetes, type 2 diabetes
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
Interventions
Dapagliflozin 5 mg per os once daily will be used for the prediabetic group (1)
DRUGMetfomin 500 mg
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
Sponsors
Sherihan AboElyazed Mohamed Khalil
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients of both sexes aged≥ 18 years * Obese and non-obese patients * Patients with prediabetes or type 2 diabetes
Exclusion criteria
* Patients with liver disease other than NAFLD * Patients with type 1 diabetes * pregnant patients * Patients with malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | one year | 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 |
| Glycated hemoglobin (HbA1C) | one year | Glycated hemoglobin (HbA1c) will be measured on day 0, then followed up after 3 months and 1 year |
| blood pressure control | one year | Measurements of systolic and diastolic blood pressure (mmHg). Will be measured on day 0, then reassessed after 3 months and 1 year. |
| lipid profile | one year | Lipid profile (total cholesterol, LDL, triglycerides, HDL, and non-HDL). Will be assessed on day 0, then reassessed after 3 months and 1 year. |
| Body mass index (BMI) | one year | BMI = weight in kilograms/height in square meters. Will be assessed on day 0, then reassessed after 3 months and 1 year. |
Countries
Egypt
Contacts
CONTACTsherihan Aboelyazed, lecturer
CONTACTyvette iskandar, lecturer
Outcome results
None listed