Rational: Type 2 DM is one of the major risk factors for development of non-alcoholic fatty liver disease. The pooled prevalence of fatty liver among diabetics is 54% (95% CI 45%-64%). Until now there is no well-established treatment for fatty liver disease.~Study setting: Randomized controlled trial~Study population:~Patients with type 2 DM plus Fatty Liver.~NAFLD diagnostic criteria:~Fatty Liver Index (FLI) 60 or more plus Ultrasound features of fatty liver.~- Inclusion criteria~Age above 18. 2- HbA1C less than 10.~Sample size: Based on the result reported by Armstrong et al, the proportion of patients on standard care who showed resolution of steatosis versus intervention group on liraglutide was 9% vs 39%, using power of 80%, precision of 5%, the minimal required sample size was 24 for each group and we increased it to 30 to compensate for drop-out. So, 120 subjects will be divided into 4 equal groups.~Study Design: Interventional (Randomized Clinical Trial) Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking. Study duration: 12 months of follow up~Data collection methods and tools~Filling the pre-designed structured interview questionnaire from patients that includes:~Demographic traits: age, sex, marital status, education, occupation and residency.~Habits: smoking, physical exercise, dietary habits, drug use.~Social history, focusing on smoking status, occupation, presence of children at home and plans for future pregnancy (as appropriate).~Drug history~Clinical data about:~Present/ past/ family history on thyroid diseases, and autoimmune disease.~Comorbidities: hypertension, coronary heart disease, chronic obstructive air way disease (COPD), obesity and others.~Medications used: dose, frequency and route of administration.~Hospitalization.~Body measures: weight, height, body mass index (BMI), waist circumference.~Vital signs: pulse, blood pressure, heart rate.~The compliance was ascertained through direct questioning at each clinic visits and by inspecting her pill bottles.~Patient satisfaction and quality of life will be measured at baseline and at the end of Intervention.~Investigations~Lab: HCV Ab, HBsAg, HBcAb, ALT, AST, GGT, FBS, HBA1c, PPBS, Fasting insulin, CBC, Cholesterol, LDL, HDL, TGs, uric acid.~Calculation of the following score FLI, NAFLD-LFS, FIB-4, NFS.~Imaging: ultrasound/FIBROSCAN/ MRI.~Adverse effects of the drugs were systematically identified by careful health interview and clinical examinations. T-Bil, AST, ALT, and hematological values were measured for evaluation at every outpatient clinic visit.~Follow-up~All patients were followed up for twelve months:~Dietary follow up.~Liver enzymes (ALT, AST and GGT) at least every 3 months and more if clinically indicated~Scores follow up: NFS and FIB-4 every 3 months.~Fibroscan at end of 1-year follow up.~MRI at end of 1-year follow up.
Type 2 DM is one of the major risk factors for development of non-alcoholic fatty liver disease. The pooled prevalence of fatty liver among diabetics is 54% (95% CI 45%-64%). Until now there is no well-established treatment for fatty liver disease.~Study setting: Randomized controlled trial~Study population:~Patients with type 2 DM plus Fatty Liver.~Arms and Interventions~1. Experimental arms: Group 1: metformin +/- insulin +/- sulfonylurea Group 2: Metformin plus vildagliptin+/- insulin +/- sulfonylurea Group 3: Metformin plus liraglutide+/- insulin+/- sulfonylurea Group 4: Metformin plus empagliflozin +/- insulin +/- sulfonylurea