NCT05041673

Anti-diabetic Drugs and Fatty Liver Management

Efficacy of Vildagliptin, Liraglutide and Empagliflozin in the Management of Fatty Liver Disease Among Patients With Type 2 Diabetes

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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 1. 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 <!-- --> 1. 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 2. 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. 3. 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.

Conditions

• Fatty Liver, Nonalcoholic
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Metformin	Antidiabetic drugs

Timeline

• Start date: 2021-02-23
• Primary completion: 2021-09-30
• Completion: 2022-09-30
• First posted: 2021-09-13
• Last updated: 2022-01-18

Locations

1 site across 1 country: Egypt