Anti-diabetic Drugs and Fatty Liver Management

Diabetes Mellitus, Type 2 Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Fatty Liver
• Fatty Liver, Nonalcoholic
• Non-alcoholic Fatty Liver Disease

• NCT number: NCT05041673
• Study type: Interventional
• Source: Alexandria University
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 23, 2021
• Completion date: September 30, 2022