Non-Alcoholic Fatty Liver Disease
Conditions
Interventions
Study setting: The study will be conducted at Mega Medical Complex Hospital in collaboration with Armed Forces Institute of Pathology and Armed Forces Institute of Radiology (AFIRI) Rawalpindi Pakis
Sponsors
National University of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Both men and women 2. Aged 20-70 years 3. Presence of fatty liver on abdominal CT scan with a liver to spleen (L/S) attenuation ratio of less than 1.1 (indicating more than 30% hepatic steatosis) 4. Fatty Liver Index (FLI) of equal to or more than 60 5. Alanine transaminase (ALT) within reference range or mildly raised i.e. not greater than 3 times the upper limit of 42 IU/L in male and 36 IU/L in female
Exclusion criteria
Exclusion criteria: 1. Chronic hepatitis B and C 2. Alcoholic fatty liver Disease 3. Autoimmune liver disease 4. History or clinical evidence of liver cirrhosis 5. Hemochromatosis, Wilson’s disease 6. Diabetic patients with Hemoglobin A1c (HbA1c) more than 8.5% 7. A history of cardiovascular disease, pulmonary disease & renal disease 9. Pregnant or lactating females or females planning to become pregnant during the study period Patients on oral insulin-sensitizing agents, herbs and vitamin supplements 10.Patients under treatment with tamoxifen, methotrexate, amiodarone, diltiazem or other drugs able to induce fatty liver
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Mean reduction in Fatty Liver Index (FLI) from baseline to week 24 and 48 [Baseline and week 24 and week 48] 2. Mean reduction in the measurement of Liver Fat on CT scan (indicated by an increase in the liver-to-spleen (L/S) attenuation ratio) [ Baseline and week 24 and week 48] 3. Mean reduction in the measurement of Fibrosis score-4 (FIB-4) [Baseline and week 24 and week 48] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean reduction in the measurement of Alanine tranaminase (IU/L) Aspartate transaminase (IU/L) and Gamma-glutamyl transferase (IU/L) 2. Mean reduction in the measurement of Fasting plasma glucose (mmol/L), Insulin (mIU/L) and Homeostatic Model Assessment for Insulin Resistance (HOMA IR) 3. Mean reduction in the measurement of serum High sensitivity C-reactive protein (mg/L), Interleukin-6 (pg/mL), Tumor necrosis factor alpha (pg/mL) and Leptin (ng/mL) 4. Mean increase in the measurement of serum Adiponectin (µg/mL) 5. Mean reduction in the measurement of serum Malondialdehyde (µmol/L) 6. Mean reduction in the measurement of serum Cytokeratin18 (CK18-M30) (mIU/ml) 7. Mean reduction in measurement of serum Total cholesterol (mmol/L), Triglycerides (mmol/L) and LDL-cholesterol (mmol/L) 8. Mean reduction in the measurement of Aspartate Aminotransferase to Platelet Count Ratio Index (APRI) 9. Mean reduction in the measurement of NAFLD Fibrosis Score (NFS) 10. Mean fold change in Circulatory miRNAs (miR-122-5p, miR-192-5p, miR-34a-5p, miR-103a, miR-451, miR-21) [Baseline, week 24 and week 48] | — |
Countries
Pakistan
Contacts
Public ContactDr. Dilshad Ahmed Khan
Professor of Pathology
Outcome results
None listed