Nonalcoholic fatty liver disease (NAFLD)
Conditions
Interventions
Patients attending outpatient department of Hepatology, Bangabandhu Sheikh Mujib Medical University (BSMMU) with sonological evidence of fatty liver will be recruited. Participants meeting inclusion a
Sponsors
Department of Hepatology,Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged 18-60 years. 2. Ultrasonographic evidence of fatty liver (Increased hepatic echogenicity compared to the kidneys or the spleen) 3. Raised ALT (more than 30U/L for males, more than 19 U/L for females)
Exclusion criteria
Exclusion criteria: 1. History of significant alcohol intake (more than 30 gm/day in males and more than 20 gm/day in females) 2. History of taking drugs a. Drugs that may cause fatty liver (i.e. tamoxifen, valproate, amiodarone, methotrexate) b. Concomitant drugs: Vitamin E, statins, metformin, Silymarin. 3. Chronic viral hepatitis (hepatitis B virus and Hepatitis C virus) as determined by serological investigations – HBs Ag, Anti HBc(T), Anti HCV 4. Known and overt case of any other liver diseases, Wilson’s disease (by Serum Ceruloplasmin), autoimmune liver diseases(by Anti Nuclear antibody), hemochromatosis, cirrhosis of liver (other than NASH). 5. Pregnancy 6. Diagnosed psychiatric disorders. 7. Recent Myocardial infarction, liver failure or hypothyroidism. 8. Diagnosed co-morbid conditions (Cronic obstructive pulmonary disease,chronic renal failure, cardiac failure etc).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver stiffness measurement (LSM) as determined by fibroscan of liver [At baseline and 6 months after the commencement of the intervention (end of treatment)] Hepatic steatosis with controlled attenuation parameter (CAP) [At baseline and 6 months after the commencement of the intervention (end of treatment)] | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood pressure (using standardized mercury sphygmomanometer and measurement techniques) [At baseline and 6 months after the commencement of the intervention (end of treatment) Note: FBS, 2HABF & HbA1c and Lipid profile will be done at baseline, then monthly for 3 months and at the end of 6 months for patients with diabetes and dyslipiaemia] Anthropometric parameters: waist circumference and body mass index (BMI) [At baseline and 6 months after the commencement of the intervention (end of treatment)] Liver functions tests as determined by serum alanine transaminase (ALT), aspartate transaminase (AST), gamma glutamyl transpeptidase (GGT) [At baseline and 6 months after the commencement of the intervention (end of treatment)] Lipid profile as determined by total cholesterol (TC), triglycerides (TG), high density lipoproteins (HDL) and low density lipoproteins (LDL) [At baseline and 6 months after the commencement of the intervention (end of treatment) Lipid profile will be done at baseline, then monthly for 3 months and at the end of 6 months for patients with diabetes and dyslipiaemia] Metabolic parameters: fasting blood sugar (FBS), blood sugar 2 hours after breakfast (2HABF), glycosylated haemoglobin (HbA1c), beta cell function using HOMA-IR (homeostasis model assessment – insulin resistance) [At baseline and 6 months after the commencement of the intervention (end of treatment) FBS, 2HABF & HbA1c will be done at baseline, then monthly for 3 months and at the end of 6 months for patients with diabetes and dyslipiaemia] | — |
Countries
Bangladesh
Contacts
Public ContactDr. Muhammad Abedur Rahman Bhuyan
Resident Phase B, MD Hepatology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Outcome results
None listed