NAFLD
Conditions
Brief summary
BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is a spectrum of hepatic disease ranging from fat accumulation in liver to fibrosis and cirrhosis. It affects 25% of the world population on average. Objective of this study is to compare the effect of metformin (1000 milligrams daily) versus pioglitazone (30 milligrams daily) in improving liver transaminases and ultrasound changes in non-diabetic patients of NAFLD when given for six months. METHODS: A Quasi-experimental study was conducted in Mayo Hospital Lahore from October 2019 to November 2020.Out of 96 half Patients were assigned randomly to Group-A (metformin) or Group-B (pioglitazone). Demographic history, abdominal ultrasound & liver enzymes were recorded on Proforma monthly till 6 months. Data was put into and analyzed by SPSS version 26; t-test was used to compare the mean liver transaminases between the two groups. Ultrasound findings were compared by Chi square. The P value of less than 0.05 was counted as significant.
Interventions
DRUGMetformin and Pioglitazone
Every participant in Group-A took tablet metformin 500 mg daily and every participant in Group-B took tablet pioglitazone 30 mg daily.
Sponsors
King Edward Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Gender: Both male and female 2. Age: 18-80 Years 3. Ultrasound evidence of fatty liver as per operational definition 4. Liver enzymes as per operational definition
Exclusion criteria
1. Pregnancy 2. Cirrhotic patients as per operational definition 3. Chronic Hepatitis B or chronic hepatitis C 4. Patients taking long term steroids, highly active antiretroviral therapy, diltiazem, irinotecan, oxaliplatin and amiodarone 5. Patients taking alcohol (based on history and AST to ALT ratio) 6. Patients with heart failure (NYHA Classification class III or IV status: patients comfortable at rest but less than ordinary physical activity causes undue fatigue, dyspnea or palpitations) 7. Patients with renal failure (serum creatinine ≥ 1.4 mg% or eGFR \< 45 ml/min/1.73 m2)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver transaminase levels | The comparison is done after 6 months of drug treatment | There should be a 22% or more change in transaminases levels from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatty Liver Grade | The comparison is done after 6 months of drug treatment | There should be a change of liver fat content determined by ultrasound as Fatty Liver Grade |
Countries
Pakistan
Outcome results
None listed