drugset / Trial / NCT05521633

Comparison of the Effects of Metformin and Pioglitazone on Liver Enzymes and Ultrasound Changes in Non-Diabetic Non-Alcoholic Fatty Liver

NCT05521633

Phase 3 Completed 96 enrolled King Edward Medical University
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2019-06-06
Primary completion
2021-01-19
Completion
2022-05-24

Drugs

EvaluationDrugModalityDoseRoute
Comparator Metformin Small molecule 500 mg
Comparator Pioglitazone Small molecule 30 mg

Indications