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

Phase 3

Completed

• Conditions: NAFLD
• Interventions: Drug: Metformin and Pioglitazone

• Registration Number: NCT05521633
• Lead Sponsor: King Edward Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-06
• Primary Completion: 2021-01-19
• Study Completion: 2022-05-24
• Status Verified: 2022-08
• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-08-26
• Last Update Submitted: 2022-08-26
• Study First Posted: 2022-08-30
• Last Update Posted: 2022-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin Group	Metformin and Pioglitazone	Group-A; every participant took 500 mg of metformin daily
Pioglitazone Group	Metformin and Pioglitazone	Group-B; every participant took 30 mg of pioglitazone daily

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

King Edward Medical University/Mayo Hospital; 🇵🇰 Lahore, Punjab, Pakistan