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

NAFLD Clinical Trial

Official title:

Comparison of the Effects of Metformin and Pioglitazone on Liver Enzymes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05521633
• Other study ID #: King EdwardMU
• Status: Completed
• Phase: Phase 3
• Start date: June 6, 2019
• Est. completion date: May 24, 2022

Study information

• Verified date: August 2022
• Source: King Edward Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: May 24, 2022
• Est. primary completion date: January 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• NAFLD

Intervention

Drug:
• Metformin 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.

Locations

Country	Name	City	State
Pakistan	King Edward Medical University/Mayo Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
King Edward Medical University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver transaminase levels	There should be a 22% or more change in transaminases levels from baseline.	The comparison is done after 6 months of drug treatment
Secondary	Fatty Liver Grade	There should be a change of liver fat content determined by ultrasound as Fatty Liver Grade	The comparison is done after 6 months of drug treatment