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

Comparison of the Effects of Metformin and Pioglitazone on Liver Enzymes

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.

Study Overview

• Status: Completed
• Conditions: NAFLD
• Intervention / Treatment: Drug: Metformin and Pioglitazone

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 3

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • King Edward Medical University/Mayo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Metformin Group; Group-A; every participant took 500 mg of metformin daily	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.
Active Comparator: Pioglitazone Group; Group-B; every participant took 30 mg of pioglitazone daily	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: King Edward Medical University
• Investigators: Principal Investigator: Dr. Mohammad Ibrahim, MBBS, MD, King Edward Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2019
• Primary Completion (Actual): January 19, 2021
• Study Completion (Actual): May 24, 2022

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: August 26, 2022
• First Posted (Actual): August 30, 2022

Study Record Updates

• Last Update Posted (Actual): August 30, 2022
• Last Update Submitted That Met QC Criteria: August 26, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Metformin; Pioglitazone
• Other Study ID Numbers: King EdwardMU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No