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

NCT05521633 | Completed Phase 3 DMC

• 1 other identifier: King EdwardMU
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

NAFLD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Fatty Liver Grade

  The comparison is done after 6 months of drug treatment

Study Arms (2)

Metformin Group

ACTIVE COMPARATOR

Group-A; every participant took 500 mg of metformin daily

Drug: Metformin and Pioglitazone

Pioglitazone Group

ACTIVE COMPARATOR

Group-B; every participant took 30 mg of pioglitazone daily

Drug: Metformin and Pioglitazone

Interventions

Metformin and Pioglitazone DRUG

Every participant in Group-A took tablet metformin 500 mg daily and every participant in Group-B took tablet pioglitazone 30 mg daily.

Metformin Group; Pioglitazone Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gender: Both male and female
• Age: 18-80 Years
• Ultrasound evidence of fatty liver as per operational definition
• Liver enzymes as per operational definition

You may not qualify if:

• Pregnancy
• Cirrhotic patients as per operational definition
• Chronic Hepatitis B or chronic hepatitis C
• Patients taking long term steroids, highly active antiretroviral therapy, diltiazem, irinotecan, oxaliplatin and amiodarone
• Patients taking alcohol (based on history and AST to ALT ratio)
• 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)
• Patients with renal failure (serum creatinine ≥ 1.4 mg% or eGFR \< 45 ml/min/1.73 m2)

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

King Edward Medical University/Mayo Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Metformin; Pioglitazone

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Thiazolidinediones; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dr. Mohammad Ibrahim, MBBS, MD

  King Edward Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Resident of Internal Medicine

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 30, 2022
• Study Start: June 6, 2019
• Primary Completion: January 19, 2021
• Study Completion: May 24, 2022
• Last Updated: August 30, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)