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

NCT ID: NCT05521633

Last Updated: 2022-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-06

Study Completion Date

2022-05-24

Brief Summary

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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

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Conditions

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NAFLD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Metformin Group

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

Group Type ACTIVE_COMPARATOR

Metformin and Pioglitazone

Intervention Type DRUG

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

Pioglitazone Group

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

Group Type ACTIVE_COMPARATOR

Metformin and Pioglitazone

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Edward Medical University

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Ibrahim

Postgraduate Resident of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr. Mohammad Ibrahim, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

King Edward Medical University

Locations

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King Edward Medical University/Mayo Hospital

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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King EdwardMU

Identifier Type: -

Identifier Source: org_study_id

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