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

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ClinicalTrials.gov Identifier: NCT05521633
Recruitment Status : Completed
First Posted : August 30, 2022
Last Update Posted : August 30, 2022
Sponsor:
Information provided by (Responsible Party):
Mohammad Ibrahim, King Edward Medical University

Study Description
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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.


Condition or disease Intervention/treatment Phase
NAFLD Drug: Metformin and Pioglitazone Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of the Effects of Metformin and Pioglitazone on Liver Enzymes
Actual Study Start Date : June 6, 2019
Actual Primary Completion Date : January 19, 2021
Actual Study Completion Date : May 24, 2022

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Liver transaminase levels [ Time Frame: 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 :
  1. Fatty Liver Grade [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05521633


Locations
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Pakistan
King Edward Medical University/Mayo Hospital
Lahore, Punjab, Pakistan, 54000
Sponsors and Collaborators
King Edward Medical University
Investigators
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Principal Investigator: Dr. Mohammad Ibrahim, MBBS, MD King Edward Medical University
More Information
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Responsible Party: Mohammad Ibrahim, Postgraduate Resident of Internal Medicine, King Edward Medical University
ClinicalTrials.gov Identifier: NCT05521633    
Other Study ID Numbers: King EdwardMU
First Posted: August 30, 2022    Key Record Dates
Last Update Posted: August 30, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Metformin
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs