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
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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COMPLETED
PHASE3
96 participants
INTERVENTIONAL
2019-06-06
2022-05-24
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Metformin Group
Group-A; every participant took 500 mg of metformin daily
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.
Pioglitazone Group
Group-B; every participant took 30 mg of pioglitazone daily
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.
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.
Eligibility Criteria
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Inclusion Criteria
2. Age: 18-80 Years
3. Ultrasound evidence of fatty liver as per operational definition
4. Liver enzymes as per operational definition
Exclusion Criteria
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)
18 Years
80 Years
ALL
No
Sponsors
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King Edward Medical University
OTHER
Responsible Party
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Mohammad Ibrahim
Postgraduate Resident of Internal Medicine
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
Countries
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Other Identifiers
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King EdwardMU
Identifier Type: -
Identifier Source: org_study_id
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