NAFLDPhase 3NCT05521633
Comparison of the Effects of Metformin and Pioglitazone on Liver Enzymes and Ultrasound Changes in Non-Diabetic Non-Alcoholic Fatty Liver
A Phase 3 study testing Metformin and Pioglitazone in people with NAFLD, run by King Edward Medical University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- NAFLD
- What is being tested?
- Metformin and Pioglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Jun 2019to 24 May 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gender: Both male and female
- Age: 18-80 Years
- Ultrasound evidence of fatty liver as per operational definition
- Liver enzymes as per operational definition
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
King Edward Medical University/Mayo Hospital
Lahore, Punjab Province, 54000
About this study
Official title: 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.
- Conditions
- NAFLD
- Being tested
- Metformin and Pioglitazone
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin and PioglitazoneDrug
Every participant in Group-A took tablet metformin 500 mg daily and every participant in Group-B took tablet pioglitazone 30 mg daily.
| Study group | Role | What they receive |
|---|---|---|
| Metformin Group | Active comparator | Group-A; every participant took 500 mg of metformin daily Receives: Drug: Metformin and Pioglitazone |
| Pioglitazone Group | Active comparator | Group-B; every participant took 30 mg of pioglitazone daily Receives: Drug: Metformin and Pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver transaminase levels
There should be a 22% or more change in transaminases levels from baseline.
Measured: The comparison is done after 6 months of drug treatment
Secondary outcomes (1)
Fatty Liver Grade
There should be a change of liver fat content determined by ultrasound as Fatty Liver Grade
Measured: The comparison is done after 6 months of drug treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start6 Jun 2019
- Primary completion19 Jan 2021
- Study completion24 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Ibrahim, King Edward Medical University
- Investigators
- Dr. Mohammad Ibrahim, MBBS, MD, Principal investigator, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521633
- Sponsor's protocol ID
- King EdwardMU
- Status last verified
- Aug 2022
- First submitted
- 24 Aug 2022
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Metformin and Pioglitazone on Liver Enzymes
- ClinicalTrials.gov ID
- NCT05521633
- Acronym / sponsor ID
- King EdwardMU
- Conditions
- NAFLD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 19 Jan 2021 (actual)
- Study completion
- 24 May 2022 (actual)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin Group | Active comparator | Drug: Metformin and PioglitazoneGroup-A; every participant took 500 mg of metformin daily |
| Pioglitazone Group | Active comparator | Drug: Metformin and PioglitazoneGroup-B; every participant took 30 mg of pioglitazone daily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Gender: Both male and female
- Age: 18-80 Years
- Ultrasound evidence of fatty liver as per operational definition
- Liver enzymes as per operational definition
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin and PioglitazoneEvery participant in Group-A took tablet metformin 500 mg daily and every participant in Group-B took tablet pioglitazone 30 mg daily. | Drug | Metformin Group, Pioglitazone Group |
Primary outcome
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.
1 secondary outcome
Fatty Liver Grade
Time frame: The comparison is done after 6 months of drug treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for NAFLD
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Mohammad Ibrahim, MBBS, MD principal investigator
King Edward Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metformin and Pioglitazone in people with NAFLD, run by King Edward Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver transaminase levels (time frame: The comparison is done after 6 months of drug treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2022.