Study of Pioglitazone and Metformin combination treatment for patients with Metabolic Associated Fatty Liver Disease and prediabetes

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What is this study about?

This study focuses on Metabolic Associated Fatty Liver Disease in people who have prediabetes, a condition where blood sugar levels are higher than normal but not high enough to be diagnosed as diabetes. The study uses two medications: Pioglitazone and Metformin, which are taken as tablets by mouth to help control blood sugar levels and improve liver function.

The main purpose is to find out which treatment approach works best in reducing liver fat over an 18-month period. The amount of fat in the liver will be measured using Magnetic Resonance Imaging (MRI), which is a scanning technique that creates detailed pictures of the inside of the body without using radiation.

During the study, participants will receive different combinations of these medications along with lifestyle recommendations. The study will also look at how the body processes insulin, examine various substances in the blood, study gut bacteria, and look at how genetic differences might affect how well the treatments work. The total duration of treatment is 18 months, during which participants will take either Pioglitazone (15 mg daily) or Metformin (up to 1000 mg daily), or both medications together.

1 Initial assessment

Your participation begins with an evaluation to confirm the presence of fatty liver disease through magnetic resonance imaging (MRI).

Medical professionals will check your blood sugar levels to confirm prediabetes condition.

A complete medical assessment will be performed to verify your eligibility, including body mass index (BMI) measurement.

2 Treatment assignment

You will be assigned to one of three treatment groups.

The treatment includes oral medications: pioglitazone (15 mg tablets) and metformin hydrochloride (500 mg tablets).

Your healthcare provider will give you specific instructions about when and how to take your medications.

3 Regular monitoring

You will undergo periodic MRI scans to measure liver fat content.

Regular blood tests will monitor your sugar levels and overall health.

Body composition measurements will be taken using bioimpedance analysis.

Samples will be collected to study your intestinal bacteria and blood metabolites.

4 Long-term follow-up

The study continues for 18 months to evaluate long-term effects.

Regular assessments will track changes in your liver fat content.

Healthcare providers will monitor and record any side effects from the medication.

5 Study completion

Final MRI scan and blood tests will be performed to assess overall treatment results.

The study aims to determine which treatment approach is most effective in reducing liver fat.

The study is expected to conclude by February 2026.

Who Can Join the Study?

Must be diagnosed with Metabolic Associated Fatty Liver Disease according to international expert criteria
Age between 18 and 75 years
Can be either:
- Male
- Female who has gone through menopause (no longer having menstrual periods)
Must have significant fatty liver disease shown by magnetic resonance imaging (MRI scan) with more than 10% fat content in the liver
Must be overweight or obese with a Body Mass Index (BMI) between 25 and 40 (BMI is a measure of body fat based on height and weight)
Must have prediabetes, shown by one of these test results:
- Fasting blood sugar between 100-125 mg/dl (measured after not eating for 8 hours), or
- HbA1c (average blood sugar over 3 months) between 5.7% and 6.4%, or
- Blood sugar between 140-199 mg/dl when measured 2 hours after drinking a sugar solution

Who Cannot Join the Study?

Patients younger than 18 years or older than 64 years of age
Presence of type 2 diabetes (as this study is for prediabetes only)
History of alcohol consumption exceeding 30g/day for men or 20g/day for women
Presence of other liver diseases such as viral hepatitis (liver inflammation caused by viruses)
Use of medications known to cause fatty liver disease
Pregnancy or planning to become pregnant during the study period
Active cancer or cancer treatment in the past 5 years
Serious heart conditions or history of heart failure
Inability to undergo MRI (Magnetic Resonance Imaging) scanning
Participation in other clinical trials within the past 30 days
Having any condition that could interfere with the 18-month follow-up period
Severe psychiatric disorders that could affect compliance with the study
Chronic kidney disease or significant kidney dysfunction
Body Mass Index (BMI) greater than 40 kg/m²
Regular use of anti-inflammatory medications

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Hospital Universitari Joan XXIII De Tarragona	Tarragona	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Universitario Virgen De La Victoria	Malaga	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	24.02.2022

Trial locations

Investigated drugs:

Based on the provided trial information, there are no specific medications or therapies listed in the source data. The trial appears to be studying different therapeutic intervention models for fatty liver disease and prediabetes, but the specific medications or interventions are not detailed in the provided data. Without information about the specific treatments being used, I cannot provide descriptions of medications or therapies for this clinical trial.

The trial focuses on comparing different treatment approaches for fatty liver disease in prediabetic patients, using MRI to measure outcomes, but the actual interventions are not specified in the source data.

Investigated diseases:

Metabolic Associated Fatty Liver Disease – A condition where excess fat builds up in the liver cells of people who have metabolic health issues. The disease develops when the body stores too much fat in the liver, often related to insulin resistance and metabolic problems. Over time, fat accumulation can lead to liver inflammation and changes in liver tissue. The condition is closely linked with prediabetes, where blood sugar levels are higher than normal but not high enough to be diagnosed as diabetes. This disease often occurs alongside other metabolic conditions such as obesity and high blood pressure. The liver can become enlarged and less efficient at performing its normal functions as the condition progresses.

Prediabetes – A condition where blood sugar levels are higher than normal but not high enough to be classified as type 2 diabetes. In this state, the body begins to show signs of insulin resistance, where cells don’t respond normally to insulin. The condition develops gradually and may not cause any noticeable symptoms. Prediabetes affects the body’s ability to process glucose efficiently. This metabolic state often occurs alongside other health conditions and can affect various body systems.

Trial ID:

2024-516561-37-01

Protocol code:

PROMETEO-HG

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Pioglitazone and Metformin combination treatment for patients with Metabolic Associated Fatty Liver Disease and prediabetes

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?