Study on the Effects of Metformin in Patients with Cirrhosis and Portal Hypertension Already Treated with Carvedilol

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What is this study about?

This clinical trial is focused on studying the effects of the medication Metformin in patients who have a liver condition known as cirrhosis and a related complication called portal hypertension. Cirrhosis is a condition where the liver becomes severely scarred, and portal hypertension refers to increased blood pressure in the vein that carries blood to the liver. The study will compare the effects of Metformin with a placebo, which is a substance with no active medication, to see how it impacts the blood pressure in the liver over a period of 28 days.

The purpose of this study is to evaluate how Metformin affects the hepatic venous pressure gradient (HVPG), which is a measure of blood pressure in the liver, in patients who are already being treated with another medication called carvedilol. Participants in the study will be randomly assigned to receive either Metformin or a placebo. The treatment will be taken orally, meaning it is swallowed, for a total of 28 days. The main focus will be on observing any changes in the HVPG after this treatment period.

This study aims to provide insights into whether Metformin can help manage portal hypertension in patients with cirrhosis. By understanding the effects of Metformin, researchers hope to find better ways to treat this condition and improve the health outcomes for those affected by it. The study is designed to be safe and will be conducted under careful medical supervision.

1 joining the study

Upon joining the study, the patient must meet specific criteria, including being 18 years or older, having a diagnosis of cirrhosis, and a high likelihood of having a hepatic venous pressure gradient (HVPG) of 12 mm Hg or more.

The patient must have been on a stable dose of carvedilol, a medication used to treat high blood pressure, for at least one month prior to the study.

2 treatment phase

The patient will be randomly assigned to receive either metformin or a placebo. Metformin is a medication commonly used to treat type 2 diabetes, but in this study, it is being evaluated for its effects on portal hypertension.

The treatment will last for 28 days. The patient will take the assigned medication orally each day during this period.

3 monitoring and assessment

Throughout the 28-day treatment period, the patient’s health and response to the medication will be monitored closely.

The primary goal is to assess the change in the hepatic venous pressure gradient (HVPG) after the treatment period.

4 completion of the study

After completing the 28-day treatment, the patient’s participation in the study will conclude.

The final assessment will focus on the primary endpoint, which is the measurement of HVPG to determine the effect of the treatment.

Who Can Join the Study?

Must be at least 18 years old.
Must not have liver cancer, except for one nodule larger than 3 cm or more than three nodules, as shown by an ultrasound, CT scan, or MRI done in the last 6 months.
Must agree in writing to participate in the study.
Must have medical insurance.
If a woman can have children, she must use birth control methods like pills, an intrauterine device, or other mechanical methods.
Must have a diagnosis of cirrhosis, which is a liver condition, confirmed by a liver biopsy or other medical tests and evidence.
The cause of cirrhosis must be active or resolved for at least 6 months. This can include stopping alcohol, successful treatment for hepatitis C, or starting treatment for hepatitis B.
Must have a Child-Pugh score of A or B, which is a way to measure liver function.
Must have a high chance of having HVPG (hepatic venous pressure gradient) of 12 mm Hg or more, based on the doctor’s judgment.
Must be taking carvedilol at a stable dose of at least 6.25 mg per day for at least one month. Carvedilol is a medication used to treat high blood pressure and heart conditions.

Who Cannot Join the Study?

Patients who have a condition called portal hypertension with complications from cirrhosis cannot participate. Portal hypertension is high blood pressure in the veins that bring blood to the liver, and cirrhosis is severe liver damage.
Patients who are not already being treated with a medication called carvedilol cannot participate. Carvedilol is a medicine used to treat high blood pressure and heart problems.
Patients with a hepatic venous pressure gradient (HVPG) less than 12 mm Hg cannot participate. HVPG is a measure of the blood pressure in the liver.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Intercommunal Creteil	Creteil	France

Other Sites

Site Name	City	Country
Hospital Foch	Suresnes	France
Hopital Beaujon	Clichy	France
Centre Hospitalier De Saint-Denis	St Denis	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	02.09.2024

Trial locations

Investigated drugs:

Metformin Embonate

Metformin is a medication commonly used to manage blood sugar levels in people with type 2 diabetes. In this trial, it is being studied to see if it can help reduce the pressure in the veins of the liver in patients with cirrhosis and portal hypertension.

Carvedilol is a medication that is typically used to treat high blood pressure and heart failure. In this trial, patients are already being treated with carvedilol to manage their condition, and the study is investigating the additional effects of metformin.

Portal Hypertension – This condition occurs when there is an increase in blood pressure within the portal venous system, which includes the veins coming from the stomach, intestine, spleen, and pancreas that merge into the portal vein. The portal vein then branches into smaller vessels and travels through the liver. When the liver is damaged, as in cirrhosis, blood flow through the liver is obstructed, leading to increased pressure in the portal vein. Over time, this increased pressure can cause the development of enlarged veins (varices) in the esophagus and stomach, which may rupture and bleed. Other complications can include fluid accumulation in the abdomen (ascites) and spleen enlargement.

Trial ID:

2023-508535-32-00

Protocol code:

APHP230872

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Metformin in Patients with Cirrhosis and Portal Hypertension Already Treated with Carvedilol

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?