Metformin Experience on Minimal Hepatic Encephalopathy

Study Overview
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Brief Summary
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Primary aim: -To assess the effect of metformin use on the treatment of minimal hepatic encephalopathy in patients with liver cirrhosis. Secondary aim: -To evaluate if metformin is a safety drug in patients showing liver cirrhosis.

Detailed Description
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In this study, 30 patients will be included divided in two arms. Investigators and patients will not know the treatment used (double blind). Arm 1: Metformin 1000mg twice a day (2000 mg/day), during 12 weeks. Arm 2: Placebo 1000mg twice a day (2000mg/day), during 12 weeks. At the end of the study, patients will be followed-up 8 weeks more to control the appearance of adverse effects.

Official Title
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Metformin Experience on Minimal Hepatic Encephalopathy in Patients With Liver Cirrhosis

Conditions
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Liver Cirrhosis, Hepatic Encephalopathy

Intervention / Treatment
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* Drug: Metformin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with > 18 years old Patients with the results of all the factors evaluable at the time of inclusion Patients who have accepted their participation in the study through informed consent Patients showing liver cirrhosis by ultrasound, transient elastography or liver biopsy Patients showing minimal hepatic encephalopathy (PHES < 4 or Critical Flicker Frequency < 39 Hz) Exclusion Criteria: Patients with any contraindications to the drugs used Patients showing type 1 diabetes mellitus Patients showing type 2 diabetes mellitus and previous or current use of exogenous insulin, metformin or other oral antidiabetic drug

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metformin<br>Patients receiving metformin | Drug: Metformin<br>* Metformin 1000mg twice a day<br>* Other names: Drug 1;|
| Placebo Comparator: Placebo<br>Patients receiving placebo | Drug: Placebo<br>* Placebo 1000mg twice a day<br>* Other names: Drug 2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with Minimal hepatic encephalopathy | Measurement of the results of critical flicker frequency after 12 weeks of metformin treatment | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with Minimal hepatic encephalopathy | Measurement of the results of PHES after 12 weeks of metformin treatment | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatic encephalopathy, Metformin, Liver cirrhosis