Metformin Experience on Minimal Hepatic Encephalopathy

Phase 4

• Conditions: Hepatic Encephalopathy; Liver Cirrhosis
• Interventions: Drug: Placebo; Drug: Metformin

• Registration Number: NCT02470546
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-09-04
• Study Start: 2015-03
• Status Verified: 2015-06
• Study First Submitted QC: 2015-06-09
• Last Update Submitted: 2015-06-09
• Study First Posted: 2015-06-12
• Last Update Posted: 2015-06-12
• Primary Completion: 2016-06
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients receiving placebo
Metformin	Metformin	Patients receiving metformin

Primary Outcome Measures

Name	Time	Method
Number of patients with Minimal hepatic encephalopathy	12 weeks	Measurement of the results of critical flicker frequency after 12 weeks of metformin treatment

Secondary Outcome Measures

Name	Time	Method
Number of patients with Minimal hepatic encephalopathy	12 weeks	Measurement of the results of PHES after 12 weeks of metformin treatment

Trial Locations

Locations (1)

Fundación Pública Andaluza para la Gestión de la investigación en salud de Sevilla (FISEVI); 🇪🇸 Sevilla, Spain