Metformin Experience on Minimal Hepatic Encephalopathy (EME)

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status and phase: Unknown; Phase 4

Conditions: Hepatic Encephalopathy; Liver Cirrhosis

Treatments: Drug: Placebo; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT02470546

EME-2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Metformin

Active Comparator group

Description:

Patients receiving metformin

Treatment:

Drug: Metformin

Placebo

Placebo Comparator group

Description:

Patients receiving placebo

Treatment:

Drug: Placebo