Metformin Experience on Minimal Hepatic Encephalopathy

Metformin Experience on Minimal Hepatic Encephalopathy in Patients With Liver Cirrhosis

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02470546

Acronym

EME

Enrollment

Registered

2015-06-12

Start date

2015-03-31

Completion date

2016-12-31

Last updated

2015-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Encephalopathy, Liver Cirrhosis

Keywords

Hepatic encephalopathy, Metformin, Liver cirrhosis

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.

Interventions

DRUGMetformin

Metformin 1000mg twice a day

DRUGPlacebo

Placebo 1000mg twice a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Number of patients with Minimal hepatic encephalopathy	12 weeks	Measurement of the results of PHES after 12 weeks of metformin treatment

Countries

Spain

Contacts

Primary ContactManuel Romero-Gomez, PhD, MD

mromerogomez@us.es

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026