Metformin Experience on Minimal Hepatic Encephalopathy

Liver Cirrhosis Clinical Trial

— EME  

Official title:

Metformin Experience on Minimal Hepatic Encephalopathy in Patients With Liver Cirrhosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02470546
• Other study ID #: EME-2015
• Status: Recruiting
• Phase: Phase 4
• First received: September 4, 2014
• Last updated: June 9, 2015
• Start date: March 2015
• Est. completion date: December 2016

Study information

• Verified date: June 2015
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: Manuel Romero-Gomez, PhD, MD
• Email: mromerogomez[@]us.es
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy
• Liver Cirrhosis

Intervention

Drug:
• Metformin
Metformin 1000mg twice a day
• Placebo
Placebo 1000mg twice a day

Locations

Country	Name	City	State
Spain	Fundación Pública Andaluza para la Gestión de la investigación en salud de Sevilla (FISEVI)	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with Minimal hepatic encephalopathy	Measurement of the results of critical flicker frequency after 12 weeks of metformin treatment	12 weeks	No
Secondary	Number of patients with Minimal hepatic encephalopathy	Measurement of the results of PHES after 12 weeks of metformin treatment	12 weeks	No