Metformin Experience on Minimal Hepatic Encephalopathy (EME)

June 9, 2015 updated by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Metformin Experience on Minimal Hepatic Encephalopathy in Patients With Liver Cirrhosis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Sevilla, Spain
        • Recruiting
        • Fundación Pública Andaluza para la gestión de la Investigación en Salud de Sevilla (FISEVI)
        • Contact:
        • Sub-Investigator:
          • Javier Ampuero, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Metformin
Patients receiving metformin
Drug: Metformin
Metformin 1000mg twice a day
Other Names:
  • Drug 1
PLACEBO_COMPARATOR: Placebo
Patients receiving placebo
Drug: Placebo
Placebo 1000mg twice a day
Other Names:
  • Drug 2

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Investigators

  • Principal Investigator: Manuel Romero-Gomez, PhD, MD, Valme University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (ANTICIPATED)

June 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

September 4, 2014

First Submitted That Met QC Criteria

June 9, 2015

First Posted (ESTIMATE)

June 12, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

June 12, 2015

Last Update Submitted That Met QC Criteria

June 9, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EME-2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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