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Metformin Experience on Minimal Hepatic Encephalopathy (EME)

Primary Purpose

Liver Cirrhosis, Hepatic Encephalopathy

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Metformin
Placebo
Sponsored by
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring Hepatic encephalopathy, Metformin, Liver cirrhosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Fundación Pública Andaluza para la Gestión de la investigación en salud de Sevilla (FISEVI)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Metformin

Placebo

Arm Description

Patients receiving metformin

Patients receiving placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 4, 2014
Last Updated
June 9, 2015
Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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1. Study Identification

Unique Protocol Identification Number
NCT02470546
Brief Title
Metformin Experience on Minimal Hepatic Encephalopathy
Acronym
EME
Official Title
Metformin Experience on Minimal Hepatic Encephalopathy in Patients With Liver Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Hepatic Encephalopathy
Keywords
Hepatic encephalopathy, Metformin, Liver cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Metformin
Arm Type
Active Comparator
Arm Description
Patients receiving metformin
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients receiving placebo
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Drug 1
Intervention Description
Metformin 1000mg twice a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Drug 2
Intervention Description
Placebo 1000mg twice a day
Primary Outcome Measure Information:
Title
Number of patients with Minimal hepatic encephalopathy
Description
Measurement of the results of critical flicker frequency after 12 weeks of metformin treatment
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of patients with Minimal hepatic encephalopathy
Description
Measurement of the results of PHES after 12 weeks of metformin treatment
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel Romero-Gomez, PhD, MD
Email
mromerogomez@us.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel Romero-Gomez, PhD, MD
Organizational Affiliation
Valme University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundación Pública Andaluza para la Gestión de la investigación en salud de Sevilla (FISEVI)
City
Sevilla
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Romero-Gomez, PhD, MD
Email
mromerogomez@us.es
First Name & Middle Initial & Last Name & Degree
Javier Ampuero, MD

12. IPD Sharing Statement

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Metformin Experience on Minimal Hepatic Encephalopathy

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