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Metformin Experience on Minimal Hepatic Encephalopathy (EME)

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ClinicalTrials.gov Identifier: NCT02470546
Recruitment Status : Unknown
Verified June 2015 by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla.
Recruitment status was:  Recruiting
First Posted : June 12, 2015
Last Update Posted : June 12, 2015
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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.


Condition or disease Intervention/treatment Phase
Liver Cirrhosis Hepatic Encephalopathy Drug: Metformin Drug: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Metformin Experience on Minimal Hepatic Encephalopathy in Patients With Liver Cirrhosis
Study Start Date : March 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016


Arm Intervention/treatment
Active Comparator: Metformin
Patients receiving metformin
Drug: Metformin
Metformin 1000mg twice a day
Other Name: Drug 1

Placebo Comparator: Placebo
Patients receiving placebo
Drug: Placebo
Placebo 1000mg twice a day
Other Name: Drug 2




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Number of patients with Minimal hepatic encephalopathy [ Time Frame: 12 weeks ]
    Measurement of the results of PHES after 12 weeks of metformin treatment



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470546


Contacts
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Contact: Manuel Romero-Gomez, PhD, MD mromerogomez@us.es

Locations
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Spain
Fundación Pública Andaluza para la Gestión de la investigación en salud de Sevilla (FISEVI) Recruiting
Sevilla, Spain
Contact: Manuel Romero-Gomez, PhD, MD       mromerogomez@us.es   
Sub-Investigator: Javier Ampuero, MD         
Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Investigators
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Principal Investigator: Manuel Romero-Gomez, PhD, MD Valme University Hospital

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Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT02470546     History of Changes
Other Study ID Numbers: EME-2015
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: June 12, 2015
Last Verified: June 2015

Keywords provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
Hepatic encephalopathy
Metformin
Liver cirrhosis

Additional relevant MeSH terms:
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Liver Cirrhosis
Hepatic Encephalopathy
Brain Diseases
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs