Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2015-03-31
2016-12-31
Brief Summary
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-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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Metformin
Patients receiving metformin
Metformin
Metformin 1000mg twice a day
Placebo
Patients receiving placebo
Placebo
Placebo 1000mg twice a day
Interventions
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Metformin
Metformin 1000mg twice a day
Placebo
Placebo 1000mg twice a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
70 Years
ALL
No
Sponsors
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER
Responsible Party
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Principal Investigators
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Manuel Romero-Gomez, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Valme University Hospital
Locations
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Fundación Pública Andaluza para la Gestión de la investigación en salud de Sevilla (FISEVI)
Seville, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EME-2015
Identifier Type: -
Identifier Source: org_study_id
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