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
-To assess the effect of metformin use on the treatment of minimal hepatic encephalopathy in patients with liver cirrhosis.
-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|
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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Active Comparator: Metformin
Patients receiving metformin
Metformin 1000mg twice a day
Other Name: Drug 1
Placebo Comparator: Placebo
Patients receiving placebo
Placebo 1000mg twice a day
Other Name: Drug 2
- 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
- Number of patients with Minimal hepatic encephalopathy [ Time Frame: 12 weeks ]Measurement of the results of PHES after 12 weeks of metformin treatment
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
|Contact: Manuel Romero-Gomez, PhD, MDfirstname.lastname@example.org|
|Fundación Pública Andaluza para la Gestión de la investigación en salud de Sevilla (FISEVI)||Recruiting|
|Contact: Manuel Romero-Gomez, PhD, MD email@example.com|
|Sub-Investigator: Javier Ampuero, MD|
|Principal Investigator:||Manuel Romero-Gomez, PhD, MD||Valme University Hospital|