NCT02470546

Metformin Experience on Minimal Hepatic Encephalopathy

Metformin Experience on Minimal Hepatic Encephalopathy in Patients With Liver Cirrhosis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Cirrhosis
• Hepatic Encephalopathy

Interventions

Type	Name	Description
DRUG	Metformin	Metformin 1000mg twice a day
DRUG	Placebo	Placebo 1000mg twice a day

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-06-01
• Completion: 2016-12-01
• First posted: 2015-06-12
• Last updated: 2015-06-12

Locations

1 site across 1 country: Spain