NCT02470546

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 12, 2015

Status Verified

June 1, 2015

Enrollment Period

1.3 years

First QC Date

September 4, 2014

Last Update Submit

June 9, 2015

Conditions

Liver CirrhosisHepatic Encephalopathy

Keywords

Hepatic encephalopathyMetforminLiver cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Number of patients with Minimal hepatic encephalopathy

    Measurement of the results of critical flicker frequency after 12 weeks of metformin treatment

    12 weeks

Secondary Outcomes (1)

  • Number of patients with Minimal hepatic encephalopathy

    12 weeks

Study Arms (2)

Metformin

ACTIVE COMPARATOR

Patients receiving metformin

Drug: Metformin

Placebo

PLACEBO COMPARATOR

Patients receiving placebo

Drug: Placebo

Interventions

MetforminDRUG

Metformin 1000mg twice a day

Also known as: Drug 1
Metformin
PlaceboDRUG

Placebo 1000mg twice a day

Also known as: Drug 2
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with \> 18 years old
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seville, Spain

RECRUITING

MeSH Terms

Conditions

Liver CirrhosisHepatic Encephalopathy

Interventions

Metformin

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsLiver FailureHepatic InsufficiencyBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Manuel Romero-Gomez, PhD, MD

    Valme University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuel Romero-Gomez, PhD, MD

CONTACT

mromerogomez@us.es

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2014

First Posted

June 12, 2015

Study Start

March 1, 2015

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

June 12, 2015

Record last verified: 2015-06

Locations

ES(1)