Metformin treatment of minimal hepatic encephalopathy in patients with liver cirrhosis

• Conditions: minimal hepatic encephalopathy in patients with liver cirrhosis; MedDRA version: 16.0Level: LLTClassification code 10014630Term: Encephalopathy hepaticSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2013-000563-81-ES
• Lead Sponsor: FUNDACION PUBLICA ANDALUZA PARA LA GESTION DE LA INVESTIGACION EN SALUD DE SEVILLA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-26
• Last Update Posted: 5 August 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Men and women aged 18 years. Diagnosis of EHM, introducing at least one of the following alterations:
PHES <4.
FCP <39 Hz Diagnosis of liver cirrhosis by imaging techniques (ultrasound, CT computeriazada, MRI) or liver biopsy (Metavir classification F4). In women of childbearing potential, negative pregnancy test. Effective contraceptive measures during treatment and for 6 months after treatment ends.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients who have experienced an episode of hepatic encephalopathy before the start of the study. Patients with type 1 diabetes mellitus. Patients with type 2 diabetes mellitus treated with insulin, metformin or any other oral antidiabetic. Patients treated with benzodiazepines. Pregnant or breastfeeding. Systemic antineoplastic treatment or immunomodulators (including steroids and supraphysiological doses of radiation) 6 months prior to the first dose of treatment. Treatment with any investigational drug within 6 weeks prior to the first dose of treatment. Signs or symptoms of hepatocellular carcinoma. Background or other evidence of bleeding from esophageal varices. Neutrophil count <1500 cells/mm3 or a platelet count <90,000 cells/mm3 at the time of screening. Hgb <10 at the time of evaluation. Patients with documented or suspected coronary artery disease or cerebrovascular disease should not be treated if in the judgment of the investigator, could see their conditions worsened during the study. Serum creatinine> 1.5 times the upper limit of normal at the time of evaluation. History of severe psychiatric illness, particularly depression. It is defined as a severe psychiatric disorder that requires treatment with antidepressants or major tranquillizers in therapeutic doses required for major depression or psychosis, respectively, for at least three months at any time before or any of the following background: attempted suicide, hospitalization for of psychiatric illness, or disability period due to psychiatric illness. Background severe seizure disorder or current use of anticonvulsants. History of autoimmune disease, chronic lung disease associated with limited functionality, serious heart disease, congestive heart failure, advanced arteriosclerosis, increased organ transplant or other indications of serious disease, neoplasia, or any other condition that, in the opinion of the investigator, would prevent the patient is suitable for the study. History of thyroid disease poorly controlled with medications prescribed, elevated thyroid stimulating hormone (TSH) with increased thyroid peroxidase antibodies and any clinical manifestations of thyroid disease. Acute conditions involving a risk of impaired renal function: dehydration (diarrhea, vomiting), fever, infectious conditions and / or severe hypotonic (shock, sepsis, urinary tract infection, neuropathy).
Radiological examination with intravenous administration of contrast media (IVP, angiography). Evidence of drug use in the six months preceding the survey. Alcohol. Inability or unwillingness to give informed consentiomiento or to meet the requirements of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the effect of decreasing insulin resistance by administration of metformin in the treatment of minimal hepatic encephalopathy in patients with liver cirrhosis.;Secondary Objective: To evaluate the efficacy and safety of treatment with metformin in patients with liver cirrhosis.;Primary end point(s): Minimal hepatic encephalopathy improvement after reducing insulin resistance in patients treated with metformin.;Timepoint(s) of evaluation of this end point: END OF TREATMENT

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Efficacy and safety of treatment with metformin in patients with liver cirrhosis;Timepoint(s) of evaluation of this end point: END OF TREATMENT