minimal hepatic encephalopathy in patients with liver cirrhosis MedDRA version: 16.0 Level: LLT Classification code 10014630 Term: Encephalopathy hepatic System Organ Class: 100000004852
Conditions
Interventions
Product Name: METFORMIN
Product Code: HCL
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
FUNDACION PUBLICA ANDALUZA PARA LA GESTION DE LA INVESTIGACION EN SALUD DE SEVILLA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men and women aged 18 years. Diagnosis of EHM, introducing at least one of the following alterations: PHES =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Spain
Contacts
Public ContactUNIDAD MEDICO QUIRURGICA DE ENFERME
GRUPO DE INVESTIGACION DEL DOCTOR ROMERO
Outcome results
None listed