Fatty Liver Disease, Steatohepatitis, Nonalcoholic
Conditions
Brief summary
The aim of the study is to test the implication of esomeprazole as a possible potential therapy for patients with NASH through evaluating its effect on ultrasound and fibrosis risk scores, serum levels of liver fibrosis biomarkers (fibronectin 1), insulin resistance, metabolic and inflammatory parameters.
Interventions
DRUGEsomeprazole
esomeprazole 20 mg once daily
DRUGPlacebo
Placebo once daily
Sponsors
Sadat City University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Both males and females. * Diabetic and non-diabetic patients. * Age \>18 years old. * Overweight and obese patient: Body mass index (BMI) ≥ 25 kg/ m2 but \<40 kg/ m2. * Patients with heartburn, peptic ulcer, gastrointestinal reflux disease, erosive esophagitis, Zollinger-Ellison syndrome and helicobacter pylori infection. * Patients with established diagnosis of NASH based on liver ultrasonography, mild to moderate elevation in aminotransferase activities (\>2 but \<5 times upper limit of normal), hepatic steatosis index (HIS) \>36, HAIR score of 2 or 3.
Exclusion criteria
* Patients with a history of hypersensitivity to esomeprazole. * Patients with BMI ≥ 40 kg/ m2. * Patients taking warfarin, clopidogrel, digoxin, diazepam and phenytoin to avoid drug-drug interactions as these drugs are CYP2C19 substrates. * Patients infected with human immune deficiency virus taking antiretroviral medicines or dosage forms containing rilpivirine. * Patients with a history of viral hepatitis, autoimmune hepatitis, sclerosing cholangitis, biliary obstruction, primary biliary cirrhosis, hemochromatosis, Wilson's disease and alpha-1 antitrypsin deficiency. * Patients on medications associated with steatosis such as NSAIDs, amiodarone, tamoxifen, estrogen, sodium valproate, corticosteroids, and methotrexate. * Patients with cancer or with a history of cancer. * Patients with cardiovascular diseases. * Pregnant and lactating females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in non-alcoholic fatty liver disease (NAFLD) fibrosis score (NFS) | Before and after 3 months of the intervention | Increase in NAFLD fibrosis score indicates high probability of advanced liver fibrosis Score lower than -1.5 indicates low probability of advanced liver fibrosis (F0-F2). Score higher than or equals -1.5 to \< 0.67 indicates intermediate probability of advanced liver fibrosis. Score higher than or equals 0.67 indicates high probability of advanced liver fibrosis (F3-F4) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Liver function improvement | Before and after 3 months of the intervention | change in the other measured parameters such as liver panel |
| Reduction of oxidative stress | Before and after 3 months of the intervention | Decrease in the serum level of malondialdehyde (MDA) |
Countries
Egypt
Contacts
Primary Contactaya hesham eltabbakh, bachelor
Outcome results
None listed