Evaluation the Safety and Efficacy of Cilostazol in Treatment of Patients With Fatty Liver Disease

Study Overview
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Brief Summary
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The aim of the current study is to evaluate the safety and efficay of cilostazol in treatment of patients with fatty liver disease. Several previous reports have shown that cilostazol ameliorates lipid imbalances in NAFLD. Cilostazol appeared to exert beneficial effects against NAFLD

Official Title
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Evaluation the Safety and Efficacy of Cilostazol in Treatment of Patients With Fatty Liver Disease: A Randomized, Controlled Trial.

Conditions
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Fatty Liver, Nonalcoholic

Intervention / Treatment
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* Drug: Cilostazol 50 MG
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults between 18 and 60 years of age, both men and women, Clinical diagnosis of NAFLD, confirmed by imaging exams, Patients who present levels above the reference values of ALT, AST and ferritin. Exclusion Criteria: Women in the menacing period, with the exception of those who have performed definitive sterilization, such as hysterectomy or tubal ligation. Patients with established prior diagnosis of chronic noncommunicable disease (congestive heart failure, decompensated or severe lung disease, neoplasms, renal disease, advanced liver disease - Child Pugh C classification) Patients with schistosomiasis; Hemochromatosis Wilson's disease Viral or autoimmune hepatitis HIV virus carriers Woman who is breastfeeding Users of illicit drugs Patients with an intake of more than 20 g / day of alcohol and / or past alcoholism with abstention less than 6 months; Patients with ingestion of medications such as steroids, estrogens, amiodarone, warfarin, anti-convulsants, antipsychotics, tamoxifen or other chemotherapeutic agents in the last 6 months Patients with clinically manifest infections or inflammation, surgery, trauma or hospitalization in the last 30 days Chronic non-hepatic degenerative diseases (sclerosis, Parkinson's disease or -Alzheimer's disease) Patients who do not participate in all stages of the research.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cilostazol<br> | Drug: Cilostazol 50 MG<br>* Cilostazol 50 MG tablet twice daily<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo tablet twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic transaminases | Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) will be evaluated in U/L | week 12 | 
| Serum ferritin | Serum ferritin | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid profile | Total cholesterol (mg/dL), LDL-cholesterol (mg/dL), HDL-cholesterol (mg/dL), VLDL-cholesterol (mg/dL) and triglycerides (mg/dL) will be measured before and after the intervention. | week 12 | 
| Glycated haemoglobin | Hb A1c (%) | week 12 | 
| Serum stem cell transforming factor beta | Serum stem cell transforming factor beta | 12 weeks | 
| Adverse effects | Adverse effects | 12 weeks | 
| FAM19A5 serum level | FAM19A5 serum level | 12 weeks |