The Leukotriene Receptor Antagonist Montelukast in the Treatment of Non-alcoholic Steatohepatitis

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 Montelukast in treatment of patients with fatty liver disease.

Official Title
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The Leukotriene Receptor Antagonist Montelukast in the Treatment of Non-alcoholic Steatohepatitis: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial

Conditions
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Steatohepatitis, Nonalcoholic

Intervention / Treatment
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* Drug: Control group
* Drug: Montelukast group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - The inclusion criteria were adult patients (age >18 years old) of both sexes, overweight/obese subjects with presence of evidence of hepatic steatosis by imaging (increased liver echogenicity, stronger echoes in the hepatic parenchyma, vessel blurring, and narrowing of the lumen of the hepatic veins). Patients with mild to moderate elevation in aminotransferase activities (> 2 but <5 times upper limit of normal), hepatic steatosis index (HIS) >36, Fibro-scan score >7 kpa and <12.5 kpa (F0-F3), and HAIR score of 2 or 3 were included in the study. Exclusion Criteria: - The exclusion criteria included smokers, patients with secondary hepatic fat accumulation which results from using steatogenic medications or hereditary disorders. Alcohol consumers, patients with Wilson's disease, hemochromatosis, viral hepatitis, decompensated liver disease, inflammatory diseases, diabetes, depression and patients with other comorbid conditions that elevate transaminases (congestive heart failure and malignancy) pregnancy and lactating women were excluded

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 |
| --- | --- |
| Placebo Comparator: Control group<br>26 patients will receive placebo (Control group) | Drug: Control group<br>* patients received matching-image placebo once daily at bedtime for 12 weeks.<br>|
| Experimental: Montelukast group<br>26 patients will receive montelukast 10 mg/ day | Drug: Montelukast group<br>* patients received montelukast (10-mg chewable tablet) once daily at bedtime for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibro-scan score | change in liver stiffness measurement (Fibro-scan score) | At baseline and after 12 weeks of intervention | 
| Liver Panel | Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) will be evaluated in U/L | after 12 weeks of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HOMA-IR | Homeostatic Model Assessment of Insulin Resistance | after 12 weeks of intervention | 
| 8-OHdG | Serum level of 8-OHdG | after 12 weeks of intervention | 
| TNF-Alpha | Serum level of TNF-Alpha | after 12 weeks of intervention | 
| hyaluronic acid | Serum level of hyaluronic acid | after 12 weeks of intervention | 
| TGF-β1 | Serum level of TGF-β1 | after 12 weeks of intervention | 
| Assessment of drugs tolerability: Side effects | Side effects of montelukast | after 12 weeks of intervention |