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Completed

NCT Number: NCT04080947

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

The aim of the current study is to evaluate the safety and efficay of Montelukast in treatment of patients with fatty liver disease.

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Key information

Conditions

Steatohepatitis, Nonalcoholic Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Faculty of Medicine

Shibīn al Kawm, Menoufia, 13829, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control group

Drug

patients received matching-image placebo once daily at bedtime for 12 weeks.

Montelukast group

Drug

patients received montelukast (10-mg chewable tablet) once daily at bedtime for 12 weeks.

Primary outcomes

  1. Fibro-scan score

    Time frame: At baseline and after 12 weeks of intervention

    change in liver stiffness measurement (Fibro-scan score)

  2. Liver Panel

    Time frame: after 12 weeks of intervention

    Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) will be evaluated in U/L

Secondary outcomes

  1. HOMA-IR

    Time frame: after 12 weeks of intervention

    Homeostatic Model Assessment of Insulin Resistance

  2. 8-OHdG

    Time frame: after 12 weeks of intervention

    Serum level of 8-OHdG

  3. TNF-Alpha

    Time frame: after 12 weeks of intervention

    Serum level of TNF-Alpha

  4. hyaluronic acid

    Time frame: after 12 weeks of intervention

    Serum level of hyaluronic acid

  5. TGF-β1

    Time frame: after 12 weeks of intervention

    Serum level of TGF-β1

  6. Assessment of drugs tolerability: Side effects

    Time frame: after 12 weeks of intervention

    Side effects of montelukast

Sponsors and collaborators

Lead sponsor

Sadat City University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Sep 6, 2019
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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