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临床试验/NCT03687229
NCT03687229Unknown不适用

The Effect Of Direct Acting Antiviral Drugs on miRNA-122 And Insulin Resistance In Chronic HCV Patients

Assiut University0 个研究点目标入组 60 人开始时间: 2019年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
主要终点
Percentage of change in the level of serum micro ribonucleic acid-122 in Chronic Hepatitis C patients

研究概览

简要总结

The hepatitis C virus is a major cause of chronic liver diseases, including cirrhosis and hepatocellular carcinoma, and infects approximately 3 % of the world population (150-170 million). It is estimated that approximately 80 % of patients with acute hepatitis C fail to eliminate the virus and become chronically infected Hepatitis C virus infection is strongly associated with the dysregulation of glucose homoeostasis such as insulin resistance and type 2 diabetes. Despite these findings of insulin resistance development via direct effects on insulin signalling pathway, the complex relationship between intrahepatic Hepatitis C virus infection and extrahepatic insulin resistance remains elusive.

One of the countries most affected by Hepatitis C virus is Egypt. The Egyptian Demographic and Health Surveys measured antibody prevalence among the adult population aged 15-59 years at 10.0% in 2015-substantially higher than global levels.

Several micro ribonucleic acids have been determined to play a key role in regulating viral replication and pathogenesis during infection. micro ribonucleic acid-122 expression is enriched in the liver, accounting for approximately 70 % of the total micro ribonucleic acid population in normal adult hepatocytes. Moreover, a particularly intriguing function of micro ribonucleic acid-122 involves its role in the Hepatitis C virus replication cycle.

Antagonism of micro ribonucleic acid-122 not only reduces viral replication but also reduces Hepatitis C virus propagation by decreasing the expression of enzymes involved in lipid metabolism, which can enhance Hepatitis C virus replication in cell culture models.

详细描述

The hepatitis C virus (HCV) is an enveloped, single-stranded positive-sense Ribo-Nucleic Acid virus which is a major cause of chronic liver diseases, including cirrhosis and hepatocellular carcinoma (HCC), and infects approximately 3 % of the world population(150-170 million).

One of the countries most affected by HCV is Egypt. The Egyptian Demographic and Health Surveys measured antibody prevalence among the adult population aged 15-59 years at 14.7% in 2009 and at 10.0% in 2015 To attend to this challenge, Egypt developed a national strategy for Hepatitis C Virus control and established HCV prevention and treatment programs using Direct Acting-Antivirals (DAAs).

Egypt launched an ambitious national HCV treatment program aiming to treat over 250,000 chronically infected individuals per year, with the goal of achieving a national chronic infection prevalence of <2% by 2025.

Although the consequences of chronic HCV infection are generally associated with liver manifestations such as hepatic fibrosis, cirrhosis, steatosis (known as non-alcoholic fatty liver disease, NAFLD) and HCC, the liver-related mortality of 350,000 individuals annually is still underestimated due to the lack of consideration of extrahepatic effect including a growing evidence showing that HCV infection is strongly associated with the dysregulation of glucose homoeostasis such as insulin resistance (IR) and type 2 diabetes (T2D).

HCV-related type 2 diabetes mellitus may arise from a complex interaction between IR, steatosis and inflammatory processes People infected with HCV are 4 times more likely to develop Type 2 Diabetes; and HCV-infected patients with uncontrolled glucose are at higher risk to develop advanced liver fibrosis, HCC, and exhibit decreased sustained virologic response (SVR) to traditional interferon treatment.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Chronic HCV patients eligible for treatment with Direct Acting Antivirals.
  • Chronic HCV patients 3 months after starting of treatment

排除标准

  • Cirrhosis
  • Diabetes Mellitus
  • Hemochromatosis
  • Hepatocellular carcinoma (HCC)
  • Chemotherapy
  • Organ transplantation

结局指标

主要结局

Percentage of change in the level of serum micro ribonucleic acid-122 in Chronic Hepatitis C patients

时间窗: 3 months

Measure the level of micro ribonucleic acid-122 on the viral load of chronic hepatitis C patients treated with Sofosbuvir/Daclatasvir regimen using Real Time Polymerase Chain Reaction

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

RAAbdelmegid

Principal Investigastor

Assiut University

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