The Effect Of Direct Acting Antiviral Drugs on miRNA-122 And Insulin Resistance In Chronic HCV Patients
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
- 是
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
RAAbdelmegid
Principal Investigastor
Assiut University
